UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM SB-2 REGISTRATION STATEMENT Under THE SECURITIES ACT OF 1933 UROPLASTY, INC (Name of Small Business Issuer in its Charter) Minnesota 3841 41- 1719250 (State of (Primary Standard Industrial (I.R.S. Employer Incorporation) Classification Code Number) Identification No.) 2718 Summer Street N.E., Minneapolis, Minnesota 55413 Telephone 612/378-1180 FAX 612/378-2027 (Address and telephone number of principal executive offices, and of principal place of business) Daniel G. Holman, Chairman, President, CEO, CFO Uroplasty, Inc. 2718 Summer Street N.E., Minneapolis, Minnesota 55413 Telephone 612/378-1180 FAX 612/378-2027 (Name, address and telephone number of agent for service) ----------------------- Copies to: Richard P. Keller, Esq. Keller & Lokken, P.A. First National Bank Building, Suite W-790 332 Minnesota Street St. Paul, Minnesota 55101 (612) 292-1001 (612) 292-8912 (FAX) ----------------------- Approximate date of proposed sale to the public: As soon as practicable after the effective date of this Registration Statement. CALCULATION OF REGISTRATION FEE Proposed Proposed Maximum Maximum Title of Each Class of Amount Offering Aggregate Amount of Securities to be Registered To Be Price Per Offering Registration Registered Unit Price Fee Common Stock, $.01 1,702,950(1) $3.1875(2) $5,428,153 $1,601.31 par value per share TOTAL: 1,702,950 $5,428,153 $1,601.31 (1) All shares to be registered hereby are already outstanding and owned by various Selling Shareholders identified herein. (2) Estimated solely for the purpose of calculating the registration fee pursuant to Rule 230.457 (c). Based on the average of prices of $2.875 bid and 3.50 asked on July 8, 1998. The Registrant hereby amends this Registration Statement on such date or dates as may be necessary to delay its effective date until the Registrant shall file a further amendment which specifically states that this Registration Statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933 or until the Registration Statement shall become effective on such date as the Commission, acting pursuant to said Section 8(a), may determine. UROPLASTY, INC Registration Statement on Form SB-2 - ---------------------------------------------------------------------------- Cross Reference Sheet Between Items of Form SB-2 and Prospectus as to 1,702,950 Shares - ---------------------------------------------------------------------------- Item in Form SB-2 Caption or Location in Prospectus 1. Front of Registration Statement and Front of Registration Statement; Outside Front Cover of Prospectus front cover page of Prospectus 2. Inside Front and Outside Back Cover Inside Front and outside back Pages of Prospectus Cover Page 3. Summary Information and Risk Factors Summary of Offering; High Risk Factors 4. Use of Proceeds Use of Proceeds 5. Determination of Offering Price Not applicable 6. Dilution Not applicable 7. Selling Security Holders Selling Shareholders 8. Plan of Distribution Plan of Offering 9. Legal Proceedings Business - Legal Proceedings 10. Directors, Executive Officers, Management - Directors and Executive Promoters and Control Persons Officers 11. Security Ownership of Certain Principle Shareholders Beneficial Owners and Management 12. Description of Securities Description of Securities 13. Interest of Named Experts and Not Applicable Counsel 14. Disclosure of Commission Position Management-Limitation of Directors' on Indemnification for Securities Liability; Item 28.c. of Act Liabilities Registration Statement 15. Organization Within Last Five Years Certain Transactions 16. Description of Business Business 17. Management's Discussion and Analysis Management's Discussion and Analysis or Plan of Operation 18. Description of Property Business-Property 19. Certain Relationships and Related Certain Transactions Transactions 20. Market for Common Equity and Related Cover Page of Prospectus; Stockholder Matters Description of Securities 21. Executive Compensation Management - Executive Compensation 22. Financial Statements Financial Statements 23. Changes in and Disagreements with Not Applicable Accountants on Accounting and Financial Disclosure Legend Required by Item 1 of Form SB-2 and Item 501(a)(8) of Regulation S-B: Information contained herein is subject to completion or amendment. A registration statement relating to these securities has been filed with the Securities and Exchange Commission. These securities may not be sold nor may offers to buy be accepted prior to the time the registration statement becomes effective. This prospectus shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any State in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such State. No copies of any Preliminary Prospectus will be delivered to any person without such legend appearing on the cover page thereof in compliance with Item 501(a)(8) of Regulation S-B. Should any copy of the Preliminary Prospectus be delivered to any person, it will include on its cover the above legend and the following words: Preliminary Prospectus, dated July 10,1998 Subject to Completion UROPLASTY, INC. 1,702,950 Shares of Common Stock This Prospectus pertains to 1,702,950 shares of common stock (the "Shares") of Uroplasty, Inc. (the "Company"). All of the Shares are owned by and may be offered and sold at market prices by certain Selling Shareholders identified herein. The Company is not selling and will not receive any proceeds resulting from the sale of any of the Shares. The Shares were issued by the Company in certain private transactions. The Company's Common Stock is traded in the local over-the-counter (Bulletin Board) market under the symbol "UROP". THE SECURITIES OFFERED HEREBY ARE HIGHLY SPECULATIVE, INVOLVE A HIGH DEGREE OF RISK AND SHOULD BE PURCHASED ONLY BY PERSONS WHO CAN AFFORD TO LOSE THEIR ENTIRE INVESTMENT. See "Risk Factors" herein. THESE SECURITIES HAVE NOT BEEN APPROVED OR DISAPPROVED BY THE SECURITIES AND EXCHANGE COMMISSION, OR ANY STATE COMMISSION, NOR HAS THE SECURITIES AND EXCHANGE COMMISSION OR ANY STATE COMMISSION PASSED UPON THE ACCURACY OR ADEQUACY OF THIS PROSPECTUS. ANY REPRESENTATION TO THE CONTRARY IS A CRIMINAL OFFENSE. The Company expects that the Shares will be sold at market prices. The expenses of this offering, estimated to be $20,000, not counting any commissions or expenses payable by the Selling Shareholders, will be paid by the Company. Selling shareholders are responsible for any brokerage commissions payable upon the sale of their Shares. The Company will not receive any proceeds from the sale of any of the Shares. The date of this Prospectus is July ___, 1998. TABLE OF CONTENTS SUMMARY 4 RISK FACTORS 6 MARKET FOR COMMON STOCK 14 USE OF PROCEEDS 13 DIVIDEND POLICY 14 CAPITALIZATION 15 SELECTED FINANCIAL DATA 16 MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS 17 BUSINESS 19 MANAGEMENT 31 PRINCIPAL SHAREHOLDERS 35 DESCRIPTION OF SECURITIES 42 REPORTS TO SHAREHOLDERS 45 LEGAL MATTERS 45 EXPERTS 45 AVAILABLE, ADDITIONAL AND SUPPLEMENTAL INFORMATION 45 FINANCIAL STATEMENTS F-1 IMPORTANT INFORMATION THIS PROSPECTUS DOES NOT CONSTITUTE AN OFFER OF SECURITIES TO ANY PERSON OTHER THAN THE RECIPIENT OF THIS PROSPECTUS. THE CONTENTS OF THIS PROSPECTUS ARE THE RESPONSIBILITY OF THE COMPANY. NO PERSON HAS BEEN AUTHORIZED BY THE COMPANY TO GIVE ANY INFORMATION OR TO MAKE ANY REPRESENTATIONS OTHER THAN AS CONTAINED IN THIS PROSPECTUS AND, IF GIVEN OR MADE, MUST NOT BE RELIED UPON. NEITHER THE DELIVERY OF THIS PROSPECTUS NOR ANY SALES HEREUNDER SHALL UNDER ANY CIRCUMSTANCES CREATE ANY IMPLICATION THAT THERE HAS BEEN NO CHANGE IN THE AFFAIRS OF THE COMPANY SINCE THE DATE HEREOF. FORWARD-LOOKING STATEMENTS The Company may from time to time make written or oral "forward-looking statements", within the meaning of the Private Securities Litigation Reform Act of 1995, including statements contained in this Prospectus and in documents filed by the Company with the Securities and Exchange Commission and in its reports to stockholders, as well as elsewhere. "Forward-looking statements" are statements such as those contained in projections, plans, objectives, estimates, statements of future economic performance, and assumptions related to any of the foregoing, and may be identified by the use of forward-looking terminology, such as "may, "expect," "anticipate," "estimate, "goal," "continue," or other comparable terminology. By their very nature, forward-looking statements are subject to known and unknown risks and uncertainties relating to the Company's future performance that may cause the actual results, performance or achievements of the Company, or industry results, to differ materially from those expressed or implied in any such "forward-looking statements". Any such statement is qualified by reference to the following cautionary statements. The Company's business operates in highly competitive markets and is subject to changes in general economic conditions, competition, customer and market preferences, government regulation, the impact of tax regulation, foreign exchange rate fluctuations, the degree of market acceptance of products, the uncertainties of potential litigation, as well as other risks and uncertainties detailed elsewhere herein and from time to time in the Company's Securities and Exchange Commission filings. In this Prospectus, the following sections contain "forward- looking statements": "Summary"; "Risk Factors"; "Business"; and "Management's Discussion and Analysis of Financial Condition and Results of Operation". Various factors and risks (not all of which are identifiable at this time) could cause the Company's results, performance or achievements to differ materially from that contained in the Company's forward-looking statements, and investors are cautioned that any forward-looking statement contained herein or elsewhere is qualified by and subject to the warnings and cautionary statements contained above and in the Risk Factors section of this Prospectus. The Company does not undertake and assumes no obligation to update any forward-looking statement that may be made from time to time by or on behalf of the Company. SUMMARY This summary is intended for quick reference purposes only and does not contain all facts material to a determination to invest in the securities offered hereby, and is qualified in its entirety by the more detailed information and financial information appearing elsewhere in this prospectus. The Company The Company designs, develops, manufactures and markets medical products primarily for the treatment of urinary incontinence. Currently, the Company sells its products only to customers outside the United States through its foreign subsidiaries. The Company's key product is Macroplastique(R), an injectable soft tissue bulking agent currently used to treat certain types of stress urinary incontinence ("SUI"), the most common form of urinary incontinence. SUI refers to involuntary loss of urine as a result of activities that increase intra- abdominal pressure, such as coughing, laughing or exercising. Macroplastique also is used to treat vesicoureteral reflux ("VUR"), a condition occurring mostly in children in which urine flows backward from the bladder into the kidney. In addition, some doctors in Europe are beginning to use Macroplastique to treat incontinence in men recovering from prostate surgery. In June 1996, Macroplastique received a CE mark in Europe (similar to FDA approval in the United States), allowing the product to be sold throughout the European Union. Macroplastique is not sold in the United States because it has not been approved for marketing by the Food and Drug Administration ("FDA"). Through this offering, the Company seeks to fund its efforts to obtain FDA pre-market approval for Macroplastique, which would allow the Company to enter the United States female urinary incontinence treatment market. It is estimated that urinary incontinence afflicts about 5% of the general population and women comprise about 85% of the sufferers. In Europe, currently the Company's largest market, approximately 17 million people suffer from various forms of urinary incontinence and about 14.5 million of these sufferers are women. Bulking agents such as Macroplastique are used to treat women with SUI caused by intrinsic sphincter deficiency, estimated by the Company to comprise 10% of the female incontinence market or about 1.4 million women in Europe alone. VUR is primarily a pediatric concern, with a prevalence estimated to be as high as 1% of the pediatric population. The Company estimates that about half of this population are candidates for Macroplastique treatments. Of the estimated 2.6 million European men who are incontinent, the Company believes about 25% are candidates for treatment with Macroplastique. Macroplastique consists of solid, highly textured particles that are soft and flexible, made by heat vulcanizing polydimethylsiloxane (silicone). The particles are suspended in a water-based biocompatible carrier solution. Macroplastique is not a silicone gel, the compound which became controversial in connection with its use in breast implants. Macroplastique has been used to treat approximately 15,000 patients in Europe over the last seven years with no reported serious product-related adverse incidents. The Company was incorporated in Minnesota in 1992 as a wholly-owned subsidiary of Bioplasty, Inc. ("Bioplasty"), a manufacturer of breast implants, which, along with other breast implant manufacturers, became subject to numerous product liability class action lawsuits. In 1993, Bioplasty and Uroplasty filed for protection under Chapter 11 of the Federal Bankruptcy Code. The Company emerged from Chapter 11 in February 1994 as a separate and distinct entity from Bioplasty. Capital Structure Common Stock outstanding as of June 30, 1998: 5,917,475 shares of Common Stock(1) (1) Does not include 483,200 shares underlying outstanding options, as of June 30, 1998, nor 150,000 Shares underlying an Agent's Warrant. Risk Factors The securities offered hereby are highly speculative, illiquid, involve a high degree of risk and immediate substantial dilution and should be purchased only by persons who can afford to lose their entire investment. See "Risk Factors" and "Dilution" herein. Summary Financial Data (In thousands, except per share data and shares outstanding.) Years ended March 31, 1998 1997 Consolidated Statement of Operations Data: Net sales $4,336 $3,335 Operating profit 662 376 Net income $ 408 $ 218 Net income per share $ .10$ .06 Weighted average number of common shares outstanding(1) 4,026,571 3,575,609 March 31, 1998 Actual Pro Forma As Adjusted(2) Consolidated Balance Sheet Data: Cash and cash equivalents $ 890 4,334 Working capital 1,514 4,958 Total shareholders' equity 2,051 5,495 (1) Does not include 505,200 shares, as of March 31, 1998, (483,200 shares, as of June 30, 1998) underlying outstanding options, nor 150,000 shares underlying an Agent's Warrant, as of June 30, 1998. (2) As adjusted on a pro forma basis to reflect the sale of 1,702,950 shares in May and June, 1998, and the application of the net proceeds therefrom. Address/Telephone Numbers The mailing address and telephone/fax numbers of the principal executive offices of the Company are: Uroplasty, Inc. 2718 Summer Street N.E. Minneapolis, MN 55413 Telephone (612) 378-1180 Fax (612) 378-2027 RISK FACTORS The securities offered hereby are highly speculative, illiquid, involve a high degree of risk and immediate substantial dilution and should be purchased only by persons who can afford to lose their entire investment. In evaluating an investment in such securities, prospective investors should carefully consider the following risk factors and other information contained in this Prospectus. Government Regulation - International and United States; Inability to Market or Sell Macroplastique in United States; Uncertainty of Obtaining FDA Marketing Approval. The Company's product, manufacturing processes and product development activities are subject to extensive and rigorous regulation by governmental and regulatory authorities in foreign countries similar to the U.S. Food and Drug Administration ("FDA"). In Europe, where the Company has been marketing Macroplastique since 1991, the Company's introduction of medical devices as well as its design, manufacturing, labeling, distribution, sale, marketing, advertising, promotion and recordkeeping procedures for its products are subject to laws and regulations governing medical devices contained in the European Medical Device Directives ("MDD"). In June, 1996, the Company received a Certificate of Authorization for affixing the CE mark (Conformite Europeene) on Macroplastique based upon compliance with the MDD. In the United States, the Company cannot market or sell Macroplastique until Investigational Device Exemption ("IDE") and subsequent Pre-Market Approval ("PMA") authorization for Macroplastique are received from the FDA. As of the date of this Private Placement Prospectus, the Company had not submitted an IDE application to the FDA to request authority to commence human clinical studies in the United States. There can be no assurance that the requisite approvals or certifications will be granted for Macroplastique or any other product, on a timely basis, or at all, or that such regulatory reviews will not involve delays that would conflict with the Company's ability to commercialize its products in the United States. Even if regulatory approval to market a product is obtained from the FDA, this approval may necessitate limitations on the indicated uses of the product. Marketing approval can also be withdrawn by the FDA in the United States (and by regulatory authorities in foreign countries) due to failure to comply with regulatory requirements or the occurrence of unforeseen problems following initial approval. The Company may be required to make further filings with the FDA and other regulatory authorities in foreign countries under certain circumstances, such as the addition of product claims or product reformulation. The FDA and other regulatory authorities in foreign countries could also limit or prevent the manufacture or distribution of the Company's products and has the power to demand the recall of such products. FDA medical device regulations depend strongly on administrative interpretation, and there can be no assurance that future interpretation made by the FDA or other regulatory bodies, with possible retroactive effect, will not adversely affect the Company. The FDA and various other authorities either currently inspect or will inspect the Company and its facilities from time to time to determine whether the Company is in compliance with regulations relating to medical device manufacturing, including regulations concerning design, manufacturing, testing, quality control, product labeling, distribution, promotion and record keeping practices. A determination that the Company is in material violation of such regulations could lead to the imposition of civil penalties, including fines, product recalls, product seizures or, in extreme cases, criminal sanctions. See "Business - Government Regulations". Dependence on Single Product. The Company expects to derive substantially all of its revenues for the next several years from sales of Macroplastique. The Company's failure to continue its commercialization of Macroplastique in Europe would have a material adverse effect on the Company's business, financial condition and results of operations. The Company does not expect that commercialization of other new products will be feasible without a substantial, continuing commitment to research and development for an extended period of time or acquisitions of new products, or both. Also, new medical products must typically undergo clinical trials and regulatory clearance or approval before commercialization. There can be no assurance as to whether or when commercialization of other products might begin or as to the likelihood that any such initiative would be successful. The market for medically-related products changes constantly, and if the market changes, or if new or strengthened competition emerges, or customer preferences change, or if new technology causes Macroplastique to be viewed as a less effective treatment, the Company's business, financial condition and results of operation would be adversely affected. Unlike larger companies with many products in the marketplace, the Company is dependent on one product and its fate is, consequently, much more closely tied to market acceptance of that product. Dependence on Patents and Proprietary Rights. The Company's success depends in part on its ability to preserve trade secrets, obtain and maintain patent protection for its products under United States and international patent laws and other intellectual property laws and operate without infringing upon the proprietary rights of third parties. Patents covering the materials, process and applications have been issued to the Company by the Patent Offices in the United States, United Kingdom, Japan and Germany. Applications are also currently pending in various other countries, including Canada and other European countries. No assurances can be given that the scope of any patent protection will prevent competitors (most of which have financial and other resources substantially greater than the Company) from introducing products competitive with the Company's products, the Company's patents will be held valid if subsequently challenged, others will not claim rights in or ownership of the patents and other proprietary rights held by the Company, or the Company's product and processes will not infringe, or be alleged to infringe, the proprietary rights of others. A number of patents have been issued to others in the area of injectable bulking agents. The validity and breadth of claims covered in medical device technology patents involve complex legal and factual questions and may therefore be highly uncertain. The Company also relies upon unpatented trade secrets to protect its proprietary technology. No assurance can be given that others will not independently develop or otherwise acquire substantially equivalent techniques and/or gain access to and disclose the Company's proprietary technology. Further, no assurance can be given that the Company can ultimately protect meaningful rights to such unpatented proprietary technology. There has been substantial litigation regarding patent and other intellectual property rights in the medical device industry. Companies in the medical device industry have employed intellectual property litigation to gain a competitive advantage. Litigation may be necessary to enforce any patents issued to the Company, protect trade secrets or proprietary information owned by the Company against claimed infringement of the rights of others or determine the scope and validity of the proprietary rights of others. The defense and prosecution of patent litigation or other legal and/or administrative proceedings related to patents is costly and time-consuming regardless of the outcome. An adverse outcome in any litigation could subject the Company to significant liabilities to third parties, require disputed rights to be licensed from others and/or require the Company to cease making, using or selling any products. There can be no assurance that any licenses required under any patents or proprietary rights would be made available on terms acceptable to the Company, if at all. See "Business - Patents, Trademarks, and Licenses". Uncertainty Relating to Third-Party Reimbursement. The success of the Company will depend, in part, upon, satisfactory reimbursement for Macroplastique procedures from third party health care payers. In the United States and many foreign countries, third-party reimbursement is currently generally available for surgical procedures for urinary incontinence, but there is no uniform policy for such reimbursements. The Company sells Macroplastique to physicians, hospitals and other users, which bill various third-party payers, such as government health programs, private health insurance plans, managed care organizations and other similar programs, for the health care products and services provided to their patients. Payers may deny reimbursement if they determine that a product used in a procedure was not used in accordance with established payer protocols regarding cost-efficient treatment methods, was used for an unapproved indication or was not otherwise covered. Third-party payers are increasingly challenging the prices charged for medical products and services and, in some instances, have pressured medical suppliers to lower their prices. The availability of third-party reimbursement for Macroplastique or competitors' products and continuing efforts to reduce the costs of health care by decreasing reimbursement rates may reduce the price received by the Company for Macroplastique or increase the relative expense to the consumer. Failure to receive sufficient reimbursement from health care payers for procedures using Macroplastique or adverse changes in governmental and third-party payers' policies toward reimbursement for such procedures would materially adversely affect the Company's business, financial condition and results of operations. See "Business - Third Party Reimbursement". Potential Unfavorable Public Reaction to Use of Silicone Products/Earlier Silicone Controversies. Macroplastique is comprised of heat vulcanized polydimethylsiloxane, which results in a solid flexible silicone elastomer. The United States breast implant industry in the 1990's became the subject of significant controversies (some of which continue at this time) surrounding the possible effects upon the human body of the use of silicone gel in breast implants. One consequence was a massive flood of products liability litigation, leading to the bankruptcy of several companies, including Uroplasty's former parent, Bioplasty, Inc., (which in turn, caused Uroplasty, Inc. to file for bankruptcy in 1993). The Company uses only solid silicone material, and not semi-liquid silicone gel (as was used in breast implants), in its Macroplastique product. However, since the controversies in the United States surrounding the use of silicone in breast implants have been so widespread and resulted in such extensive litigation, there can be no assurance that the use by the Company, and others, of solid silicone in medical devices implanted in the human body will not result in controversies, or even litigation. There can be no assurance that studies or research unknown to date will not some day cast doubt, in the mind of the public, on the safety of the Company's products and the appropriateness of their intended use. The Company expects its competitors will attempt to portray silicone as an undesirable feature of Macroplastique, and the effects of such efforts cannot be predicted at this time. The earlier silicone controversies may adversely affect the Company's ability to market Macroplastique in the United States if and when the Company receives PMA approval from the FDA for Macroplastique. Research and Development Expenses in Fiscal Year 1999; Expected Losses. The Company's future success will depend upon, among other factors, its ability to introduce and market Macroplastique on a timely basis in the United States, and to that end, it has committed the largest portion of the proceeds of this offering. Although the Company has been profitable in fiscal years 1998 and 1997, the Company expects to incur significant operating losses in its fiscal year 1999, due largely to the significant costs associated with clinical trials and other aspects of the FDA approval process. The development and commercialization by the Company of Macroplastique and other products in the United States will require substantial additional product development, clinical, regulatory and other expenditures for the foreseeable future. See "Management's Discussion and Analysis of Financial Condition and Results of Operations," "Business," "Financial Statements", and "Risk Factors - Need for Additional Capital". Need for Additional Capital. The Company anticipates the proceeds from the sale of the maximum number of Shares together with cash flow from operations will be sufficient to fund its IDE submission, clinical studies and the completion of its PMA application to the FDA for Macroplastique. However, if any number of Shares less than the maximum is sold or if the maximum number is sold and expenses or operating profits differ from expected levels, the Company will require additional financing to complete its PMA application to the FDA for Macroplastique. Further, the Company will need additional funds in order to introduce Macroplastique to the U.S. vesicoureteral reflux and male incontinence markets because separate regulatory approval is needed for each of these conditions. There can be no assurance that additional capital will be available to the Company when needed or on terms acceptable to the Company. The net proceeds of this offering, together with the Company's existing capital resources and any funds provided by future operations, will not be sufficient to fund new product development, and funds for such purpose may not be available, on reasonable terms, and there can be no assurance that other sources of funding will be available. See "Use of Proceeds" and "Management's Discussion and Analysis". Lack of Marketability and Liquidity of Shares/Registration Rights Do Not Assure Liquidity and May Not Apply in All States. The transferability of the Shares will be restricted, so an investment in the Shares should be considered illiquid for an extended period of time. Although purchasers of the Shares hold mandatory registration rights (which are contained in the Subscription and Registration Rights Agreement, Exhibit A hereto), which require the Company to use its best efforts to register the Shares following the completion of this offering, there can be no assurance that any such registration effort will be successful, and the Company may not be required to register the Shares in all states in which the Shares may be sold. Highly Competitive Industry. Competition in the urinary incontinence management and treatment products market is fierce. The medical condition treated by using the Company's product also may be managed or treated using a variety of alternative products or techniques, including adult diapers, absorbent pads, behavior therapy, pelvic muscle exercises, drugs, surgery, implantable devices, other injectable bulking agents and other medical devices. There is no assurance the Company's products will be a substitute for such alternative products or techniques or that advancements in these alternative products or techniques will not make the Company's products obsolete. In addition, the Company believes some of its competitors who do not currently have injectable bulking agents are attempting to develop injectable bulking agents which will directly compete with Macroplastique. Many of the Company's existing as well as potential competitors have substantially greater capital resources, name recognition, distribution capabilities, well-known and well-established product lines and larger marketing, research and development staffs and facilities than the Company. These competitors may also have greater expertise than the Company in research and development, manufacturing, marketing and sales and regulatory affairs. There can be no assurance that the Company and Macroplastique will be able to compete effectively with such alternative products or techniques or with such competitors and potential competitors. In addition, the Company's ability to compete in the urinary incontinence treatment market will depend primarily upon physician, patient and healthcare payer acceptance of Macroplastique as a safe, effective and cost-effective treatment for stress urinary incontinence. The Company's ability to compete in this market will also depend upon product pricing and the consistency of its product quality and delivery. Other factors within or outside the Company's control include its product development and innovation capabilities, ability to obtain required regulatory approvals, ability to protect its proprietary technology, manufacturing and marketing capabilities and ability to attract and retain skilled employees. See "Business - Competition". Risks and Effects of Technological Developments. The Company competes in a market characterized by technological innovation, extensive research efforts and significant competition. Improvements in existing treatment options or developments of new treatment methods may have a material adverse effect on the Company's ability to increase sales of Macroplastique and successfully commercialize any future products and may render such products noncompetitive or obsolete. Other companies are currently engaged in the development of products and innovative methods for treating stress urinary incontinence that are similar to, or compete with, Macroplastique. Significant developments by any of these companies or advances by medical researchers at universities, government research facilities or private research laboratories could eliminate the market for Macroplastique or otherwise render Macroplastique obsolete. See "Business-Competition." Risk of Product Liability; No Assurance Insurance is Adequate. The medical products industry is subject to substantial litigation. As a manufacturer of an implantable medical product, the Company faces an inherent business risk of exposure to product liability claims in the event that the use of its product is alleged to have resulted in adverse effects to a patient. The Company maintains product liability insurance, but there can be no assurance that its coverage limits are adequate to protect the Company from any liabilities which it might incur in connection with the clinical trials and commercialization of Macroplastique or any other product. Such insurance is expensive and in the future may not be available on acceptable terms, if at all. Furthermore, the Company does not expect to be able to obtain insurance covering its costs and losses as a result of any recall of its products due to alleged defects, whether such a recall is instituted by the Company or required by a regulatory agency. Consequently, a product liability claim, recall or other claim with respect to uninsured liabilities or in excess of insured liabilities could have a material adverse effect on the business, financial condition and results of operations of the Company. See "Business-Product Liability". Uncertainty of Future Market Acceptance. The Company sells Macroplastique in Europe and other foreign countries, where it has established a small, though significant, marketshare for the product. Acceptance of Macroplastique by physicians in preference to other treatment options, including other bulking agents, will depend upon the demonstration of its safety and effectiveness, relative performance of Macroplastique compared to other market approved products, ease of use and relative cost compared to other bulking agents and treatment alternatives. Physicians may elect not to prescribe treatment using Macroplastique unless adequate reimbursement from health care payers is available. Health care payer acceptance of a treatment utilizing Macroplastique will require, among other things, evidence of the cost effectiveness of this treatment as compared to other treatment options. There can be no assurance that the acceptance of Macroplastique by urological and gynecological health care providers will continue to grow in Europe and other areas where Macroplastique is already used. The Company does not sell Macroplastique in the United States. There can be no assurance that Macroplastique will achieve any significant degree of market acceptance in the United States among physicians, health care payers or patients, even if the safety and effectiveness of Macroplastique is established in the United States and the necessary regulatory approvals are obtained. Even if those approvals were granted, the Company's future success in the United States market would be entirely dependent on the successful commercialization and market acceptance of Macroplastique. Accordingly, any delay or failure by the Company in demonstrating that Macroplastique is safe and effective, receiving required regulatory approvals to market Macroplastique or achieving significant market acceptance of Macroplastique in the United States among physicians, health care payers and/or patients would have a material adverse effect on the Company's business, financial condition and results of operations. In addition, the earlier controversies surrounding silicone, and possible lingering public concerns about it, could impede the acceptance of Macroplastique. See "Business". Dependence on Key Personnel. The Company's success depends to a significant degree upon the continued contributions of its key management personnel. The Company believes that its future success will depend in large part on its ability to attract and retain highly skilled managerial, engineering, operations and marketing personnel who are in great demand. Failure to attract and retain key personnel could have a material adverse effect on the Company's results of operations. The Company does not have an employment agreement or non-compete agreement with Daniel G. Holman, its Chairman, President, CEO and CFO, or Susan Hartjes-Doherty, its Vice President of Operations and Regulatory Affairs and Secretary. Risks Associated with International Operations; Currency Risks. At this time, the Company only sells Macroplastique outside the United States through its wholly-owned foreign subsidiaries. Sales and operations outside of the United States are subject to certain inherent risks, including, without limitation, fluctuations in the value of the U.S. dollar relative to foreign currencies, tariffs, quotas, taxes and other market barriers, political and economic instability, restrictions on the import and export of technology, difficulties in staffing and managing international operations, difficulties in obtaining work permits for employees, difficulties in collecting receivables, potentially adverse tax consequences, potential language barriers, and difficulties in operating in a different culture and legal system. There can be no assurance that any of these factors will not have a materially adverse effect on the Company's financial condition or results of operations. In particular, because the Company's international sales are denominated primarily in Dutch guilders, currency fluctuations in countries where the Company does business may render the Company's products less price competitive than those of foreign companies whose sales are denominated in weaker currencies. The Company reports its financial results in U.S. dollars, and fluctuations in the value of the dollar or the currencies in which the Company transacts business can have a negative impact on its financial results. Dependence on Suppliers. The Company currently purchases all raw materials from single sources. Alternative suppliers for these materials exist should the current suppliers discontinue production or distribution. However, the Company would need to complete additional testing to qualify the materials obtained from any new suppliers. Additionally, limited notice of the need to switch suppliers for either of these materials could result in production delays and inventory depletion. The Company has not experienced any shortage of these materials to date; however, no assurance can be given that shortages of these materials will not be experienced in the future. Limited Public Market for Common Stock; Possible Stock Price Volatility. Prior to this offering, there has been only a limited public market for the Company's common stock, and there can be no assurance that an active trading market for the common stock will develop in the future or be sustained following any subsequent registration of the common stock. There can be no assurance that future market prices of the common stock will not be lower than the purchase price of the Shares sold in this offering. The market price of the common stock following the offering may be highly volatile. Announcements of new products and services by the Company or its competitors, technological innovations, disputes regarding patents or other proprietary rights, regulatory developments and economic and other external factors, as well as period- to-period fluctuations in the Company's financial results, could cause the market price of the common stock to fluctuate significantly. In addition, the stock market in general and, in particular the market prices for medical technology companies, have historically experienced significant volatility which has affected the market price of securities of many companies and which has sometimes been unrelated to the operating performance of such companies. Such volatility may adversely affect the market price of the common stock. Absence of Long-Term Human Clinical Studies. Although the Company believes that Macroplastique is safe when used as recommended by the Company, there are no long-term well-controlled human clinical studies of this product. Accordingly, no assurance can be given that Macroplastique, even when used as recommended, will have the effects intended or will not have adverse effects over a patient's lifetime. For example, there can be no assurance as to whether or how frequently patients will require additional injections of Macroplastique and whether any such additional injections will be effective or will have a negative effect on physician, payer or patient acceptance. Fluctuations In Quarterly Operating Profit and Net Income. The Company may experience variability in its net sales and operating profit on a quarterly basis as a result of many factors, including, among others, buying habits of European health care providers, size and timing of orders by certain customers, shifts in demand for types of products, technological changes and industry announcements of new products. If revenues do not meet expectations in any given quarter, operating results may be materially adversely affected. The Company may, in addition, experience variability in its net income on a quarterly basis as a result of many factors, including currency fluctuations. As a result of these potential fluctuations in quarterly results, period-to-period comparisons of the Company's financial results should be approached cautiously. Possible Adverse Market Effect of Shares Eligible for Future Sale. Sales of substantial amounts of Common Stock (including shares issued upon the exercise of outstanding options and warrants) in the public market could have an adverse effect on the price of the Company's Common Stock. Such sales may also make it more difficult for the Company to sell equity or equity-related securities in the future at a time and price that the Company would deem appropriate. As of June 30, 1998, the Company had 5,917,475 shares of Common Stock issued and outstanding. In addition to the 1,702,950 shares of Common Stock covered hereby, (i) approximately 3,400,000 shares are eligible for immediate sale on the date of this Prospectus in accordance with Rule 144(k) under the Securities Act of 1933, as amended ("Rule 144"); or otherwise; and (ii) approximately 1,100,000 additional shares will be eligible for sale in the public market beginning in July, 1998, in accordance with Rule 144 subject, in certain cases, to volume and manner of sale limitations under Rule 144. See "Description of Securities - Shares Eligible for Future Sale". Possible Adverse Effect of Anti-Takeover Provisions and Staggered Board. As a Minnesota corporation, the Company is subject to certain anti-takeover provisions of the Minnesota Business Corporation Act. The authority of the Board with regard to the anti-takeover provisions of such Act could have the effect of delaying, deferring or preventing a change in control of the Company, may discourage bids for the Company's Common Stock at a premium over the then prevailing market price of the Common Stock, and may adversely affect the market price of, and the voting and other rights of the holders of, Common Stock. See "Description of Securities". The Company's Articles of Incorporation and Bylaws include certain provisions (the "Staggered Board Provisions") for staggering the election of the members of the Board of Directors. The Board is divided into three classes with each class serving for an independent term. The classification of directors is intended to make it more difficult to change the composition of the Board. At least two shareholders' meetings, instead of one, will generally be required for shareholders to effect a change in control of the Board. The Staggered Board Provisions will apply to every election of directors, whether or not a change in the Board, in the opinion of some or a majority of the Company's shareholders, would be desirable. The Staggered Board Provisions relating to the removal of directors and the filling of vacancies are designed to protect the staggered Board structure in the event a third party gains control of a majority of the Company's voting power and could discourage an attempt to gain control of the Company. See "Description of Securities". Potential Applicability of "Penny Stock Rules"; Possible Impact on Liquidity of Stock. If the Company fails to become listed on Nasdaq or, after such listing, fails to satisfy the Nasdaq requirements to maintain listing on Nasdaq in the future, the Common Stock will likely continue to be quoted only in the local over-the-counter "pink sheets" market. The public trading market for the Common Stock could be adversely affected by such limited quotation. In addition, the Common Stock would be subject to SEC rules under the Securities Exchange Act of 1934 relating to "penny stocks." The "penny stock rules" apply to companies whose common stock trades at less than $5.00 per share or which have a tangible net worth of less than $5,000,000 ($2,000,000 if the company has been operating for three or more years). These rules require brokers who sell securities subject to such rules to persons other than established customers and "institutional accredited investors" to complete certain documentation, make suitability inquiries of investors and provide investors with certain information concerning the risks of trading in the security. The application of these rules may restrict the ability of brokers to sell the Common Stock, may adversely affect the liquidity of the Shares, and may affect the ability of purchasers in this offering to sell their Shares in the secondary market. Immediate, Substantial Dilution to Purchasers in this Offering. Purchasers of the Shares offered hereby will incur immediate and substantial dilution in the net tangible book value of their purchased Shares. Investors may also experience additional dilution as a result of the exercise of outstanding stock options and warrants. See "Dilution". No Dividends. The Company has never paid any cash dividends on its Common Stock and does not anticipate paying such dividends for the foreseeable future. See "Dividend Policy". Net Operating Loss Carryforwards; Effect of International Operations on Tax Position. The Company has net operating loss carryforwards for U.S. income tax reporting purposes of approximately $2,061,000, which can be used to offset U.S. taxable income in future years. Sales of the Company's voting common shares during the prior three years, combined with the current equity offering will most likely cause a change in ownership under Section 382 of the Internal Revenue Code of 1996. Section 382 limits the annual use of the Company's U.S. net operating loss carryforwards existing as of the date of the ownership change. Notwithstanding the application of Section 382, it is not anticipated that any limitation would have a material adverse effect on the Company. The Company has significant operations in the United States and internationally. United States net operating loss carryforwards cannot be used to offset taxable income in foreign jurisdictions. Furthermore, repatriation of dividends to the U.S. parent may result in additional foreign or U.S. taxes. PLAN OF OFFERING All of the 1,702,950 shares of Common Stock offered hereby (the "Shares") are owned by Selling Shareholders. None of the Shares is owned by the Company, and the Company will receive none of the proceeds resulting from the sale of any of the Shares. Selling Shareholders will make their own arrangements for the offer and sale of any of the Shares and will be responsible for all sales and brokerage commissions associated with such sales. The Company will bear the costs of registration of the Shares, such as legal and accounting fees, filing fees, printing expenses and the like. The Company will not select and does not expect to have any contact with any of the broker-dealer firms that may be used by Selling Shareholders in making sales of the Shares. USE OF PROCEEDS The Company will receive none of the proceeds resulting from the sale of any of the Shares, nor will any such proceeds become the property of the Company. All of the Shares are owned by and will be offered and sold by Selling Shareholders. MARKET FOR COMMON STOCK As of the date hereof, there is only a limited public trading market for the Company's common stock. Although one broker dealer published bid and ask quotations for the Company's common stock on an irregular basis during the period March through June, 1997, the Company is not aware of any shares that were either purchased or sold through such broker dealer. The following table sets forth the high and low bid prices for the Company's Common Stock, as reported in the NASD'S Bulletin Board system (market symbol UROP), on a quarterly basis, from July 1997, through June 1998, and for the period July 1, 1998 through July 7, 1998. Such quotations represent interdealer prices, without retail markup, markdown or commission, and do not necessarily represent actual transactions. Quarter Low Bid High Bid July 1 - September 30, 1997 $ 1/2 $ 3 3/16 October 1 - December 31, 1997 3 3 1/2 January 1 - March 31, 1998 2 1/4 3 1/4 April 1 - June 30, 1998 3 5 July 1 - July 7, 1998 2 7/8 3 As of June 30, 1998, the Company's Common Stock was held of record by approximately 600 holders. Registered ownership includes nominees who may hold securities on behalf of multiple beneficial owners. DIVIDEND POLICY The Company has never declared nor paid any cash dividends on its Common Stock. The Company currently intends to retain any earnings for use in the development and growth of its business and therefore does not anticipate paying any cash dividends in the foreseeable future. CAPITALIZATION The following table sets forth the capitalization of the Company as of March 31, 1998, and as adjusted to reflect the sale of 1,702,950 shares of Common Stock pursuant to a private placement in May and June, 1998. This table should be read in conjunction with the financial statements of the Company included elsewhere in this Prospectus. See "Financial Statements." Outstanding as of March 31, 1998 Actual As Adjusted Long-term debt (1) $ 609,606 $ 609,606 Shareholders' equity: Common stock 41,915 58,945 Additional paid-in capital 2,432,599 5,859,289 Accumulated deficit (256,629) (256,629) Cumulative translation adjustment (162,129) (162,129) Note receivable ( 5,000) ( 5,000) Total shareholders' equity $2,050,756 $5,494,476(2) Total capitalization $2,660,362 $6,104,082 Number of shares of common stock outstanding (3) 4,191,525 5,895,475 (1) Includes real estate mortgage note and capital leases, but not current maturities nor real estate leases. (2) Assumes gross proceeds of $4,044,506 resulting from the sale of 1,702,950 shares at $2.375 per share, less commissions (10%), non-accountable expenses (3%) and estimated expenses of the offering ($75,000), and net proceeds of $3,443,720. (3) Does not include outstanding options for 505,200 shares as of March 31, 1998, (483,200 shares as of June 30, 1998) nor an Agent's warrant for 150,000 shares as of June 30, 1998. SELECTED FINANCIAL DATA The following selected financial data of the Company as of March 31, 1998, and for the fiscal years ended March 31, 1998 and 1997 have been derived from, and are qualified by reference to, the consolidated financial statements of the Company which have been audited by KPMG Peat Marwick LLP, independent auditors, included elsewhere in this Prospectus. The selected financial data should be read in conjunction with the Company's Consolidated Financial Statements, related Notes, and the independent auditors' report, "Management's Discussion and Analysis of Financial Condition and Results of Operations," and other financial information included elsewhere in this Prospectus. (In thousands, except per share data and shares outstanding.) Years ended March 31, 1998 1997 Consolidated Statement of Operations Data: Net sales $ 4,336 $ 3,335 Operating profit 662 376 Net income $ 408 $ 218 Net income per share $ .10 $ .06 Weighted average number of common shares outstanding(1) 4,026,571 3,575,609 March 31, 1998 Actual Pro Forma As Adjusted(2) Consolidated Balance Sheet Data: Cash and cash equivalents $ 890 4,334 Working capital 1,514 4,958 Total shareholders' equity 2,051 5,495 (1) Does not include 505,200 shares as of March 31, 1998 (483,200 shares as of June 30, 1998) underlying outstanding options, nor 150,000 shares underlying an Agent's Warrant as of June 30, 1998. (2) As adjusted on a pro forma basis to reflect the sale of 1,702,950 Shares in May and June, 1998, and the application of the net proceeds therefrom. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS THIS DISCUSSION OF THE FINANCIAL CONDITION AND THE RESULTS OF OPERATIONS OF THE COMPANY SHOULD BE READ IN CONJUNCTION WITH, AND IS QUALIFIED IN ITS ENTIRETY BY, THE FINANCIAL STATEMENTS AND NOTES THERETO INCLUDED ELSEWHERE WITHIN THIS PROSPECTUS, AND THE MATERIAL CONTAINED IN THE "RISK FACTORS" AND "BUSINESS" SECTIONS OF THIS PROSPECTUS. Overview The Company was incorporated in Minnesota in 1992 as a wholly-owned subsidiary of Bioplasty, Inc. ("Bioplasty"), a manufacturer of breast implants. Bioplasty, along with other breast implant manufacturers, became subject to numerous product liability class action lawsuits. As a result, Bioplasty and the Company filed for protection under Chapter 11 of the Federal Bankruptcy Code in 1993. The Company emerged from Chapter 11 in February, 1994, as a separate and distinct entity from Bioplasty. The Company sells Macroplastique and the related ancillary products for use in augmenting soft tissues for the purpose of treating urinary incontinence At this time, sales are only made outside the United States because the Company does not have regulatory approval to market its product in the United States. The Company's current objectives are to focus on growth in sales and market penetration of Macroplastique in the European market for urinary incontinence and vesicoureteral reflux treatment, and to begin the U.S. regulatory process for Macroplastique as a treatment for female stress urinary incontinence. The Company also sells the Macroplastique product in a different configuration for plastic surgery applications under the name BioplastiqueT, in limited markets. In addition, the Company has been selling some specialized wound care products as a distributor. Results of Operations During the year ended March 31, 1998, net sales were $4,335,908 compared to $3,334,563 during the year ended March 31, 1997. This increase of $1,001,345 (30%) is the result of substantially higher sales of the Macroplastique product line as a result of increased market penetration by existing distribution outlets. Unit sales of Macroplastique increased 46% for the same period. Sales of Macroplastique were approximately 91% of total sales. It is expected that Macroplastique sales will continue to grow through further market penetration by existing distribution outlets, expansion of its distribution network and the introduction of innovations in Macroplastique implantation techniques. The gross margin percentage improved from 77% in fiscal 1997 to 78% in fiscal 1998. Management believes that this high level of the gross margin percentage can be maintained as a result of the establishment of a new manufacturing facility, located in Eindhoven, The Netherlands. Operating expenses increased 24% from $2,204,590 in fiscal 1997 to $2,736,288 in fiscal 1998. The increase in operating expenses is primarily attributable to an increase in the number of employees and the initiation of several research and development projects. General and administrative costs increased from $685,430 in fiscal 1997 to $994,068 in fiscal 1998. Research and development expenses increased from $610,677 in fiscal 1997 to $778,082 in fiscal 1998. Selling and marketing costs increased from $908,483 in fiscal 1997 to $964,138 in fiscal 1998. Management believes there will be upward pressure on selling, general and administrative expenses as efforts continue to market Macroplastique. Additionally, management anticipates increased expenditures for research and development projects associated with U.S. regulatory activities for fiscal 1999. The operating profit for the year ended March 31, 1998, was $661,642, compared to $376,204 for the same period last year, an increase of 76%. This increase is attributed to a higher sales level and controlled operating expenses. Income tax expense for the year ended March 31, 1998, was $111,860, compared to $0 for the twelve months ended March 31, 1997. The increase in income tax expense results primarily from the non- availability in 1998 of foreign net operating losses which were available in 1997. For the year ended March 31, 1998, net income totaled $407,841, compared to $218,221 for the twelve months ended March 31, 1997, an increase of 87%. Liquidity and Capital Resources The Company and its wholly-owned subsidiaries' capital resources are derived from existing sales of the Company's products. As of March 31, 1998, the Company had approximately $890,000 in cash and cash equivalents. There is currently no financing arrangement in place for the Company's working capital needs, and the Company has no material unused sources of liquidity other than its cash reserves and its accounts receivable balances. In November, 1997, due to expansion, the Company purchased an office building for its international headquarters in Geleen, The Netherlands. The purchase price of the building was $590,000 and was fully financed through the issuance of a Note Payable, with a variable interest rate (5% per annum at March 31, 1998). Monthly payments consist of $2,563 of principal plus variable rate interest through November 2017. In addition, during the fiscal year the Company made other capital purchases of approximately $450,000, including primarily building improvements and equipment for a new manufacturing plant in Eindhoven, The Netherlands, which was financed by cash from operations. The proceeds of the sale, in May and June, 1998, of 1,702,950 shares of Common Stock, in addition to cash generated by product sales, will be used to pursue an Investigational Device Exemption (IDE) application and Premarket Approval (PMA) application for Macroplastique with the U.S. Food and Drug Administration. If such proceeds are not sufficient to complete the PMA, additional cash from internal or other sources will be needed. The Company has significant operations in the United States and internationally. United States net operating loss carryforwards can not be used to offset taxable income in foreign jurisdictions. Furthermore, repatriation of dividends to the U.S. parent may result in additional foreign or U.S. taxes. Year 2000 Compliance The financial impact to the Company of year 2000 compliance has not been and is not expected to be material to the Company's financial position or results of operations in any given year. The Company's existing information system, consisting of hardware and software supplied by third parties, is year 2000 compliant. However, because most computer systems are by their nature, interdependent, it is possible that non-compliant third party computers could "reinfect" the Company's computer systems. The Company could be adversely affected by the year 2000 problem if it or unrelated parties fail to successfully address this problem. The Company intends to develop a plan to communicate with the unrelated parties, including its regulatory consultants with whom it deals, to coordinate year 2000 compliance. The costs incurred in addressing year 2000 compliance will be expensed as incurred, in compliance with GAAP. BUSINESS General The Company designs, develops, manufactures and markets medical products primarily for the treatment of urinary incontinence. The Company's key product is Macroplastique(R), an injectable soft tissue bulking agent currently used to treat certain types of stress urinary incontinence ("SUI"), the most common form of urinary incontinence. SUI refers to involuntary loss of urine as a result of activities that increase intra-abdominal pressure, such as coughing, laughing or exercising. Macroplastique also is used to treat vesicoureteral reflux ("VUR"), a condition occurring mostly in children in which urine flows backward from the bladder into the kidney. In addition, some doctors in Europe are beginning to use Macroplastique to treat incontinence in men recovering from prostate surgery. In June 1996, Macroplastique received a CE mark in Europe (similar to FDA approval in the United States), allowing the product to be sold throughout the European Union. Macroplastique is not sold in the United States because it has not been approved for marketing by the Food and Drug Administration ("FDA"). Through this offering, the Company seeks to fund its efforts to obtain FDA pre-market approval for Macroplastique, which would allow the Company to enter the U.S. female stress urinary incontinence treatment market. It is estimated that urinary incontinence afflicts about 5% of the general population and women comprise about 85% of the sufferers. In Europe, currently the Company's largest market, approximately 17 million people suffer from various forms of urinary incontinence and about 14.5 million of these sufferers are women. Bulking agents such as Macroplastique are used to treat women with SUI caused by intrinsic sphincter deficiency, estimated by the Company to comprise 10% of the female incontinence market or about 1.4 million women in Europe alone. VUR is primarily a pediatric concern, with a prevalence estimated to be as high as 1% of the pediatric population. The Company estimates that about half of this population are candidates for Macroplastique treatments. Of the estimated 2.6 million European men who are incontinent, the Company believes about 25% are candidates for treatment with Macroplastique. Macroplastique consists of soft, flexible, solid, highly textured particles of heat vulcanized polydimethylsiloxane (solid silicone) suspended in a water-based biocompatible carrier solution. Macroplastique is not a silicone gel, the compound which became controversial in its use in breast implants. Macroplastique was first introduced in the European urological marketplace in 1991 and has been used to treat approximately 15,000 patients over the last seven years with no reported serious product related adverse incidents. Urinary Incontinence Market Urinary incontinence is an involuntary loss of urine, so severe it has social and/or hygienic consequences. In varying degrees, urinary incontinence is a problem suffered by millions of people worldwide. The Agency for Health Care Policy and Research (a division of the Public Health Service, U.S. Department of Health and Human Services) estimated in 1996 that there were approximately 13 million adults with urinary incontinence in the United States. The same agency estimated the total cost (utilizing all management and curative approaches) of treating incontinence of all types in the United States as $15 billion in 1996. Urinary incontinence can result in a substantial decrease in a person's quality of life and is often the main reason a family commits an elderly person to nursing home care. The Company estimates there are approximately 11 million female urinary incontinence sufferers in the United States and 14.5 million female urinary incontinence sufferers in Europe. Of these populations, the Company believes that there are approximately 1 million American women and 1.4 million European women who are suitable for treatment with Macroplastique. The Company expects that the incidence of urinary incontinence will rise as the percentage of elderly people continues to increase. Types of Urinary Incontinence The mechanisms of urinary incontinence are complicated and involve the interaction between several anatomical structures. In females, urinary continence is primarily controlled by the urinary sphincter. This muscle surrounds the urethra and provides constrictive pressure to prevent urine from flowing out of the bladder. Urination occurs when the urinary sphincter relaxes as the bladder contracts, allowing urine to flow through the urethra. The urinary sphincter is also responsible for maintaining continence during periods of physical stress. Urinary incontinence may result when any part of the urinary incontinence tract fails to function as intended. A broad range of conditions and disorders can cause incontinence, including birth defects (e.g. spina bifida), pelvic surgery, injuries to the pelvic region or the spinal cord, neurological diseases, (e.g. multiple sclerosis, poliomyelitis) and degenerative changes associated with aging. Stress Urinary Incontinence: Stress urinary incontinence ("SUI") refers to the involuntary loss of urine due to an increase in intra-abdominal pressure from coughing, sneezing, laughing, straining or lifting. In women, the most common cause of SUI is hypermobility, a lack of anatomic stability primarily caused by weak surrounding tissue, which results in the abnormal movement of the bladder neck and urethra. This anatomical problem is often the result of childbirth. SUI can also be caused by intrinsic sphincter deficiency (ISD), or the inability of the urinary sphincter valve or muscle to function properly. ISD can be due to congenital sphincter weakness or deterioration of the muscular wall of the urethra after trauma, prostatectomy, spinal cord lesion or radiation therapy. To date, Macroplastique has been used to treat incontinence in women suffering from SUI caused by intrinsic sphincter deficiency. Urge Incontinence: Urge incontinence refers to the involuntary loss of urine associated with an abrupt and strong desire to urinate. Urge incontinence often occurs with neurologic problems, causing the bladder to contract and empty with little or no warning. Urge incontinence is typically caused by central nervous system lesions (such as a stroke) which impair inhibition of bladder contraction, and local irritating factors such as urinary infection or bladder tumors. Overflow Incontinence: Overflow incontinence is associated with an over-distention of the bladder. This can be the result of an underactive bladder or an obstruction in the bladder or urethra. Mixed Incontinence: Mixed incontinence is the combination of urge and stress incontinence (and, in some cases, overflow). Since prostate enlargement often obstructs the urethra, older men often have urge incontinence coupled with overflow incontinence. Management and Treatment of Urinary Incontinence There are two general approaches to dealing with urinary incontinence. One approach is to manage the symptoms of urinary incontinence, such as with pads or diapers. The other approach consists of curative measures that attempt to restore continence, such as surgery or treatment with bulking agents. The Company suggests the treatment of stress urinary incontinence should proceed from the least invasive to the most invasive therapy. Management of Urinary Incontinence Absorbent Products: Absorbent products are probably the most common treatment for urinary incontinence of all types; most men and women use these products without consulting a physician. The cost of diapers and pads can be substantial, thus creating a continuous financial burden for patients. Additionally, this management technique requires frequent changing of diapers and pads to control patient embarrassment due to odor. Behavior Modification: The techniques used in behavior modification include bladder training, scheduled voiding and pelvic floor muscle exercises ("kegels"). Some of the tools used in conjunction with these training regimes are vaginal cones or weights, biofeedback devices and electrical stimulation. While these are typically low-risk procedures, they do not work for many patients and even where effective they only partly alleviate the symptoms and are seldom curative. Penile Compression Devices: Penile clamps are reserved for temporary use with male incontinence. Complications such as penile and urethral erosion, penile edema, pain and obstruction can occur if clamps are improperly used. Pelvic Organ Support Devices: Pelvic organ support devices such as pessaries (doughnut-shaped devices made of flexible materials) are designed to temporarily reduce pelvic prolapse and alleviate symptoms of pelvic relaxation in females with and without incontinence. Complications can result when these devices are misused or neglected and can include ulceration of the vagina and rectovaginal and vesicovaginal fistula. Persons using pessaries require frequent and regular monitoring. Occlusion Devices: Urethral occlusion devices, or "plugs," consist of tiny disposable products intended to be used by a sub-segment of stress incontinent women (women that are younger, more physically active, and are motivated to use a disposable urethral plug on a daily basis). The primary problems with this device are urinary tract infections, treatment compliance and progressive urethral dilation which may require larger plugs over time. Urinary Catheters and Collection Devices: There are four types of urinary catheters: 1) intermittent (inserted through the urethra into the bladder every 3 to 6 hours for bladder drainage; may be appropriate for the management of acute or chronic urinary retention); 2) indwelling (closed sterile system inserted through the urethra to allow for bladder drainage; may be needed for short-term treatment and for terminally ill patients); 3) suprapubic (requires percutaneous or surgical introduction of a catheter into the bladder through the abdominal wall, for short-term use following gynecologic, urologic and other types of surgery or as an alternative to long-term urethral catheter use in men); and 4) external collection (devices made from latex rubber, polyvinyl or silicone like a condom and are secured on the shaft of the penis by a double-sided adhesive, latex or foam strap and are connected to urine collecting bags by a tube; may be useful for short-term maintenance). The type and severity of incontinence and the patient's physical and mental condition determine which is the best catheter option for the patient. Drug Therapy: Drug treatment is used to manage multiple types of urinary incontinence. These drugs tend to fall into one of two categories: those that manage urge urinary incontinence by affecting the contraction of the muscle tissue of the bladder and those that manage stress urinary incontinence by either affecting contraction of the muscle tissue of the bladder neck or improving the quality of the mucosal lining of the bladder neck and urethra. Drugs seldom cure stress urinary incontinence and the potential side effects include urinary retention, nausea, dizziness, blurred vision and the possibility of unwanted interactions with other drugs. Curative Treatments for Urinary Incontinence Surgery: In women, stress urinary incontinence can be surgically corrected through various suspension and sling procedures. In these procedures, the physician elevates and stabilizes the urethra and bladder neck. Current surgical procedures require vaginal or abdominal incisions and are typically performed under general anesthesia. Surgery is expensive, traumatic and involves a 3-10 day hospital stay with several months required for full recovery. In men, the main surgical option is an implanted artificial urinary sphincter. However, it carries with it the inherent risks of device malfunction, tissue erosion and atrophy and infection. In practice, the artificial urinary sphincter is rarely applicable to the management of uncomplicated stress incontinence. Injectable Bulking Agents: Bulking agents are inserted with a needle into the area around the urethra, thereby augmenting the sphincter. Hence, these materials are often called "bulk-enhancing agents" or "injectables." Bulking agents may be either synthetic or biologically derived. Bulking agents are an attractive alternative to surgery because they are considerably less invasive than many of the surgical procedures described above. For this reason, bulking agents represent a particularly desirable treatment option for the elderly or infirm who may not otherwise be able to withstand the trauma and morbidity resulting from a fully invasive surgical procedure. Active women also can benefit from the use of bulking agents since their use will often allow the patient to return to normal activities in a matter of days instead of weeks for fully invasive surgical procedures. The 1996 Clinical Practice Guidelines published by the U.S. Department of Health and Human Services recommend periurethral bulking agents as first line treatment for men with intrinsic sphincter deficiency and for women with intrinsic sphincter deficiency who do not have co-existing hypermobility. The two major types of bulking agents are biologically derived agents and synthetic bulking agents. Biologically derived bulking agents include injections of autologous fat and bovine collagen. Fat injections involve complex, invasive harvesting of the patient's own fat cells and reinjecting them into the bladder neck. Another procedure involves the injection of processed bovine collagen. The two most commonly used synthetic bulking agents are Macroplastique (polydimethylsiloxane) and Teflon(C) paste (polytetrafluoroethylene, also known as PTFE). Macroplastique The Company's Macroplastique product is an injectable soft tissue bulking agent primarily used to treat stress urinary incontinence in women. Macroplastique is a proprietary composition of heat vulcanized, highly textured, solid, soft and irregularly shaped polydimethylsiloxane (solid silicone) particles suspended in a biocompatible carrier solution. Based on the Company's clinical experience, Macroplastique does not cause chronic inflammation, is not absorbable by the body and does not migrate. Macroplastique is used to provide permanent bulking or augmentation of the urethral sphincter. The actual implantation of Macroplastique is minimally invasive and can be accomplished using less than 30 minutes of the physician's time in an inpatient or outpatient setting. It is designed to restore the patient to normal urinary continence almost immediately following treatment. Macroplastique is also used to treat vesicoureteral reflux, a condition occurring primarily in children, and urinary incontinence in men after prostate surgery. The Company markets Macroplastique on the basis that its use can lead to lower surgical risk, shorter recovery time and less expense than more invasive alternatives. The advantages of Macroplastique, in the Company's view, include the following: No Absorption/Migration: The Macroplastique elastomer particles are soft, heavily textured and irregularly shaped, to provide numerous surfaces to allow for rapid deposit of host collagen (a form of scar tissue) between the individual particles and around the periphery of the injected product. The highly irregular shapes of optimally sized particles minimize the potential for migration by the propensity of individual particles to interlock with each other to form larger agglomerates. Biocompatible: The medical grade polydimethylsiloxane used in Macroplastique is commonly utilized in many other biomedical applications and has a well-documented safety record for biomedical usage. For example, such elastomers have been and are used for long term implants such as pacemaker leads and hydrocephalic shunts. Macroplastique itself has undergone extensive testing to confirm its favorable biocompatibility characteristics. Clinical Experience: The Company's seven year clinical experience with more than 15,000 patients, all outside the United States, supports the effectiveness of Macroplastique. During this time period, no serious product-related adverse reaction of any kind has been reported to the Company. Minimally Invasive/Cost Effective: Macroplastique is designed to offer surgeons and their patients a minimally invasive, long-lasting and cost- effective treatment for female and male stress urinary incontinence and vesicoureteral reflux. The Company has developed an implantation procedure for Macroplastique that is technologically feasible, easily performed and effective. Marketing, Distribution and Sales The Company markets and sells Macroplastique and the related ancillary products used in the implantation procedure only in countries outside the United States, primarily in Europe. The Company uses a direct sales force of six persons in the United Kingdom and three persons in the Netherlands. For approximately 20 other countries in which the Company markets Macroplastique, it uses a network of distributors, for whom training is provided by the Company's technical staff in the Netherlands. Other Products The Company also sells the materials contained in Macroplastique for plastic surgery applications under the name BioplastiqueT Implants, in limited markets. In addition, the Company has been selling some specialized wound care products as a distributor. The Company recently introduced a new product to the gynecology and urology market called the UroScopeT. This is a modified short endoscope specifically designed for the administration of Macroplastique in females. Government Regulations As a medical device manufacturer, the Company is subject to government regulations in every market where its products are sold. In markets such as the United States and Europe, these regulations are substantial and play a significant role in the Company's designing, testing, manufacturing, and marketing of its products. In order to market its products within the countries of the European Union, the Company is required to obtain CE marking for its products. To obtain CE marking, a product must comply with the requirements set forth in Council Directive 93/42/EEC published in Volume 36 (12 July 1993) of the Official Journal of the European Communities. This document is often called the "Medical Device Directives" (MDD) in Europe. The requirements for new medical devices set forth in this document are based upon their relative risk to the patient. Medical devices that present a low risk to the patient (Class I devices) have relatively few requirements for CE mark authorization. Medical devices that present a greater risk to the patient such as long-term implantables (Class IIb and III) have more rigorous requirements for CE mark approval. CE mark authorization is granted by organizations called "Notified Bodies" that are approved by their respective national "Competent Authorities" (which are usually referred to as national Health Ministries) to conduct medical device evaluations. Notified Bodies are technical expert organizations that serve as the auditing and certifying arm of the Competent Authorities. Under the European MDD, Macroplastique is considered a Class IIb device. To obtain the CE Mark for Macroplastique, the Company was required to submit extensive information regarding the product design, labeling, safety, preclinical and clinical testing results to its Notified Body for evaluation by expert reviewers. In addition, the Company maintains registration to rigorous quality standards ISO 9001 and EN46001 (EN46001 references ISO 9001 with additional medical device requirements). After successfully demonstrating full compliance to the MDD, the Notified Body issued a "Certificate of Authorization" to the Company in June 1996 which allowed the Company to place the CE mark on Macroplastique. With CE marking, Macroplastique can be marketed throughout the European Union after fulfilling any additional national requirements. The Company is subject to periodic surveillance audits by its Notified Body to ensure it adheres to the requirements of the MDD. Changes in existing requirements or adoption of new requirements or policies could adversely affect the ability of the Company to comply with regulatory requirements. Failure to comply with regulatory requirements could have a material adverse effect on the Company's business, financial condition and results of operations. There can be no assurance the Company will not be required to incur significant costs to comply with laws and regulations in the future, or that laws or regulations will not have a material adverse effect upon the Company's business, financial condition or results of operations. The Company maintains facilities in the United States, United Kingdom and The Netherlands, each of which has numerous federal, state and local laws relating to such matters as safe working conditions, manufacturing practices, environmental protection, fire hazard control and disposal of hazardous or potentially hazardous substances. There can be no assurance that the Company will not be required to incur significant costs to comply with such laws and regulations now or in the future or that such laws or regulations will not have a material adverse effect upon the Company's ability to do business. In the United States, the Company must comply with the Federal, Food, Drug and Cosmetic Act, as amended, which is enforced by the Food and Drug Administration (the "FDA"). These regulations are complex but generally function by associating a level of risk with a proposed product. Products which are lower risk, such as surgical gloves (considered a Class I device) have fewer requirements for marketing than products which are life sustaining, diagnostic, or long-term implants (considered Class III devices). The FDA has determined that urethral bulking agents such as Macroplastique are Class III devices subject to a Pre-Market Approval (PMA) application prior to marketing in the United States. A PMA application is a rigorous submission that requires the manufacturer to substantiate the product's claims of safety and effectiveness with valid scientific evidence. The PMA process is lengthy and expensive with no guarantee of final approval at its completion. A typical PMA submission includes very detailed, technical descriptions of the proposed device, the device's manufacturing and quality control systems, the pre-clinical (biocompatibility) testing performed on the device, and the results of human clinical studies. After receiving the PMA submission from the manufacturer, the FDA will normally review the information for 1-2 years. During this time period the FDA usually assembles a panel of clinicians to make a non-binding recommendation of whether to approve the product. The FDA will also conduct an onsite inspection of the manufacturer to establish that the FDA's manufacturing and quality system requirements (called Good Manufacturing Practices, or GMP's) will be followed during the production of the device. In some instances, the FDA will decide that additional testing or clinical studies are necessary to support the PMA submission. Such a decision considerably lengthens the time and expense required for obtaining U.S. marketing approval. If the FDA approves PMA submission, it may still place certain conditions on the manufacturer, such as the initiation of a post-marketing study or restrictions to the product's intended use. After approval of the PMA submission, the Company must comply with other FDA regulations to maintain its U.S. marketing approval. The Company's manufacturing facilities will be subjected to routine inspections by the FDA to ensure that the Company is in compliance with GMP regulations. Because the Company's quality system has already achieved ISO 9001 registration, the Company believes that few additional elements will be required to satisfy the GMP regulations. However, there can be no assurance that the FDA would find the Company's quality system to be in compliance with all relevant aspects of the requirements (See "Business - Manufacturing"). The Company must also comply with U.S. Medical Device Reporting (MDR) regulations, which require companies to document and investigate device malfunctions or any deaths or serious injuries that may be associated with the use of their products. The FDA will also scrutinize all labeling and marketing claims made by the Company to ensure that only the product indications specifically approved by the FDA are promoted by the company. The Company is also subject to a variety of state and local laws and regulations in those states or localities where its product will be marketed. Any applicable state or local regulations may hinder the Company's ability to market its products in those states or localities. Third-Party Reimbursement Throughout much of the world, the Company sells Macroplastique to hospitals and other users who often transfer the cost of the medical product and services to various third-party payers, such as government health programs, private health insurance plans, managed care organizations and other similar programs. These third-party payers may deny or substantially limit reimbursement if they believe that a medical device was not used in accordance with established payer protocols regarding cost-efficient treatment methods, was used for an unapproved indication or was not otherwise covered. In some markets, medical device manufacturers are being forced to demonstrate the clinical efficacy and cost-effectiveness of their products to third-party payers before these organizations will agree to provide reimbursement to users. Changes to third-party reimbursement policies in the United States, Europe and other potential Macroplastique markets could result in diminished revenues to the Company. In most European nations and other Macroplastique markets, third party reimbursement is currently available for Macroplastique for the treatment of urinary incontinence. Within the United States, third- party reimbursement is currently available for certain bulking agents and the Company expects to obtain third-party reimbursement for Macroplastique if and when the product is approved for marketing. However, there is currently no uniform policy for reimbursement in the United States and no guarantee Macroplastique will be reimbursed at the levels expected by the Company, if at all. The availability of third-party reimbursement for Macroplastique or competitors' products and continuing efforts to reduce the costs of health care by decreasing reimbursement rates may reduce the price received by the Company for Macroplastique. Product Liability The medical device industry is subject to substantial litigation. The Company is a manufacturer of a long-term implantable device and consequently faces an inherent business risk of exposure to product liability claims resulting from alleged adverse effects to the patient. The Company currently carries product liability insurance but there can be no assurance the Company's existing insurance coverage limits are adequate to protect the Company from any liabilities which it might incur in connection with the clinical trials of Macroplastique or the initial commercialization of Macroplastique in the United States. There can be no assurance that liability claims will not exceed coverage limits. Such insurance is expensive and in the future may not be available on acceptable terms, if at all. Furthermore, the Company does not expect to be able to obtain insurance covering its costs and losses as a result of any recall of its products due to alleged defects, whether such a recall is instituted by the Company or required by a regulatory agency. A product liability claim, recall or other claim with respect to uninsured liabilities or in excess of insured liabilities could have a material adverse effect on the business, financial condition and results of operations of the Company. Manufacturing The Company manufactures Macroplastique at its own facilities in The Netherlands from medical grade materials obtained from qualified suppliers. The Company's facilities utilize dedicated heating, ventilation, and high efficiency particulate air (HEPA) filtration systems for the manufacturing area to provide a controlled working environment. All manufacturing processes, including material storage and handling, gowning, and cleaning are performed according to written procedures approved by the Company's quality department. All critical manufacturing processes are performed in a cleanroom environment by trained production technicians. An outside vendor sterilizes Macroplastique using a validated method and returns the product to the Company for final inspection and testing. The Company currently purchases all raw materials from single sources. Alternative suppliers for these materials do exist should the current suppliers discontinue production or distribution. However, the Company would need to complete additional testing to qualify the materials obtained from any new suppliers. Additionally, limited notice of the need to switch suppliers for either of these materials could result in production delays and inventory depletion. The Company's manufacturing facilities are periodically audited by an independent registrar to ensure compliance with ISO 9001 and EN 46001 quality system requirements. Prior to marketing the product in the United States, the Company will also be inspected by the U.S. FDA and will also be subject to any additional state, local and federal government regulations in both the United States and The Netherlands applicable to the manufacture of the Company's products. See "Business - Government Regulations". Competition Competition in the urinary incontinence products market is intense. The Company faces competition from existing manufacturers of management and curative treatments for urinary incontinence, including competing manufacturers of commercially available bulking agents, as well as from companies developing new or improved treatment methods for urinary incontinence. The Company believes the principal competitive factors among treatment methods for urinary incontinence include physician and patient acceptance of the method in managing or curing incontinence, cost and the availability of third-party reimbursement, marketing and sales capability and the existence of meaningful patent protection. The Company's ability to compete in this market also will depend on the consistency of its product quality and delivery and product pricing. Other factors within and outside the Company's control include its product development and innovation capabilities, ability to obtain required regulatory approvals, ability to protect its proprietary technology, manufacturing and marketing capabilities and ability to attract and retain skilled employees. Current major competitors who compete in the urinary incontinence management and treatment market include Kimberly-Clark Corp. and Procter & Gamble Co. for adult diapers and absorbent pads; Empi, Inc. and MedCare Technologies, Inc. with electrical pelvic floor stimulators and behavioral treatments; Abbott Laboratories, Warners Wellcome and Hoechst Marion Roussell for pharmaceutical treatments; C. R. Bard, Inc., Kendall Co., Mentor Corp. and Baxter International for catheter/urine collection bag drainage systems; and American Medical Systems, Inc., a division of Pfizer, Boston Scientific Corporation, Influence, Inc. and Johnson & Johnson for sling procedures and artificial sphincter implants. The Company believes that some of its current competitors and others that do not have injectable bulking products are also seeking to develop competing bulking agents. There are currently at least two injectable soft tissue bulking agent products that compete directly with Macroplastique, both of which are supplied by companies with considerably larger financial and other resources than Uroplasty. These products are Urethrin(R), manufactured and distributed only outside the United States by Mentor, Inc. and Contigen(R), manufactured by Collagen Corporation and distributed by C.R. Bard, in both the United States and foreign markets. The Company expects other devices for treating urinary incontinence by means of soft tissue injection therapy will become available in the future and competition will continue to intensify. In addition, Advanced Uroscience, Inc. and the Convatec division of Bristol, Meyers, Squibb are seeking regulatory approval for an injectable bulking agent. Many of the Company's competitors and potential competitors have significantly greater financial, manufacturing, marketing, distribution and technical resources and experience than the Company. In addition, many of the Company's competitors offer broader product lines within the urology market, which may give such competitors the ability to negotiate exclusive, long-term supply contracts and to offer comprehensive pricing for their products. It is possible that other large health care and consumer products companies may enter this industry in the future. Furthermore, smaller companies, academic institutions, governmental agencies and other public and private research organizations will continue to conduct research, seek patent protection and establish arrangements for commercializing products. Such products may compete directly with any products which may be offered by the Company in the future. Dependence on One or a Few Major Customers Approximately 14% of the Company's total sales during the fiscal year period ended March 31, 1998 were made to ABS, the distributor covering France. ABS holds 100,000 shares of Uroplasty common stock. Patents, Trademarks, and Licenses The Company's success depends in part on its ability to obtain and maintain patent protection for its products, to preserve its trade secrets and to operate without infringing the proprietary rights of third parties. The Company seeks to protect its technology by filing patent applications for patentable technologies that it considers important to the development of its business based on an analysis of the cost of obtaining a patent, the likely scope of protection and the relative benefits of patent protection compared to trade secret protection, among other considerations. The Company also relies upon trade secrets, know-how and continuing technological innovation to develop and maintain its competitive position. Multiple patents covering the Macroplastique materials, processes and applications have been issued to the Company by the United States, United Kingdom, German and Japanese Patent Offices. Applications are also currently pending in various other countries, including Canada and other European countries. There can be no assurance that any of the Company's pending or future U.S. or foreign patent applications will result in issued patents, or that any issued patents will be of sufficient scope or strength to provide meaningful protection of the Company's products. The coverage sought in a patent application can be denied or significantly reduced before the patent is issued. In addition, there can be no assurance that any current or future U.S. or foreign patents of the Company will not be challenged or circumvented by competitors or others, or that such patents will be found to be valid or sufficiently broad to protect the Company's technology or provide the Company with any competitive advantage. Should attempts be made to challenge, circumvent or invalidate the Company's patents in the U.S. Patent and Trademark Office or courts of competent jurisdiction, including administrative boards or tribunals, the Company may have to participate in legal or quasi-legal proceedings therein to maintain, defend or enforce its rights in these patents. Any legal proceedings to maintain, defend or enforce the Company's patent rights could be lengthy and costly, with no guarantee of success. The Company also relies heavily upon trade secrets and other proprietary information. The Company seeks to maintain the confidentiality of such information by requiring employees, consultants and other parties to sign confidentiality agreements and by limiting access by parties outside the Company to such information. There can be no assurance, however, that these measures will prevent the unauthorized disclosure or use of this information or that others will not be able to independently develop such information. Additionally, there can be no assurance that any agreements regarding confidentiality and non-disclosure will not be breached, or, in the event of any breach, that adequate remedies would be available to the Company. In 1992, the Company and its then parent, Bioplasty, Inc., were sued by Collagen Corporation, which alleged that Macroplastique infringed on one of its U.S. patents for a bulking agent. The parties entered into a license and settlement agreement in 1993 pursuant to which the Company pays Collagen a royalty of 5% of net sales of certain products sold in the United States with a minimum of $50,000 per year. Recently, the Company received several letters from Collagen's counsel questioning whether additional royalties were payable as a result of either the manufacture or sale by the Company of Macroplastique in the United States. The Company's position is that royalties are payable only on "net sales" in the United States, and, there having been none, no additional royalties are payable. Collagen has not brought any new or renewed legal action in connection with its claims and allegations. There can be no assurance, however, that Collagen or any other third party will not pursue legal action with respect to these matters. Claims by competitors such as Collagen and other third parties that the Company's products allegedly infringe the patent or other intellectual property rights of others could have a material adverse effect on the Company. There has been substantial litigation regarding patent and other intellectual property rights in the medical device industry, and intellectual property litigation may be used against the Company as a means of gaining a competitive advantage. Intellectual property litigation is complex, time-consuming and expensive, and the outcome of such litigation is difficult to predict. Any future litigation, regardless of outcome, could result in substantial expense to the Company and significant diversion of the efforts of the Company's technical and management personnel. An adverse outcome in any litigation could subject the Company to significant liabilities to third parties, require disputed rights to be licensed from others, if licenses to such rights could be obtained, or require the Company to cease making, using or selling certain products. There can be no assurance that any licenses required under any patents or proprietary rights would be made available on terms acceptable to the Company, if at all. In addition to being costly, protracted litigation to defend or prosecute intellectual property could result in the Company being unable to commercialize Macroplastique on a timely basis or at all, and could have a material adverse effect on the Company's business, financial condition and results of operations. Although the Company intends to apply for additional patents and vigorously defend issued patents, management believes that its success as a business will depend primarily upon its development and marketing skills, and the quality and economic value of its products rather than on its ability to obtain and defend patents. The Company has a Royalty Agreement with three individuals, two of whom are former officers and directors. Under such Agreement, the Company pays royalties, in the aggregate, of three to five percent of net sales of Macroplastique, subject to a monthly minimum of $4,500. The royalties payable under this Agreement will continue for the life of the patent referenced in the Agreement. In December 1995, the Company obtained a license for a urethral guiding device designed to make implantation of Macroplastique easier and more precise. Under this agreement, the Company made a cash payment of approximately $30,000 to the licensor and will make royalty payments at the rate of 10% of the worldwide net sales of this device for a period of 10 years. Research and Development The Company has an active Research and Development program working to develop new products in the field of incontinence. The Company is also continually working on new methods and devices for the implantation of Macroplastique and on new applications for this material. Expenditures for research and development totaled $778,082 and $610,677 for the fiscal years ended March 31, 1998 and March 31, 1997, respectively. None of these costs were borne directly by customers. For fiscal year 1999, the Company's research and development expenses will increase significantly. This is due, in part, to the accounting protocol of treating regulatory expenses as research and development expenses. See "Management's Discussion and Analysis". The Company has acquired the rights to a urethral guiding device designed to make implantation of Macroplastique in women simpler and more precise. The Company intends to introduce this device late in fiscal year 1999. The Company currently does not intend to charge doctors separately for this product. Instead, the Company will provide an implantation kit including Macroplastique, the urethral guiding device and administration needles. The Company expects the new device to make implantation easier and allow it to be performed on an outpatient basis at the doctor's office. Currently, Macroplastique is injected using a more cumbersome endoscope and patients are usually admitted to the hospital and put under general anesthesia during the procedure. The Company is developing a pubovaginal sling which is a surgically implanted device providing support for the bladder neck and urethrea. This device is expected to expand the Company's product line to cover a broader range of female SUI. The Company intends to introduce this product into the U.S. market in early fiscal 2000, pending submission and approval of a 510(k) review by the FDA. Compliance with Environmental Laws Compliance by the Company with applicable environmental requirements during its fiscal years ended March 31, 1998 and 1997 has not had a material effect upon the capital expenditures, earnings or competitive position. Employees As of March 31, 1998, the Company had thirty-eight employees, of which thirty-two were full-time, two temporary and four part time. None of such employees has a collective bargaining agreement with the Company. Property The Company owns office and warehouse space at Hofkamp 2, 6161 DC Geleen, The Netherlands. In addition, the Company leases office, warehouse, laboratory and production space at 2718 Summer Street NE, Minneapolis Minnesota 55413-2820, USA; and office and warehouse space at Unit 3, Woodside business Park, Whitley Wood Lane, Reading, Berkshire RG2 8LW, United Kingdom; and office, warehouse, laboratory and manufacturing space at Industrieweg 12, 5627 BS Eindhoven, The Netherlands; and office space at Hertogsingel 54, 6214 AE Maastricht, The Netherlands. The Company considers its facilities adequate for its foreseeable needs. Litigation The Company is not, as of the date hereof, a party to any material pending legal proceedings, nor is its property the subject of any such proceedings. Former Parent, and Current Subsidiaries The Company was incorporated in January 1992 as a wholly- owned subsidiary of Bioplasty, Inc., which was primarily a manufacturer and distributor of breast implants. Because of extensive products liability litigation brought against Bioplasty and all other manufacturers of breast implant products, Bioplasty, Inc. and Uroplasty, Inc. filed for protection from creditors under Chapter 11 of the United States Bankruptcy Code in April 1993. On January 31, 1994, the U.S. Bankruptcy Court confirmed the Joint Plan of Reorganization (the "Plan") of Bioplasty, Inc. and Uroplasty, Inc. Under the Plan, all equity interests held by Bioplasty, Inc. in Uroplasty, Inc. were canceled and new shares of each of Bioplasty, Inc. and Uroplasty, Inc. were issued to creditors, claimants and certain investors. Such persons became the shareholders of Uroplasty, Inc. In addition, under the Plan all pre-petition claims, including known and unknown products liability claims, against Bioplasty, Inc. and Uroplasty, Inc. were discharged, except for certain claims and expenses identified by name and amount, which were allowed by the Court. In January 1995, Uroplasty, Inc. acquired from Bioplasty, Inc. in a tax-free exchange transaction approved by the shareholders of both companies all its remaining operating assets and liabilities, including the stock of its foreign subsidiaries, in satisfaction of obligations due Uroplasty, Inc. generated in the normal course of business. The Company's wholly-owned foreign subsidiaries and their respective principal functions are as follows: Uroplasty BV - Incorporated in The Netherlands, is the manufacturer of Macroplastique, and sells Macroplastique outside of The Netherlands to distributors Uroplasty LTD - Incorporated in and acts as the sole distributor of Macroplastique, Bioplastique and wound care products in the United Kingdom Bioplasty BV - Incorporated in and acts as a distributor of Macroplastique, Bioplastique and wound care products in The Netherlands MANAGEMENT Directors and Executive Officers The Company's Directors and Executive Officers, as of March 31, 1998, were as follows: Name Age Position Director Since Term Expires Daniel G. Holman 52 Chairman, President, 1994 2000 CEO, CFO Joel R. Pitlor 59 Director 1994 1999 R. Patrick Maxwell 53 Director 1994 1999 Carolyn A. Bruhjell 48 Director 1997 1998 Susan Hartjes-Doherty 44 Vice President of Operations and Regulatory Affairs, Secretary Germain E. Willem 51 Vice President of Sales and Marketing Christopher Harris 39 Vice President of Corporate Development All directors are members of the Nominating Committee; all directors except Mr. Holman are members of the Compensation Committee; and Mr. Maxwell and Ms. Bruhjell are members of the Audit Committee. The Company does not have any employment or non-compete agreement with Mr. Holman or Ms. Doherty, whose employment, as such, is at will. The following paragraphs describe the business experience of each of the Company's directors and officers. Several of these individuals have served as directors or officers of Bioplasty, Inc., which filed for bankruptcy in April 1993. See "Business - Former Parent and Current Subsidiaries". Daniel G. Holman has served as Chairman of the Board, President and Chief Executive Officer of Uroplasty, Inc. since February 1994, and as Chief Financial Officer since June 1996. Mr. Holman was Executive Vice President of Bioplasty, Inc. from 1973 to 1985, its President from 1985 to 1987, and Secretary from 1986 to March 1992. Mr. Holman has been Chairman of the Board of Bioplasty, Inc. since March 1992, and President and CEO since February 22, 1993. Mr. Holman served as Chairman of the Board and Chief Executive Officer of Bio-Vascular, Inc. from June 1988, to September 1991, served as a director of Genetic Laboratories Wound Care, Inc. from February 1988 until July 1993, and as Vice President from February 1988 through November 1992. Mr. Holman holds a Bachelor of Arts degree in Biology from St. Cloud State University. Joel R. Pitlor has been a director since February 1994. Mr. Pitlor served as a director of Bioplasty from January 1989 until May 1996. For over sixteen years, he has been the owner and manager of a management consulting firm. Mr. Pitlor is presently a Director of Precision Optics Corporation, which is publicly-held. Mr. Pitlor holds a Bachelor of Science degree from MIT and serves as Personal Advisor to several CEOs. R. Patrick Maxwell was appointed a Director of Uroplasty in April 1994 and elected by shareholders in August 1997. Mr. Maxwell has been an attorney since 1969. Mr. Maxwell holds and has held management positions in numerous other businesses (primarily temporary placement services, telemarketing and legal expense insurance). Carolyn A. Bruhjell was elected a Director of Uroplasty in August 1997. Ms. Bruhjell is a public accountant and financial consultant. Ms. Bruhjell was from 1996 through January 1998, the Controller of Integrated Network Technologies, Inc., Mendota Heights, Minnesota, a computer integration and networking company. From 1994 to 1996, Ms. Bruhjell was a Senior Audit Manager for Graves, McKenna, Lundeen and Almquist, PLLP, public accountants, as well as Treasurer for Minn Shares Inc., a closed-end management investment company. From 1979 to 1994, she was Co-Owner and Accountant for First Commercial Leasing, Inc., an equipment leasing firm. Ms. Bruhjell received her B.S. in Accounting from the University of Wisconsin. She is a Certified Public Accountant and a Certified Management Accountant. Susan Hartjes-Doherty joined Bioplasty, Inc. in September 1991 as Director of Operations and served as Vice President of Operations from April 1993 until May 1996. In November 1994, Ms. Doherty was appointed Vice-President of Operations for Uroplasty, Inc. and was elected Secretary in September, 1996. Prior to 1991, Ms. Doherty was Director of Operations at Bio-Vascular, Inc. in St. Paul, Minnesota from November 1989 to September 1991. Prior to that time, she served at various other pharmaceutical and medical device companies in management-oriented positions in production, quality assurance and research. Ms. Doherty has Bachelor of Arts degrees in Biology- Microbiology and BioMedical Science from St. Cloud State University, and has done graduate work in the biological sciences. Ms. Doherty is a senior member and a Certified Quality Auditor of the American Society for Quality and served several years on its Executive Committee and is a member of the American Society of Microbiology, and the Henrici Society for Microbiologists. She has served on several national and international standards committees. Germain E. Willem joined the Company in November 1994 as Director of International Sales and Marketing and became Vice President of Sales and Marketing in January 1997. Mr. Willem has 20 years of experience in international sales and marketing of medical devices, including the AMS division of Pfizer Product Group. Mr. Willem has a degree in engineering from the 'Industriele Hogeschool West Vlaanderen' in Belgium. He has been active in standardization organizations for medical devices both in Belgium and The Netherlands. Christopher Harris joined Bioplasty in October 1989 as Area Sales Manager in the United Kingdom. Since September 1994, Mr. Harris has been the Managing Director of the Company's subsidiary in the United Kingdom. In February 1996, Mr. Harris was appointed as Director of Corporate Development and in January 1997 he was appointed Vice President of Corporate Development. Mr. Harris, a certified nurse in the United Kingdom, practiced general surgery nursing for two years and operating room nursing for nine years prior to 1989. Management Compensation The following table sets forth, in summary form, (1) the compensation paid for the years shown in the table, to Daniel G. Holman, the Company's Chairman, President, CEO and CFO and to Susan Hartjes- Doherty, the Company's Vice President of Regulatory Affairs and Operations and Secretary; (2) the stock options and stock appreciation rights granted to such individuals for the years shown; and (3) long-term payouts and other compensation for the years shown: Summary Compensation Table Long Term Compensation (1) Fiscal Year -------------------------- Annual Compensation Awards - ------------------------------------------------------------------------------------------------- Other Securities Name Annual Restricted Under- and Compen- Stock lying Principal sation Awards Options Position Year Salary($) Bonus($) ($) ($) SARs(#) - ------------------------------------------------------------------------------------------------- Daniel G. Holman 1998 161,919 -- 25,632 (2) -- 70,000 CEO 1997 154,162 -- 28,818 (2) -- 0 1996 146,534 -- 18,016 (2) -- 15,000 Susan Hartjes-Doherty 1998 102,160 5,000 -- -- 40,000 Vice President Total Compensation for All Executive Officers For Fiscal Year 1998: (Four Persons) 475,617 (1) There were no payouts under a "long-term incentive plan" (called "LTIP") for the years shown, nor was any other form of compensation paid or awarded. (2) Reimbursement of expatriot living expenses in The Netherlands. Mr. Pitlor receives a $2,000 per month consulting fee from the Registrant under a month to month agreement. All non-employee Board members who do not receive any other form of compensation from the Registrant receive $500 per board meeting attended. In addition, directors participate in the Registrant's option plan. Option/SAR Grants Table Option Grants in Fiscal Year Ended March 31, 1998 - ----------------------------------------------------------------------------- Number of Percent of Securities Total Op- Underlying tions/SARS Options Granted to Exercise or Securities /SARS Employees in Base Price Expiration Name Granted(#) Fiscal Year ($/Share) Date - ----------------------------------------------------------------------------- Daniel G. 50,000 15.1% $1.00 April 2002 Holman, CEO 20,000 6.0% $3.25 February 2003 Susan Hartjes- 25,000 7.6% $1.00 April 2002 Doherty, V.P. 15,000 4.5% $3.25 February 2003 (1) Options for 250,000 shares were granted to officers and directors during the fiscal year ended March 31, 1998. The Company adopted an Incentive Stock Option Plan (the "1995 Plan") in May 1995 which provided for the granting of options to purchase 350,000 shares of stock. At March 31, 1998 there were 177,200 options outstanding under the 1995 Plan. In April 1997, the Board of Directors adopted and in August 1997, the Company's shareholders approved the 1997 Stock Option Plan (the "1997 Plan") pursuant to which 500,000 shares of common stock have been reserved. At March 31, 1998 there were 313,000 options outstanding under the 1997 Plan. (In addition, the Company had 15,000 options outstanding not issued pursuant to either Plan.) Both Plans required that options be granted at exercise prices equal to or greater than the fair market value of the stock at the time of the grant. Aggregated Option/SAR Exercises and Fiscal Year-End Option/SAR Value Table Number of Securities Value of Underlying Unexercised Unexercised In-the-Money Option/SARs Options/SARs Shares acquired Value At FY-End (#) at FY-End ($) Name on Exercise Realized ($) Exercisable Exercisable - ---------------------------------------------------------------------------------- Daniel G. 10,000 27,000 95,000 181,250 Holman, CEO Susan Hartjes- -- -- 65,000 125,000 Doherty, V.P. PRINCIPAL SHAREHOLDERS At June 30, 1998, the Company had 5,917,475 shares of common stock outstanding and options for 483,200 shares of common stock outstanding. The following table sets forth the number of shares of the Company's common stock and the percentage of the total number of shares outstanding beneficially owned, as of June 30, 1998, by (i) each person known to the Company to be the beneficial owner of more than five percent of the Company's Common Stock, (ii) each director, (iii) each executive officer of the Company who is named in "Management Compensation" above, and by (iv) all directors and executive officers as a group: Name and Address of Number of Shares Beneficial Owner Beneficially Owned Percent of Class(7) - ---------------------------------------------------------------------------- Bruce P. Mindich 555 White Plains Road Tarrytown, NY 10591 1,100,000 18.6% Daniel G. Holman 2718 Summer Street NE Minneapolis, MN 55413-2820 299,981 (1) 5.1% Robert A. Ersek, M.D. Continental Intervest 630 West 34th Street, Suite 200 Austin, TX 78205 227,988 3.9% Susan Hartjes-Doherty 2718 Summer Street NE Minneapolis, MN 55413-2820 122,203 (2) 2.1% Joel R. Pitlor 19 Chalk Street Cambridge, MA 02139 145,000 (3) 2.5% R. Patrick Maxwell Templeton & Associates 10 South Fifth Street, Suite #990 Minneapolis, MN 55402 65,307 (3) 1.1% Carolyn A. Bruhjell CAB Consulting 703 Bartosh Lane River Falls, WI 55402 57,488 (4) 1.0% Directors and Executive Officers as a Group (7 persons) 771,979 (5)(6) 13.0% (1) Includes 95,000 shares held under options to purchase common stock. (2) Includes 65,000 shares held under options to purchase common stock. (3) Includes 45,000 shares held under options to purchase common stock. (4) Includes 30,000 shares held under options to purchase common stock. (5) Includes 340,000 shares held under options to purchase common stock. (6) To the Company's knowledge, the persons named have both voting and investment power over the shares listed. (7) Percentages were calculated on the basis of outstanding securities owned by each person or group of persons named, plus, for each person or group any securities that can be acquired within 60 days pursuant to exercise of options. SELLING SHAREHOLDERS All of the shares of the Company's Common Stock offered hereby are being offered by certain shareholders of the Company (referred to herein as the "Selling Shareholders"). None of the Selling Shareholders is an affiliate of the Company, except for Patrick Maxwell, who is a director of the Company. The names of the Selling Shareholders are stated below. None of such persons has had or held a position, office or material relationship with the Company or any of its predecessors or affiliates within the past three years, except for Patrick Maxwell, who is a director of the Company. The table below also states the total number of shares of the Company's Common Stock registered in the name of each of such persons which are covered by this Prospectus. This table covers only shares of the Company's stock covered by this Prospectus and owned by the Selling Shareholders. Such persons may own other shares of the Company's stock. Name of Shareholder Number of Shares Frank S. Amendola, Jr. 5,000 Robert W. Amis, Jr. 15,000 Frederick P. Angst 10,000 Glenn Bartoo 6,000 John D. Bartsh and Lonna Bartsh, JTWROS 2,500 Robert James Beck 5,000 First Trust NATL ASSN TTEE FBO Arthur A. Beisang IRA 20,000 First Trust NATL ASSN TTEE FBO Shirley F. Beisang IRA 20,000 William W. Berg 2,500 Herbert J. Bernick 10,000 Randy E. Bickmann 5,000 James G. Bigelow, Sr. 10,000 Vannoy C. Black and Cynthia F. Black JTWROS 10,000 First Trust NATL ASSN TTEE FBO Gertrude L. Blackshear IRA 5,000 Robert Blain 30,000 Frederick C. Boos 10,000 First Trust NATL ASSN TTEE FBO Dennis G. Bottjen IRA 10,500 First Trust NATL ASSN TTEE FBO Dennis G. Bottjen M/P/P 17,500 Elraine A. Brennan 5,500 O. Charles Brown 2,500 Joseph J. Buska 10,000 Michael F. Cassel 10,000 First Trust NATL ASSN TTEE FBO Patricia A. Cellitti IRA 10,000 Walter T. Cleveland TTEE Martha E. Cleveland TTEE Walter T. Cleveland Trust 10,000 James G. Cowan 7,000 Larry R. Cramer 5,000 Joseph J. Christensen 5,000 Dennis M. Davidson and Barbara A. Davidson, JTWROS 5,000 First Trust NATL ASSN TTEE FBO Bruce N. Davis IRA 10,000 First Trust NATL ASSN TTEE FBO Jack G. Davis IRA 8,400 Daniel J. Dokken and Ruth Dokken, JTWROS 5,000 Jeff Dousette 10,000 Del Dozak 6,000 Justin Droessler 7,300 Paul K. Ebel 5,000 First Trust NATL ASSN TTEE FBO Werner H. Egli IRA 10,000 Ronald A. Erickson, Trustee 10,000 Lary B. Falck and Judith A. Falck, FTWROS 2,500 John E. Feltl 10,000 Carol M. Ford 5,000 John M. Friedges 6,500 Karl Fromm 20,000 Craig R. Geller 2,500 Alexander S. Gerwer and Dena J. Gerwer, JTWROS 13,800 Kathryn R. Gilbertson 20,000 First Trust NATL ASSN TTEE FBO Joseph Hafermann IRA 5,000 William E. Hanneman 5,000 Hartman Hanson and Marguerite Hanson, JTWROS 10,000 Gerald L. Heinzen and Andrea M. Heinzen, JTWROS 6,500 Joseph P. Hennen 10,000 Douglas L. Hildreth and Ruth M. Hildreth, JTWROS 5,000 First Trust NATL ASSN TTEE FBO James A. Hinrichs IRA 10,000 William J. Holman Jr. and Dianna J. Holman, JTWROS 5,000 Randall D. Horan 2,500 Per Huffeldt, Trustee 10,000 Robert G. Hulke 5,000 Thomas Hunt 10,000 William D. Hunt TTEE and Constance J. Hunt TTEE 2,500 Richard Huselid and Marlys Huselid, JTWROS 5,000 David P. Ihle 10,000 Industricorp & Co. FBO, Twin City Carpenters Pension 60,000 Dana J. Isaacson 10,000 Roland Isaacson 10,000 John B. Jasper 10,000 Morris G. Jesperson and Beverly A. Jesperson, JTWROS 10,000 First Trust National Association, Trustee FBO Cheryl L. Johnson Roth IRA 5,000 David T. Johnson 10,000 Donald O. Johnson 5,000 Earl Johnson and Cheryl L. Johnson, JTWROS 4,500 First Trust National Association, Trustee FBO Earl Johnson IRA 2,500 Bryan L. Jones 5,000 Peggy Kaplan 10,000 Jennifer Katz 5,000 Claire M. King 10,000 Steven King 10,000 Daniel T. Koch 50,000 Richard J. Koehler and Sally J. Koehler, JTWROS 5,000 William W. Koop 10,000 Robert J. Korkowski and Phyllis M. Korkowski, JTWROS 10,000 First Trust National Association, Trustee FBO Raymond P. Kruse IRA 10,000 Mark Laskowski 10,000 Larry Laughlin 5,000 James E. Lindell 5,600 Mac W. Lutz III 2,000 Dennis Leslie Maetzold 20,000 Jan Magnuson 15,000 Stanley R. Magnuson and Jayne M. Magnuson JTWROS 10,000 Piper Jaffray as Custodian FBO Wallace A. Marx 10,000 R. Patrick Maxwell 20,000 Timothy J. McCarthy 2,000 Timothy J. McCoy 10,000 First Trust National Association, Trustee FBO Timothy J. McCoy IRA 5,000 First Trust National Association, Trustee FBO Lyle McMurchie 3,750 First Trust NATL ASSN TTEE FBO Charles J. Meler, Jr. IRA 10,000 Dean L. Melnyk 10,000 Brian H. Miller 9,900 Robert Duane Miller 10,000 Dennis M. Mills and Nancy M. Mills, JTWROS 5,000 James J. Moore 10,000 Phil C. Murray 1,200 Ronald S. Musich 20,000 Theodore C. Nagel and Judy Ann Nagel, JTWROS 5,000 Philip A. Nasby 10,000 Drs. Nelson & Schultz Profit Sharing Trust 12,500 Daniel W. O'Brien 9,000 Kome Okposo 10,000 Rodney L. Olsen and Alyce J. Olsen, JTWROS 10,000 Donald L. Olson and Kaye F. Olson JTWROS 5,000 Roger A. Olson, Trustee 5,000 Michael Ormond and Miriam E. Cameron JTWROS 5,000 Perkins Foundation 10,000 R.W. Perkins TTE, Perkins Capital Management 15,000 Richard W. Perkins, TTEE 25,000 Warren E. Peterson 3,000 Warren E. Peterson 5,000 David W. Powell 10,000 Pyramid Partners L.P. 100,000 James E. Reasoner and Suzanne M. Reasoner JTWROS 10,000 Ben Reuben and Sophie Reuben JTWROS 20,000 Thomas Reynolds 5,000 Devin Patrick Rice 1,700 First Trust National Association, Trustee FBO Devin Patrick Rice IRA 3,300 Dale Roberts 10,000 Gary A. Ross 10,000 Anita A.H.Y Rullens 30,000 First Trust National Association, Trustee FBO Terry H. Rust IRA 10,000 Peter Sajevic 10,000 Frank W. Smith 5,000 Gary Specketer and Eileen Specketer, JTWROS 5,000 SRMI Inc. 10,000 First Trust NATL ASSN TTEE FBO James F. Stattmiller IRA 5,500 Barbara H. Steinkamp, Trustee 1,500 Richard Stiers and Janice Stiers, JTWROS 10,000 First Trust NATL ASSN TTEE FBO William G. Strop IRA 8,000 Gerald Swedeen and Marcia Swedeen, JTWROS 10,000 Denise W. Templeton and James W. Templeton, JTWROS 10,000 William I. Thompson 10,000 Dennis J. Truempi 10,000 Leo Tutewohl and Sharon Tutewohl, JTWROS 10,000 Sylvester M. Vanyo 10,000 Francis P. Veit 4,000 Dean Vlahos and Michelle Redmond Vlahos, JTWROS 10,000 Carl Vogt and Marjorie Vogt, JTWROS 10,000 Donald W. Walczak 5,000 Ronald E. Wald, Jr. and Michele R. Wald, JTWROS 10,000 William G. Walker, Sr. 2,500 First Trust NATL ASSN TTEE FBO William G. Walker, Sr. IRA 5,000 Jerome R. Welle and Mary K. Welle, JTWROS 10,000 Don W. Wennberg 10,000 Jeffrey I. Werbalowsky 20,000 Joseph H. Whitney 10,000 Brian D. Wilcox and Mary T. Wilcox, JTWROS 15,000 Ronald J. Will 5,000 Duane H. Windhorst and Marilyn Windhorst JTWROS 10,000 Judith C. Winge 5,000 Steven E. Wirth and Kathryn E. Wirth, 3,000 David Y. Wolfenson 10,000 Marvin Wolfenson and Elayne Wolfenson JTWROS 20,000 First Trust National Association, Trustee FBO James E. Wolff IRA 7,000 First Trust National Association, Trustee FBO Roberta M. Wolff IRA 3,000 Roger Wothe 5,000 Yushya Yang 95,000 James R. Zylla TTEE 10,000 Total 1,702,950 CERTAIN TRANSACTIONS The Company has a Royalty Agreement with three individuals, namely Arthur A. Beisang, Jr., Robert A. Ersek, M.D., and Arthur A. Beisang, III, M.D. Mr. Beisang and Dr. Ersek are former officers and directors of the Company (see "Business - Patents, Trademarks, and Licenses"), and, as far as the Company knows, each holds, or did hold, more than 5% of the Company's outstanding stock. The aggregate amount of royalty expense recognized by the Company pursuant to such Royalty Agreement during each of the past three fiscal years was as follows. Fiscal Year ended 3/31/98 Uroplasty, Inc. $ 147,860 Fiscal Year ended 3/31/97 Uroplasty, Inc. $ 110,495 Fiscal Year ended 3/31/96 Bioplasty, Inc. $ 1,000 Uroplasty, Inc. 64,695 Total $ 65,695 On July 11, 1997, the Company's then second largest shareholder, the Bioplasty Product Claimants Trust (the "Trust"), which prior to such date owned 640,000 shares, or 17.5% of the Company's then outstanding shares of common stock, sold such shares to a group of investors (the "Investors"). In connection with such transaction, the Trust sold to the Investors its interest in that certain Promissory Note, dated March 30, 1994, which, at March 31, 1997, had a principal balance outstanding of $496,000. Concurrently with the sale by the Trust of the 640,000 shares to the Investors, the Company agreed to convert and did convert the Note into 496,000 shares of Common Stock, at a conversion ratio of $1.00 per share. The Investors, who included certain registered representatives (or their customers) employed by RJ Steichen & Co., the Agent, consisted of 33 individuals, retirement accounts and corporations located primarily in the Minneapolis/St. Paul, Minnesota area. The aforementioned transaction was facilitated by certain registered representatives of RJ Steichen & Co., but they were not directly compensated for their efforts by either the Trust or the Company, and the Investors did not pay a commission on the transaction. There was no involvement whatsoever by the Agent as an entity. DESCRIPTION OF SECURITIES The Company is not presently aware of any arrangements which may result in a change in its control. Common Stock The Company's authorized capital stock consists of 20,000,000 shares of Common Stock, $.01 par value. There were 5,917,475 shares of Common Stock issued and outstanding as of June 30, 1998. There are no preemptive, subscription, conversion or redemption rights pertaining to the Common Stock. The absence of preemptive rights could result in a dilution of the interest of existing shareholders should additional shares of Common Stock be issued. Holders of the Common Stock are entitled to receive such dividends as may be declared by the Board of Directors out of assets legally available therefore, and to share ratably in the assets of the Company available upon liquidation. Each share of Common Stock is entitled to one vote for all purposes and cumulative voting is not permitted in the election of directors. Accordingly, the holders of more than fifty percent of all of the outstanding shares of voting stock can elect all of the directors. Significant corporate transactions such as amendments to the articles of incorporation, mergers, sales of assets and dissolution or liquidation require approval by the affirmative vote of the majority of the outstanding shares of the voting stock. Other matters to be voted upon by the holders of voting stock normally require the affirmative vote of a majority of the shares present at the particular shareholder's meeting. The rights of holders of the shares of Common Stock may become subject in the future to prior and superior rights and preferences in the event the Board of Directors establishes one or more additional classes of Common Stock or one or more additional series of Preferred Stock. The Board of Directors has no present plans to establish any such additional class or series. Shares Eligible For Future Sale There are 5,917,475 shares of Common Stock issued and outstanding as of June 30, 1998. The 1,702,950 shares of Common Stock covered by this Prospectus (the "Shares") are freely tradable without registration or other restriction under the Securities Act of 1933, as amended (the "Securities Act"), except for any Shares owned by an "affiliate" of the Company (as defined in the Securities Act). In addition to the Shares, 3,400,000 shares are presently eligible for sale under Rule 144 and an additional 1,100,000 shares will become eligible for sale under Rule 144 by the end of July, 1998, assuming all of the other requirements of Rule 144 have been satisfied. In general, under Rule 144 as currently in effect, any person (or persons whose shares are aggregated) including persons deemed to be affiliates, whose restricted securities have been fully paid for and held for at least one year from the later of the date of issuance by the Company or acquisition from an affiliate, may sell such securities in broker's transactions or directly to market makers, provided that the number of shares sold in any three month period may not exceed the greater of 1% of the then outstanding shares of Common Stock or the average weekly trading volume of the shares of Common Stock in the over-the-counter market during the four calendar weeks preceding the sale. Sales under Rule 144 are also subject to certain notice requirements and the availability of current public information about the Company. After two years have elapsed from the later of the issuance of restricted securities from the Company or their acquisition from an affiliate, such securities may be sold without limitation by persons who are not affiliates under the rule. The Company cannot predict the effect, if any, that sales of its Common Stock or the availability of such Common Stock for sale, will have on the market price prevailing from time to time. Nevertheless, sales by existing shareholders of substantial amounts of Common Stock could adversely affect prevailing market prices for the Company's Common Stock. Minnesota Anti-Takeover Law The Company is governed by the provisions of Sections 302A.671 and 302A.673 of the Minnesota Business Corporation Act. In general, Section 302A.671 provides that the shares of a corporation acquired in a "control share acquisition" have no voting rights unless voting rights are approved in a prescribed manner. A "control share acquisition" is an acquisition, directly or indirectly, of beneficial ownership of shares that would, when added to all the other shares beneficially owned by the acquiring person, entitle the acquiring person to have voting power of 20% or more in the election of directors. In general, Section 302A.673 prohibits a publicly held Minnesota corporation from engaging in a "business combination" with an "interested shareholder" for a period of four years after the date of the transaction in which the person became an interested shareholder, unless the business combination is approved in a prescribed manner. "Business combination" includes mergers, asset sales and other transactions resulting in a financial benefit to the interested shareholder. An "interested shareholder" is a person who is the beneficial owner, directly or indirectly, of 10% or more of the corporation's voting stock or who is an affiliate or associate of the corporation and at any time within four years prior to the date in question was the beneficial owner, directly or indirectly, of 10% or more of the corporation's voting stock. Transfer Agent and Registrar The Company has selected Stock Trans, Inc., Philadelphia, PA, telephone (610) 649-7300, to act as Registrar and Transfer Agent for the Company's Common Stock. Indemnification The Company's Bylaws and the provisions of the Minnesota Business Corporation Act, which govern the actions of the Company, provide that present and former directors and officers of the Company shall be indemnified against certain liabilities and expenses which any of them may incur as a result of being, or having been, a director or officer of the Company. Indemnification is contingent upon certain conditions being met, including, that the person: has not been previously indemnified by another party for the same matter; has acted in good faith; has received no improper personal benefit; and, in the case of a criminal proceeding, has no reason to believe that the conduct complained of was unlawful and reasonably believed that the conduct complained of was in the best interests of the Company, or in certain circumstances, reasonably believed that, the conduct complained of was not opposed to the best interests of the Company. In addition, the Company's Articles of Incorporation provide that a director of the Company shall not be liable for monetary damages for a breach of such director's fiduciary duty, except for a breach of the duty of loyalty, acts not in good faith or in knowing violation of law, violations of state securities laws, or for actions from which the director derived an improper personal benefit. The Company has obtained directors and officers liability insurance. Insofar, as the indemnification of liabilities arising under the Securities Act may be permitted to directors, officers and controlling persons of the Company pursuant to the provisions of its Articles of Incorporation, Bylaws and the provisions of the Minnesota Business Corporation Act, or otherwise, the Company has been advised that, in the opinion of the Securities and Exchange Commission, such indemnification is against public policy as expressed in the Securities Act and is, therefore, unenforceable. Penny Stock The Company's securities are considered "penny stock" under a Securities and Exchange Commission rule that imposes additional sales practice requirements on agents and broker-dealers who sell such securities to persons other than established customers and institutional accredited investors (generally institutions with assets in excess of $5,000,000). For transactions covered by the rule, the agent or broker- dealer must make a special suitability determination about the purchaser (which concerns financial and business sophistication, previous investment experience and financial condition) and have received the purchaser's written agreement to the transaction prior to the sale. Such agents or broker-dealers must also, prior to the purchase, provide the customer with a risk disclosure document which identifies risks associated with investing in "penny stocks" and which describes the market therefor as well as a brief description of the broker-dealer's obligations under certain "Penny Stock Rules" and rights and remedies available to customers under federal and state securities laws. The broker-dealer must obtain a signed and dated acknowledgement from its customer demonstrating that the customer has actually received the required risk disclosure document before the first transaction in a penny stock. Consequently, such rules will affect the ability of the Agent and any broker-dealers to sell the Company's securities and will affect the ability of purchasers in this offering to sell their securities in the secondary market, if any. REPORTS TO SHAREHOLDERS The Company is currently a reporting company and it will make available to its shareholders annual reports containing audited financial statements and a report by independent certified public accountants, and quarterly reports for the first three quarters of each fiscal year containing unaudited financial information. LEGAL MATTERS The validity of the issuance of the Shares covered hereby will be passed upon for the Company by Keller & Lokken, P.A., St. Paul, Minnesota. EXPERTS The consolidated financial statements of Uroplasty, Inc. and subsidiaries as of March 31, 1998, and 1997, and for the years then ended, have been included herein and in the Registration Statement in reliance upon the report of KPMG Peat Marwick LLP, independent certified public accountants, appearing elsewhere herein, and upon the authority of said firm as experts in accounting and auditing. The report of KPMG Peat Marwick LLP covering the March 31, 1998 financial statements refers to a prior period adjustment. AVAILABLE AND ADDITIONAL INFORMATION The Company is a reporting company under the Securities Exchange Act of 1934, as amended, and therefore files periodic reports with the Securities and Exchange Commission. For further information with respect to the Company and the Shares, reference is made to the Company's periodic reports and other documents filed with the Securities and Exchange Commission ("SEC") in Washington, D.C., which may be inspected without charge, or copies of which may be obtained from the Public Reference Section of the SEC's Washington, D.C. office, 450 Fifth Street N.W., Washington, D.C. 20549 upon payment of the prescribed fees. In addition, such information is available without charge through use of the SEC's EDGAR system, which allows interested persons to obtain on-line access to such information. The SEC maintains a Web site that contains reports, proxy and information statements and other information regarding registrants that file electronically with the SEC, including the Company. The address is (http://www.sec.gov). The Company will provide without charge to each person who receives a copy of this Prospectus, upon written or oral request of such person, a copy of the information, if any, that is incorporated by reference in this Prospectus. Inquiries should be directed to Uroplasty, Inc., 2718 Summer Street NE, Minneapolis, MN 55413-2820, telephone number 612-378-1180, FAX 612-378-2027. UROPLASTY, INC. AND SUBSIDIARIES Consolidated Financial Statements March 31, 1998 and 1997 TABLE OF CONTENTS Page(s) Independent Auditors' Report F-2 Financial Statements: Consolidated Balance Sheets F-3 Consolidated Statements of Operations F-4 Consolidated Statements of Shareholders' Equity F-5 Consolidated Statements of Cash Flows F-6 Notes to Consolidated Financial Statements F-7 - F-16 Independent Auditors' Report The Board of Directors and Shareholders Uroplasty, Inc.: We have audited the accompanying consolidated balance sheets of Uroplasty, Inc. and subsidiaries as of March 31, 1998 and 1997, and the related consolidated statements of operations, shareholders' equity, and cash flows for the years then ended. These consolidated financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on these consolidated financial statements based on our audits. We conducted our audits in accordance with generally accepted auditing standards. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion. In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the financial position of Uroplasty, Inc. and subsidiaries as of March 31, 1998 and 1997, and the results of their operations and their cash flows for the years then ended in conformity with generally accepted accounting principles. As discussed in footnote 7, the fiscal 1997 consolidated financial statements have been revised to reflect a prior period adjustment. KPMG Peat Marwick LLP April 23, 1998 UROPLASTY, INC. AND SUBSIDIARIES Consolidated Financial Statements March 31, 1998 and 1997 CONSOLIDATED BALANCE SHEETS March 31, 1998 AND 1997 1998 1997 Assets Current assets: Cash and cash equivalents $ 889,541 814,603 Accounts receivable trade, less allowance for doubtful accounts of $64,930 in 1998 and $124,000 in 1997 766,835 502,744 Inventories 294,424 387,373 Prepaid expenses 184,628 105,625 Total current assets 2,135,428 1,810,345 Property, plant, and equipment 1,261,059 241,075 Less accumulated depreciation 216,529 92,745 1,044,530 148,330 Intangible assets, net of accumulated amortization of $64,252 in 1998 and $44,500 in 1997 101,586 80,030 Total assets $ 3,281,544 2,038,705 Liabilities and Shareholders' Equity Current liabilities: Accounts payable 358,782 160,811 Accrued liabilities: Compensation and payroll taxes 81,526 62,364 Royalties 16,900 12,400 Other 116,755 95,575 Capital lease obligations current maturities 16,463 32,191 Note payable-current maturities 30,756 36,954 Total current liabilities 621,182 400,295 Capital lease obligations, less current maturities 31,893 0 Note payable, less current maturities 577,713 407,994 Total liabilities 1,230,788 808,289 Shareholders' equity Common stock $.01 par value; authorized 20,000,000 shares 4,191,525 and 3,649,525 issued and outstanding at March 31, 1998 and 1997, respectively 41,915 36,495 Additional paid-in capital 2,432,599 1,963,560 Accumulated deficit (256,629) (664,470) Cumulative translation adjustment (162,129) (100,169) Note receivable shareholder (5,000) (5,000) Total shareholders' equity 2,050,756 1,230,416 Commitments and contingencies (note 4) Total liabilities and shareholders' equity $ 3,281,544 2,038,705 <FN> See accompanying notes to consolidated financial statements. UROPLASTY, INC. AND SUBSIDIARIES Consolidated Statements of Operations Years ended March 31, 1998 and 1997 1998 1997 Net sales $ 4,335,908 3,334,563 Cost of goods sold 937,978 753,769 Gross profit 3,397,930 2,580,794 Operating expenses: General and administrative 994,068 685,430 Research and development 778,082 610,677 Selling and marketing 964,138 908,483 2,736,288 2,204,590 Operating profit 661,642 376,204 Other income (expense) Interest income 8,294 2,389 Interest expense (20,732) (36,884) Liquidation loss on foreign subsidiary 0 (12,307) Foreign currency exchange loss (129,503) (204,315) Other 0 93,134 (141,941) (157,983) Net income before income taxes 519,701 218,221 Income tax expense 111,860 0 Net income $ 407,841 218,221 Net income per common share $ 0.10 0.06 Net income per common share assuming dilution 0.09 0.06 Weighted average common shares outstanding: Basic 4,026,571 3,575,609 Diluted 4,321,132 3,670,275 [FN] See accompanying notes to consolidated financial statements. UROPLASTY, INC. AND SUBSIDIARIES Consolidated Statements of Shareholders' Equity Years ended March 31, 1998 and 1997 Common Stock Additional Accu- Cumulative Total Paid in mulated translation Note shareholders' Shares Amount capital deficit adjustment receivable equity Balance at March 31, 1996 3,472,525 $ 34,725 1,811,830 (882,691)(224,922) (5,000) 733,942 Issuance of 130,000 shares of common stock 130,000 1,300 128,700 0 0 0 130,000 Issuance of 17,000 shares of common stock pursuant to stock option exercise 17,000 170 8,330 0 0 0 8,500 Issuance of 30,000 shares of common stock for note payable conversion 30,000 300 14,700 0 0 0 15,000 Net income 0 0 0 218,221 0 0 218,221 Translation adjustment 0 0 0 0 124,753 0 124,753 Balance at March 31, 1997 3,649,525 36,495 1,963,560 (664,470)(100,169) (5,000) 1,230,416 Issuance of 46,000 shares of common stock pursuant to stock option exercise 46,000 460 23,540 0 0 0 24,000 Issuance of 496,000 shares of common stock for note payable conversion, net of $5,146 of conversion costs 496,000 4,960 436,499 0 0 0 441,459 Stock options issued in lieu of cash compensation 0 0 9,000 0 0 0 9,000 Net income 0 0 0 407,841 0 0 407,841 Translation adjustment 0 0 0 0 (61,960) 0 (61,960) Balance at March 31, 1998 4,191,525 $ 41,915 2,432,599 (256,629)(162,129) (5,000) 2,050,756 <FN> See accompanying notes to consolidated financial statements. UROPLASTY, INC. AND SUBSIDIARIES Consolidated Statements of Cash Flows Years ended March 31, 1998 and 1997 1998 1997 Cash flows from operating activities: Net income $ 407,841 218,221 Adjustments to reconcile net income to net cash provided by operations: Depreciation and amortization 121,640 63,913 Loss on disposal of assets 0 45,000 Liquidation loss on foreign subsidiary 0 12,307 Stock options issued in lieu of cash compensation 9,000 Changes in operating assets and liabilities: Accounts receivable (264,091) (166,596) Inventories 92,949 (130,718) Prepaid expenses (79,003) (12,062) Accounts payable 197,971 (47,592) Accrued liabilities 44,842 (40,525) Net cash provided by (used in) operating activities 531,149 (58,052) Cash flows from investing activities: Payments for property, plant, and equipment (1,045,386) (85,276) Payments relating to intangible assets (41,308) (7,202) Net cash used in investing activities (1,086,694) (92,478) Cash flows from financing activities: Repayment of long-term obligations (63,404) (35,947) Proceeds from issuance of notes payable 684,549 8,909 Net proceeds from issuance of stock 24,000 138,500 Payments received on note receivable 0 22,595 Net cash provided by financing activities 645,145 134,057 Effect of exchange rates on cash and cash equivalents (14,662) 112,446 Net increase in cash and cash equivalents 74,938 95,973 Cash and cash equivalents at beginning of year 814,603 718,630 Cash and cash equivalents at end of year $ 889,541 814,603 Supplemental disclosure of Cash Flow information: Cash paid during the year for interest $ 20,732 37,425 Cash paid during the year for income taxes 87,522 0 Supplemental disclosure of non-cash financing activities: During the years ended March 31, 1998 and 1997, $441,459 and $15,000, respectively, in notes payable were converted into common stock. <FN> See accompanying notes to consolidated financial statements. UROPLASTY, INC. AND SUBSIDIARIES Notes to Consolidated Financial Statements March 31, 1998 and 1997 (1) Summary of Significant Accounting Policies (a) Nature of Business Uroplasty, Inc. (the Company or UPI) is a manufacturer and distributor of urological and plastic surgery implantable medical devices. The primary focus of the Company's business is the marketing of an implantable device for the management of stress urinary incontinence and vesicoureteral reflux. Currently, all sales of the Company's products are to customers outside the United States by the Company's foreign subsidiaries. (b) Principles of Consolidation The consolidated financial statements include the accounts of the Company and its wholly owned foreign subsidiaries. All significant intercompany accounts and transactions have been eliminated. (c) Revenue Recognition The Company recognizes revenue upon shipment of product to customers. (d) Cash and Cash Equivalents The Company considers highly liquid debt instruments purchased with an original maturity of three months or less to be cash equivalents. (e) Patents Patents are stated at cost and are amortized over six years using the straight line method. (f) Income Taxes Deferred tax assets and liabilities are recognized for future tax consequences attributable to differences between the financial carrying amounts of existing assets and liabilities and their respective tax bases. (g) Use of Estimates The preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from these estimates. (h) Inventories Inventories are stated at the lower of cost, (first-in, first-out method), or market (net realizable value), and consist of the following at March 31, 1998 and 1997: 1998 1997 Raw materials $47,891 88,864 Work-in-process 118,973 136,204 Finished goods 127,560 162,305 $294,424 387,373 (i) Property, Plant, and Equipment Property, plant, and equipment are carried at cost and consist of the following at March 31, 1998 and 1997: 1998 1997 Land $129,465 - Building 526,639 - Equipment 604,955 241,075 1,261,059 241,075 Less accumulated depreciation (216,529) (92,745) $1,044,530 148,330 Depreciation is provided for using both straight-line and accelerated methods over useful lives of four to seven years for equipment and 40 years for the building. Maintenance and repairs are charged to expense as incurred. Renewals and betterments are capitalized and depreciated over their estimated useful service lives. (j) Research and Development Research and development costs are expensed as incurred. (k) Foreign Currency Translation The financial statements of the Company's foreign subsidiaries were translated in accordance with the provisions of Statement of Financial Accounting Standards No. 52. Under this Statement, all assets and liabilities are translated using period-end exchange rates and statements of operations items are translated using average exchange rates for the period. The resulting translation adjustment is recorded as a separate component of shareholders' equity. Foreign currency transaction gains and losses are recognized currently in net income. (l) Stock Based Compensation The Company applies the intrinsic value method described in Accounting Principles Board (APB) Opinion No. 25 in accounting for the issuance of stock incentives to employees and directors and, accordingly, no compensation expense has been recognized in the financial statements. Effective April 1, 1996, in accordance with Statement of Financial Accounting Standards No. 123 (SFAS 123), Accounting for Stock Based Compensation, pro forma information reflecting compensation cost for such issuances is presented in the Shareholders' Equity footnote. (m) Net Income Per Common Share Effective December 31, 1997, the Company adopted Statement of Financial Accounting Standards No. 128 (SFAS 128), Earnings per Share. SFAS 128 simplifies the computation of earnings per share ("EPS") previously required by replacing primary and fully diluted EPS with basic and diluted EPS. Under SFAS 128, basic EPS is calculated by dividing net earnings by the weighted-average common shares outstanding during the period. Diluted EPS reflects the potential dilution to basic EPS that could occur upon conversion or exercise of securities, options, or other such items, to common shares using the treasury stock method based upon the weighted-average fair value of the Company's common shares during the period. Reconciliations of basic and diluted average common shares outstanding are as follows: 1998 1997 Average common shares outstanding 4,026,571 3,575,609 Assumed conversion of stock options 294,561 94,666 Average common and assumed conversion shares 4,321,132 3,670,275 Options to purchase 17,753 and 8,740 shares of common stock at $3.19 and $3.25 per share, respectively, were outstanding during 1998 but were not included in the computation of diluted earnings per share because the exercise prices of the options were greater than the average market price of the common shares. The options expire from 2002 to 2004. (n) Reclassifications Certain prior year amounts have been reclassified to conform with the current year presentation. (o) New Accounting Pronouncements Statement of Financial Accounting Standards No. 130 (SFAS 130), Reporting Comprehensive Income, and Statement of Financial Accounting Standards No. 131 (SFAS 131), Disclosures about Segments of an Enterprise and Related Information, were issued in June 1997. SFAS 130 and SFAS 131 are effective for fiscal years beginning subsequent to December 15, 1997 and, therefore, will be adopted by the Company on April 1, 1998. The Company does not expect the adoption of SFAS 130 or SFAS 131 to result in any substantive changes in its disclosure, except that comprehensive income will be adjusted by the amount of the annual translation adjustment. (2) Long-term Debt Long-term debt consists of the following at March 31, 1998 and 1997: 1998 1997 Non-interest bearing, unsecured promissory note payable, discounted at 8% per annum, $16,000 quarterly payments, remaining balance due February 1999 $ - 444,948 Mortgage note, monthly payments of $2,563 plus variable rate interest through November 2017 (rate at March 31, 1998 - 5%) 608,469 - Less current maturities 30,756 36,954 $577,713 407,994 The promissory note payable was converted into 496,000 shares of common stock during 1998. Future payments of long-term debt are as follows: 1999 $ 30,756 2000 30,756 2001 30,756 2002 30,756 2003 30,756 Thereafter 454,689 $ 608,469 (3) Shareholders' Equity (a) Stock Options Pursuant to the Uroplasty, Inc. Qualified Incentive Stock Option Plans, the Company has reserved 677,200 shares of its common stock for issuance to employees and directors. Employee options vest on the date of grant and director options vest evenly over two years. Outstanding options generally expire five years from date of grant. Options are granted at the discretion of the directors and are exercisable in amounts equal to or greater than the fair market value of the Company's common stock at date of grant. The plans provide for the exercise of options during a limited period following termination of employment, death, or disability. Stock option activity under these plans is summarized as follows: Weighted-average Shares exercise price outstanding per share Balance at March 31, 1996 246,700 0.50 Granted 3,000 1.00 Exercised (17,000) 0.50 Canceled (9,500) 0.50 Balance at March 31, 1997 223,200 0.51 Granted 328,000 1.58 Exercised (46,000) 0.52 Balance at March 31, 1998 505,200 $ 1.20 At March 31, 1998, the range of exercise prices and weighted-average remaining contractual life of outstanding options was $0.50- $3.25 and 3.8 years, respectively. (b) Fair Value of Stock Plans The Company applies APB Opinion No. 25, Accounting for Stock Issued to Employees in accounting for its stock incentive plans for designated persons and, accordingly, no compensation cost has been recognized in the financial statements for employee and director stock options granted under its stock option plans. Had the Company determined compensation cost based on the fair value at the grant date for its stock options under SFAS 123, Accounting for Stock-based Compensation, the Company's net income would have decreased to the pro forma amounts shown below: 1998 1997 Net income: As reported $ 407,841 218,221 Pro forma 167,695 217,705 Net income per common share - basic: As reported 0.10 0.06 Pro forma 0.04 0.06 Pro forma net income only reflects options granted in 1998, 1997, and 1996. Therefore, the full impact of calculating compensation cost for stock options under SFAS 123 is not reflected in the pro forma net income amounts presented above because compensation cost is reflected over the options' vesting period and compensation cost for options granted prior to April 1, 1995 is not considered. The per share weighted-average fair value of stock options granted during 1998 and 1997 was $0.97 and $0.17, respectively, on the date of grant, using the Black-Scholes option-pricing model with the following weighted-average assumptions: 1998 1997 Expected dividend yield 0.0% 0.0% Risk-free interest rate 6.0% 6.5% Expected volatility 156.0% 0.0% Expected life, in years 3.0 3.0 (4) Commitments and Contingencies (a) License Agreement On December 7, 1995, the Company entered into an agreement as licensee to obtain exclusive patent rights covering certain injection-related instrumentation. Under this agreement, the Company made a cash payment of approximately $30,000 to the licensor and will make royalty payments at the rate of 10% of the worldwide net sales for a period of 10 years. No additional payments have been made in either fiscal 1998 or 1997. (b) Savings and Retirement Plans The Company sponsors various plans for eligible employees both domestically as well as in the United Kingdom and the Netherlands. The total contibution expense associated with these plans was $43,782 and $13,985 for the years ended March 31, 1998 and 1997, respectively. (c) Operating Lease Commitments UPI leases office, warehouse, and production space under four operating leases and leases various automobiles for its European employees. Future minimum lease payments under noncancelable operating leases with an initial or remaining lease term in excess of one year for the ensuing years ending March 31 are as follows: 1999 $ 279,959 2000 193,606 2001 98,159 2002 56,728 2003 11,211 $ 639,663 Total rent expense paid for operating leases was $241,732 and $167,999 in 1998 and 1997, respectively. (d) Capital Lease Obligations UPI leases various equipment under noncancelable capital leases. The leases call for aggregate monthly payments of $2,034 with various expiration dates through July 2002. Equipment includes $85,854 and $46,661 of cost and $22,070 and $10,340 of accumulated amortization as of March 31, 1998 and 1997, respectively, related to these leases. Future minimum capital lease payments are as follows as of March 31, 1998: 1999 $ 20,371 2000 17,783 2001 10,146 2002 8,665 2003 4,667 61,632 Amount representing interest (13,276) Present value of capital lease payments 48,356 Current maturities 16,463 Obligations under capital leases less current maturities $ 31,893 (e) Royalties Under the terms of an agreement with former officers and directors of the Company, UPI pays royalties equal to between three percent and five percent of the net sales of certain products, subject to a specified monthly minimum of $4,500. The royalties payable under this agreement will continue for the longer of the term of the patent or ten years from the date of this agreement, which began in November, 1993. Total expense recognized under the agreement was $147,860 and $110,495 for the years ended March 31, 1998 and 1997, respectively. Under the terms of a settlement agreement for a patent suit brought by a competitor in 1991, UPI is obligated to pay the plaintiff a royalty equal to five percent of the net sales of certain products in the United States, or a minimum of $50,000 per year as long as the products are being marketed abroad. Total expense recognized under the agreement was $50,000 for each of the years ended March 31, 1998 and 1997. (f) Contingencies The Company, as of March 31, 1998, is not party to any material pending legal proceedings; however, because of the nature of its business, it may become subject to certain claims and lawsuits filed in the ordinary course of business that could adversely affect the Company's financial position. (5) Income Taxes The components of income tax expense for each of the years in the two-year period ended March 31, 1998 consist of the following: 1998 1997 Income tax provision: Current: U.S. and state $ 1,000 - Foreign 111,000 - Total income tax expense $ 112,000 - Effective tax rates differ from statutory federal income tax rates for the year ended March 31, 1998 and 1997 as follows: 1998 1997 Statutory federal income tax rate 34.0% 34.0% State income taxes, net of federal benefit (1.2) 2.0 Valuation allowance decrease (22.6) (36.0) Other permanent differences 2.0 0.0 Impact of foreign operations 9.6 0.0 21.8% 0.0% Deferred taxes as of March 31, 1998 and 1997 consist of the following: 1998 1997 Deferred tax assets: Other reserves and accruals $ 14,000 8,000 Deferred profit on intercompany sales 208,000 300,000 Net operating loss carryforwards 1,001,000 1,031,000 1,223,000 1,339,000 Less valuation allowance (1,223,000) (1,339,000) $ - - At March 31, 1998, the Company had U.S. net operating loss carryforwards (NOL) of approximately $2,061,000 for U.S. income tax purposes, which begin to expire in 2012, and a foreign NOL of approximately $739,000, which carries forward indefinitely. U.S. net operating loss carryforwards cannot be used to offset taxable income in foreign jurisdictions. In addition, U.S. tax rules impose limitations on the use of net operating losses following certain changes in ownership. Such a change in ownership may limit the amount of these benefits that would be available to offset future taxable income each year, starting with the year of ownership change. The Company has not reflected any benefit of such net operating loss carryforwards in the accompanying financial statements in accordance with Financial Accounting Standards Board Statement No. 109. (6) Major Customers and Domestic and Foreign Operations During fiscal 1998 and 1997, approximately 12% and 14% of the Company's net sales were to one customer. Information regarding operations in different geographies for the years ended March 31, 1998 and 1997 is as follows: United Adjustments States Europe and eliminations Consolidated Fiscal 1998 Sales to unaffiliated customers $ - 6,335,002 (1,999,094) 4,335,908 Income from operations (719,552) 1,056,408 324,786 661,642 Other income (expense) 99,104 (240,649) (396) (141,941) Net income (loss) (621,010) 704,461 324,390 407,841 Identifiable assets at March 31, 1998 $3,919,360 2,391,218 (3,029,034) 3,281,544 Fiscal 1997 Sales to unaffiliated customers $ - 3,972,740 (638,177) 3,334,563 Income from operations 201,931 909,960 (735,687) 376,204 Other income (expense) 29,764 57,058 (244,805) (157,983) Net income 231,694 967,024 (980,497) 218,221 Identifiable assets at March 31, 1997 $4,434,731 3,032,906 (5,428,932) 2,038,705 (7) Liquidation Loss on Foreign Subsidiary-Prior Period Adjustment In 1997, the Company liquidated its interest in a wholly owned foreign subsidiary and recognized a net gain of $59,245 in the statement of operations. However, cumulative translation losses of $71,552 related to the Company's net investment in this subsidiary were excluded from the gain or loss on liquidation. Statement of Financial Accounting Standards No. 52, Foreign Currency Translation, requires that upon complete or substantial liquidation of an investment in a foreign entity, the amount attributable to that entity and accumulated in the translation adjustment component of equity shall be removed from the separate component of equity and shall be reported as part of the gain or loss on sale or liquidation of the investment for the period during which the sale or liquidation occurs. Accordingly, the net loss on liquidation charged to other income in 1997 is $12,307, rather than previously reported net gain on liquidation of $59,245. At March 31, 1997 this adjustment reduces previously reported 1997 net income by $71,552 and increases the accumulated deficit, which increase is offset within shareholders' equity by an equivalent reduction in the cumulative translation adjustment. THIS PROSPECTUS DOES NOT 1,702,950 CONSTITUTE AN OFFER TO BUY ANY SHARES OF COMMON STOCK SECURITIES OTHER THAN THE SECURITIES TO WHICH IT RELATES. THIS PROSPECTUS DOES NOT CONSTITUTE AN OFFER TO ANYONE IN UROPLASTY, INC. ANY JURISDICTION IN WHICH SUCH OFFER OR SOLICITATION IS NOT AUTHORIZED OR IN WHICH THE PERSON MAKING SUCH OFFER OR SOLICITATION IS NOT QUALIFIED TO DO SO, OR TO ANY PERSON TO WHOM IT IS UNLAWFUL TO MAKE SUCH OFFER OR SOLICITATION. ALL INFORMATION CONTAINED PROSPECTUS HEREIN IS AS OF THE DATE OF THIS PROSPECTUS, AND NEITHER THE DELIVERY OF THIS PROSPECTUS NOR ANY SALES MADE HEREUNDER SHALL, UNDER ANY CIRCUMSTANCES, IMPLY THAT THERE HAS BEEN NO CHANGE IN THE AFFAIRS OF THE COMPANY SINCE SUCH DATE. BROKERS OR DEALERS EXECUTING A TRANSACTION ON BEHALF OF A SELLING SHAREHOLDER MAY BE REQUIRED TO DELIVER A PROSPECTUS. July ,1998 PART II INFORMATION NOT REQUIRED IN PROSPECTUS Item 24. Indemnification of Directors and Officers. Section 302A.521, Subd. 2., Minnesota Statutes, requires the Registrant to indemnify its directors, officers and employees against liabilities incurred as a result of legal proceedings, unless the Registrant's Articles or Bylaws provide otherwise. Article Five of the Registrant's Bylaws, incorporated by reference as Exhibit 3.2, requires indemnification to the full extent required by Minnesota law. The general effect of such provisions is to relieve the directors and officers of the Registrant from personal liability which may be imposed for certain acts performed in their capacity as directors or officers of the Registrant. Item 25. Other Expenses of Issuance and Distribution. The estimated expenses of the Registrant in connection with the registration of the securities covered hereby are set forth in the following table: SEC Registration Fee $ 1,633 Blue Sky Registration Fees 2,000 NASD Filing Fee 1,732 Transfer agent 1,000 Printing and engraving 2,000 Legal 5,000 Accounting 5,000 Miscellaneous 1,636 Total: $ 20,000 Note: All of such expenses will be paid by the Registrant, and none by the Selling Shareholders. The foregoing estimated expenses do not include any commissions or expenses payable by the Selling Shareholders on their own behalf. Item 26. Recent Sales of Unregistered Securities. During the period of three or more years since June 30, 1995, the Registrant has sold securities not registered under the Securities Act in the transactions described below. 1. In November, 1995, the Registrant sold 1,000,000 shares of its Common Stock to one accredited investor for $500,000 in cash and short-term notes pursuant to a private placement. 2. In August, 1996, the Registrant sold 100,000 shares for $100,000 to one investor, a French corporation, for cash pursuant to a private placement. 3. During the period October,1996, through June 1998, the Registrant sold 116,000 shares to various employees upon exercise of stock options. 4. In October,1996 the Registrant sold 60,000 shares to Precision Optics Corporation pursuant to the conversion of a promissory note. 5. In July, 1997, the Registrant sold 496,000 shares to a group of investors upon conversion of a promissory note. See Item 12 of Form 10-KSB for the fiscal year ended March 31, 1998, or Certain Transactions in the Prospectus which is part of this Registration Statement. 6. In May and June, 1998, the Registrant sold 1,702,950 shares of its Common Stock for an aggregate of $4,044,506.20 to a group of accredited investors for cash pursuant to a private placement. As part of the transaction, the Registrant paid to R.J. Steichen & Co., as Placement Agent, an Agent's commission of $404,450.62 (10% of gross proceeds) and a non-accountable expense allowance of $121,335.18 (3% of gross proceeds). Except for item no. 6, there were no underwriting discounts or sales commissions paid by the Registrant as part of any such transactions. All securities transactions identified above were made in reliance upon the exemptions from registration under Sections 3(b) and 4(2) of the Securities Act of 1933, as amended (in that sales were made to a small number of persons, many of whom were accredited investors, and all of whom were required to purchase for investment purposes only, and each of the instruments recited that they were issued for investment purposes only). Item 27. Exhibits. (a) The following Exhibits are incorporated by reference to the Registrant's Registration Statement on Form 10-SB, filed July 10, 1996: 2.1 First Amended Joint Plan of Reorganization (Modified), of the Registrant, dated January 31, 1994. (Filed as Exhibit 8.1 to Form10SB) 3.1 Articles of Incorporation of Uroplasty, Inc. (Filed as Exhibit 2.1 to Form 10SB) 3.2 Bylaws of Uroplasty, Inc. (Filed as Exhibit 2.2 to Form 10SB) 4.1 Form of Stock Certificate of the Registrant, representing shares of the Registrant's common stock. (Filed as Exhibit 3.1 to Form 10SB) 10.1 Settlement Agreement and Release dated November 30, 1993 by and between Bioplasty, Inc., Bio-Manufacturing, Inc., Uroplasty, Inc., Arthur A. Beisang, Arthur A. Beisang, III, MD and Robert A. Ersek, MD. (Filed as Exhibit 6.1 to Form 10SB) 10.2 Purchase and Sale Agreement dated December 1, 1995 by and among Bio-Vascular, Inc., Bioplasty, Inc. and Uroplasty, Inc. (Filed as Exhibit 6.2 to Form 10SB) 10.3 License Agreement dated December 1, 1995 by and among Bio-Vascular, Inc. and Uroplasty, Inc. (Filed as Exhibit 6.3 to Form 10SB) 10.4 Lease Agreement dated January 10, 1995 between Summer Business Center Partnership and Uroplasty, Inc. (Filed as Exhibit 6.4 to Form 10SB) 10.5 Unsecured $640,000 Promissory Note dated March 30, 1994 by and between Bioplasty, Inc., Uroplasty, Inc. and Bioplasty Product Claimants' Trust. (Filed as Exhibit 6.5 to Form 10SB) 10.6 Agreement and Satisfaction dated January 30, 1995 by and between Bioplasty Product Claimants' Trust and Bioplasty, Inc. (Filed as Exhibit 6.6 to Form 10SB) 10.7 Asset Sale and Satisfaction of Debt Agreement dated June 23, 1995 by and between Bioplasty, Inc. and Uroplasty, Inc. (Filed as Exhibit 6.7 to Form 10SB) 10.8 Executory Contract Assumption Stipulation dated December 28, 1993 by and between Bioplasty, Inc., Uroplasty, Inc. and Collagen Corporation. (Filed as Exhibit 6.8 to Form 10SB) 10.9 Settlement and License Agreement dated July 23, 1992 by and between Collagen Corporation, Bioplasty, Inc. and Uroplasty, Inc. (Filed as Exhibit 6.9 to Form 10SB) (b) The following exhibits are filed as part of this report: 21.1 Subsidiaries of the Registrant (Incorporated by reference to Exhibit 21.1 to the Registrant's Annual Report on Form 10-KSB for the fiscal year ended March 31, 1998). *23.1 Consent of KPMG Peat Marwick LLP - Independent Auditor. *24.1 Form of Power of Attorney, running from each of the Registrant's directors namely Joel R. Pitlor, R. Patrick Maxwell, Carolyn A. Bruhjell, and Daniel G. Holman to Daniel G. Holman CEO, CFO, Chairman and President and Susan Hartjes-Doherty, Vice President of Operations and Regulatory Affairs, of the Registrant, respectively, with respect to signing of this Registration Statement and any amendments. 27.1 Financial Data Schedule (Incorporated by reference to Exhibit 27.1 to the Registrant's Annual Report on Form 10-KSB for the fiscal year ended March 31, 1998). *Included with this filing (c) The following exhibits will be filed by amendment: 5.1. Opinion of Keller & Lokken, P.A. regarding legality of securities being registered. 23.2 Consent of Keller & Lokken, P.A. Contained in Exhibit 5.1 to this Registration Statement. Item 28. Undertakings. a. Rule 415 Offering [Item 512(a) of Regulation S-B] The small business issuer will: (1) File, during any period in which it offers or sells securities, a post-effective amendment to this registration statement to: (i) Include any prospectus required by section 10(a)(3) of the Securities Act of 1933 (the "Securities Act"); (ii) Reflect in the prospectus any facts or events which, individually or together, represent a fundamental change in the information in the registration statement; and (iii) Include any additional or changed material information on the plan of distribution. (2) For determining liability under the Securities Act, treat each post-effective amendment as a new registration statement of the securities offered, and the offering of the securities at that time to be the initial bona fide offering. (3) File a post-effective amendment to remove from registration any of the securities that remain unsold at the end of the offering. b. Request for Acceleration of Effective Date [Item 512(e) of Regulation S-B]: Insofar as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers and controlling persons of the small business issuer pursuant to the foregoing provisions, or otherwise, the small business issuer has been advised that in the opinion of the Securities and Exchange Commission such indemnification is against public policy as expressed in the Act and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the small business issuer of expenses incurred or paid by a director, officer or controlling person of the small business issuer in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, the small business issuer will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the Securities Act and will be governed by the final adjudication of such issue. Signatures In accordance with the requirements of the Securities Act of 1933, the Registrant certifies that it has reasonable grounds to believe that it meets all of the requirements for filing on Form SB-2 and authorized this Registration Statement to be signed on its behalf by the undersigned, in the City of Minneapolis, State of Minnesota, on July 10, 1998. UROPLASTY INC. /s/ Daniel G. Holman By: Daniel G. Holman, Chairman,President, CEO, CFO In accordance with the requirements of the Securities Act of 1933, this Registration Statement has been signed by the following persons in the capacities and on the dates stated. Signature Title Dated: /s/ Daniel G. Holman Chairman, President, July 10, 1998 Daniel G. Holman CEO and CFO (Principal executive officer, principal financial officer and principal accounting officer) * Director ) Joel R. Pitlor ) ) ) * Director ) R. Patrick Maxwell ) ) ) * Director ) By: /s/ Daniel G. Holman Carolyn A. Bruhjell ) Daniel G. Holman ) Attorney-in-Fact July 10, 1998 * Executed by Daniel G. Holman as Attorney-in-Fact