For the three months ended June 30, 2009, the company recorded revenue of $42,301, after posting no revenue from the sale of our products in the three months ended June 30, 2008. The company has acquired sufficient inventory, affected a meaningful product launch, and has sold various quantities of each of the twelve sizes of its Brain Access System product to both domestic and international customers.
Research and development expenses decreased from $9,228 to $0 for the three months ended June 30, 2009. This decrease can be attributed to the ceasing of research and development activities on the existing product line.
General and administrative expenses decreased by 38.63%, or $147,320 from $381,365 for the three months ended June 30, 2008 to $234,045 for the three months ended June 30, 2009. The decrease was attributable to the elimination of certain nonrecurring legal and consulting costs related to the company’s capital transactions in 2008.
The company recorded interest expense of $54,639 and $157,099 for the three months ended June 30, 2009 and 2008, respectively. The decrease occurred since the majority of the debt discount attributable to the company’s existing convertible debt was recognized prior to the three months ended June 30, 2009. For the three months ended June 30, 2009 and 2008, interest expense was offset with interest income of $45 and $2,527, respectively.
The following table presents the dollar amount changes from period to period of the line-items included in our Statements of Operations for the six months ended June 30, 2009 and 2008:
For the six months ended June 30, 2009, the company recorded revenue of $112,389, after posting no revenue from the sale of our products in the six months ended June 30, 2008. The company has acquired sufficient inventory, affected a meaningful product launch, and has sold various quantities of each of the twelve sizes of its Brain Access System product to both domestic and international customers.
Research and Development Expenses:
Research and development expenses decreased from $15,561 to $0 for the six months ended June 30, 2009. This decrease can be attributed to the ceasing of research and development activities on the existing product line.
General and Administrative Expenses:
General and administrative expenses decreased by 33.02%, or $283,982 from $859,993 for the six months ended June 30, 2008 to $576,011 for the six months ended June 30, 2009. The decrease was attributable to the elimination of certain nonrecurring legal and consulting costs related to the company’s capital transactions in 2008.
Interest Expense (Income):
The company recorded interest expense of $193,393 and $250,598 for the six months ended June 30, 2009 and 2008, respectively. The decrease occurred since the majority of the debt discount attributable to the company’s existing convertible debt was recognized prior to the six months ended June 30, 2009. For the six months ended June 30, 2009 and 2008, interest expense was offset with interest income of $246 and $4,231, respectively.
Liquidity and Capital Resources
Liquidity
On February 15, 2008, the company entered into a transaction with Regent Private Capital, LLC, whereby Regent Private Capital, LLC agreed to invest $1,000,000 in the purchase of the company’s Convertible Debentures—such investment to be made in two tranches of $500,000 each. These Convertible Debentures have a term of one year and are convertible into shares of the our common stock at a price of approximately $.123 per share. If fully converted, the Convertible Debentures would result in the issuance of 8,129,529 shares to Regent Private Capital, LLC. On April 22, 2008 Regent Private Capital assigned $250,000 of the principal amount of the Convertible Debentures representing the first tranche to Derek Johannson and $100,000 of the principal amount of the Convertible Debentures to Altcar Investments Ltd. On December 2, 2008 Derek Johannson converted $250,000 of his debenture to 2,032,520 shares of common stock of the company. On March 23, 2009, Altcar Investments converted $100,000 of the debenture plus accrued interest of $6,625 into 866,867 shares of common stock.
For the six months ended June 30, 2009, the Company issued common stock valued at $5,000 for consulting services. During the same period, share-based compensation of $62,297 was recognized relating to previously executed consulting agreements and the vesting of employee-held options.
For the six months ended June 30, 2009, the Company realized a reduction in cash and cash equivalents of $141,211. This amount was entirely attributable to cash used in operating activities, as there was no cash used in or provided by either investing or financing transactions during the period.
The company believes that its existing cash, cash equivalents and available borrowings will only be sufficient to meet our anticipated cash needs for working capital and capital expenditures for a very limited period. The company will need to immediately seek additional funding through public or private financings or other arrangements on a current basis and hereafter. Adequate funds may not be available when needed or may not be available on terms favorable to us. If additional funds are raised by issuing equity securities, dilution to existing stockholders may result. If the company raises additional funds by obtaining loans from third parties, the terms of those financing arrangements may include negative covenants or other restrictions on our business that could impair our operational flexibility, and would also require us to fund additional interest expense. If funding is insufficient at any time in the future, the company may be unable to develop or enhance our products, take advantage of business opportunities or respond to competitive pressures, any of which could have a material adverse effect on our business, financial condition and results of operations.
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Going Concern
Our independent auditors have added an explanatory paragraph to their audit issued in connection with the financial statements for the period ended December 31, 2008, relative to our ability to continue as a going concern. This means that there is substantial doubt that the company can continue as an ongoing business for the next 12 months. The financial statements do not include any adjustments that might result from the uncertainty about our ability to continue our business. The company has incurred losses since inception, including net losses of $2,381,295 for the year ended December 31, 2008 and $671,849 for the six months ended June 30, 2009, and expects to incur substantial additional losses, including additional development costs, costs related to marketing and manufacturing expenses. The company has incurred negative cash flows from operations since inception. As of June 30, 2009 and December 31, 2008, the company had stockholders’ deficiencies of $1,419,355 and $921,427, respectively, and cash and cash equivalents balance of $54,927 and $196,138 at June 30, 2009 and December 31, 2008, respectively. The Company also has certain debt obligations that were not paid by their respective due dates. Since there is no record of profitable operations, there is high a possibility that you may suffer a complete loss of your investment. Because our auditors have issued a going concern opinion, there is substantial uncertainty we will continue operations in which case you could lose your investment. In these circumstances the Company believes it may not have enough cash to meet its various cash needs through August 2009 unless the Company is able to obtain additional cash from the issuance of debt or equity securities. There is no assurance that additional funds from the issuance of equity will be available for the Company to finance its operations on acceptable terms. These conditions raise substantial doubt about the Company’s ability to continue as a going concern. The financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities that may result from the outcome of this uncertainty.
Recently Issued Accounting Pronouncements
The Company has adopted all recently issued accounting pronouncements. The adoption of the accounting pronouncements, including those not yet effective, is not anticipated to have a material effect on the financial position or results of operations of the Company.
Critical Accounting Policies and Estimates
Uses of estimates in the preparation of financial statements
The preparation of financial statements in conformity with accounting principles generally accepted in the United States (“GAAP”) requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Currently, the Company estimates depreciation, amortization of intangible assets, and the fair values of options and warrants.
The most critical estimates that impact the financial position and results of operation of the company have to do with the methodologies and assumptions used in determining the fair value of various debt estimates. These include assumptions associated with warrants, options and stock issued in conjunction with such debt. Additionally, the Black-Scholes option pricing model and its related assumptions of volatility, risk free interest, stock price also significantly impacted share based compensation and the results of operations.
Research and Development
The Company expenses all research and development costs as incurred. For the six months ended June 30, 2009 and 2008, the amounts charged to research and development expenses were $ 0 and $15,561, respectively.
Cash and cash equivalents
The Company considers all highly liquid debt investments with original maturities of six months or less when purchased to be cash equivalents. The carrying amounts approximate fair market value because of the short maturity. The Company maintains cash balances at various financial institutions. Accounts at each institution are insured by the Federal Deposit Insurance Corporation up to $250,000. The Company's accounts at these institutions may, at times, exceed the federally insured limits. The Company has not experienced any losses in such accounts.
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Fair Values of Financial Instruments
At June 30, 2009 and 2008, fair values of cash and cash equivalents, accounts payable, convertible promissory notes, and options and warrants approximate their carrying amount due to the short period of time to maturity and various fair value model calculations.
Property and equipment
The Company records property and equipment at cost and calculates depreciation using the straight-line method over the estimated useful life of the assets, which is estimated to be between three and ten years.
Income taxes
The Company accounts for income taxes in accordance with SFAS 109, Accounting for Income Taxes. This statement prescribes the use of the liability method whereby deferred tax assets and liability account balances are determined based on differences between financial reporting and tax bases of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. The Company provides a valuation allowance, if necessary, to reduce deferred tax assets to their estimated realizable value.
Patents
The Company capitalizes legal and related costs associated with the establishment of patents for its products. Costs associated with the development of the patented item or process are charged to research and development costs as incurred. The costs associated with the establishment of the patents are amortized over the life of the patent.
The Company reviews existing patents as well as those in the approval process for impairment on an annual basis using a present value, cash flow method pursuant to Statement of Financial Accounting Standards 142, Goodwill and Other Intangible Assets. Since the Company’s patents are either very new or still in the process of approval, the Company does not believe that any impairment of these amounts exists.
Revenue Recognition
The Company records revenue at the time, pursuant to Staff Accounting Bulletin Topic 13(a), that a completed contract for the sale exists, title transfers to the buyer and the product is invoiced and shipped to the customer. The Company intends to sell a surgical access system which has already cleared the U.S. FDA 510(k) review process. It has been granted a 510(k) number to market to hospitals and other medical professionals. The Company does not expect the need to provide for product returns or warrantee costs but will review such potential costs after the commencement of sales.
Educational and marketing expenses
The Company may incur costs for the education of customers on the uses and benefits of its products. The Company will expense such costs as a component of selling, general and administrative costs as such costs are incurred.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Not applicable
ITEM 4. CONTROLS AND PROCEDURES
(a) | Disclosure Controls and Procedures |
The Company’s management, with the participation of its principal executive officer and principal financial officer, has evaluated the effectiveness of the Company’s disclosure controls and procedures (as defined in Rules 13a-15(e) or 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”)) as of the end of the period covered by this Quarterly Report on Form 10-Q. Based on such evaluation, the Company’s principal
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executive officer and principal financial officer have concluded that, as of the end of such period, the Company’s disclosure controls and procedures were adequate and effective.
(b) | Changes in Internal Controls |
There have not been any changes in the Company’s internal control over financial reporting (as such term is defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) during the quarter ended June 30, 2009 that have materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting.
PART II
ITEM 1. LEGAL PROCEEDINGS
We are subject from time to time to litigation, claims and suits arising in the ordinary course of business. As of June 30, 2009, we were not a party to any material litigation, claim or suit whose outcome could have a material effect on our financial statements.
ITEM 2 UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
None
ITEM 3 DEFAULTS UPON SENIOR SECURITIES |
The Company is in default on the following Senior Securities:
| a) | Convertible Debenture in the original face amount of $150,000 in favor of Fountainhead Capital Partners Limited dated February 15, 2008 which matured on February 15, 2009; |
| b) | Convertible Debenture in the original face amount of $150,000 in favor of Regent Private Capital, LLC dated February 15, 2008 which matured on February 15, 2009; |
| c) | Convertible Debenture in the original face amount of $150,000 in favor of Fountainhead Capital Partners Limited dated April 15, 2008 which matured on April 15, 2009; |
| d) | Convertible Debenture in the original face amount of $500,000 in favor of Regent Private Capital, LLC dated April 22, 2008 which matured on April 22, 2009; |
| e) | Senior Subordinated Debenture in the original face amount of $40,000 in favor of Fountainhead Capital Partners Limited and Regent Private Capital, LLC dated June 30, 2009 which matured on July 31, 2009. |
The Company is engaged in periodic discussions with the holders of these securities, however, as of this date there has been no definitive resolution of any of these defaults.
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
ITEM 5. OTHER INFORMATION
SUBSEQUENT EVENTS
On July 30, 2009 the Company issued Senior Subordinated Debentures totaling $53,000 to Fountainhead Capital Management Limited and Regent Private Capital, LLC for proceeds of equivalent value. These debentures, due on or before August 31, 2009, accrue interest at the “Applicable Federal Rate” as defined by Internal Revenue Code. These are senior obligations of the Company, subordinate only to other existing debt instruments to these parties.
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On July 31, 2009, the Company became in default on Senior Subordinated Debentures totaling $40,000 held by Fountainhead Capital Management Limited and Regent Private Capital, LLC. There is no existing plan to cure said default at this time.
In accordance with existing consulting agreements, the Company issued the following common shares on July 28, 2009:
| Steven Girgenti | 26,316 |
| Dr. Konstantin Slavin | 39,145 |
On August 13, 2009, the Company received correspondence from one of its primary suppliers which ostensibly asserts that the Company owes the vendor approximately $117,000 on account of goods manufactured but not yet shipped and for certain allowances representing their claim of increases in the cost of producing goods. The Company has recorded the cost of all inventory it has previously received from this vendor, however, this additional amount has not been recorded as the goods have not shipped, been reviewed or accepted by the Company and is in dispute. The vendor has advised the Company that no further goods will be shipped to the Company until this matter is resolved to the satisfaction of the vendor.
ITEM 6. EXHIBITS
Index to Exhibits
| |
31.1 | Certification of Chief Executive Officer under Rule 13(a) - 14(a) of the Exchange Act. |
31.2 | Certification of Chief Financial Officer under Rule 13(a) - 14(a) of the Exchange Act. |
32 | Certification of CEO and CFO under 18 U.S.C. Section 1350 |
SIGNATURES
In accordance with Section 13 or 15(d) of the Exchange Act, the registrant caused this report to be signed on its behalf by the undersigned, thereunto duly authorized, on August 14, 2009.
| | | |
| VYCOR MEDICAL, INC. | |
| | | |
| By: | /s/ Kenneth T. Coviello | |
| | Kenneth T. Coviello | |
| | Chief Executive Officer and Director (Principal Financial Officer) | |
| | | |
| | | |
| By: | /s/ Heather N. Jensen | |
| | Heather N. Jensen | |
| | President, Founder and Director (Principal Executive Officer) | |
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