Document_And_Entity_Informatio
Document And Entity Information (USD $) | 12 Months Ended | ||
Dec. 31, 2014 | Mar. 10, 2015 | Jun. 27, 2014 | |
Document and Entity Information [Abstract] | |||
Entity Registrant Name | Kips Bay Medical, Inc. | ||
Document Type | 10-K | ||
Current Fiscal Year End Date | -19 | ||
Entity Common Stock, Shares Outstanding | 33,014,079 | ||
Entity Public Float | $9,287,192 | ||
Amendment Flag | FALSE | ||
Entity Central Index Key | 1460198 | ||
Entity Current Reporting Status | Yes | ||
Entity Voluntary Filers | No | ||
Entity Filer Category | Smaller Reporting Company | ||
Entity Well-known Seasoned Issuer | No | ||
Document Period End Date | 31-Dec-14 | ||
Document Fiscal Year Focus | 2014 | ||
Document Fiscal Period Focus | FY |
Balance_Sheets
Balance Sheets (USD $) | Dec. 31, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Current assets: | ||
Cash and cash equivalents | $3,138 | $2,316 |
Short-term investments, net | 457 | 2,684 |
Accounts receivable | 8 | 28 |
Inventories | 673 | 793 |
Prepaid expenses and other current assets | 109 | 88 |
Total current assets | 4,385 | 5,909 |
Property and equipment, net | 353 | 400 |
Total assets | 4,738 | 6,309 |
Current liabilities: | ||
Accounts payable | 78 | 141 |
Accrued liabilities | 355 | 314 |
Total current liabilities | 433 | 455 |
Commitments and contingencies (Note 10) | ||
Stockholders’ equity: | ||
Undesignated stock, $0.01 par value, 10,000,000 shares authorized, no shares issued and outstanding as of December 31, 2014 and 2013. | 0 | 0 |
Common stock, $0.01 par value, 90,000,000 shares authorized as of December 31, 2014 and 40,000,000 shares authorized as of December 31, 2013, 33,014,079 and 26,979,079 shares issued and outstanding as of December 31, 2014 and 2013, respectively | 330 | 270 |
Additional paid-in capital | 45,492 | 41,494 |
Accumulated other comprehensive loss | 0 | 0 |
Accumulated deficit | -41,517 | -35,910 |
Total stockholders’ equity | 4,305 | 5,854 |
Total liabilities and stockholders’ equity | $4,738 | $6,309 |
Balance_Sheets_Parentheticals
Balance Sheets (Parentheticals) (USD $) | Dec. 31, 2014 | Dec. 31, 2013 |
Undesignated stock, par value (in Dollars per share) | $0.01 | $0.01 |
Undesignated stock, shares authorized | 10,000,000 | 10,000,000 |
Undesignated stock, shares issued | 0 | 0 |
Undesignated stock, shares outstanding | 0 | 0 |
Common stock, par value (in Dollars per share) | $0.01 | $0.01 |
Common stock, shares authorized | 90,000,000 | 40,000,000 |
Common stock, shares issued | 33,014,079 | 26,979,079 |
Common stock, shares outstanding | 33,014,079 | 26,979,079 |
Statements_of_Operations
Statements of Operations (USD $) | 12 Months Ended | ||
In Thousands, except Share data, unless otherwise specified | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 |
Net sales | $84 | $130 | $226 |
Cost of sales | -44 | -63 | -98 |
Gross profit | 40 | 67 | 128 |
Operating expenses: | |||
Research and development | 2,503 | 3,075 | 2,483 |
Selling, general and administrative | 3,150 | 3,068 | 3,167 |
Operating loss | -5,613 | -6,076 | -5,522 |
Interest income | 6 | 16 | 15 |
Net loss | ($5,607) | ($6,060) | ($5,507) |
Basic and diluted net loss per share (in Dollars per share) | ($0.17) | ($0.23) | ($0.34) |
Weighted average shares outstanding — basic and diluted (in Shares) | 32,534,586 | 26,916,060 | 16,402,363 |
Statements_of_Comprehensive_Lo
Statements of Comprehensive Loss (USD $) | 12 Months Ended | ||
In Thousands, unless otherwise specified | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 |
Net loss | ($5,607) | ($6,060) | ($5,507) |
Other comprehensive income: | |||
Unrealized gain on available-for-sale securities | 3 | ||
Comprehensive loss | ($5,607) | ($6,060) | ($5,504) |
Statements_of_Stockholders_Equ
Statements of Stockholders’ Equity (USD $) | Sale Of Common Stock Under Common Stock Purchase Agreement [Member] | Sale Of Common Stock Under Common Stock Purchase Agreement [Member] | Sale Of Common Stock Under Common Stock Purchase Agreement [Member] | Sale of Common Stock in Public Offering 1 [Member] | Sale of Common Stock in Public Offering 1 [Member] | Sale of Common Stock in Public Offering 1 [Member] | Issued to Underwriters [Member] | Issued to Underwriters [Member] | Issued to Underwriters [Member] | Sale of Common Stock in Public Offering 3 [Member] | Sale of Common Stock in Public Offering 3 [Member] | Sale of Common Stock in Public Offering 3 [Member] | Common Stock [Member] | Additional Paid-in Capital [Member] | Retained Earnings [Member] | Accumulated Other Comprehensive Income (Loss) [Member] | Total |
In Thousands, except Share data | Common Stock [Member] | Additional Paid-in Capital [Member] | Common Stock [Member] | Additional Paid-in Capital [Member] | Common Stock [Member] | Additional Paid-in Capital [Member] | Common Stock [Member] | Additional Paid-in Capital [Member] | |||||||||
Balance at Dec. 31, 2011 | $162 | $34,591 | ($24,343) | ($3) | $10,407 | ||||||||||||
Balance (in Shares) at Dec. 31, 2011 | 16,245,579 | ||||||||||||||||
Net loss | -5,507 | -5,507 | |||||||||||||||
Unrealized gain on investments, net | 3 | 3 | |||||||||||||||
Common stock issued, value | 1 | 134 | 135 | 100 | 5,341 | 5,441 | |||||||||||
Common stock issued, shares (in Shares) | 100,000 | 10,000,000 | |||||||||||||||
Stock-based compensation expense | 588 | 588 | |||||||||||||||
Exercise of stock options | 1 | 1 | |||||||||||||||
Exercise of stock options (in Shares) | 500 | ||||||||||||||||
Balance at Dec. 31, 2012 | 263 | 40,655 | -29,850 | 11,068 | |||||||||||||
Balance (in Shares) at Dec. 31, 2012 | 26,346,079 | ||||||||||||||||
Net loss | -6,060 | -6,060 | |||||||||||||||
Common stock issued, value | 5 | 271 | 276 | ||||||||||||||
Common stock issued, shares (in Shares) | 475,000 | ||||||||||||||||
Restricted stock grants | 1 | -1 | |||||||||||||||
Restricted stock grants (in Shares) | 120,000 | ||||||||||||||||
Vendor payments in common stock | 1 | 38 | 39 | ||||||||||||||
Vendor payments in common stock (in Shares) | 38,000 | ||||||||||||||||
Stock-based compensation expense | 531 | 531 | |||||||||||||||
Balance at Dec. 31, 2013 | 270 | 41,494 | -35,910 | 5,854 | |||||||||||||
Balance (in Shares) at Dec. 31, 2013 | 26,979,079 | ||||||||||||||||
Common stock issued, shares (in Shares) | 6,035,000 | ||||||||||||||||
Balance at Jan. 29, 2014 | |||||||||||||||||
Balance at Dec. 31, 2013 | 41,494 | -35,910 | 5,854 | ||||||||||||||
Net loss | -5,607 | -5,607 | |||||||||||||||
Common stock issued, value | 60 | 3,583 | 3,643 | ||||||||||||||
Common stock issued, shares (in Shares) | 6,035,000 | ||||||||||||||||
Stock-based compensation expense | 415 | 415 | |||||||||||||||
Balance at Dec. 31, 2014 | $330 | $45,492 | ($41,517) | $4,305 | |||||||||||||
Balance (in Shares) at Dec. 31, 2014 | 33,014,079 |
Statements_of_Stockholders_Equ1
Statements of Stockholders’ Equity (Parentheticals) (USD $) | 12 Months Ended | ||
In Thousands, unless otherwise specified | Dec. 31, 2012 | Dec. 31, 2013 | Dec. 31, 2014 |
Sale of Common Stock in Public Offering 1 [Member] | |||
Common stock issued, issuance costs | $1,059 | ||
Issued to Underwriters [Member] | |||
Common stock issued, issuance costs | 33 | ||
Sale of Common Stock in Public Offering 3 [Member] | |||
Common stock issued, issuance costs | $581 |
Statements_of_Cash_Flows
Statements of Cash Flows (USD $) | 12 Months Ended | ||
Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | |
Cash flows from operating activities: | |||
Net loss | ($5,607,000) | ($6,060,000) | ($5,507,000) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation expense | 49,000 | 55,000 | 109,000 |
Stock-based compensation | 415,000 | 570,000 | 588,000 |
Amortization of premium on short-term investments | 20,000 | 74,000 | 79,000 |
Other | 17,000 | 17,000 | |
Changes in operating assets and liabilities: | |||
Accounts receivable | 20,000 | 3,000 | 9,000 |
Inventories | 120,000 | 122,000 | -23,000 |
Prepaid expenses and other current assets | -21,000 | 15,000 | -3,000 |
Accounts payable | -63,000 | -192,000 | 248,000 |
Accrued liabilities | 41,000 | -141,000 | 280,000 |
Net cash used in operating activities | -5,026,000 | -5,537,000 | -4,203,000 |
Cash flows from investing activities: | |||
Proceeds from sales and maturities of short-term investments | 3,423,000 | 3,814,000 | 6,459,000 |
Purchases of short-term investments | -1,216,000 | -5,625,000 | -4,526,000 |
Purchase of property and equipment | -2,000 | -17,000 | -117,000 |
Proceeds from sale of property and equipment | 2,000 | 2,000 | |
Net cash provided (used in) by investing activities | 2,205,000 | -1,826,000 | 1,818,000 |
Cash flows from financing activities: | |||
Proceeds from the exercise of employee stock options | 1,000 | ||
Net cash provided by financing activities | 3,643,000 | 276,000 | 5,577,000 |
Net increase (decrease) in cash and cash equivalents | 822,000 | -7,087,000 | 3,192,000 |
Cash and cash equivalents at beginning of period | 2,316,000 | 9,403,000 | 6,211,000 |
Cash and cash equivalents at end of period | 3,138,000 | 2,316,000 | 9,403,000 |
Sale of Common Stock in Public Offering 1 [Member] | |||
Cash flows from financing activities: | |||
Proceeds from sale of common stock | 3,643,000 | ||
Sale of Common Stock in Public Offering 2 [Member] | |||
Cash flows from financing activities: | |||
Proceeds from sale of common stock | 276,000 | ||
Sale of Common Stock in Public Offering 3 [Member] | |||
Cash flows from financing activities: | |||
Proceeds from sale of common stock | 5,441,000 | ||
Sale Of Common Stock Under Common Stock Purchase Agreement [Member] | |||
Cash flows from financing activities: | |||
Proceeds from sale of common stock | $135,000 |
Statements_of_Cash_Flows_Paren
Statements of Cash Flows (Parentheticals) (USD $) | 12 Months Ended | ||
Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | |
Sale of Common Stock in Public Offering 1 [Member] | |||
Issuance costs | $581,000 | ||
Sale of Common Stock in Public Offering 2 [Member] | |||
Issuance costs | 33,000 | ||
Sale of Common Stock in Public Offering 3 [Member] | |||
Issuance costs | 1,059,000 | ||
Sale Of Common Stock Under Common Stock Purchase Agreement [Member] | |||
Issuance costs | $4,000 |
Note_1_Organization_and_Busine
Note 1 - Organization and Business | 12 Months Ended |
Dec. 31, 2014 | |
Disclosure Text Block [Abstract] | |
Organization, Consolidation and Presentation of Financial Statements Disclosure [Text Block] | 1. Organization and Business |
Kips Bay Medical, Inc. (“we”, “us” or “our”) is a medical device company focused on manufacturing and commercializing our external saphenous vein support technology, or eSVS® Mesh, for use in coronary artery bypass grafting (“CABG”) surgery. Our eSVS Mesh is designed to be fitted like a sleeve on the outside of saphenous vein grafts (“SVG”) to strengthen SVGs used in coronary artery bypass graft surgery. By strengthening the SVG and preventing the damaging expansion of the vein graft, we hope to reduce or prevent the resulting injury which can lead to SVG failure and potentially costly and complicated re-interventions for patients undergoing CABG surgery and also improve patient quality of life. To strengthen an SVG, the eSVS Mesh is manufactured from nitinol wire which gives the eSVS Mesh considerable strength, while remaining highly flexible and kink-resistant. | |
CABG surgery is one of the most commonly performed cardiac surgeries in the United States. In CABG procedures, surgeons harvest blood vessels, including the left internal mammary artery from the chest wall and the saphenous vein from the leg, and attach the harvested vessels to the heart in order to bypass, or provide blood flow around, blocked coronary arteries. | |
We are currently conducting a feasibility trial for the FDA. This trial is a multi-center, randomized study of external saphenous vein support using our eSVS Mesh in CABG surgery and is titled the “eMESH I” clinical feasibility trial. Enrollments in eMESH I feasibility trial commenced internationally in late August 2012 at the Bern University Hospital in Switzerland and in the United States in February 2013 at the Northeast Georgia Medical Center in Gainesville, Georgia. The primary safety endpoint is the 30-day rate of MACE, defined as the rate of the composite of total mortality, myocardial infarction (heart attack), and/or coronary target vessel revascularization (either percutaneous coronary intervention or CABG) within 30 days of the procedure. The eSVS Mesh performance will be evaluated based upon the angiographic patency rate of the enrolled grafts, where patency is defined as less than 50% stenosis, or blockage, of the SVG at six months after surgery. Patients in the eMESH I clinical feasibility trial will be followed through hospital discharge, with additional follow-up visits at 30 days, three months, six months, one year and yearly thereafter through five years. However, only the results through the six-month follow-up visit will be submitted to the FDA as part of an application for an IDE to conduct a pivotal trial in the United States. | |
Enrollment in the eMESH I clinical feasibility trial has reached our targeted goal of 45 to 50 patients treated with the new surgical technique. As of March 5, 2015, 105 patients have been enrolled in the feasibility trial, including 49 patients enrolled with the new technique. Based upon the progress in our enrollments, in December 2014, we terminated our clinical trial agreements with two U.S. sites that had not enrolled any patients. This reduced the U.S. study sites from seven to five. No assurance can be provided that our eMESH I clinical feasibility trial will be successful, that the FDA will approve an IDE for a pivotal study or that once these studies are concluded, we will receive U.S. marketing approval for the eSVS Mesh. If these events do not occur, we may be forced to cease operations and liquidate our company since we do not have any other products in development. In addition, we need additional financing to continue our operations, and in particular, to complete our eMESH I clinical feasibility trial. If we do not receive such additional financing, we may be forced to cease operations and liquidate our company. |
Note_2_Risks_and_Uncertainties
Note 2 - Risks and Uncertainties | 12 Months Ended |
Dec. 31, 2014 | |
Risks and Uncertainties [Abstract] | |
Concentration Risk Disclosure [Text Block] | 2. Risks and Uncertainties |
For the years ended December 31, 2014 and 2013, we incurred net losses of $5.6 million and $6.1 million, respectively, and negative cash flows from operating activities of $5.0 million and $5.5 million, respectively. We expect to continue to incur substantial losses, which will continue to generate negative net cash flows from operating activities as we continue to develop additional clinical data, pursue U.S. marketing approval of our eSVS Mesh, and market and sell our eSVS Mesh in European and other international markets. | |
We received CE Mark approval in May 2010 based upon our international human clinical trial. We began marketing and commenced shipments of our eSVS Mesh in select European markets in June 2010. In November 2013, we received an updated CE Mark expanding our ability to market the eSVS Mesh for use with sequential grafts. In August 2014, we received an updated CE Mark incorporating changes in the application of our eSVS Mesh to the SVG and to the surgical implant technique for the eSVS Mesh treated graft that were approved by the FDA in March 2014 for use in our eMESH I clinical feasibility trial. We believe sales of our eSVS Mesh have been, and will continue to be, adversely impacted by the limited amount of clinical data on the performance of the eSVS Mesh, limited reimbursements available to hospitals and the effects of economic difficulties in certain European countries. On January 5, 2015, we reorganized our operations, which included terminating our two sales directors as part of our plan to conserve our capital while we pursue the completion of the eMESH I clinical feasibility trial. As a result, in the near term we are not focusing our efforts on sales of the eSVS Mesh, and therefore do not expect our sales to improve during the near foreseeable future. See note 16 entitled “Subsequent Events.” | |
We are currently conducting the eMESH I clinical feasibility trial, the objective of which is to demonstrate the initial safety and performance of the eSVS Mesh for use as an external saphenous vein graft support device during CABG surgery. In March 2014, the FDA approved a combination of changes in the application of the eSVS Mesh to the SVG and to the surgical implant technique for the eSVS Mesh treated graft. Due to our concern that the results of our feasibility trial prior to the change in the implant technique would not be adequate to allow us to obtain an IDE to perform a pivotal study and based upon our discussions with the FDA, we believe that the success of the feasibility trial is completely dependent upon the results from patients implanted with the eSVS Mesh using the new implant technique. Since enrollment using the new implant technique did not commence in earnest until October 2014, we do not expect to receive a meaningful number of follow-up angiographic results from the new implant technique patients until May or June 2015. No assurance can be provided that our eMESH I clinical feasibility trial will be successful, that the FDA will approve an IDE for a pivotal study or that once these studies are concluded, we will receive U.S. marketing approval for the eSVS Mesh. | |
As of December 31, 2014, we did not have any existing credit facilities under which we could borrow funds. We historically have financed our operations principally from the sale of convertible debt and equity securities. While we have been successful in the past in obtaining the necessary capital to support our operations, and have similar future plans to obtain additional financing, there is no assurance that we will be able to obtain additional financing under commercially reasonable terms and conditions, or at all. If we do not receive such additional financing, we may be forced to cease operations and liquidate our company. | |
The accompanying financial statements have been prepared assuming that we will continue as a going concern which contemplates the realization of assets and liquidation of liabilities in the normal course of business. Our ability to continue as a going concern, realize the carrying value of our assets and discharge our liabilities in the ordinary course of business is dependent upon a number of factors, including our ability to obtain additional financing to fund our operations until we ultimately generate profitable operations, the results of our eMESH I clinical feasibility trial and anticipated pivotal study, our ability to obtain U.S. marketing approval for our eSVS Mesh and our ability to market and sell our eSVS Mesh. See note 3 entitled “Liquidity and Management’s Plans.” |
Note_3_Liquidity_and_Managemen
Note 3 - Liquidity and Management's Plans | 12 Months Ended |
Dec. 31, 2014 | |
Liquidity And Managements Plans [Abstract] | |
Liquidity And Managements Plans [Text Block] | 3. Liquidity and Management’s Plans |
On January 5, 2015, we streamlined and scaled back our operations to focus our efforts and resources on regulatory and clinical activities which further the clinical development of the eSVS Mesh. As part of this reorganization, we reduced our personnel from thirteen to eight employees. These reductions included our two sales directors, two administrative positions and one operations position. In addition, our officers agreed to accept temporary salary reductions. We believe that these actions will reduce our monthly operating expenses, excluding costs related to our eMESH I clinical feasibility trial, to approximately $200,000. See note 16 entitled “Subsequent Events.” | |
As of December 31, 2014, we had $3.6 million of cash, cash equivalents and short-term investments. We believe our cash, cash equivalents and short-term investments as of December 31, 2014, after considering the effects of our January 2015 reorganization, will be sufficient to fund our planned operations through December 2015. However, we may require significant additional funds earlier than we currently expect in order to continue our feasibility trial and plan for our anticipated larger pivotal study. Accordingly, there is no assurance that we will not need or seek additional funding prior to such time. We may elect to raise additional funds even before we need them if market conditions for raising additional capital are favorable. | |
Our future success is dependent upon our ability to obtain additional financing, the success of our eMESH I clinical feasibility trial and our anticipated pivotal study, our ability to obtain U.S. marketing approval for our eSVS Mesh and our ability to market and sell our eSVS Mesh. If we are unable to obtain additional financing when needed, if our eMESH I clinical feasibility trial is not successful, if the FDA does not approve an IDE for a pivotal study or if once these studies are concluded, we do not receive U.S. marketing approval for the eSVS Mesh, we may not be able to continue as a going concern and may be forced to cease operations and liquidate our company. These factors, among others, raise substantial doubt about our ability to continue as a going concern. |
Note_4_Summary_of_Significant_
Note 4 - Summary of Significant Accounting Policies | 12 Months Ended | ||||||||||||
Dec. 31, 2014 | |||||||||||||
Accounting Policies [Abstract] | |||||||||||||
Significant Accounting Policies [Text Block] | 4. Summary of Significant Accounting Policies | ||||||||||||
Use of Estimates | |||||||||||||
The preparation of financial statements in conformity with accounting principles generally accepted in the United States (“US GAAP”) requires management to make estimates and assumptions that affect the reported amounts and disclosures in the combined consolidated financial statements and accompanying notes. Actual results could differ from those estimates. | |||||||||||||
Cash and Cash Equivalents | |||||||||||||
Cash and cash equivalents consist of cash, money market funds and bank certificates of deposit with original maturities of three months or less. The carrying value of these instruments approximates fair value. We have not experienced any losses in our cash and cash equivalents. | |||||||||||||
Short-term Investments | |||||||||||||
Short-term investments may consist of bank certificates of deposits, money market funds, commercial paper and corporate debt. Our investment policy seeks to manage these investments to achieve our goal of preserving principal, maintaining adequate liquidity at all times, and maximizing returns subject to our investment guidelines. Short-term investments have been classified and accounted for as available-for-sale securities and are reported on the balance sheet at fair value with unrealized gains or losses reported as a component of other comprehensive income. Interest earned on short-term investments is included in interest income. We periodically evaluate our investments in marketable securities for potential impairment due to declines in market value deemed by us to be other-than-temporary. If cost exceeds fair value, we consider, among other factors, the duration and extent to which cost exceeds fair value, the financial strength of the issuer, and our intent and ability to hold the investment to maturity. Once a decline in value is deemed to be other-than-temporary, an impairment charge is recorded and a new cost basis in the investment is established. | |||||||||||||
In 2014 and 2013, our short-term investments included a bank certificate of deposit which we pledged as collateral for our corporate purchasing card. The balance of this bank certificate of deposit was $50,000 and $100,000 as of December 31, 2014 and December 31, 2013, respectively. | |||||||||||||
Accounts Receivable | |||||||||||||
Accounts receivable are recorded at the invoiced amount and are due within 60 to 90 days of shipment. We grant credit to customers in the normal course of business and do not require collateral. Accounts receivable do not bear interest and are presented net of allowances for doubtful accounts, if any. We determine our allowance for doubtful accounts by considering a number of factors, including the length of time trade accounts receivable are past due, the customer’s current ability to pay its obligation to us and the condition of the general economy and the industry as a whole. | |||||||||||||
Inventories | |||||||||||||
Inventories are stated at the lower of cost (first-in, first-out method) or market. Inventory cost includes purchased materials and overhead costs which are applied to work in process and finished goods based on annual estimates of production volume and overhead spending. Appropriate consideration is given to deterioration, obsolescence, excess inventory and other factors in evaluating net realizable value. Inventories consist of the following as of December 31 (in thousands): | |||||||||||||
2014 | 2013 | ||||||||||||
Raw materials | $ | 80 | $ | 81 | |||||||||
Work in process | 306 | 333 | |||||||||||
Finished goods | 287 | 379 | |||||||||||
Total | $ | 673 | $ | 793 | |||||||||
Property and Equipment | |||||||||||||
Property and equipment is stated at cost less accumulated depreciation. Depreciation is computed based upon the estimated useful lives of the respective assets, or the lesser of the estimated useful life or the remaining life of the underlying facility lease for leasehold improvements, ranging from three to seven years, and is recorded using the straight-line method. Upon sale or retirement of assets, the costs and related accumulated depreciation are removed from the balance sheet and the resulting gain or loss is reflected in the statement of operations. Repairs and maintenance costs are expensed as incurred. | |||||||||||||
Impairment of Long-Lived Assets | |||||||||||||
In accordance with Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 360, Property, Plant and Equipment, long-lived assets, such as property and equipment, are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to estimated undiscounted future cash flows expected to be generated by the asset. If the carrying amount of an asset exceeds its estimated future cash flows, then an impairment charge is recognized as the amount by which the carrying amount of the asset exceeds the fair value of the asset. As of December 31, 2014 and 2013, no modification of the remaining useful lives or write-down of long-lived assets is required. | |||||||||||||
Revenue Recognition | |||||||||||||
We sell our eSVS Mesh to international distributors primarily in Europe, who subsequently resell it to hospitals and clinics. We recognize revenue when persuasive evidence of an arrangement exists, delivery of goods occurs through the transfer of title and the risks and rewards of ownership, the selling price is fixed or determinable and collectability is reasonably assured. | |||||||||||||
We recognize revenue as products are shipped based on agreements with each of our distributors, which provide that title and risk of loss pass to the distributor upon shipment of the products to the distributor and do not provide the distributors a right of return. We invoice shipping charges to our distributors and include them in net sales. We expense royalties and shipping costs at the time we report the related revenue and record them in cost of sales. | |||||||||||||
Research and Development Expenses | |||||||||||||
Research and development costs consist of costs incurred for internally sponsored research and development, direct expenses and research-related overhead. Research and development costs also include costs related to the execution of clinical trials and related efforts to obtain regulatory approval for our eSVS Mesh. | |||||||||||||
We charge research and development costs, including clinical trial costs, to expense when incurred. Clinical trial costs are a significant component of research and development expenses. All of our clinical trials are performed at clinical trial sites and are administered jointly by us with assistance from contract research organizations (“CROs”). Costs of setting up clinical trial sites are accrued upon execution of the study agreement. Expenses related to the performance of clinical trials generally are accrued based on contracted amounts and the achievement of agreed upon milestones, such as patient enrollment, patient follow-up, etc. We monitor levels of performance under each significant contract, including the extent of patient enrollment and other activities through communications with the clinical trial sites and CROs, and adjust the estimates, if required, on a quarterly basis so that clinical expenses reflect the actual effort expended at each clinical trial site and by each CRO. | |||||||||||||
All material CRO contracts are terminable by us upon written notice and we are generally only liable for actual effort expended by the CROs and certain non-cancelable expenses incurred at any point of termination. | |||||||||||||
We expense costs incurred to obtain patents or acquire licenses as the ultimate recoverability of the amounts paid is uncertain. | |||||||||||||
Comprehensive Income/Loss | |||||||||||||
Comprehensive income/loss consists of net loss and the effect of unrealized gains and losses on available-for-sale securities. | |||||||||||||
Income Taxes | |||||||||||||
Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carry-forwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. Valuation allowances are established when necessary to reduce deferred tax assets to the amount that is more likely than not to be realized. | |||||||||||||
Stock-Based Compensation | |||||||||||||
Stock-based incentive awards are accounted for under the provisions of FASB ASC 718, Compensation — Stock Compensation, which requires companies to measure and recognize the cost of employee and non-employee services received in exchange for awards of equity instruments based on the grant date fair value of those awards. Compensation cost is recognized ratably using the straight-line attribution method over the expected vesting period, which is considered to be the requisite service period. We estimate pre-vesting award forfeitures when calculating the compensation costs and revise those estimates in subsequent periods if actual forfeitures differ from those estimates. | |||||||||||||
The fair value of stock-based awards is estimated at the date of grant using the Black-Scholes option pricing model. Risk free interest rates are based upon U.S. Treasury rates appropriate for the expected term. Expected volatility and forfeiture rates are based primarily on the volatility rates of a set of guideline companies, which consist of public and recently public medical technology companies. The assumed dividend yield is zero, as we do not expect to declare any dividends in the foreseeable future. The expected term of options granted is determined using the “simplified” method. Under this approach, the expected term is presumed to be the mid-point between the vesting date and the end of the contractual term. | |||||||||||||
Stock-based compensation expense in our statements of operations is summarized as follows (in thousands): | |||||||||||||
December 31, | |||||||||||||
2014 | 2013 | 2012 | |||||||||||
Manufacturing | $ | — | $ | — | $ | 29 | |||||||
Research and development | 134 | 152 | 150 | ||||||||||
Sales, general and administrative | 281 | 418 | 409 | ||||||||||
Total stock-based compensation | $ | 415 | $ | 570 | $ | 588 | |||||||
Net Loss per Share | |||||||||||||
We compute net loss per share by dividing our net loss (the numerator) by the weighted-average number of common shares outstanding (the denominator) during the period. Shares issued during the period and shares reacquired during the period are weighted for the portion of the period that they were outstanding. The computation of diluted earnings per share, or EPS, is similar to the computation of basic EPS except that the denominator is increased to include the number of additional common shares that would have been outstanding if the dilutive potential common shares had been issued. Diluted EPS is the same as basic EPS due to common equivalent shares being excluded from the calculation, as their effect is anti-dilutive. | |||||||||||||
The following table summarizes our calculation of net loss per common share for the periods (in thousands, except share and per share data): | |||||||||||||
December 31, | |||||||||||||
2014 | 2013 | 2012 | |||||||||||
Net loss | $ | (5,607 | ) | $ | (6,060 | ) | $ | (5,507 | ) | ||||
Weighted average shares outstanding—basic and diluted | 32,534,586 | 26,916,060 | 16,402,363 | ||||||||||
Basic and diluted net loss per share | $ | (0.17 | ) | $ | (0.23 | ) | $ | (0.34 | ) | ||||
The following outstanding potential common shares were not included in the diluted net loss per share calculations as their effects were not dilutive: | |||||||||||||
December 31, | |||||||||||||
2014 | 2013 | 2012 | |||||||||||
Employee and non-employee stock options | 2,114,250 | 1,609,250 | 1,174,250 | ||||||||||
Common shares issuable to underwriters under purchase agreements (See note 12) | 865,625 | 603,125 | 603,125 | ||||||||||
Common shares issuable to outside consultant under warrant | 75,000 | 75,000 | — | ||||||||||
Fiscal Year | |||||||||||||
We operate on a manufacturing calendar with our fiscal year always ending on December 31. Each quarter is 13 weeks, consisting of two four-week and one five-week periods. | |||||||||||||
Recently IssuedAccounting Pronouncements | |||||||||||||
In August 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2014-15, Presentation of Financial Statements – Going Concern (Subtopic 205-40): Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern. The guidance requires an entity to evaluate whether there are conditions or events, in the aggregate, that raise substantial doubt about the entity’s ability to continue as a going concern within one year after the date that the financial statements are issued or available to be issued and to provide related footnote disclosures in certain circumstances. The guidance is effective for the annual period ending after December 15, 2016, and for annual and interim periods thereafter (our fiscal 2016). Early application is permitted and we have adopted this guidance for the current period presented. | |||||||||||||
In May 2014, FASB issued Revenue from Contracts with Customers, Topic 606 (Accounting Standards Update No. 2014-09 (ASU 2014-09)), which provides a framework for the recognition of revenue, with the objective that recognized revenues properly reflect amounts an entity is entitled to receive in exchange for goods and services. This guidance will be effective for interim and annual reporting periods beginning after December 15, 2016 (our fiscal 2017). We are currently evaluating the impact of adopting ASU 2014-09 on our financial statements. |
Note_5_Cash_Cash_Equivalents_a
Note 5 - Cash, Cash Equivalents and Short-term Investments | 12 Months Ended | ||||||||
Dec. 31, 2014 | |||||||||
Disclosure Text Block Supplement [Abstract] | |||||||||
Cash, Cash Equivalents, and Short-term Investments [Text Block] | 5. Cash, Cash Equivalents and Short-Term Investments | ||||||||
Cash, cash equivalents and short-term investments consist of the following (in thousands): | |||||||||
31-Dec-14 | 31-Dec-13 | ||||||||
Cash and cash equivalents | |||||||||
Cash | $ | 508 | $ | 366 | |||||
Money market funds | 2,379 | 1,699 | |||||||
Bank certificate of deposit | 251 | 251 | |||||||
Total cash and cash equivalents | $ | 3,138 | $ | 2,316 | |||||
Short-term investments | |||||||||
Corporate debt securities | $ | 407 | $ | 2,083 | |||||
Commercial paper | — | 250 | |||||||
Bank certificates of deposit | 50 | 351 | |||||||
Total short-term investments | $ | 457 | $ | 2,684 | |||||
Note_6_Fair_Value_of_Financial
Note 6 - Fair Value of Financial Instruments | 12 Months Ended | ||||||||||||||||||||||||||||||||
Dec. 31, 2014 | |||||||||||||||||||||||||||||||||
Fair Value Disclosures [Abstract] | |||||||||||||||||||||||||||||||||
Fair Value Disclosures [Text Block] | 6. Fair Value of Financial Instruments | ||||||||||||||||||||||||||||||||
We apply the provisions of FASB ASC Topic 820, Fair Value Measurement, which defines fair value, establishes a framework for measuring fair value under US GAAP, and enhances disclosures about fair value measurements. | |||||||||||||||||||||||||||||||||
Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between knowledgeable and willing market participants. Valuation techniques used to measure fair value, as required by ASC Topic 820, must maximize the use of observable inputs and minimize the use of unobservable inputs. | |||||||||||||||||||||||||||||||||
The standard describes a fair value hierarchy based on three levels of inputs, of which the first two are considered observable and the last unobservable, that may be used to measure fair value. Our assessment of the significance of a particular input to the fair value measurements requires judgment, and may affect the valuation of the assets and liabilities being measured and their placement within the fair value hierarchy. The three levels of input are: | |||||||||||||||||||||||||||||||||
Level 1—Quoted prices in active markets for identical assets or liabilities. | |||||||||||||||||||||||||||||||||
Level 2—Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. | |||||||||||||||||||||||||||||||||
Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. | |||||||||||||||||||||||||||||||||
Our cash and equivalents and short-term investments consist of bank deposits, bank certificates of deposit, money market funds, commercial paper and corporate debt securities. Our money market funds are traded in active markets and are recorded at fair value based upon quoted market prices. | |||||||||||||||||||||||||||||||||
We determine the fair value of our bank certificates of deposit, commercial paper and corporate debt securities using other observable inputs which may include quoted prices for similar assets in active markets, quoted prices for identical or similar assets in markets which are not active, other quoted prices which are directly observable and/or market inputs that are not directly observable, but are derived from or corroborated by other observable market data. Accordingly, we have classified the valuation of these securities as Level 2. | |||||||||||||||||||||||||||||||||
Other financial instruments, including accounts receivable, accounts payable and accrued liabilities, are carried at cost, which we believe approximates fair value because of the short-term maturity of these instruments. | |||||||||||||||||||||||||||||||||
A summary of financial assets (in thousands) measured at fair value on a recurring basis at December 31, 2014 and 2013 is as follows: | |||||||||||||||||||||||||||||||||
31-Dec-14 | 31-Dec-13 | ||||||||||||||||||||||||||||||||
Total | Quoted Prices | Other Observable | Significant | Total | Quoted Prices | Other Observable | Significant | ||||||||||||||||||||||||||
In Active | Inputs | Unobservable | In Active | Inputs | Unobservable | ||||||||||||||||||||||||||||
Markets | (Level 2) | Inputs | Markets | (Level 2) | Inputs | ||||||||||||||||||||||||||||
(Level 1) | (Level 3) | (Level 1) | (Level 3) | ||||||||||||||||||||||||||||||
Money market funds | $ | 2,379 | $ | 2,379 | $ | — | $ | — | $ | 1,699 | $ | 1,699 | $ | — | $ | — | |||||||||||||||||
Bank certificate of deposit | 301 | — | 301 | — | 602 | — | 602 | — | |||||||||||||||||||||||||
Commercial paper | — | — | — | — | 250 | — | 250 | — | |||||||||||||||||||||||||
Corporate debt securities | 407 | — | 407 | — | 2,083 | — | 2,083 | — | |||||||||||||||||||||||||
Total | $ | 3,087 | $ | 2,379 | $ | 708 | $ | — | $ | 4,634 | $ | 1,699 | $ | 2,935 | $ | — | |||||||||||||||||
Note_7_Shortterm_Investments
Note 7 - Short-term Investments | 12 Months Ended |
Dec. 31, 2014 | |
Investments Schedule [Abstract] | |
Investment [Text Block] | 7. Short-Term Investments |
Short-term investments consist of bank certificates of deposit, commercial paper and corporate debt securities. As of December 31, 2014 and 2013, the remaining contractual maturities of all investments were less than 12 months. Due to the short-term nature of our investments, amortized cost approximates fair value for all investments. |
Note_8_Property_and_Equipment
Note 8 - Property and Equipment | 12 Months Ended | ||||||||
Dec. 31, 2014 | |||||||||
Property, Plant and Equipment [Abstract] | |||||||||
Property, Plant and Equipment Disclosure [Text Block] | 8. Property and Equipment | ||||||||
At December 31, 2014 and 2013, property and equipment consist of the following (in thousands): | |||||||||
December 31, | |||||||||
2014 | 2013 | ||||||||
Furniture and fixtures | $ | 58 | $ | 58 | |||||
Machinery, equipment and tooling | 505 | 505 | |||||||
Computers and software | 193 | 191 | |||||||
Leasehold improvements | 90 | 90 | |||||||
Accumulated depreciation | (493 | ) | (444 | ) | |||||
Property and equipment, net | $ | 353 | $ | 400 | |||||
Depreciation expense for the years ended December 31, 2014, 2013 and 2012 was $49,000, $55,000 and $109,000, respectively. |
Note_9_Accrued_Liabilities
Note 9 - Accrued Liabilities | 12 Months Ended | ||||||||
Dec. 31, 2014 | |||||||||
Payables and Accruals [Abstract] | |||||||||
Accounts Payable and Accrued Liabilities Disclosure [Text Block] | 9. Accrued Liabilities | ||||||||
At December 31, 2014 and 2013, accrued liabilities consist of the following (in thousands): | |||||||||
December 31, | |||||||||
2014 | 2013 | ||||||||
Clinical study related expense | $ | 256 | $ | 216 | |||||
Professional services | 54 | 61 | |||||||
Payroll and related expenses | 36 | 35 | |||||||
Other | 9 | 2 | |||||||
Accrued liabilities | $ | 355 | $ | 314 | |||||
Note_10_Commitments_and_Contin
Note 10 - Commitments and Contingencies | 12 Months Ended | ||||
Dec. 31, 2014 | |||||
Commitments and Contingencies Disclosure [Abstract] | |||||
Commitments and Contingencies Disclosure [Text Block] | 10. Commitments and Contingencies | ||||
Leases | |||||
On October 1, 2007, we entered into an operating lease agreement for our current facility which houses our corporate offices and manufacturing space. The term of this lease originally ran from October 1, 2007 through September 30, 2010. We have executed multiple amendments to our lease to extend the lease term. The most recent amendment was executed in August 2014 and extends the lease term through September 30, 2017. Under the terms of the most recent amendment, our base rent was increased by 2.5% effective October 1, 2014, with scheduled increases of 2.5% on October 1, 2015 and 2016. | |||||
On June 2, 2011, we entered into an operating sub-lease agreement for approximately 2,800 square feet of office space adjoining our current facility. The original term of this lease ran from June 15, 2011 through September 30, 2014. In August 2014, we executed an amendment to this lease to extend the lease term through September 30, 2017. The monthly base rent amount did not change with this amendment and remains fixed over the entire term of the sub-lease. | |||||
We also lease certain other office equipment under non-cancelable operating lease arrangements which are not recognized on our balance sheets. | |||||
Annual future minimum lease obligations under our operating lease agreements as of December 31, 2014 are as follows (in thousands): | |||||
2015 | $ | 88 | |||
2016 | 86 | ||||
2017 | 64 | ||||
Total | $ | 238 | |||
Rent expense was $120,000 for each of the years ended December 31, 2014, 2013 and 2012. | |||||
Clinical Studies | |||||
We are currently conducting the eMESH I clinical feasibility trial evaluating the safety and performance of our eSVS Mesh in humans for the U.S. FDA. This clinical trial requires patients to be followed at regular intervals during the first year after implant and then annually out to five years. We are required to pay for patient follow up visits only to the extent they occur. In the event a patient does not attend a follow-up visit, we have no financial obligation. Clinical trial costs are expensed as incurred. | |||||
Royalty Payments | |||||
The core intellectual property relating to our eSVS Mesh was acquired from Medtronic, Inc. (“Medtronic”) pursuant to an Assignment and License Agreement dated October 9, 2007. As consideration for the assignment of such intellectual property, we have agreed to pay Medtronic an aggregate of up to $15.0 million upon the achievement of certain sales milestones and a royalty of 4% on sales of our eSVS Mesh. Two milestones, and their related payments, remain unpaid and consist of $5.0 million due when our cumulative net sales reach $15.0 million and $5.0 million due when our cumulative net sales reach $40.0 million. Royalty obligations are payable 60 days after the end of each fiscal quarter, are recorded as a component of our cost of sales and will terminate upon the earlier of the expiration of all of the patents and patent applications acquired from Medtronic or when the aggregate royalties paid reaches $100.0 million. We recognized royalty expense of $3,000 and $5,000 for the years ended December 31, 2014 and 2013, respectively. | |||||
Legal Proceedings | |||||
We are not currently engaged in any pending litigation. | |||||
Employment Agreements | |||||
On July 31, 2012, we entered into an employment agreement (the ‘‘Agreement’’) with Manny Villafaña, our founder and Chief Executive Officer, which replaces in its entirety the Company’s prior employment agreement with Mr. Villafaña, dated July 19, 2007, and the Company’s change in control agreement with Mr. Villafaña, dated September 12, 2008, both of which previously governed Mr. Villafaña’s employment relationship with us. | |||||
The Agreement provides that Mr. Villafaña will continue in his positions as our Chairman of the Board, Chief Executive Officer and President until July 1, 2015, if not earlier terminated. The Agreement provides for an annual base salary, which amount may be reviewed and changed periodically by our Board of Directors. The Agreement also provides that Mr. Villafaña will be eligible to earn an annual performance-based bonus in accordance with our bonus policies, if and when any such policies are put in place by the Company’s Board of Directors, and provides that Mr. Villafaña is eligible to participate in our employee benefit and retirement plans generally available to employees of the Company, in addition to reimbursement of reasonable business expenses incurred by Mr. Villafaña. | |||||
The Agreement may be terminated immediately by us for Cause (as defined in the Agreement), or without Cause upon 60 days written notice to Mr. Villafaña, upon determination by our Board of Directors to cease business, or upon the death or Disability (as defined in the Agreement) of Mr. Villafaña. The Agreement may be terminated by Mr. Villafaña for Good Reason (as defined in the Agreement) upon written notice to the Company, or without Good Reason upon 60 days written notice to the Company. | |||||
In the event that the Agreement is terminated by us for Cause, upon determination by our Board of Directors to cease business, upon Mr. Villafaña’s death or Disability, by Mr. Villafaña without Good Reason, or on July 1, 2015, the Agreement provides that Mr. Villafaña will be entitled to unpaid base salary and accrued benefits through the date of termination. | |||||
In the event that the Agreement is terminated by us without Cause or by Mr. Villafaña for Good Reason, the Agreement provides that Mr. Villafaña will be entitled to unpaid base salary and accrued benefits through the date of termination, the pro-rata amount of Mr. Villafaña’s annual incentive bonus at target for Mr. Villafaña’s applicable employment period during the fiscal year of termination (provided only if a bonus plan is put in place by our Board of Directors and our senior management are paid a bonus at or above target for the applicable fiscal year), secretarial services for one year following termination, and severance pay of two years of base salary in the event of termination by us without Cause or one year of base salary in the event of termination by Mr. Villafaña for Good Reason, in accordance with our normal payroll practices. | |||||
In the event of a termination by us without Cause or by Mr. Villafaña for Good Reason within two years of a Change in Control (as defined in the Agreement), Mr. Villafaña will be entitled to unpaid base salary and accrued benefits through the date of termination, the pro-rata amount of Mr. Villafaña’s annual incentive bonus at target for Mr. Villafaña’s applicable employment period during the fiscal year of termination (provided only if a bonus plan is put in place by our Board of Directors and our senior management are paid a bonus at or above target for the applicable fiscal year), secretarial services for one year following termination, and severance pay of three years of base salary payable in a lump sum. | |||||
The severance and annual incentive bonus payments above are conditioned upon our receipt of a separation agreement and release of claims from Mr. Villafaña. The Agreement also provides that Mr. Villafaña will not compete with us or solicit our customers or employees while employed by and for two years after being employed by us. The Agreement also contains certain confidentiality and assignment of inventions and copyrights provisions. | |||||
We have entered into employment agreements with certain other officers and key employees providing for an annual salary and such benefits in the future as may be approved by the Board of Directors. We have also entered into change of control agreements with certain of our officers and employees which provide that if the individual is terminated for a reason other than cause, or resigns for good reason, upon a merger, acquisition, sale of substantially all of our assets, or liquidation, the individual will receive a severance payment equal to his or her monthly base salary for 12 to 24 months. | |||||
Indemnification Agreements | |||||
The Company, as permitted under Delaware law and in accordance with its Bylaws, indemnifies its officers and directors for certain events or occurrences, subject to certain limits, while the officer or director is or was serving at the Company’s request in such capacity. The term of the indemnification period is for the officer’s or director’s lifetime. The Company may terminate the indemnification agreements with its officers and directors upon 90 days written notice, but termination will not affect claims for indemnification relating to events occurring prior to the effective date of termination. The maximum amount of potential future indemnification is unlimited; however, the Company has a director and officer liability insurance policy that limits its exposure and may enable it to recover a portion of any future amounts paid. The Company believes the fair value of these indemnification agreements is minimal. Accordingly, the Company has not recorded any liabilities for these agreements as of December 31, 2014 or 2013. |
Note_11_Stockholders_Equity
Note 11 - Stockholders' Equity | 12 Months Ended | ||||
Dec. 31, 2014 | |||||
Stockholders' Equity Note [Abstract] | |||||
Stockholders' Equity Note Disclosure [Text Block] | 11. Stockholders’ Equity | ||||
The total number of shares of capital stock that the Company is authorized to issue is 100,000,000 shares, with 90,000,000 shares designated as common stock and 10,000,000 shares undesignated stock issuable as preferred stock. On February 4, 2014, a special meeting of our stockholders was held during which the stockholders approved an amendment to our Certificate of Incorporation which increased the number of authorized shares of common stock from 40,000,000 to 90,000,000. We filed a Certificate of Amendment to our Certificate of Incorporation with the Secretary of State of the State of Delaware on February 4, 2014 to effect this amendment. | |||||
Common Stock | |||||
Holders of common stock are entitled to one vote per share on all matters to be voted upon by the stockholders of the Company. Subject to the preferences that may be applicable to any outstanding shares of preferred stock, the holders of common stock are entitled to receive ratably such dividends, if any, as may be declared by the Board of Directors. No dividends have been declared to date. | |||||
Common Stock Offerings | |||||
On January 29, 2014, we completed a public offering of 6,035,000 shares of our common stock at a purchase price of $0.70 per share for gross proceeds of $4.2 million. All shares sold in the offering were newly issued by us. We incurred $581,000 in issuance costs for this offering. In connection with this offering, we entered into an underwriting agreement with Aegis Capital Corp., or Aegis, dated January 23, 2014, pursuant to which at closing on January 29, 2014 we paid Aegis fees of $333,000, which consisted of underwriting discounts of $296,000 and non-accountable expense reimbursements of $37,000. After deducting the underwriting discounts and commissions and other expenses, we realized net proceeds of approximately $3.6 million. As additional consideration, we issued to the underwriter and its designees warrants to purchase an aggregate of 262,500 shares of our common stock at an exercise price of $0.875 per share, or 125% of the purchase price of shares sold in the offering. The warrants have a five-year term and became exercisable on January 23, 2015, one year after the effective date of the offering. | |||||
On December 28, 2012, we issued 10,000,000 shares of our common stock in a public offering at $0.65 per share for gross proceeds of $6.5 million. All shares sold in the offering were newly issued by us. We incurred $1.1 million in issuance costs for such offering. In connection with the offering, we entered into an underwriting agreement with Sunrise Securities Corp., or Sunrise, dated December 20, 2012, pursuant to which at closing on December 28, 2012, we paid Sunrise fees of $520,000, which consisted of underwriting discounts of $455,000 and non-accountable expense reimbursements of $65,000. In addition, we issued to the underwriter and its designees warrants to purchase an aggregate of 500,000 shares of our common stock at an exercise price of $0.8125 per share, or 125% of the per share purchase price of shares sold in the offering. These warrants have a five-year term and became exercisable on December 21, 2013, one year after the effective date of the offering. On January 28, 2013, we issued an additional 475,000 shares to the underwriter at a purchase price of $0.65 per share pursuant to the underwriter’s partial exercise of its over-allotment option from the offering. After deducting expenses, net proceeds were $276,000. | |||||
UndesignatedStock | |||||
The Company has 10,000,000 shares of authorized undesignated stock issuable as preferred stock in one or more series. Upon issuance, the Company can determine the number of shares constituting any series and the designation of such series and the rights, preferences, privileges and restrictions thereof. These rights, preferences and privileges could include dividend rights, conversion rights, voting rights, terms of redemption, liquidation preferences and sinking fund terms, any or all of which may be greater than the rights of common stock. The issuance of the preferred stock could adversely affect the voting power of holders of common stock and the likelihood that such holders will receive dividend payments and payments upon liquidation. In addition, the issuance of preferred stock could have the effect of delaying, deferring or preventing a change in control of the Company or other corporate action. There was no preferred stock outstanding as of December 31, 2014 or 2013. | |||||
Kips Bay Investments, LLC Consent | |||||
We are a party to an Investment Agreement dated July 19, 2007 with Manny Villafaña and Kips Bay Investments, LLC (“KBI”), which had no relationship with us prior to entering into the Investment Agreement. Pursuant to this Investment Agreement, prior to our issuing any capital stock with rights, preferences or limitations equal or superior to our common stock owned by KBI or debt securities convertible into capital stock with rights, preferences or limitations equal or superior to our common stock owned by KBI, we must obtain the consent of KBI and no assurance can be provided that KBI would provide such consent, which could limit our ability to raise additional financing. | |||||
Shares Reserved | |||||
Shares of common stock reserved for future issuance are as follows: | |||||
31-Dec-14 | |||||
Stock options outstanding | 2,114,250 | ||||
Shares available for grant under equity incentive plan | 1,675,000 | ||||
Warrants for purchase of common stock | 940,625 | ||||
Total | 4,729,875 | ||||
Note_12_Stockbased_Compensatio
Note 12 - Stock-based Compensation | 12 Months Ended | ||||||||||||||||||||||
Dec. 31, 2014 | |||||||||||||||||||||||
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |||||||||||||||||||||||
Disclosure of Compensation Related Costs, Share-based Payments [Text Block] | 12. Stock-Based Compensation | ||||||||||||||||||||||
2013 Equity Incentive Plan | |||||||||||||||||||||||
The Kips Bay Medical, Inc. 2013 Equity Incentive Plan (the “2013 Plan”) was adopted by the Board of Directors in March 2013 and approved by our stockholders at our annual meeting of stockholders held on May 22, 2013. The 2013 Plan permits the granting of incentive and non-statutory stock options, restricted stock, stock appreciation rights, performance units, performance shares and other stock awards to eligible employees, directors and consultants. We grant options to purchase shares of common stock under the 2013 Plan at no less than the fair market value of the underlying common stock as of the date of grant. Options granted under the 2013 Plan have a maximum term of ten years and generally vest over four years for employees, at the rate of 25% of total shares underlying the option each year, and over three years for non-employees, with 25% vesting upon grant and 25% vesting each year thereafter, except in the case of grants to non-employee directors which generally vest in full on the one-year anniversary of the date of grant. Under the 2013 Plan, a total of 2,500,000 shares of common stock have been reserved for issuance. As of December 31, 2014, options to purchase 825,000 shares of common stock had been granted under the 2013 Plan. | |||||||||||||||||||||||
2007 Long-Term Incentive Plan | |||||||||||||||||||||||
The Kips Bay Medical, Inc. 2007 Long-Term Incentive Plan (the “2007 Plan”) was adopted by the Board of Directors in July 2007. In conjunction with stockholder approval of the 2013 Plan, the Board terminated the 2007 Plan, although awards outstanding under the 2007 Plan will remain outstanding in accordance with and pursuant to the terms thereof. Options granted under the 2007 Plan have a maximum term of ten years and generally vest over four years for employees, at the rate of 25% of total shares underlying the option each year, and over three years for non-employees, with 25% vesting upon grant and 25% vesting each year thereafter. As of December 31, 2014, options to purchase an aggregate of 1,289,250 and restricted stock awards for 62,500 shares of common stock remained outstanding under the 2007 Plan. | |||||||||||||||||||||||
A summary of option activity is as follows: | |||||||||||||||||||||||
Shares Under | Weighted | ||||||||||||||||||||||
Option | Average | ||||||||||||||||||||||
Exercise Price | |||||||||||||||||||||||
Options outstanding at December 31, 2012 | 1,174,250 | $ | 3.64 | ||||||||||||||||||||
Granted | 630,000 | 0.72 | |||||||||||||||||||||
Exercised | — | — | |||||||||||||||||||||
Forfeited and cancelled | (195,000 | ) | 3.05 | ||||||||||||||||||||
Options outstanding at December 31, 2013 | 1,609,250 | 2.56 | |||||||||||||||||||||
Granted | 535,000 | 0.39 | |||||||||||||||||||||
Exercised | — | — | |||||||||||||||||||||
Forfeited and cancelled | (30,000 | ) | 4.51 | ||||||||||||||||||||
Options outstanding at December 31, 2014 | 2,114,250 | $ | 1.98 | ||||||||||||||||||||
A summary of the status of our unvested shares during the year ended and as of December 31, 2014 is as follows: | |||||||||||||||||||||||
Shares Under | Weighted Average | ||||||||||||||||||||||
Option | Grant-Date | ||||||||||||||||||||||
Fair Value | |||||||||||||||||||||||
Unvested at December 31, 2013 | 802,250 | $ | 0.91 | ||||||||||||||||||||
Granted | 535,000 | 0.21 | |||||||||||||||||||||
Vested | (422,063 | ) | 0.9 | ||||||||||||||||||||
Forfeited and cancelled | (7,500 | ) | 0.6 | ||||||||||||||||||||
Unvested at December 31, 2014 | 907,687 | $ | 0.5 | ||||||||||||||||||||
Information about stock options outstanding, vested and expected to vest as of December 31, 2014, is as follows: | |||||||||||||||||||||||
Outstanding, Vested and Expected to Vest | Options Vested | ||||||||||||||||||||||
Weighted Average | Weighted Average | ||||||||||||||||||||||
Remaining | Weighted | Remaining | |||||||||||||||||||||
Per Share | Contractual | Average | Options | Contractual | |||||||||||||||||||
Exercise Price | Shares | Life (Years) | Exercise Price | Exercisable | Life (Years) | ||||||||||||||||||
$0.14 | 180,000 | 9.94 | $ | 0.14 | — | — | |||||||||||||||||
0.51 | – | 0.76 | 865,000 | 8.84 | 0.63 | 278,750 | 8.71 | ||||||||||||||||
0.91 | – | 1.01 | 305,000 | 4.22 | 0.98 | 251,250 | 3.32 | ||||||||||||||||
2 | – | 3.21 | 333,250 | 6.67 | 2.05 | 280,563 | 6.65 | ||||||||||||||||
5.18 | – | 5.83 | 222,000 | 4.67 | 5.61 | 203,250 | 4.52 | ||||||||||||||||
6 | – | 7 | 209,000 | 5.39 | 6.65 | 192,750 | 5.33 | ||||||||||||||||
2,114,250 | 5.86 | $ | 1.98 | 1,206,563 | 5.86 | ||||||||||||||||||
The cumulative grant date fair value of employee options vested during the years ended December 31, 2014, 2013 and 2012 was $256,000, $294,000 and $347,000, respectively. Total proceeds received for options exercised during the years ended December 31, 2014, 2013 and 2012 were $0, $0 and $500, respectively. On an aggregated basis, as of December 31, 2014, there was $2,000 in intrinsic value for our total outstanding options and no intrinsic value for those outstanding options which are exercisable. | |||||||||||||||||||||||
As of December 31, 2014, 2013 and 2012, total compensation expense related to unvested employee stock options not yet recognized was $197,000, $302,000 and $577,000, respectively, which is expected to be allocated to expenses over a weighted-average period of 2.03, 2.03 and 2.28 years, respectively. | |||||||||||||||||||||||
The assumptions used in the Black-Scholes option-pricing model for the years ended December 31, 2014, 2013 and 2012 are as follows: | |||||||||||||||||||||||
December 31, | |||||||||||||||||||||||
2014 | 2013 | 2012 | |||||||||||||||||||||
Risk free interest rate | 1.67%-1.86% | 0.88%-1.80% | 0.92% | ||||||||||||||||||||
Dividend yield | 0% | 0% | 0% | ||||||||||||||||||||
Expected volatility | 55% | 56% | 57% | ||||||||||||||||||||
Expected term (years) | 5.50-6.25 | 5.50-6.25 | 6.25 | ||||||||||||||||||||
Weighted average grant date fair value | $0.21 | $0.38 | $0.54 | ||||||||||||||||||||
Nonemployee Stock-Based Compensation | |||||||||||||||||||||||
We account for stock options granted to nonemployees in accordance with FASB ASC 718. In connection with stock options granted to nonemployees, we recorded $2,000, $24,000 and $20,000 for nonemployee stock-based compensation during the years ended December 31, 2014, 2013 and 2012, respectively. These amounts were based upon the fair values of the vested portion of the grants. | |||||||||||||||||||||||
Amounts expensed during the remaining vesting period will be determined based on the fair value at the time of vesting. | |||||||||||||||||||||||
Restricted Stock Awards | |||||||||||||||||||||||
A summary of restricted stock award activity is as follows: | |||||||||||||||||||||||
Number of Shares | Weighted Average | ||||||||||||||||||||||
Fair Value | |||||||||||||||||||||||
Awards outstanding at December 31, 2012 | 67,500 | $ | 8 | ||||||||||||||||||||
Granted | 120,000 | 0.77 | |||||||||||||||||||||
Vested | (82,500 | ) | 3.43 | ||||||||||||||||||||
Cancelled | — | — | |||||||||||||||||||||
Awards outstanding at December 31, 2013 | 105,000 | 4.13 | |||||||||||||||||||||
Granted | — | — | |||||||||||||||||||||
Vested | (42,500 | ) | 4.81 | ||||||||||||||||||||
Cancelled | — | — | |||||||||||||||||||||
Awards outstanding at December 31, 2014 | 62,500 | $ | 3.67 | ||||||||||||||||||||
The fair value of each restricted stock award is equal to the fair market value of our common stock at the date of grant. Restricted stock awards vest over a period of time that varies with the purpose of the individual award. As of December 31, 2014, outstanding awards vest over three or four year terms. The estimated fair value of restricted stock awards, including the effect of estimated forfeitures, is recognized on a straight-line basis over the restricted stock’s vesting period. We recorded stock-based compensation expense for restricted stock grants of $205,000, $242,000 and $255,000 for the years ended December 31, 2014, 2013 and 2012, respectively. | |||||||||||||||||||||||
Common Stock Purchase Options Issued to Underwriters and Consultants | |||||||||||||||||||||||
In conjunction with the completion of our public offering in January 2014, we issued to the underwriter and its designees warrants to purchase an aggregate of 262,500 shares of our common stock at an exercise price of $0.875, or 125% of the purchase price of shares sold in the public offering. These options have a five-year term and became exercisable on January 23, 2015, one year after the effective date of the public offering. These options were not issued under the 2013 Plan. | |||||||||||||||||||||||
In conjunction with the completion of our public offering in December 2012, we issued to the underwriter and its designees warrants to purchase an aggregate of 500,000 shares of our common stock at an exercise price of $0.8125, or 125% of the purchase price of shares sold in the public offering. These warrants have a five-year term and became exercisable on December 21, 2013, one year after the effective date of the public offering. These warrants were not issued under the 2007 Plan. | |||||||||||||||||||||||
In conjunction with the completion of our initial public offering in February 2011, we issued to the underwriters and their designees options to purchase an aggregate of 103,125 shares of our common stock at an exercise price of $10.00, or 125% of the purchase price of shares sold in the offering. These warrants have a five-year term and became exercisable on February 10, 2012, one year after the effective date of the offering. These warrants were not issued under the 2007 Plan. | |||||||||||||||||||||||
In the third quarter of 2013, we engaged an outside consultant to provide certain services to us upon terms that provided for the issuance of a common stock purchase warrant for the purchase of up to 75,000 shares of our common stock. The fair value of each share of the common stock purchase warrant was determined using a Black-Scholes option-pricing model with an estimated risk free interest rate of 0.35%, an expected volatility of 56% and an expected term of 2.0 years resulting in an estimated fair value per share of $0.24. | |||||||||||||||||||||||
Stock-Based Payments | |||||||||||||||||||||||
In the first quarter of 2013, we engaged an outside consultant to provide certain services to us upon terms that provided for payment in shares of our common stock, with the number of shares tied to agreed-upon performance criteria. Upon completion of the engagement and consideration of the achievement of the agreed-upon performance criteria, our Board of Directors authorized the issuance of 38,000 shares of our common stock. The fair value of each share of common stock was determined based upon the closing price of our common stock on the date payment was authorized, and accordingly, we recorded an expense of $39,000. |
Note_13_Employee_Benefit_Plan
Note 13 - Employee Benefit Plan | 12 Months Ended |
Dec. 31, 2014 | |
Compensation and Retirement Disclosure [Abstract] | |
Pension and Other Postretirement Benefits Disclosure [Text Block] | 13. Employee Benefit Plan |
On January 1, 2013, we implemented an employee 401(k) retirement savings plan (the “401(k) Plan”). The 401(k) Plan provides eligible employees with an opportunity to make tax-deferred contributions into a long-term investment and savings program. All employees over the age of 21 who have completed one month of service are automatically enrolled in the 401(k) Plan, but may elect to not participate. The 401(k) Plan allows eligible employees to contribute a portion of their annual compensation, subject only to maximum limits required by law. We contribute an amount equal to 3% of each employees’ compensation under the safe harbor provisions provided by the Internal Revenue Service rules governing 401(k) plans. Employee contributions vest immediately and employer contributions vest fully after two years of service. | |
Prior to January 1, 2013, we maintained a simplified employee retirement plan, or SEP, which commenced on January 1, 2008. The SEP was a defined contribution plan; employee contributions were voluntary and were determined on an individual basis, limited by the maximum amounts allowable under federal tax regulations. | |
We contributed up to 3% of each individual’s base salary as required under the safe harbor provisions of Internal Revenue Service rules governing SEP plans. Employer contributions vested immediately and were expensed when paid. | |
We have recorded contribution expenses of $61,000, $62,000 and $51,000 for the years ended December 31, 2014, 2013 and 2012, respectively. |
Note_14_Income_Taxes
Note 14 - Income Taxes | 12 Months Ended | ||||||||||||
Dec. 31, 2014 | |||||||||||||
Income Tax Disclosure [Abstract] | |||||||||||||
Income Tax Disclosure [Text Block] | 14. Income Taxes | ||||||||||||
We have incurred net operating losses since inception. We have not reflected the benefit of net operating loss carryforwards in the accompanying financial statements and have established a full valuation allowance against our deferred tax assets. | |||||||||||||
Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes, and operating losses and tax credit carryforwards. | |||||||||||||
The significant components of our deferred tax assets and liabilities are as follows (in thousands): | |||||||||||||
December 31, | |||||||||||||
2014 | 2013 | ||||||||||||
Deferred tax assets: | |||||||||||||
Net operating loss carryforwards | $ | 10,615 | $ | 8,840 | |||||||||
Intangible assets—patent prosecution costs | 139 | 140 | |||||||||||
Stock-based compensation | 540 | 484 | |||||||||||
Milestone obligation | 1,190 | 1,313 | |||||||||||
Research credit carryforwards | 209 | 209 | |||||||||||
Other | 95 | 79 | |||||||||||
Total deferred tax assets | 12,788 | 11,065 | |||||||||||
Deferred tax liabilities: | (73 | ) | (75 | ) | |||||||||
Total deferred taxes, net | 12,715 | 10,990 | |||||||||||
Valuation allowance | (12,715 | ) | (10,990 | ) | |||||||||
Net deferred tax asset | $ | — | $ | — | |||||||||
A reconciliation of the statutory tax rates and the effective tax rates is as follows: | |||||||||||||
Year Ended December 31, | |||||||||||||
2014 | 2013 | 2012 | |||||||||||
Statutory rate | 34 | % | 34 | % | 34 | % | |||||||
Permanent differences | (1.5 | ) | (1.6 | ) | (2.1 | ) | |||||||
State and local income taxes | — | 0.2 | 0.4 | ||||||||||
Credits and other | — | (0.2 | ) | — | |||||||||
State tax rate true-up | (1.7 | ) | (1.0 | ) | (16.0 | ) | |||||||
Valuation allowance | (30.8 | ) | (31.4 | ) | (16.3 | ) | |||||||
Effective rate | 0 | % | 0 | % | 0 | % | |||||||
Realization of the future tax benefits is dependent on our ability to generate sufficient taxable income within the carry-forward period. Because of our history of operating losses, management believes that the deferred tax assets arising from the above-mentioned future tax benefits are currently not likely to be realized and, accordingly, we have provided a full valuation allowance. The net valuation allowance increased by $1.7 million and $1.9 million for the years ended December 31, 2014 and 2013, respectively. | |||||||||||||
Net operating losses and tax credit carryforwards as of December 31, 2014, are as follows: | |||||||||||||
Amount | Expiration Years | ||||||||||||
(In thousands) | |||||||||||||
Net operating losses—federal | $ | 30,208 | Beginning 2027 | ||||||||||
Net operating losses—state | 7,545 | Beginning 2022 | |||||||||||
Tax credits—federal | 167 | Beginning 2026 | |||||||||||
Tax credits—state | 41 | Beginning 2022 | |||||||||||
Utilization of the net operating loss carryforwards and credits may be subject to a substantial annual limitation due to the ownership change limitations provided by the Internal Revenue Code of 1986, as amended (the “IRC”), and similar state provisions. We have not performed a detailed analysis to determine whether an ownership change under Section 382 of the IRC has occurred. The effect of an ownership change would be the imposition of an annual limitation on the use of net operating loss carryforwards attributable to periods before the change. | |||||||||||||
We would classify interest and penalties related to uncertain tax positions in income tax expense, if applicable. There was no interest expense or penalties related to unrecognized tax benefits recorded through December 31, 2014. The tax years 2009 through 2014 remain open to examination by federal and state tax authorities. |
Note_15_Selected_Quarterly_Fin
Note 15 - Selected Quarterly Financial Data (unaudited) | 12 Months Ended | ||||||||||||||||
Dec. 31, 2014 | |||||||||||||||||
Quarterly Financial Information Disclosure [Abstract] | |||||||||||||||||
Quarterly Financial Information [Text Block] | 15. Selected Quarterly Financial Data (unaudited) | ||||||||||||||||
The following summarized unaudited quarterly financial data has been prepared using our unaudited quarterly financial statements (In thousands, except per share amounts): | |||||||||||||||||
First | Second | Third | Fourth | ||||||||||||||
Quarter | Quarter | Quarter | Quarter | ||||||||||||||
Fiscal 2014 | |||||||||||||||||
Net sales | $ | 26 | $ | 31 | $ | 13 | $ | 14 | |||||||||
Gross profit | 14 | 17 | 5 | 4 | |||||||||||||
Operating loss | (1,439 | ) | (1,430 | ) | (1,425 | ) | (1,319 | ) | |||||||||
Net loss | (1,437 | ) | (1,428 | ) | (1,424 | ) | (1,318 | ) | |||||||||
Basic and diluted net loss per share | $ | (0.05 | ) | $ | (0.04 | ) | $ | (0.04 | ) | $ | (0.04 | ) | |||||
Fiscal 2013 | |||||||||||||||||
Net sales | $ | 36 | $ | 40 | $ | 13 | $ | 41 | |||||||||
Gross profit | 20 | 20 | 6 | 21 | |||||||||||||
Operating loss | (1,459 | ) | (1,509 | ) | (1,570 | ) | (1,538 | ) | |||||||||
Net loss | (1,456 | ) | (1,504 | ) | (1,566 | ) | (1,534 | ) | |||||||||
Basic and diluted net loss per share | $ | (0.05 | ) | $ | (0.06 | ) | $ | (0.06 | ) | $ | (0.06 | ) | |||||
Quarterly calculations of basic and diluted loss per share are made independently during each fiscal quarter. |
Note_16_Subsequent_Events
Note 16 - Subsequent Events | 12 Months Ended |
Dec. 31, 2014 | |
Subsequent Events [Abstract] | |
Subsequent Events [Text Block] | 16. Subsequent Events |
Reorganization | |
On January 5, 2015, we announced that we streamlined and scaled back our operations to focus our efforts and resources on regulatory and clinical activities which further the clinical development of our eSVS Mesh. As part of this reorganization, we reduced our personnel from thirteen to eight employees. These reductions included our two sales directors, two administrative positions and one operations position. In addition, our officers agreed to accept temporary salary reductions. We believe that these actions will reduce our monthly operating expenses, excluding costs related to our eMESH I clinical feasibility trial, to approximately $200,000. With our operating expense reductions, we expect that our available capital will be sufficient to fund our operations through December 2015. |
Accounting_Policies_by_Policy_
Accounting Policies, by Policy (Policies) | 12 Months Ended | ||||||||||||
Dec. 31, 2014 | |||||||||||||
Accounting Policies [Abstract] | |||||||||||||
Use of Estimates, Policy [Policy Text Block] | Use of Estimates | ||||||||||||
The preparation of financial statements in conformity with accounting principles generally accepted in the United States (“US GAAP”) requires management to make estimates and assumptions that affect the reported amounts and disclosures in the combined consolidated financial statements and accompanying notes. Actual results could differ from those estimates. | |||||||||||||
Cash and Cash Equivalents, Policy [Policy Text Block] | Cash and Cash Equivalents | ||||||||||||
Cash and cash equivalents consist of cash, money market funds and bank certificates of deposit with original maturities of three months or less. The carrying value of these instruments approximates fair value. We have not experienced any losses in our cash and cash equivalents. | |||||||||||||
Marketable Securities, Available-for-sale Securities, Policy [Policy Text Block] | Short-term Investments | ||||||||||||
Short-term investments may consist of bank certificates of deposits, money market funds, commercial paper and corporate debt. Our investment policy seeks to manage these investments to achieve our goal of preserving principal, maintaining adequate liquidity at all times, and maximizing returns subject to our investment guidelines. Short-term investments have been classified and accounted for as available-for-sale securities and are reported on the balance sheet at fair value with unrealized gains or losses reported as a component of other comprehensive income. Interest earned on short-term investments is included in interest income. We periodically evaluate our investments in marketable securities for potential impairment due to declines in market value deemed by us to be other-than-temporary. If cost exceeds fair value, we consider, among other factors, the duration and extent to which cost exceeds fair value, the financial strength of the issuer, and our intent and ability to hold the investment to maturity. Once a decline in value is deemed to be other-than-temporary, an impairment charge is recorded and a new cost basis in the investment is established. | |||||||||||||
In 2014 and 2013, our short-term investments included a bank certificate of deposit which we pledged as collateral for our corporate purchasing card. The balance of this bank certificate of deposit was $50,000 and $100,000 as of December 31, 2014 and December 31, 2013, respectively. | |||||||||||||
Receivables, Policy [Policy Text Block] | Accounts Receivable | ||||||||||||
Accounts receivable are recorded at the invoiced amount and are due within 60 to 90 days of shipment. We grant credit to customers in the normal course of business and do not require collateral. Accounts receivable do not bear interest and are presented net of allowances for doubtful accounts, if any. We determine our allowance for doubtful accounts by considering a number of factors, including the length of time trade accounts receivable are past due, the customer’s current ability to pay its obligation to us and the condition of the general economy and the industry as a whole. | |||||||||||||
Inventory, Policy [Policy Text Block] | Inventories | ||||||||||||
Inventories are stated at the lower of cost (first-in, first-out method) or market. Inventory cost includes purchased materials and overhead costs which are applied to work in process and finished goods based on annual estimates of production volume and overhead spending. Appropriate consideration is given to deterioration, obsolescence, excess inventory and other factors in evaluating net realizable value. Inventories consist of the following as of December 31 (in thousands): | |||||||||||||
2014 | 2013 | ||||||||||||
Raw materials | $ | 80 | $ | 81 | |||||||||
Work in process | 306 | 333 | |||||||||||
Finished goods | 287 | 379 | |||||||||||
Total | $ | 673 | $ | 793 | |||||||||
Property, Plant and Equipment, Policy [Policy Text Block] | Property and Equipment | ||||||||||||
Property and equipment is stated at cost less accumulated depreciation. Depreciation is computed based upon the estimated useful lives of the respective assets, or the lesser of the estimated useful life or the remaining life of the underlying facility lease for leasehold improvements, ranging from three to seven years, and is recorded using the straight-line method. Upon sale or retirement of assets, the costs and related accumulated depreciation are removed from the balance sheet and the resulting gain or loss is reflected in the statement of operations. Repairs and maintenance costs are expensed as incurred. | |||||||||||||
Impairment or Disposal of Long-Lived Assets, Policy [Policy Text Block] | Impairment of Long-Lived Assets | ||||||||||||
In accordance with Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 360, Property, Plant and Equipment, long-lived assets, such as property and equipment, are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to estimated undiscounted future cash flows expected to be generated by the asset. If the carrying amount of an asset exceeds its estimated future cash flows, then an impairment charge is recognized as the amount by which the carrying amount of the asset exceeds the fair value of the asset. As of December 31, 2014 and 2013, no modification of the remaining useful lives or write-down of long-lived assets is required. | |||||||||||||
Revenue Recognition, Policy [Policy Text Block] | Revenue Recognition | ||||||||||||
We sell our eSVS Mesh to international distributors primarily in Europe, who subsequently resell it to hospitals and clinics. We recognize revenue when persuasive evidence of an arrangement exists, delivery of goods occurs through the transfer of title and the risks and rewards of ownership, the selling price is fixed or determinable and collectability is reasonably assured. | |||||||||||||
We recognize revenue as products are shipped based on agreements with each of our distributors, which provide that title and risk of loss pass to the distributor upon shipment of the products to the distributor and do not provide the distributors a right of return. We invoice shipping charges to our distributors and include them in net sales. We expense royalties and shipping costs at the time we report the related revenue and record them in cost of sales. | |||||||||||||
Research and Development Expense, Policy [Policy Text Block] | Research and Development Expenses | ||||||||||||
Research and development costs consist of costs incurred for internally sponsored research and development, direct expenses and research-related overhead. Research and development costs also include costs related to the execution of clinical trials and related efforts to obtain regulatory approval for our eSVS Mesh. | |||||||||||||
We charge research and development costs, including clinical trial costs, to expense when incurred. Clinical trial costs are a significant component of research and development expenses. All of our clinical trials are performed at clinical trial sites and are administered jointly by us with assistance from contract research organizations (“CROs”). Costs of setting up clinical trial sites are accrued upon execution of the study agreement. Expenses related to the performance of clinical trials generally are accrued based on contracted amounts and the achievement of agreed upon milestones, such as patient enrollment, patient follow-up, etc. We monitor levels of performance under each significant contract, including the extent of patient enrollment and other activities through communications with the clinical trial sites and CROs, and adjust the estimates, if required, on a quarterly basis so that clinical expenses reflect the actual effort expended at each clinical trial site and by each CRO. | |||||||||||||
All material CRO contracts are terminable by us upon written notice and we are generally only liable for actual effort expended by the CROs and certain non-cancelable expenses incurred at any point of termination. | |||||||||||||
We expense costs incurred to obtain patents or acquire licenses as the ultimate recoverability of the amounts paid is uncertain. | |||||||||||||
Comprehensive Income, Policy [Policy Text Block] | Comprehensive Income/Loss | ||||||||||||
Comprehensive income/loss consists of net loss and the effect of unrealized gains and losses on available-for-sale securities. | |||||||||||||
Income Tax, Policy [Policy Text Block] | Income Taxes | ||||||||||||
Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carry-forwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. Valuation allowances are established when necessary to reduce deferred tax assets to the amount that is more likely than not to be realized. | |||||||||||||
Share-based Compensation, Option and Incentive Plans Policy [Policy Text Block] | Stock-Based Compensation | ||||||||||||
Stock-based incentive awards are accounted for under the provisions of FASB ASC 718, Compensation — Stock Compensation, which requires companies to measure and recognize the cost of employee and non-employee services received in exchange for awards of equity instruments based on the grant date fair value of those awards. Compensation cost is recognized ratably using the straight-line attribution method over the expected vesting period, which is considered to be the requisite service period. We estimate pre-vesting award forfeitures when calculating the compensation costs and revise those estimates in subsequent periods if actual forfeitures differ from those estimates. | |||||||||||||
The fair value of stock-based awards is estimated at the date of grant using the Black-Scholes option pricing model. Risk free interest rates are based upon U.S. Treasury rates appropriate for the expected term. Expected volatility and forfeiture rates are based primarily on the volatility rates of a set of guideline companies, which consist of public and recently public medical technology companies. The assumed dividend yield is zero, as we do not expect to declare any dividends in the foreseeable future. The expected term of options granted is determined using the “simplified” method. Under this approach, the expected term is presumed to be the mid-point between the vesting date and the end of the contractual term. | |||||||||||||
Stock-based compensation expense in our statements of operations is summarized as follows (in thousands): | |||||||||||||
December 31, | |||||||||||||
2014 | 2013 | 2012 | |||||||||||
Manufacturing | $ | — | $ | — | $ | 29 | |||||||
Research and development | 134 | 152 | 150 | ||||||||||
Sales, general and administrative | 281 | 418 | 409 | ||||||||||
Total stock-based compensation | $ | 415 | $ | 570 | $ | 588 | |||||||
Earnings Per Share, Policy [Policy Text Block] | Net Loss per Share | ||||||||||||
We compute net loss per share by dividing our net loss (the numerator) by the weighted-average number of common shares outstanding (the denominator) during the period. Shares issued during the period and shares reacquired during the period are weighted for the portion of the period that they were outstanding. The computation of diluted earnings per share, or EPS, is similar to the computation of basic EPS except that the denominator is increased to include the number of additional common shares that would have been outstanding if the dilutive potential common shares had been issued. Diluted EPS is the same as basic EPS due to common equivalent shares being excluded from the calculation, as their effect is anti-dilutive. | |||||||||||||
The following table summarizes our calculation of net loss per common share for the periods (in thousands, except share and per share data): | |||||||||||||
December 31, | |||||||||||||
2014 | 2013 | 2012 | |||||||||||
Net loss | $ | (5,607 | ) | $ | (6,060 | ) | $ | (5,507 | ) | ||||
Weighted average shares outstanding—basic and diluted | 32,534,586 | 26,916,060 | 16,402,363 | ||||||||||
Basic and diluted net loss per share | $ | (0.17 | ) | $ | (0.23 | ) | $ | (0.34 | ) | ||||
The following outstanding potential common shares were not included in the diluted net loss per share calculations as their effects were not dilutive: | |||||||||||||
December 31, | |||||||||||||
2014 | 2013 | 2012 | |||||||||||
Employee and non-employee stock options | 2,114,250 | 1,609,250 | 1,174,250 | ||||||||||
Common shares issuable to underwriters under purchase agreements (See note 12) | 865,625 | 603,125 | 603,125 | ||||||||||
Common shares issuable to outside consultant under warrant | 75,000 | 75,000 | — | ||||||||||
Fiscal Period, Policy [Policy Text Block] | Fiscal Year | ||||||||||||
We operate on a manufacturing calendar with our fiscal year always ending on December 31. Each quarter is 13 weeks, consisting of two four-week and one five-week periods. | |||||||||||||
New Accounting Pronouncements, Policy [Policy Text Block] | Recently IssuedAccounting Pronouncements | ||||||||||||
In August 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2014-15, Presentation of Financial Statements – Going Concern (Subtopic 205-40): Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern. The guidance requires an entity to evaluate whether there are conditions or events, in the aggregate, that raise substantial doubt about the entity’s ability to continue as a going concern within one year after the date that the financial statements are issued or available to be issued and to provide related footnote disclosures in certain circumstances. The guidance is effective for the annual period ending after December 15, 2016, and for annual and interim periods thereafter (our fiscal 2016). Early application is permitted and we have adopted this guidance for the current period presented. | |||||||||||||
In May 2014, FASB issued Revenue from Contracts with Customers, Topic 606 (Accounting Standards Update No. 2014-09 (ASU 2014-09)), which provides a framework for the recognition of revenue, with the objective that recognized revenues properly reflect amounts an entity is entitled to receive in exchange for goods and services. This guidance will be effective for interim and annual reporting periods beginning after December 15, 2016 (our fiscal 2017). We are currently evaluating the impact of adopting ASU 2014-09 on our financial statements. |
Note_4_Summary_of_Significant_1
Note 4 - Summary of Significant Accounting Policies (Tables) | 12 Months Ended | ||||||||||||
Dec. 31, 2014 | |||||||||||||
Accounting Policies [Abstract] | |||||||||||||
Schedule of Inventory, Current [Table Text Block] | 2014 | 2013 | |||||||||||
Raw materials | $ | 80 | $ | 81 | |||||||||
Work in process | 306 | 333 | |||||||||||
Finished goods | 287 | 379 | |||||||||||
Total | $ | 673 | $ | 793 | |||||||||
Schedule of Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Table Text Block] | December 31, | ||||||||||||
2014 | 2013 | 2012 | |||||||||||
Manufacturing | $ | — | $ | — | $ | 29 | |||||||
Research and development | 134 | 152 | 150 | ||||||||||
Sales, general and administrative | 281 | 418 | 409 | ||||||||||
Total stock-based compensation | $ | 415 | $ | 570 | $ | 588 | |||||||
Schedule of Earnings Per Share, Basic and Diluted [Table Text Block] | December 31, | ||||||||||||
2014 | 2013 | 2012 | |||||||||||
Net loss | $ | (5,607 | ) | $ | (6,060 | ) | $ | (5,507 | ) | ||||
Weighted average shares outstanding—basic and diluted | 32,534,586 | 26,916,060 | 16,402,363 | ||||||||||
Basic and diluted net loss per share | $ | (0.17 | ) | $ | (0.23 | ) | $ | (0.34 | ) | ||||
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share [Table Text Block] | December 31, | ||||||||||||
2014 | 2013 | 2012 | |||||||||||
Employee and non-employee stock options | 2,114,250 | 1,609,250 | 1,174,250 | ||||||||||
Common shares issuable to underwriters under purchase agreements (See note 12) | 865,625 | 603,125 | 603,125 | ||||||||||
Common shares issuable to outside consultant under warrant | 75,000 | 75,000 | — |
Note_5_Cash_Cash_Equivalents_a1
Note 5 - Cash, Cash Equivalents and Short-term Investments (Tables) | 12 Months Ended | ||||||||
Dec. 31, 2014 | |||||||||
Disclosure Text Block Supplement [Abstract] | |||||||||
Cash, Cash Equivalents and Investments [Table Text Block] | 31-Dec-14 | 31-Dec-13 | |||||||
Cash and cash equivalents | |||||||||
Cash | $ | 508 | $ | 366 | |||||
Money market funds | 2,379 | 1,699 | |||||||
Bank certificate of deposit | 251 | 251 | |||||||
Total cash and cash equivalents | $ | 3,138 | $ | 2,316 | |||||
Short-term investments | |||||||||
Corporate debt securities | $ | 407 | $ | 2,083 | |||||
Commercial paper | — | 250 | |||||||
Bank certificates of deposit | 50 | 351 | |||||||
Total short-term investments | $ | 457 | $ | 2,684 |
Note_6_Fair_Value_of_Financial1
Note 6 - Fair Value of Financial Instruments (Tables) | 12 Months Ended | ||||||||||||||||||||||||||||||||
Dec. 31, 2014 | |||||||||||||||||||||||||||||||||
Fair Value Disclosures [Abstract] | |||||||||||||||||||||||||||||||||
Fair Value, Assets Measured on Recurring Basis [Table Text Block] | 31-Dec-14 | 31-Dec-13 | |||||||||||||||||||||||||||||||
Total | Quoted Prices | Other Observable | Significant | Total | Quoted Prices | Other Observable | Significant | ||||||||||||||||||||||||||
In Active | Inputs | Unobservable | In Active | Inputs | Unobservable | ||||||||||||||||||||||||||||
Markets | (Level 2) | Inputs | Markets | (Level 2) | Inputs | ||||||||||||||||||||||||||||
(Level 1) | (Level 3) | (Level 1) | (Level 3) | ||||||||||||||||||||||||||||||
Money market funds | $ | 2,379 | $ | 2,379 | $ | — | $ | — | $ | 1,699 | $ | 1,699 | $ | — | $ | — | |||||||||||||||||
Bank certificate of deposit | 301 | — | 301 | — | 602 | — | 602 | — | |||||||||||||||||||||||||
Commercial paper | — | — | — | — | 250 | — | 250 | — | |||||||||||||||||||||||||
Corporate debt securities | 407 | — | 407 | — | 2,083 | — | 2,083 | — | |||||||||||||||||||||||||
Total | $ | 3,087 | $ | 2,379 | $ | 708 | $ | — | $ | 4,634 | $ | 1,699 | $ | 2,935 | $ | — |
Note_8_Property_and_Equipment_
Note 8 - Property and Equipment (Tables) | 12 Months Ended | ||||||||
Dec. 31, 2014 | |||||||||
Property, Plant and Equipment [Abstract] | |||||||||
Property, Plant and Equipment [Table Text Block] | December 31, | ||||||||
2014 | 2013 | ||||||||
Furniture and fixtures | $ | 58 | $ | 58 | |||||
Machinery, equipment and tooling | 505 | 505 | |||||||
Computers and software | 193 | 191 | |||||||
Leasehold improvements | 90 | 90 | |||||||
Accumulated depreciation | (493 | ) | (444 | ) | |||||
Property and equipment, net | $ | 353 | $ | 400 |
Note_9_Accrued_Liabilities_Tab
Note 9 - Accrued Liabilities (Tables) | 12 Months Ended | ||||||||
Dec. 31, 2014 | |||||||||
Payables and Accruals [Abstract] | |||||||||
Schedule of Accrued Liabilities [Table Text Block] | December 31, | ||||||||
2014 | 2013 | ||||||||
Clinical study related expense | $ | 256 | $ | 216 | |||||
Professional services | 54 | 61 | |||||||
Payroll and related expenses | 36 | 35 | |||||||
Other | 9 | 2 | |||||||
Accrued liabilities | $ | 355 | $ | 314 |
Note_10_Commitments_and_Contin1
Note 10 - Commitments and Contingencies (Tables) | 12 Months Ended | ||||
Dec. 31, 2014 | |||||
Commitments and Contingencies Disclosure [Abstract] | |||||
Schedule of Future Minimum Rental Payments for Operating Leases [Table Text Block] | 2015 | $ | 88 | ||
2016 | 86 | ||||
2017 | 64 | ||||
Total | $ | 238 |
Note_11_Stockholders_Equity_Ta
Note 11 - Stockholders' Equity (Tables) | 12 Months Ended | ||||
Dec. 31, 2014 | |||||
Stockholders' Equity Note [Abstract] | |||||
Common Stock Reserved for Future Issuance [Table Text Block] | 31-Dec-14 | ||||
Stock options outstanding | 2,114,250 | ||||
Shares available for grant under equity incentive plan | 1,675,000 | ||||
Warrants for purchase of common stock | 940,625 | ||||
Total | 4,729,875 |
Note_12_Stockbased_Compensatio1
Note 12 - Stock-based Compensation (Tables) | 12 Months Ended | ||||||||||||||||||||||
Dec. 31, 2014 | |||||||||||||||||||||||
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |||||||||||||||||||||||
Schedule of Stock Options Roll Forward [Table Text Block] | Shares Under | Weighted | |||||||||||||||||||||
Option | Average | ||||||||||||||||||||||
Exercise Price | |||||||||||||||||||||||
Options outstanding at December 31, 2012 | 1,174,250 | $ | 3.64 | ||||||||||||||||||||
Granted | 630,000 | 0.72 | |||||||||||||||||||||
Exercised | — | — | |||||||||||||||||||||
Forfeited and cancelled | (195,000 | ) | 3.05 | ||||||||||||||||||||
Options outstanding at December 31, 2013 | 1,609,250 | 2.56 | |||||||||||||||||||||
Granted | 535,000 | 0.39 | |||||||||||||||||||||
Exercised | — | — | |||||||||||||||||||||
Forfeited and cancelled | (30,000 | ) | 4.51 | ||||||||||||||||||||
Options outstanding at December 31, 2014 | 2,114,250 | $ | 1.98 | ||||||||||||||||||||
Schedule of Nonvested Share Activity [Table Text Block] | Shares Under | Weighted Average | |||||||||||||||||||||
Option | Grant-Date | ||||||||||||||||||||||
Fair Value | |||||||||||||||||||||||
Unvested at December 31, 2013 | 802,250 | $ | 0.91 | ||||||||||||||||||||
Granted | 535,000 | 0.21 | |||||||||||||||||||||
Vested | (422,063 | ) | 0.9 | ||||||||||||||||||||
Forfeited and cancelled | (7,500 | ) | 0.6 | ||||||||||||||||||||
Unvested at December 31, 2014 | 907,687 | $ | 0.5 | ||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested and Expected to Vest, Outstanding and Exercisable [Table Text Block] | Outstanding, Vested and Expected to Vest | Options Vested | |||||||||||||||||||||
Weighted Average | Weighted Average | ||||||||||||||||||||||
Remaining | Weighted | Remaining | |||||||||||||||||||||
Per Share | Contractual | Average | Options | Contractual | |||||||||||||||||||
Exercise Price | Shares | Life (Years) | Exercise Price | Exercisable | Life (Years) | ||||||||||||||||||
$0.14 | 180,000 | 9.94 | $ | 0.14 | — | — | |||||||||||||||||
0.51 | – | 0.76 | 865,000 | 8.84 | 0.63 | 278,750 | 8.71 | ||||||||||||||||
0.91 | – | 1.01 | 305,000 | 4.22 | 0.98 | 251,250 | 3.32 | ||||||||||||||||
2 | – | 3.21 | 333,250 | 6.67 | 2.05 | 280,563 | 6.65 | ||||||||||||||||
5.18 | – | 5.83 | 222,000 | 4.67 | 5.61 | 203,250 | 4.52 | ||||||||||||||||
6 | – | 7 | 209,000 | 5.39 | 6.65 | 192,750 | 5.33 | ||||||||||||||||
2,114,250 | 5.86 | $ | 1.98 | 1,206,563 | 5.86 | ||||||||||||||||||
Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions [Table Text Block] | December 31, | ||||||||||||||||||||||
2014 | 2013 | 2012 | |||||||||||||||||||||
Risk free interest rate | 1.67%-1.86% | 0.88%-1.80% | 0.92% | ||||||||||||||||||||
Dividend yield | 0% | 0% | 0% | ||||||||||||||||||||
Expected volatility | 55% | 56% | 57% | ||||||||||||||||||||
Expected term (years) | 5.50-6.25 | 5.50-6.25 | 6.25 | ||||||||||||||||||||
Weighted average grant date fair value | $0.21 | $0.38 | $0.54 | ||||||||||||||||||||
Schedule of Share-based Compensation, Restricted Stock and Restricted Stock Units Activity [Table Text Block] | Number of Shares | Weighted Average | |||||||||||||||||||||
Fair Value | |||||||||||||||||||||||
Awards outstanding at December 31, 2012 | 67,500 | $ | 8 | ||||||||||||||||||||
Granted | 120,000 | 0.77 | |||||||||||||||||||||
Vested | (82,500 | ) | 3.43 | ||||||||||||||||||||
Cancelled | — | — | |||||||||||||||||||||
Awards outstanding at December 31, 2013 | 105,000 | 4.13 | |||||||||||||||||||||
Granted | — | — | |||||||||||||||||||||
Vested | (42,500 | ) | 4.81 | ||||||||||||||||||||
Cancelled | — | — | |||||||||||||||||||||
Awards outstanding at December 31, 2014 | 62,500 | $ | 3.67 |
Note_14_Income_Taxes_Tables
Note 14 - Income Taxes (Tables) | 12 Months Ended | ||||||||||||
Dec. 31, 2014 | |||||||||||||
Income Tax Disclosure [Abstract] | |||||||||||||
Schedule of Deferred Tax Assets and Liabilities [Table Text Block] | December 31, | ||||||||||||
2014 | 2013 | ||||||||||||
Deferred tax assets: | |||||||||||||
Net operating loss carryforwards | $ | 10,615 | $ | 8,840 | |||||||||
Intangible assets—patent prosecution costs | 139 | 140 | |||||||||||
Stock-based compensation | 540 | 484 | |||||||||||
Milestone obligation | 1,190 | 1,313 | |||||||||||
Research credit carryforwards | 209 | 209 | |||||||||||
Other | 95 | 79 | |||||||||||
Total deferred tax assets | 12,788 | 11,065 | |||||||||||
Deferred tax liabilities: | (73 | ) | (75 | ) | |||||||||
Total deferred taxes, net | 12,715 | 10,990 | |||||||||||
Valuation allowance | (12,715 | ) | (10,990 | ) | |||||||||
Net deferred tax asset | $ | — | $ | — | |||||||||
Schedule of Effective Income Tax Rate Reconciliation [Table Text Block] | Year Ended December 31, | ||||||||||||
2014 | 2013 | 2012 | |||||||||||
Statutory rate | 34 | % | 34 | % | 34 | % | |||||||
Permanent differences | (1.5 | ) | (1.6 | ) | (2.1 | ) | |||||||
State and local income taxes | — | 0.2 | 0.4 | ||||||||||
Credits and other | — | (0.2 | ) | — | |||||||||
State tax rate true-up | (1.7 | ) | (1.0 | ) | (16.0 | ) | |||||||
Valuation allowance | (30.8 | ) | (31.4 | ) | (16.3 | ) | |||||||
Effective rate | 0 | % | 0 | % | 0 | % | |||||||
Schedule of Net Operating Losses and Tax Credit Carryforwards [Table Text Block] | Amount | Expiration Years | |||||||||||
(In thousands) | |||||||||||||
Net operating losses—federal | $ | 30,208 | Beginning 2027 | ||||||||||
Net operating losses—state | 7,545 | Beginning 2022 | |||||||||||
Tax credits—federal | 167 | Beginning 2026 | |||||||||||
Tax credits—state | 41 | Beginning 2022 |
Note_15_Selected_Quarterly_Fin1
Note 15 - Selected Quarterly Financial Data (unaudited) (Tables) | 12 Months Ended | ||||||||||||||||
Dec. 31, 2014 | |||||||||||||||||
Quarterly Financial Information Disclosure [Abstract] | |||||||||||||||||
Schedule of Quarterly Financial Information [Table Text Block] | First | Second | Third | Fourth | |||||||||||||
Quarter | Quarter | Quarter | Quarter | ||||||||||||||
Fiscal 2014 | |||||||||||||||||
Net sales | $ | 26 | $ | 31 | $ | 13 | $ | 14 | |||||||||
Gross profit | 14 | 17 | 5 | 4 | |||||||||||||
Operating loss | (1,439 | ) | (1,430 | ) | (1,425 | ) | (1,319 | ) | |||||||||
Net loss | (1,437 | ) | (1,428 | ) | (1,424 | ) | (1,318 | ) | |||||||||
Basic and diluted net loss per share | $ | (0.05 | ) | $ | (0.04 | ) | $ | (0.04 | ) | $ | (0.04 | ) | |||||
Fiscal 2013 | |||||||||||||||||
Net sales | $ | 36 | $ | 40 | $ | 13 | $ | 41 | |||||||||
Gross profit | 20 | 20 | 6 | 21 | |||||||||||||
Operating loss | (1,459 | ) | (1,509 | ) | (1,570 | ) | (1,538 | ) | |||||||||
Net loss | (1,456 | ) | (1,504 | ) | (1,566 | ) | (1,534 | ) | |||||||||
Basic and diluted net loss per share | $ | (0.05 | ) | $ | (0.06 | ) | $ | (0.06 | ) | $ | (0.06 | ) |
Note_2_Risks_and_Uncertainties1
Note 2 - Risks and Uncertainties (Details) (USD $) | 3 Months Ended | 12 Months Ended | |||||||||
In Thousands, unless otherwise specified | Dec. 31, 2014 | Sep. 27, 2014 | Jun. 28, 2014 | Mar. 29, 2014 | Dec. 31, 2013 | Sep. 28, 2013 | Jun. 29, 2013 | Mar. 30, 2013 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 |
Risks and Uncertainties [Abstract] | |||||||||||
Net Income (Loss) Available to Common Stockholders, Basic | ($1,318) | ($1,424) | ($1,428) | ($1,437) | ($1,534) | ($1,566) | ($1,504) | ($1,456) | ($5,607) | ($6,060) | ($5,507) |
Net Cash Provided by (Used in) Operating Activities, Continuing Operations | ($5,026) | ($5,537) | ($4,203) |
Note_3_Liquidity_and_Managemen1
Note 3 - Liquidity and Management's Plans (Details) (USD $) | 0 Months Ended | 1 Months Ended | |
Jan. 05, 2015 | Jan. 31, 2015 | Dec. 31, 2014 | |
Note 3 - Liquidity and Management's Plans (Details) [Line Items] | |||
Cash, Cash Equivalents, and Short-term Investments | $3,600,000 | ||
Subsequent Event [Member] | |||
Note 3 - Liquidity and Management's Plans (Details) [Line Items] | |||
Monthly Operating Expenses | $200,000 | $200,000 |
Note_4_Summary_of_Significant_2
Note 4 - Summary of Significant Accounting Policies (Details) (USD $) | 12 Months Ended | |
Dec. 31, 2014 | Dec. 31, 2013 | |
Note 4 - Summary of Significant Accounting Policies (Details) [Line Items] | ||
Available-for-sale Securities Pledged as Collateral | $50,000 | $100,000 |
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Dividend Rate | 0.00% | |
Minimum [Member] | ||
Note 4 - Summary of Significant Accounting Policies (Details) [Line Items] | ||
Number of Days from Shipment Accounts Receivable Due | 60 days | |
Property, Plant and Equipment, Useful Life | 3 years | |
Maximum [Member] | ||
Note 4 - Summary of Significant Accounting Policies (Details) [Line Items] | ||
Number of Days from Shipment Accounts Receivable Due | 90 days | |
Property, Plant and Equipment, Useful Life | 7 years |
Note_4_Summary_of_Significant_3
Note 4 - Summary of Significant Accounting Policies (Details) - Inventories (USD $) | Dec. 31, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Inventories [Abstract] | ||
Raw materials | $80 | $81 |
Work in process | 306 | 333 |
Finished goods | 287 | 379 |
Total | $673 | $793 |
Note_4_Summary_of_Significant_4
Note 4 - Summary of Significant Accounting Policies (Details) - Stock-based Compensation Expense (USD $) | 12 Months Ended | ||
Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Stock-based compensation | $415,000 | $570,000 | $588,000 |
Manufacturing [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Stock-based compensation | 29,000 | ||
Research and Development Expense [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Stock-based compensation | 134,000 | 152,000 | 150,000 |
Selling, General and Administrative Expenses [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Stock-based compensation | $281,000 | $418,000 | $409,000 |
Note_4_Summary_of_Significant_5
Note 4 - Summary of Significant Accounting Policies (Details) - Calculation of Net Loss per Common Share (USD $) | 3 Months Ended | 12 Months Ended | |||||||||
In Thousands, except Share data, unless otherwise specified | Dec. 31, 2014 | Sep. 27, 2014 | Jun. 28, 2014 | Mar. 29, 2014 | Dec. 31, 2013 | Sep. 28, 2013 | Jun. 29, 2013 | Mar. 30, 2013 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 |
Calculation of Net Loss per Common Share [Abstract] | |||||||||||
Net loss | ($1,318) | ($1,424) | ($1,428) | ($1,437) | ($1,534) | ($1,566) | ($1,504) | ($1,456) | ($5,607) | ($6,060) | ($5,507) |
Weighted average shares outstanding—basic and diluted | 32,534,586 | 26,916,060 | 16,402,363 | ||||||||
Basic and diluted net loss per share | ($0.04) | ($0.04) | ($0.04) | ($0.05) | ($0.06) | ($0.06) | ($0.06) | ($0.05) | ($0.17) | ($0.23) | ($0.34) |
Note_4_Summary_of_Significant_6
Note 4 - Summary of Significant Accounting Policies (Details) - Antidilutive Securities | 12 Months Ended | ||
Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | |
Employee Stock Option [Member] | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Antidilutive securities | 2,114,250 | 1,609,250 | 1,174,250 |
Option Purchase Agreements Shares Issuable to Underwriters [Member] | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Antidilutive securities | 865,625 | 603,125 | 603,125 |
Warrant [Member] | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Antidilutive securities | 75,000 | 75,000 |
Note_5_Cash_Cash_Equivalents_a2
Note 5 - Cash, Cash Equivalents and Short-term Investments (Details) - Cash, Cash Equivalents and Short-term Investments (USD $) | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2011 |
In Thousands, unless otherwise specified | ||||
Cash and cash equivalents | ||||
Cash and cash equivalents | $3,138 | $2,316 | $9,403 | $6,211 |
Short-term investments | ||||
Short-term investments | 457 | 2,684 | ||
Corporate Debt Securities [Member] | ||||
Short-term investments | ||||
Short-term investments | 407 | 2,083 | ||
Commercial Paper [Member] | ||||
Short-term investments | ||||
Short-term investments | 250 | |||
Certificates of Deposit [Member] | ||||
Short-term investments | ||||
Short-term investments | 50 | 351 | ||
Cash [Member] | ||||
Cash and cash equivalents | ||||
Cash and cash equivalents | 508 | 366 | ||
Money Market Funds [Member] | ||||
Cash and cash equivalents | ||||
Cash and cash equivalents | 2,379 | 1,699 | ||
Certificates of Deposit [Member] | ||||
Cash and cash equivalents | ||||
Cash and cash equivalents | $251 | $251 |
Note_6_Fair_Value_of_Financial2
Note 6 - Fair Value of Financial Instruments (Details) - Summary of Financial Assets Measured at Fair Value on a Recurring Basis (Fair Value, Measurements, Recurring [Member], USD $) | Dec. 31, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Note 6 - Fair Value of Financial Instruments (Details) - Summary of Financial Assets Measured at Fair Value on a Recurring Basis [Line Items] | ||
Financial assets at fair value | $3,087 | $4,634 |
Money Market Funds [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Note 6 - Fair Value of Financial Instruments (Details) - Summary of Financial Assets Measured at Fair Value on a Recurring Basis [Line Items] | ||
Financial assets at fair value | 2,379 | 1,699 |
Money Market Funds [Member] | ||
Note 6 - Fair Value of Financial Instruments (Details) - Summary of Financial Assets Measured at Fair Value on a Recurring Basis [Line Items] | ||
Financial assets at fair value | 2,379 | 1,699 |
Certificates of Deposit [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Note 6 - Fair Value of Financial Instruments (Details) - Summary of Financial Assets Measured at Fair Value on a Recurring Basis [Line Items] | ||
Financial assets at fair value | 301 | 602 |
Certificates of Deposit [Member] | ||
Note 6 - Fair Value of Financial Instruments (Details) - Summary of Financial Assets Measured at Fair Value on a Recurring Basis [Line Items] | ||
Financial assets at fair value | 301 | 602 |
Commercial Paper [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Note 6 - Fair Value of Financial Instruments (Details) - Summary of Financial Assets Measured at Fair Value on a Recurring Basis [Line Items] | ||
Financial assets at fair value | 250 | |
Commercial Paper [Member] | ||
Note 6 - Fair Value of Financial Instruments (Details) - Summary of Financial Assets Measured at Fair Value on a Recurring Basis [Line Items] | ||
Financial assets at fair value | 250 | |
Corporate Debt Securities [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Note 6 - Fair Value of Financial Instruments (Details) - Summary of Financial Assets Measured at Fair Value on a Recurring Basis [Line Items] | ||
Financial assets at fair value | 407 | 2,083 |
Corporate Debt Securities [Member] | ||
Note 6 - Fair Value of Financial Instruments (Details) - Summary of Financial Assets Measured at Fair Value on a Recurring Basis [Line Items] | ||
Financial assets at fair value | 407 | 2,083 |
Fair Value, Inputs, Level 1 [Member] | ||
Note 6 - Fair Value of Financial Instruments (Details) - Summary of Financial Assets Measured at Fair Value on a Recurring Basis [Line Items] | ||
Financial assets at fair value | 2,379 | 1,699 |
Fair Value, Inputs, Level 2 [Member] | ||
Note 6 - Fair Value of Financial Instruments (Details) - Summary of Financial Assets Measured at Fair Value on a Recurring Basis [Line Items] | ||
Financial assets at fair value | $708 | $2,935 |
Note_8_Property_and_Equipment_1
Note 8 - Property and Equipment (Details) (USD $) | 12 Months Ended | ||
Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | |
Property, Plant and Equipment [Abstract] | |||
Depreciation, Depletion and Amortization | $49,000 | $55,000 | $109,000 |
Note_8_Property_and_Equipment_2
Note 8 - Property and Equipment (Details) - Property and Equipment (USD $) | Dec. 31, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Property, Plant and Equipment [Line Items] | ||
Accumulated depreciation | ($493) | ($444) |
Property and equipment, net | 353 | 400 |
Furniture and Fixtures [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Gross amount | 58 | 58 |
Machinery and Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Gross amount | 505 | 505 |
Computer Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Gross amount | 193 | 191 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Gross amount | $90 | $90 |
Note_9_Accrued_Liabilities_Det
Note 9 - Accrued Liabilities (Details) - Accrued Liabilities (USD $) | Dec. 31, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Accrued Liabilities [Abstract] | ||
Clinical study related expense | $256 | $216 |
Professional services | 54 | 61 |
Payroll and related expenses | 36 | 35 |
Other | 9 | 2 |
Accrued liabilities | $355 | $314 |
Note_10_Commitments_and_Contin2
Note 10 - Commitments and Contingencies (Details) (USD $) | 12 Months Ended | 1 Months Ended | ||||||
Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | Jul. 31, 2012 | Oct. 31, 2007 | Oct. 01, 2014 | Jun. 02, 2011 | Oct. 01, 2015 | |
sqft | ||||||||
Note 10 - Commitments and Contingencies (Details) [Line Items] | ||||||||
Operating Leases Subsequent Percentage Increase in Base Rent | 2.50% | |||||||
Operating Leases Sub Lease Agreement Rentable Area (in Square Feet) (in Square Feet) | 2,800 | |||||||
Operating Leases, Rent Expense | $120,000 | $120,000 | $120,000 | |||||
Indemnification Agreement [Member] | ||||||||
Note 10 - Commitments and Contingencies (Details) [Line Items] | ||||||||
Period of Secretarial Services Following Termination | 90 days | |||||||
Assignment and License Agreement [Member] | ||||||||
Note 10 - Commitments and Contingencies (Details) [Line Items] | ||||||||
Maximum Milestone Payment | 15,000,000 | |||||||
Royalty Payment Rate of Royalty Percentage on Sales | 4.00% | |||||||
Milestone Payment Due on Second Cumulative Net Sales Achievement | 5,000,000 | |||||||
Cumulative Net Sales Second Milestone | 15,000,000 | |||||||
Milestone Payment Due on Third Cumulative Net Sales Achievement | 5,000,000 | |||||||
Cumulative Net Sales Third Milestone | 40,000,000 | |||||||
Royalty Obligation Period after Fiscal Quarter in which Royalty Payments are due | 60 days | |||||||
Royalty Obligation Termination Condition Aggregate Royalty Paid | 100,000,000 | |||||||
Royalty Expense | $3,000 | $5,000 | ||||||
Scenario, Forecast [Member] | ||||||||
Note 10 - Commitments and Contingencies (Details) [Line Items] | ||||||||
Operating Leases Subsequent Percentage Increase in Base Rent | 2.50% | |||||||
Employment Agreement [Member] | Management [Member] | ||||||||
Note 10 - Commitments and Contingencies (Details) [Line Items] | ||||||||
Termination Notice Period | 60 days | |||||||
Period of Secretarial Services Following Termination | 1 year | |||||||
Severance Benefit Equivalent Period of Base Salary Termination without Cause | 2 years | |||||||
Severance Benefit Equivalent Period of Base Salary Termination for Good Reason | 1 year | |||||||
Change in Control Agreement Period after Change in Control Considered for Agreement | 2 years | |||||||
Change In Control Agreement [Member] | Minimum [Member] | Management [Member] | ||||||||
Note 10 - Commitments and Contingencies (Details) [Line Items] | ||||||||
Severance Benefit Equivalent Period of Base Salary Termination without Cause | 12 months | |||||||
Change In Control Agreement [Member] | Maximum [Member] | Management [Member] | ||||||||
Note 10 - Commitments and Contingencies (Details) [Line Items] | ||||||||
Severance Benefit Equivalent Period of Base Salary Termination without Cause | 24 months | |||||||
Change In Control Agreement [Member] | Management [Member] | ||||||||
Note 10 - Commitments and Contingencies (Details) [Line Items] | ||||||||
Period of Secretarial Services Following Termination | 1 year | |||||||
Severance Benefit Equivalent Period of Base Salary Termination without Cause | 3 years | |||||||
Change in Control Agreement Period after Change in Control Considered for Agreement | 2 years |
Note_10_Commitments_and_Contin3
Note 10 - Commitments and Contingencies (Details) - Annual Future Minimum Lease Obligations under Operating Lease Agreements (USD $) | Dec. 31, 2014 |
In Thousands, unless otherwise specified | |
Annual Future Minimum Lease Obligations under Operating Lease Agreements [Abstract] | |
2015 | $88 |
2016 | 86 |
2017 | 64 |
Total | $238 |
Note_11_Stockholders_Equity_De
Note 11 - Stockholders' Equity (Details) (USD $) | 1 Months Ended | 0 Months Ended | 1 Months Ended | ||||||||
Jan. 29, 2014 | Dec. 28, 2012 | Jan. 23, 2015 | Jan. 29, 2015 | Dec. 28, 2012 | Jan. 28, 2013 | Dec. 31, 2014 | Feb. 04, 2014 | Feb. 03, 2014 | Dec. 31, 2013 | Sep. 28, 2013 | |
Note 11 - Stockholders' Equity (Details) [Line Items] | |||||||||||
Total Number of Shares the Company is Authorized to Issue | 100,000,000 | ||||||||||
Common Stock, Shares Authorized | 90,000,000 | 90,000,000 | 40,000,000 | 40,000,000 | |||||||
Preferred Stock, Shares Authorized | 10,000,000 | ||||||||||
Gross Proceeds from Issuance of Common Stock in Public Offering (in Dollars) (in Dollars) | $4,200,000 | $6,500,000 | |||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 75,000 | ||||||||||
Undesignated Stock, Shares Authorized | 10,000,000 | 10,000,000 | |||||||||
Preferred Stock, Shares Outstanding | 0 | 0 | |||||||||
Issued to Underwriters [Member] | Public Offering [Member] | Subsequent Event [Member] | |||||||||||
Note 11 - Stockholders' Equity (Details) [Line Items] | |||||||||||
Period after Public Offering after which Warrants Become Exercisable | 1 year | ||||||||||
Issued to Underwriters [Member] | |||||||||||
Note 11 - Stockholders' Equity (Details) [Line Items] | |||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 262,500 | ||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in Dollars per share) | $0.88 | ||||||||||
Period after Public Offering after which Warrants Become Exercisable | 1 year | ||||||||||
Public Offering [Member] | Subsequent Event [Member] | Aegis [Member] | |||||||||||
Note 11 - Stockholders' Equity (Details) [Line Items] | |||||||||||
Payments of Stock Issuance Costs (in Dollars) | 333,000 | ||||||||||
Underwriting Discounts (in Dollars) | 296,000 | ||||||||||
Underwriting Non Accountable Expense Reimbursements (in Dollars) (in Dollars) | 37,000 | ||||||||||
Public Offering [Member] | Subsequent Event [Member] | |||||||||||
Note 11 - Stockholders' Equity (Details) [Line Items] | |||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 262,500 | ||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in Dollars per share) | 0.875 | ||||||||||
Options Issued to Underwriters Exercise Price Percentage of Purchase Price of Shares Sold | 125.00% | ||||||||||
Class of Warrant or Right, Term of Warrants or Rights | 5 years | ||||||||||
Public Offering [Member] | |||||||||||
Note 11 - Stockholders' Equity (Details) [Line Items] | |||||||||||
Stock Issued During Period, Shares, New Issues | 10,000,000 | ||||||||||
Share Price (in Dollars per share) | $0.65 | $0.65 | |||||||||
Payments of Stock Issuance Costs (in Dollars) | 1,100,000 | ||||||||||
Underwriting Discounts (in Dollars) | 455,000 | ||||||||||
Underwriting Non Accountable Expense Reimbursements (in Dollars) (in Dollars) | 65,000 | ||||||||||
Net Proceeds from Issuance of Common Stock (in Dollars) | 3,600,000 | 276,000 | |||||||||
Options Issued to Underwriters Exercise Price Percentage of Purchase Price of Shares Sold | 125.00% | 125.00% | |||||||||
Class of Warrant or Right, Term of Warrants or Rights | 5 years | ||||||||||
Period after Public Offering after which Warrants Become Exercisable | 1 year | ||||||||||
Underwriting Fees Cash Paid (in Dollars) | 520,000 | ||||||||||
Options Issued to Underwriters Number of Shares | 500,000 | 500,000 | 475,000 | ||||||||
Options Issued to Underwriters Exercise Price (in Dollars per share) | $0.81 | $0.81 | |||||||||
Purchase Option Shares Issued Price (in Dollars per share) (in Dollars per share) | $0.65 | ||||||||||
Common Stock [Member] | |||||||||||
Note 11 - Stockholders' Equity (Details) [Line Items] | |||||||||||
Stock Issued During Period, Shares, New Issues | 6,035,000 | ||||||||||
Share Price (in Dollars per share) | $0.70 | ||||||||||
Payments of Stock Issuance Costs (in Dollars) | $581,000 |
Note_11_Stockholders_Equity_De1
Note 11 - Stockholders' Equity (Details) - Shares of Common Stock Reserved for Future Issuance | Dec. 31, 2014 |
Note 11 - Stockholders' Equity (Details) - Shares of Common Stock Reserved for Future Issuance [Line Items] | |
Common stock reserved for future issuance | 4,729,875 |
Stock Option Outstanding [Member] | |
Note 11 - Stockholders' Equity (Details) - Shares of Common Stock Reserved for Future Issuance [Line Items] | |
Common stock reserved for future issuance | 2,114,250 |
Shares Available for Grant under Equity Incentive Plan [Member] | |
Note 11 - Stockholders' Equity (Details) - Shares of Common Stock Reserved for Future Issuance [Line Items] | |
Common stock reserved for future issuance | 1,675,000 |
Warrants for Purchase of Common Stock [Member] | |
Note 11 - Stockholders' Equity (Details) - Shares of Common Stock Reserved for Future Issuance [Line Items] | |
Common stock reserved for future issuance | 940,625 |
Note_12_Stockbased_Compensatio2
Note 12 - Stock-based Compensation (Details) (USD $) | 3 Months Ended | 12 Months Ended | 0 Months Ended | 1 Months Ended | 3 Months Ended | |||||
Sep. 28, 2013 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | Dec. 28, 2012 | Jan. 28, 2013 | Dec. 28, 2012 | Feb. 28, 2011 | Jan. 29, 2014 | Mar. 30, 2013 | |
Note 12 - Stock-based Compensation (Details) [Line Items] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number | 2,114,250 | 1,609,250 | 1,174,250 | |||||||
Proceeds from Stock Options Exercised | $1,000 | |||||||||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Not yet Recognized, Stock Options | 197,000 | 302,000 | 577,000 | |||||||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized, Period for Recognition | 2 years 10 days | 2 years 10 days | 2 years 102 days | |||||||
Allocated Share-based Compensation Expense | 415,000 | 570,000 | 588,000 | |||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 75,000 | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Risk Free Interest Rate | 0.35% | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Volatility Rate | 56.00% | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Term | 2 years | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions Weighted Average Grant Date, Fair Value | $0.24 | |||||||||
Public Offering [Member] | ||||||||||
Note 12 - Stock-based Compensation (Details) [Line Items] | ||||||||||
Period after Public Offering after which Warrants Become Exercisable | 1 year | |||||||||
Options Issued to Underwriters Number of Shares | 500,000 | 475,000 | 500,000 | |||||||
Options Issued to Underwriters Exercise Price | $0.81 | $0.81 | ||||||||
Options Issued to Underwriters Exercise Price Percentage of Purchase Price of Shares Sold | 125.00% | 125.00% | ||||||||
Term of Options Issued to Underwriters | 5 years | |||||||||
Period after Public Offering after which Options to Underwriters become Exercisable | 1 year | |||||||||
IPO [Member] | ||||||||||
Note 12 - Stock-based Compensation (Details) [Line Items] | ||||||||||
Options Issued to Underwriters Number of Shares | 103,125 | |||||||||
Options Issued to Underwriters Exercise Price | $10 | |||||||||
Options Issued to Underwriters Exercise Price Percentage of Purchase Price of Shares Sold | 125.00% | |||||||||
Term of Options Issued to Underwriters | 5 years | |||||||||
Period after Public Offering after which Options to Underwriters become Exercisable | 1 year | |||||||||
Issued to Underwriters [Member] | ||||||||||
Note 12 - Stock-based Compensation (Details) [Line Items] | ||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 262,500 | |||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $0.88 | |||||||||
Class of Warrant or Right, Exercise Price, Percentage of Purchase Price of Shares Sold | 125.00% | |||||||||
Share-based Goods and Nonemployee Services Transaction, Valuation Method, Expected Term | 5 years | |||||||||
Period after Public Offering after which Warrants Become Exercisable | 1 year | |||||||||
Common Stock [Member] | Outside Consultant [Member] | ||||||||||
Note 12 - Stock-based Compensation (Details) [Line Items] | ||||||||||
Stock Issued During Period, Shares, Issued for Services | 38,000 | |||||||||
Common Stock [Member] | ||||||||||
Note 12 - Stock-based Compensation (Details) [Line Items] | ||||||||||
Stock Issued During Period, Shares, Issued for Services | 38,000 | |||||||||
Employee Stock Option [Member] | Minimum [Member] | ||||||||||
Note 12 - Stock-based Compensation (Details) [Line Items] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Risk Free Interest Rate | 1.67% | 0.88% | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Term | 5 years 6 months | 5 years 6 months | ||||||||
Employee Stock Option [Member] | Maximum [Member] | ||||||||||
Note 12 - Stock-based Compensation (Details) [Line Items] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Risk Free Interest Rate | 1.86% | 1.80% | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Term | 6 years 3 months | 6 years 3 months | ||||||||
Employee Stock Option [Member] | The 2013 Equity Incentive Plan [Member] | ||||||||||
Note 12 - Stock-based Compensation (Details) [Line Items] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Expiration Period | 10 years | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Period | 4 years | |||||||||
Share based Compensation Arrangement by Share based Payment Award, Award Vesting Percentage Per Year | 25.00% | |||||||||
Employee Stock Option [Member] | The 2007 Long-Term Incentive Plan [Member] | ||||||||||
Note 12 - Stock-based Compensation (Details) [Line Items] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Expiration Period | 10 years | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Period | 4 years | |||||||||
Share based Compensation Arrangement by Share based Payment Award, Award Vesting Percentage Upon Grant | 25.00% | |||||||||
Employee Stock Option [Member] | ||||||||||
Note 12 - Stock-based Compensation (Details) [Line Items] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested in Period, Fair Value | 256,000 | 294,000 | 347,000 | |||||||
Proceeds from Stock Options Exercised | 0 | 0 | 500 | |||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Intrinsic Value | 0 | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Intrinsic Value | 2,000 | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Risk Free Interest Rate | 0.92% | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Volatility Rate | 55.00% | 56.00% | 57.00% | |||||||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Term | 6 years 3 months | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions Weighted Average Grant Date, Fair Value | $0.21 | $0.38 | $0.54 | |||||||
Non-employee Stock Option [Member] | The 2013 Equity Incentive Plan [Member] | ||||||||||
Note 12 - Stock-based Compensation (Details) [Line Items] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Period | 3 years | |||||||||
Share based Compensation Arrangement by Share based Payment Award, Award Vesting Percentage Per Year | 25.00% | |||||||||
Share based Compensation Arrangement by Share based Payment Award, Award Vesting Percentage Upon Grant | 25.00% | |||||||||
Non-employee Stock Option [Member] | The 2007 Long-Term Incentive Plan [Member] | ||||||||||
Note 12 - Stock-based Compensation (Details) [Line Items] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Period | 3 years | |||||||||
Share based Compensation Arrangement by Share based Payment Award, Award Vesting Percentage Per Year | 25.00% | |||||||||
Share based Compensation Arrangement by Share based Payment Award, Award Vesting Percentage Upon Grant | 25.00% | |||||||||
Restricted Stock [Member] | Minimum [Member] | ||||||||||
Note 12 - Stock-based Compensation (Details) [Line Items] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Period | 3 years | |||||||||
Restricted Stock [Member] | Maximum [Member] | ||||||||||
Note 12 - Stock-based Compensation (Details) [Line Items] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Period | 4 years | |||||||||
Restricted Stock [Member] | The 2007 Long-Term Incentive Plan [Member] | ||||||||||
Note 12 - Stock-based Compensation (Details) [Line Items] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Number | 62,500 | |||||||||
Restricted Stock [Member] | ||||||||||
Note 12 - Stock-based Compensation (Details) [Line Items] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Number | 62,500 | 105,000 | 67,500 | |||||||
Allocated Share-based Compensation Expense | 205,000 | 242,000 | 255,000 | |||||||
Non Employee [Member] | ||||||||||
Note 12 - Stock-based Compensation (Details) [Line Items] | ||||||||||
Stock Granted, Value, Share-based Compensation, Net of Forfeitures | 2,000 | 24,000 | 20,000 | |||||||
Outside Consultant [Member] | ||||||||||
Note 12 - Stock-based Compensation (Details) [Line Items] | ||||||||||
Allocated Share-based Compensation Expense | 39,000 | |||||||||
The 2013 Equity Incentive Plan [Member] | ||||||||||
Note 12 - Stock-based Compensation (Details) [Line Items] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized | 2,500,000 | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Net of Forfeitures | 825,000 | |||||||||
The 2007 Long-Term Incentive Plan [Member] | ||||||||||
Note 12 - Stock-based Compensation (Details) [Line Items] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number | 1,289,250 |
Note_12_Stockbased_Compensatio3
Note 12 - Stock-based Compensation (Details) - Summary of Option Activity (USD $) | 12 Months Ended | ||
Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | |
Summary of Option Activity [Abstract] | |||
Shares under option | 2,114,250 | 1,609,250 | 1,174,250 |
Weighted average exercise price | $1.98 | $2.56 | $3.64 |
Shares under option, granted | 535,000 | 630,000 | |
Weighted average exercise price, granted | $0.39 | $0.72 | |
Shares under option, forfeited and cancelled | -30,000 | -195,000 | |
Weighted average exercise price, forfeited and cancelled | $4.51 | $3.05 |
Note_12_Stockbased_Compensatio4
Note 12 - Stock-based Compensation (Details) - Summary of the Status of the Entity's Unvested Shares (USD $) | 12 Months Ended | |
Dec. 31, 2014 | Dec. 31, 2013 | |
Summary of the Status of the Entity's Unvested Shares [Abstract] | ||
Shares under option | 802,250 | |
Weighted average grant-date fair value | $0.91 | |
Granted | 535,000 | 630,000 |
Granted | $0.21 | |
Vested | -422,063 | |
Vested | $0.90 | |
Forfeited and cancelled | -7,500 | |
Forfeited and cancelled | $0.60 | |
Shares under option | 907,687 | 802,250 |
Weighted average grant-date fair value | $0.50 | $0.91 |
Note_12_Stockbased_Compensatio5
Note 12 - Stock-based Compensation (Details) - Stock Options Outstanding, Vested and Expected to Vest (USD $) | 12 Months Ended |
Dec. 31, 2014 | |
Note 12 - Stock-based Compensation (Details) - Stock Options Outstanding, Vested and Expected to Vest [Line Items] | |
Shares (in Shares) | 2,114,250 |
Weighted average remaining contractual life, outstanding | 5 years 313 days |
Weighted average exercise price, outstanding | $1.98 |
Options exercisable (in Shares) | 1,206,563 |
Weighted average remaining contractual life, exercisable | 5 years 313 days |
Price Range 1 [Member] | |
Note 12 - Stock-based Compensation (Details) - Stock Options Outstanding, Vested and Expected to Vest [Line Items] | |
Per share exercise price, lower | $0.14 |
Shares (in Shares) | 180,000 |
Weighted average remaining contractual life, outstanding | 9 years 343 days |
Weighted average exercise price, outstanding | $0.14 |
Price Range 2 [Member] | |
Note 12 - Stock-based Compensation (Details) - Stock Options Outstanding, Vested and Expected to Vest [Line Items] | |
Per share exercise price, lower | $0.51 |
Per share exercise price, upper | $0.76 |
Shares (in Shares) | 865,000 |
Weighted average remaining contractual life, outstanding | 8 years 306 days |
Weighted average exercise price, outstanding | $0.63 |
Options exercisable (in Shares) | 278,750 |
Weighted average remaining contractual life, exercisable | 8 years 259 days |
Price Range 3 [Member] | |
Note 12 - Stock-based Compensation (Details) - Stock Options Outstanding, Vested and Expected to Vest [Line Items] | |
Per share exercise price, lower | $0.91 |
Per share exercise price, upper | $1.01 |
Shares (in Shares) | 305,000 |
Weighted average remaining contractual life, outstanding | 4 years 80 days |
Weighted average exercise price, outstanding | $0.98 |
Options exercisable (in Shares) | 251,250 |
Weighted average remaining contractual life, exercisable | 3 years 116 days |
Price Range 4 [Member] | |
Note 12 - Stock-based Compensation (Details) - Stock Options Outstanding, Vested and Expected to Vest [Line Items] | |
Per share exercise price, lower | $2 |
Per share exercise price, upper | $3.21 |
Shares (in Shares) | 333,250 |
Weighted average remaining contractual life, outstanding | 6 years 244 days |
Weighted average exercise price, outstanding | $2.05 |
Options exercisable (in Shares) | 280,563 |
Weighted average remaining contractual life, exercisable | 6 years 237 days |
Price Range 5 [Member] | |
Note 12 - Stock-based Compensation (Details) - Stock Options Outstanding, Vested and Expected to Vest [Line Items] | |
Per share exercise price, lower | $5.18 |
Per share exercise price, upper | $5.83 |
Shares (in Shares) | 222,000 |
Weighted average remaining contractual life, outstanding | 4 years 244 days |
Weighted average exercise price, outstanding | $5.61 |
Options exercisable (in Shares) | 203,250 |
Weighted average remaining contractual life, exercisable | 4 years 189 days |
Price Range 6 [Member] | |
Note 12 - Stock-based Compensation (Details) - Stock Options Outstanding, Vested and Expected to Vest [Line Items] | |
Per share exercise price, lower | $6 |
Per share exercise price, upper | $7 |
Shares (in Shares) | 209,000 |
Weighted average remaining contractual life, outstanding | 5 years 142 days |
Weighted average exercise price, outstanding | $6.65 |
Options exercisable (in Shares) | 192,750 |
Weighted average remaining contractual life, exercisable | 5 years 120 days |
Note_12_Stockbased_Compensatio6
Note 12 - Stock-based Compensation (Details) - Assumptions Used in the Black-Scholes Option-pricing Model (USD $) | 3 Months Ended | 12 Months Ended | ||
Sep. 28, 2013 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | |
Note 12 - Stock-based Compensation (Details) - Assumptions Used in the Black-Scholes Option-pricing Model [Line Items] | ||||
Risk free interest rate | 0.35% | |||
Dividend yield | 0.00% | |||
Expected volatility | 56.00% | |||
Expected term (years) | 2 years | |||
Weighted average grant date fair value (in Dollars per share) | $0.24 | |||
Employee Stock Option [Member] | Minimum [Member] | ||||
Note 12 - Stock-based Compensation (Details) - Assumptions Used in the Black-Scholes Option-pricing Model [Line Items] | ||||
Risk free interest rate | 1.67% | 0.88% | ||
Expected term (years) | 5 years 6 months | 5 years 6 months | ||
Employee Stock Option [Member] | Maximum [Member] | ||||
Note 12 - Stock-based Compensation (Details) - Assumptions Used in the Black-Scholes Option-pricing Model [Line Items] | ||||
Risk free interest rate | 1.86% | 1.80% | ||
Expected term (years) | 6 years 3 months | 6 years 3 months | ||
Employee Stock Option [Member] | ||||
Note 12 - Stock-based Compensation (Details) - Assumptions Used in the Black-Scholes Option-pricing Model [Line Items] | ||||
Risk free interest rate | 0.92% | |||
Dividend yield | 0.00% | 0.00% | 0.00% | |
Expected volatility | 55.00% | 56.00% | 57.00% | |
Expected term (years) | 6 years 3 months | |||
Weighted average grant date fair value (in Dollars per share) | 0.21 | 0.38 | $0.54 |
Note_12_Stockbased_Compensatio7
Note 12 - Stock-based Compensation (Details) - Summary of Restricted Stock Award Activity (Restricted Stock [Member], USD $) | 12 Months Ended | |
Dec. 31, 2014 | Dec. 31, 2013 | |
Restricted Stock [Member] | ||
Note 12 - Stock-based Compensation (Details) - Summary of Restricted Stock Award Activity [Line Items] | ||
Number of Shares | 105,000 | 67,500 |
Weighted Average Fair Value | $4.13 | $8 |
Number of Shares, Granted | 120,000 | |
Weighted Average Fair Value, Granted | $0.77 | |
Number of Shares, Vested | -42,500 | -82,500 |
Weighted Average Fair Value, Vested | $4.81 | $3.43 |
Number of Shares | 62,500 | 105,000 |
Weighted Average Fair Value | $3.67 | $4.13 |
Note_13_Employee_Benefit_Plan_
Note 13 - Employee Benefit Plan (Details) (USD $) | 12 Months Ended | ||
Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | |
Note 13 - Employee Benefit Plan (Details) [Line Items] | |||
Defined Contribution Plan, Employers' Matching Contribution, Vesting Period | 2 years | ||
Defined Contribution Plan, Cost Recognized | $61,000 | $62,000 | $51,000 |
The 401K Plan [Member] | |||
Note 13 - Employee Benefit Plan (Details) [Line Items] | |||
Defined Contribution Plan, Employer Matching Contribution, Percent of Employees' Gross Pay | 3.00% | ||
SEP [Member] | |||
Note 13 - Employee Benefit Plan (Details) [Line Items] | |||
Defined Contribution Plan, Employer Matching Contribution, Percent of Employees' Gross Pay | 3.00% |
Note_14_Income_Taxes_Details
Note 14 - Income Taxes (Details) (USD $) | 12 Months Ended | |
In Millions, unless otherwise specified | Dec. 31, 2014 | Dec. 31, 2013 |
Note 14 - Income Taxes (Details) [Line Items] | ||
Effective Income Tax Rate Reconciliation, Change in Deferred Tax Assets Valuation Allowance, Amount | $1.70 | $1.90 |
Earliest Tax Year [Member] | Domestic Tax Authority [Member] | ||
Note 14 - Income Taxes (Details) [Line Items] | ||
Open Tax Year | 2009 | |
Earliest Tax Year [Member] | State and Local Jurisdiction [Member] | ||
Note 14 - Income Taxes (Details) [Line Items] | ||
Open Tax Year | 2009 | |
Latest Tax Year [Member] | Domestic Tax Authority [Member] | ||
Note 14 - Income Taxes (Details) [Line Items] | ||
Open Tax Year | 2014 | |
Latest Tax Year [Member] | State and Local Jurisdiction [Member] | ||
Note 14 - Income Taxes (Details) [Line Items] | ||
Open Tax Year | 2014 |
Note_14_Income_Taxes_Details_D
Note 14 - Income Taxes (Details) - Deferred Tax Assets and Liabilities (USD $) | Dec. 31, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Deferred tax assets: | ||
Net operating loss carryforwards | $10,615 | $8,840 |
Intangible assets—patent prosecution costs | 139 | 140 |
Stock-based compensation | 540 | 484 |
Milestone obligation | 1,190 | 1,313 |
Research credit carryforwards | 209 | 209 |
Other | 95 | 79 |
Total deferred tax assets | 12,788 | 11,065 |
Deferred tax liabilities: | -73 | -75 |
Total deferred taxes, net | 12,715 | 10,990 |
Valuation allowance | -12,715 | -10,990 |
Net deferred tax asset | $0 | $0 |
Note_14_Income_Taxes_Details_R
Note 14 - Income Taxes (Details) - Reconciliation of the Statutory Tax Rates and the Effective Tax Rates | 12 Months Ended | ||
Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | |
Reconciliation of the Statutory Tax Rates and the Effective Tax Rates [Abstract] | |||
Statutory rate | 34.00% | 34.00% | 34.00% |
Permanent differences | -1.50% | -1.60% | -2.10% |
State and local income taxes | 0.20% | 0.40% | |
Credits and other | -0.20% | ||
State tax rate true-up | -1.70% | -1.00% | -16.00% |
Valuation allowance | -30.80% | -31.40% | -16.30% |
Effective rate | 0.00% | 0.00% | 0.00% |
Note_14_Income_Taxes_Details_N
Note 14 - Income Taxes (Details) - Net Operating Losses and Tax Credit Carryforwards (USD $) | Dec. 31, 2014 |
In Thousands, unless otherwise specified | |
Domestic Tax Authority [Member] | |
Note 14 - Income Taxes (Details) - Net Operating Losses and Tax Credit Carryforwards [Line Items] | |
Net operating losses | $30,208 |
Tax credits | 167 |
State and Local Jurisdiction [Member] | |
Note 14 - Income Taxes (Details) - Net Operating Losses and Tax Credit Carryforwards [Line Items] | |
Net operating losses | 7,545 |
Tax credits | $41 |
Note_15_Selected_Quarterly_Fin2
Note 15 - Selected Quarterly Financial Data (unaudited) (Details) - Summary of Unaudited Quarterly Financial Data (USD $) | 3 Months Ended | 12 Months Ended | |||||||||
In Thousands, except Per Share data, unless otherwise specified | Dec. 31, 2014 | Sep. 27, 2014 | Jun. 28, 2014 | Mar. 29, 2014 | Dec. 31, 2013 | Sep. 28, 2013 | Jun. 29, 2013 | Mar. 30, 2013 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 |
Fiscal 2014 | |||||||||||
Net sales | $14 | $13 | $31 | $26 | $41 | $13 | $40 | $36 | $84 | $130 | $226 |
Gross profit | 4 | 5 | 17 | 14 | 21 | 6 | 20 | 20 | 40 | 67 | 128 |
Operating loss | -1,319 | -1,425 | -1,430 | -1,439 | -1,538 | -1,570 | -1,509 | -1,459 | -5,613 | -6,076 | -5,522 |
Net loss | ($1,318) | ($1,424) | ($1,428) | ($1,437) | ($1,534) | ($1,566) | ($1,504) | ($1,456) | ($5,607) | ($6,060) | ($5,507) |
Basic and diluted net loss per share (in Dollars per share) | ($0.04) | ($0.04) | ($0.04) | ($0.05) | ($0.06) | ($0.06) | ($0.06) | ($0.05) | ($0.17) | ($0.23) | ($0.34) |
Note_16_Subsequent_Events_Deta
Note 16 - Subsequent Events (Details) (Subsequent Event [Member], USD $) | 0 Months Ended | 1 Months Ended |
Jan. 05, 2015 | Jan. 31, 2015 | |
Subsequent Event [Member] | ||
Note 16 - Subsequent Events (Details) [Line Items] | ||
Monthly Operating Expenses | $200,000 | $200,000 |