Nuwellis (NUWE) 10-K 15 Mar 16 2015 FY Annual report Financial data

Document and Entity Information

Document and Entity Information - USD ($) $ in Millions	12 Months Ended
	Dec. 31, 2015	Mar. 11, 2016	Jun. 30, 2015
Document and Entity Information
Entity Registrant Name	Sunshine Heart, Inc.
Entity Central Index Key	1,506,492
Document Type	10-K
Document Period End Date	Dec. 31, 2015
Amendment Flag	false
Current Fiscal Year End Date	--12-31
Entity Well-known Seasoned Issuer	No
Entity Voluntary Filers	No
Entity Current Reporting Status	Yes
Entity Filer Category	Accelerated Filer
Entity Public Float			$ 62.5
Entity Common Stock, Shares Outstanding		18,357,796
Document Fiscal Year Focus	2,015
Document Fiscal Period Focus	FY

Consolidated Balance Sheets

Consolidated Balance Sheets - USD ($) $ in Thousands	Dec. 31, 2015	Dec. 31, 2014
Current assets
Cash and cash equivalents	$ 23,113	$ 31,293
Accounts receivable		59
Other current assets	539	360
Total current assets	23,652	31,712
Property, plant and equipment	535	661
Other Assets	383
TOTAL ASSETS	24,570	32,373
Current liabilities
Current portion of long-term debt	3,858
Accounts payable and accrued expenses	2,832	2,079
Accrued salaries, wages, and other compensation	1,368	1,079
Total current liabilities	8,058	3,158
Long-term debt, net of discount	3,941
Other Liabilities	400
Total liabilities	$ 12,399	$ 3,158
Commitments and contingencies (Note 6)
Stockholders' equity
Common stock as of December 31, 2015 and December 31, 2014, par value $0.0001 per share; authorized 100,000,000 shares; issued and outstanding 18,344,478 and 16,982,642, respectively	$ 2	$ 2
Additional paid-in capital	164,105	154,540
Accumulated other comprehensive income:
Foreign currency translation adjustment	1,246	1,272
Accumulated deficit	(153,182)	(126,599)
Total stockholders' equity	12,171	29,215
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY	$ 24,570	$ 32,373
Series A junior participating preferred stock
Stockholders' equity
Preferred stock
Preferred stock
Stockholders' equity
Preferred stock

Consolidated Balance Sheets (Pa

Consolidated Balance Sheets (Parenthetical) - $ / shares	Dec. 31, 2015	Dec. 31, 2014
Common stock, par value (in dollars per share)	$ 0.0001	$ 0.0001
Common stock, shares authorized	100,000,000	100,000,000
Common stock, shares issued	18,344,478	16,982,642
Common stock, shares outstanding	18,344,478	16,982,642
Series A junior participating preferred stock
Preferred Stock, par value (in dollars per share)	$ 0.0001	$ 0.0001
Preferred Stock, shares authorized	30,000	30,000
Preferred Stock, shares outstanding	0	0
Preferred stock
Preferred Stock, par value (in dollars per share)	$ 0.0001	$ 0.0001
Preferred Stock, shares authorized	39,970,000	39,970,000
Preferred Stock, shares outstanding	0	0

Consolidated Statements of Oper

Consolidated Statements of Operations and Comprehensive Loss - USD ($) shares in Thousands, $ in Thousands	12 Months Ended
	Dec. 31, 2015	Dec. 31, 2014	Dec. 31, 2013
Consolidated Statements of Operations and Comprehensive Loss
Net sales	$ 59	$ 295	$ 59
Operating expenses:
Selling, general and administrative	8,345	9,208	9,426
Research and development	17,672	16,874	13,504
Total operating expenses	26,017	26,082	22,930
Loss from operations	(25,958)	(25,787)	(22,871)
Interest expense	(743)
Other expense, net	(6)	(49)	(100)
Total Other Expense, net	(749)	(49)	(100)
Loss before income taxes	(26,707)	(25,836)	(22,971)
Income tax benefit, net	124	249	1,213
Net loss	$ (26,583)	$ (25,587)	$ (21,758)
Basic and diluted loss per share (in dollars per share)	$ (1.47)	$ (1.51)	$ (1.71)
Weighted average shares outstanding-basic and diluted (in shares)	18,119	16,899	12,723
Other comprehensive income:
Foreign currency translation adjustment	$ (26)	$ 65	$ 22
Total comprehensive loss	$ (26,609)	$ (25,522)	$ (21,736)

Consolidated Statements of Stoc

Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands	Common Stock	Additional Paid in Capital	Accumulated Other Comprehensive Income	Accumulated Deficit	Total
Balance at Dec. 31, 2012	$ 1	$ 91,017	$ 1,185	$ (79,254)	$ 12,949
Balance (in shares) at Dec. 31, 2012	9,283,000
Increase (Decrease) in Shareholders' Equity
Net loss				(21,758)	(21,758)
Foreign currency translation adjustment			22		22
Stock based compensation, net		2,804			2,804
Stock based compensation (in shares)	56,000
Reclassification of stock options as liability awards		(95)			(95)
Issuance of common stock, net	$ 1	57,565			57,566
Issuance of common stock, net (in shares)	7,486,000
Issuance of warrants for service agreement		239			239
Balance at Dec. 31, 2013	$ 2	151,530	1,207	(101,012)	51,727
Balance (in shares) at Dec. 31, 2013	16,825,000
Increase (Decrease) in Shareholders' Equity
Net loss				(25,587)	(25,587)
Foreign currency translation adjustment			65		65
Stock based compensation, net		2,678			2,678
Settlement of liability awards		243			243
Issuance of common stock, net		89			89
Issuance of common stock, net (in shares)	158,000
Balance at Dec. 31, 2014	$ 2	154,540	1,272	(126,599)	$ 29,215
Balance (in shares) at Dec. 31, 2014	16,983,000				16,982,642
Increase (Decrease) in Shareholders' Equity
Net loss				(26,583)	$ (26,583)
Foreign currency translation adjustment			(26)		(26)
Stock based compensation, net		2,510			2,510
Issuance of common stock, net		7,055			7,055
Issuance of common stock, net (in shares)	1,361,000
Balance at Dec. 31, 2015	$ 2	$ 164,105	$ 1,246	$ (153,182)	$ 12,171
Balance (in shares) at Dec. 31, 2015	18,344,000				18,344,478

Consolidated Statements of Cash

Consolidated Statements of Cash Flows - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2015	Dec. 31, 2014	Dec. 31, 2013
Operating Activities
Net loss	$ (26,583)	$ (25,587)	$ (21,758)
Adjustments to reconcile net loss to cash flows from operating activities:
Depreciation	325	277	185
Stock based compensation expense, net	2,154	2,678	2,953
Amortization of debt discount and financing fees	263
Amortization of debt warrants for service agreements			239
Changes in assets and liabilities:
Accounts receivable	59		(59)
Other current assets	(181)		(22)
Other assets	(92)	(5)
Accounts payable and accrued expenses	1,066	(7)	1,100
Net cash used in operations	(22,989)	(22,644)	(17,362)
Investing Activities:
Purchase of property and equipment	(199)	(351)	(293)
Net cash used in investing activities	(199)	(351)	(293)
Financing Activities:
Net proceeds from the sale of common stock	7,055	89	57,566
Proceeds from borrowing on long-term debt	8,000
Net cash provided by financing activities	15,055	89	57,566
Effect of exchange rate changes on cash	(47)	63	1
Net decrease in cash and cash equivalents	(8,180)	(22,843)	39,912
Cash and cash equivalents-beginning of period	31,293	54,136	14,224
Cash and cash equivalents-end of period	23,113	31,293	54,136
Supplemental schedule of non-cash activities
Stock options and restricted stock units classified as liabilities, net		$ (337)	$ 355
Warrants issued in connection with debt financing	355
Financing fees on debt	400
Supplemental cash flow information
Interest paid on debt borrowings	$ 388

Nature of Business and Signific

Nature of Business and Significant Accounting Policies	12 Months Ended
	Dec. 31, 2015
Nature of Business and Significant Accounting Policies
Nature of Business and Significant Accounting Policies	Note 1—Nature of Business and Significant Accounting Policies Nature of Business Sunshine Heart, Inc. was founded in November 1999 and incorporated in Delaware in August 2002. The Company is headquartered in Eden Prairie, Minnesota and has a wholly owned subsidiary, Sunshine Heart Company Pty Limited, located in Clontarf, New South Wales, Australia and a wholly owned subsidiary, Sunshine Heart Ireland Limited, located in Dublin, Ireland. The Company is a medical device company developing innovative technologies for cardiac and coronary disease. The Company’s primary product, the C-Pulse System, is an implantable, non-blood contacting, heart assist therapy for the treatment of moderate to severe heart failure which can be implanted using a minimally invasive procedure. The C-Pulse System is designed to relieve the symptoms of heart failure through the use of counter-pulsation technology by enabling an increase in cardiac output, an increase in coronary blood flow, and a reduction in the heart’s pumping load. The Company has received approval from the US Food and Drug Administration ( “FDA” ) to conduct a U.S. feasibility clinical study with the C-Pulse System. Commencing February 16, 2012, the Company’s shares of common stock began trading on NASDAQ under the symbol “SSH.” Going Concern The Company’s financial statements have been prepared and presented on a basis assuming it continues as a going concern. During the years ended December 31, 2015, 2014 and 2013, the Company incurred losses from operations and net cash outflows from operating activities as disclosed in the consolidated statements of operations and comprehensive loss and cash flows, respectively. At December 31, 2015, the Company had an accumulated deficit of $153.2 million and expects to incur losses for the foreseeable future. To date, the Company has been funded primarily by various equity and debt financings. Although the Company believes that it will be able to successfully fund its operations, there can be no assurance the Company will be able to do so or that the Company will ever operate profitably. The Company’s ability to continue as a going concern is dependent on the Company’s ability to raise additional capital based on the achievement of existing milestones as and when required. The Company expects to seek additional financing in 2016. Should future capital raising be unsuccessful, the Company may not be able to continue as a going concern. Furthermore, the ability of the Company to continue as a going concern is subject to the ability of the Company to develop and successfully commercialize the product being developed. If the Company is unable to obtain such funding of an amount and timing necessary to meet its future operational plans, or to successfully commercialize its intellectual property, the Company may be unable to continue as a going concern. No adjustments have been made relating to the recoverability and classification of recorded asset amounts and classification of liabilities that might be necessary should the Company not continue as a going concern. Basis of Presentation The accompanying consolidated financial statements include the accounts of Sunshine Heart, Inc. and its wholly owned subsidiaries, Sunshine Heart Company Pty Limited and Sunshine Heart Ireland Limited. All inter-company accounts and transactions between consolidated entities have been eliminated. Use of Estimates The preparation of financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect the reported amounts and disclosures in the consolidated financial statements and accompanying notes. Actual results could differ from those estimates. Fair Value of Financial Instruments The Company’s financial instruments consist of cash and cash equivalents, accounts receivable, accounts payable and accrued liabilities. The Company believes that the carrying amounts of the financial instruments approximate their respective current fair values due to their relatively short maturities. Pursuant to the requirements of Financial Accounting Standards Board (the “FASB” ) Accounting Standards Codification (the “ASC” ) Topic 820 “Fair Value Measurement,” the Company’s financial assets and liabilities measured at fair value on a recurring basis are classified and disclosed in one of the following three categories: · Level 1 - Financial instruments with unadjusted quoted prices listed on active market exchanges. · Level 2 - Financial instruments lacking unadjusted, quoted prices from active market exchanges, including over the counter traded financial instruments. The prices for the financial instruments are determined using prices for recently traded financial instruments with similar underlying terms as well as directly or indirectly observable inputs, such as interest rates and yield curves that are observable at commonly quoted intervals. · Level 3 - Financial instruments that are not actively traded on a market exchange. This category includes situations where there is little, if any, market activity for the financial instrument. The prices are determined using significant unobservable inputs or valuation techniques. All cash equivalents are considered Level 1 measurements for all periods presented. The Company does not have any financial instruments classified as Level 2 or Level 3 and there were no movements between these categories during the years ended December 31, 2015 and 2014. Cash and Cash Equivalents Cash and cash equivalents consist of cash and term deposits with original maturities of three months or less. The carrying value of these instruments approximate fair value. The balances, at times, may exceed federally insured limits. The Company has not experienced any losses on its cash and cash equivalents. Accounts Receivable Accounts receivable are unsecured, are recorded at net realizable value, and do not bear interest. The Company makes judgments as to its ability to collect outstanding receivables based upon significant patterns of uncollectability, historical experience, and managements’ evaluation of specific accounts and will provide an allowance for credit losses when collection becomes doubtful. The Company performs credit evaluations of its customers’ financial condition on an as-needed basis. Payment is generally due 30 days from the invoice date and accounts past 30 days are individually analyzed for collectability. When all collection efforts have been exhausted, the account is written off against the related allowance. No allowance for doubtful accounts was considered necessary as of December 31, 2015 and 2014. Other Current Assets Other current assets represent prepayments and deposits made by the Company. Property, Plant 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. Leasehold improvements are amortized using the straight-line method over the shorter of the lease term or the estimated useful life of the assets. Repairs and maintenance costs are expensed as incurred. The cost and accumulated depreciation of property, plant and equipment retired, or otherwise disposed of are removed from the related accounts, and any residual values are charged to expense. Depreciation expense has been calculated using the following estimated useful lives: Office furniture and equipment 5-15 years Computer software and equipment 3-4 years Laboratory and research equipment 3-15 years Production equipment 3-7 years Depreciation expense was $325, $277 and $185 for the years ended December 31, 2015, 2014 and 2013, respectively. Property and equipment are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset or asset group may not be recoverable. If the impairment tests indicate that the carrying value of the asset, or asset group is greater than the expected undiscounted cash flows to be generated by such asset or asset group further analysis is performed to determine the fair value of the asset or asset group. To the extent the fair value of the asset or asset group is less than its carrying value, an impairment loss is recognized equal to the amount the fair value of the asset or asset group exceeds its carrying amount. The Company generally measures fair value by considering sale prices for similar assets or asset groups, or by discounting estimated future cash flows from such assets or asset groups using an appropriate discount rate. Assets to be disposed of are carried at the lower of their carrying value or fair value less costs to sell. Considerable management judgment is necessary to estimate the fair value of assets or asset groups, and accordingly, actual results could vary significantly from such estimates. There have been no impairment losses recognized for the years ended December 31, 2015, 2014 or 2013. Other Assets Other assets consist primarily of deferred financing fees, net of amortization, recorded in connection with the term loan with Silicon Valley Bank. Upon repayment of the term loans, the Company is required to make a final payment to Silicon Valley Bank equal to 5.0% of the original principal amount. Revenue Recognition The Company recognizes revenue when (i) persuasive evidence of a customer arrangement exists; (ii) the price is fixed or determinable and free of contingencies or uncertainties; (iii) collectability is reasonably assured; and (iv) product delivery has occurred, which is when product title transfers to the customer, or services have been rendered. Sales are not conditional based on customer acceptance provisions or installation obligations. The C-Pulse System is not approved for commercial sale. However, the FDA has assigned the C-Pulse System to a Category B designation, making it eligible for reimbursement at certain U.S. sites during the Company’s clinical studies. Consequently, the Company is able to invoice hospitals and clinics that are eligible for reimbursement by Medicare, Medicaid or private insurance companies. The Company’s revenue has consisted solely of sales of the C-Pulse System to hospitals and clinics who participate in the Company’s clinical studies per the terms of the clinical study contracts. For clinical study implant revenue, the product title generally transfers on the date the product is implanted. Product costs incurred for the Company’s clinical studies are deemed to be development costs and are expensed to research and development as incurred. Upon commercialization, product costs will be capitalized in inventory and recorded to cost of sales as the inventory is sold. Foreign Currency Translation Sales and expenses denominated in foreign currencies are translated at average exchange rates in effect throughout the year. Assets and liabilities of foreign operations are translated at period-end exchange rates with the impacts of foreign currency translation recognized to cumulative translation adjustment, a component of accumulated other comprehensive income . Foreign currency transactions gains and losses are included in other expense, net in the consolidated statements of operations and other comprehensive loss. Stock-Based Compensation The Company recognizes all share-based payments to employees and directors, including grants of stock options, restricted stock units (RSUs) and common stock awards in the income statement as an operating expense, based on their fair value. The Company’s stock awards use a graded vesting schedule. The Company recognizes the option expense over the requisite service period, which is generally the vesting period. The Company computes the estimated fair values of stock options and warrants using the Black-Scholes option pricing model. The closing market price of the Company’s common stock at the date of grant is used to calculate the fair value of restricted stock units and common stock awards. Stock-based compensation expense is based on awards ultimately expected to vest and is reduced for estimated forfeitures. Forfeitures are estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. Equity instruments issued to non-employees include RSUs, warrants or options to purchase shares of the Company’s common stock. These RSUs, warrants or options are either fully-vested and exercisable at the date of grant or vest over a certain period during which services are provided. The Company expenses the fair market value of fully vested awards at the time of grant, and of unvested awards over the period in which the related services are received. Unvested awards are remeasured to fair value until they vest. See Note 5 for further information regarding the assumptions used to calculate the fair value of share-based compensation. Income Taxes Deferred income taxes are provided on a liability method whereby deferred tax assets are recognized for deductible temporary differences and operating loss and tax credit carryforwards. Deferred tax liabilities are recognized for taxable temporary differences, which are the differences between the reported amounts of assets and liabilities and their tax bases. Deferred tax assets are reduced by a valuation allowance when, in the opinion of management, it is more likely than not that some portion or all of the deferred tax assets will not be realized. Deferred tax assets and liabilities are adjusted for the effects of changes in tax laws and rates on the date of enactment. Net Loss per Share B asic net loss attributable to common stockholders, on a per share basis, is computed by dividing income available to common stockholders (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 ( “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 and computed in accordance with the treasury stock method. In addition, in computing the dilutive effect of convertible securities, the numerator is adjusted to add back the after-tax amount of interest recognized in the period associated with any convertible debt. Shares reserved for outstanding stock warrants and options and restricted stock units totaling 2,302,257, 2,832,194, and 3,623,806 for the years ended December 31, 2015, 2014 and 2013, respectively, were excluded from the computation of loss per share as their effect was antidilutive due to the Company’s net loss in each of those years. Research and Development Research and development expenses consist primarily of development personnel and non-employee contractor costs related to the development of new products and services, enhancement of existing products and services, quality assurance and testing. The Company incurred research and development expenses of $17.7 million, $16.9 million and $13.5 million for the years ended December 31, 2015, 2014 and 2013, respectively. Recent Accounting Pronouncements In May 2014, the Financial Accounting Standards Board (FASB) issued amended revenue recognition guidance to clarify the principles for recognizing revenue from contracts with customers. The guidance requires an entity to recognize revenue to depict the transfer of goods or services to customers in an amount that reflects the consideration to which an entity expects to be entitled in exchange for those goods or services. The guidance also requires expanded disclosures relating to the nature, amount, timing, and uncertainty of revenue and cash flows arising from contracts with customers. Additionally, qualitative and quantitative disclosures are required about customer contracts, significant judgments and changes in judgments, and assets recognized from the costs to obtain or fulfill a contract. In August 2015, the FASB amended the guidance to defer the effective date by one year, so this guidance will be effective for the Company’s interim and annual periods beginning January 1, 2018. The Company is currently evaluating the impact that this standard will have on its business practices, financial condition, results of operations and disclosures. In August 2014, the FASB amended guidance relating to the presentation and disclosure of the uncertainties of an entity’s ability to continue as a going concern. This guidance explicitly requires management of a company to evaluate whether there is substantial doubt about a company’s ability to continue as a going concern and to provide related footnote disclosure in certain circumstances. This guidance is effective for the Company’s annual reporting periods ending after December 15, 2016, and for annual and interim periods beginning thereafter, with early adoption permitted. The Company is evaluating the impact that the adoption of this standard will have, if any, on its financial statements and disclosures. In April 2015, the FASB issued amended guidance concerning debt issuance costs in relation to a recognized debt liability to require it be presented in the balance sheet as a direct deduction from the carrying amount of that debt liability, consistent with debt discounts. This guidance is effective for the Company’s interim and annual reporting periods beginning January 1, 2016. Upon adoption of this standard, the Company will reclassify $121,000 of unamortized debt issuance costs currently classified as Other Current Assets and as Other Assets in the accompanying balance sheet as of December 31, 2015, to an offset of Current and Long-Term Debt. In November 2015, the FASB issued amended guidance concerning the classification of deferred taxes on the balance sheet to require that deferred tax assets and deferred tax liabilities be presented as noncurrent in a classified balance sheet. The amendment is effective for our annual and interim reporting periods beginning January 1, 2017, with early adoption permitted. The adoption of this standard will not have an impact on the Company’s consolidated financial statements as all deferred tax assets are fully reserved. In February 2016, the FASB issued updated guidance to improve financial reporting about leasing transactions. This guidance will require organizations that lease assets to recognize on the balance sheet the assets and liabilities for the rights and obligations created by those leases. This guidance is effective for the Company’s annual reporting period beginning January 1, 2020, and for interim periods beginning January 1, 2021. The Company is evaluating the impact that the adoption of this standard will have, if any, on its financial statements and disclosures. The Company evaluates events through the date the financial statements are filed for events requiring adjustment to or disclosure in the financial statements.

Balance Sheet Information

Balance Sheet Information	12 Months Ended
	Dec. 31, 2015
Balance Sheet Information
Balance Sheet Information	Note 2—Balance Sheet Information Property, Plant and Equipment Property, plant and equipment were as follows: (Dollars in thousands) December 31, 2015 December 31, 2014 Office Furniture & Fixtures $ $ Leasehold Improvements Software Production Equipment Computer Equipment Total Accumulated Depreciation ) ) $ $

Debt

Debt	12 Months Ended
	Dec. 31, 2015
Debt
Debt	Note 3—Debt On February 18, 2015, the Company entered into a loan and security agreement with Silicon Valley Bank for proceeds of up to $10.0 million at an annual interest rate of 7.0%. Under this agreement, a $6.0 million term loan was funded at closing and an additional term loan in the amount of $2.0 million was funded on June 26, 2015. Availability of the second term loan was conditioned on the U.S. Food and Drug Administration (FDA) granting the Company interim analysis of COUNTER HF™, its U.S. pivotal study for the C-Pulse® Heart Assist System. The Company achieved this regulatory milestone in February 2015. The remaining $2.0 million term loan was available until September 30, 2015, provided that the Company had enrolled its one hundredth patient in the COUNTER HF study on or before that date. The Company did not achieve this milestone and did not secure additional borrowings under this facility. Total borrowings outstanding under the Silicon Valley Bank facility totaled $8.0 million as of December 31, 2015. The carrying amount of this debt approximated its fair value as of December 31, 2015. On December 8, 2015, the Company entered into an amendment to the loan and security agreement. The amendment removed the existing requirement to raise a minimum of $20.0 million in unencumbered net cash proceeds from the issuance and sale of equity securities by March 31, 2016. The Company agreed instead to a liquidity covenant requiring it to maintain cash and cash equivalents in an amount equal to or greater than eight times the Company’s monthly cash burn amount. The amendment also increased the prepayment fees required to be paid by the Company in the event that the loan is repaid before its maturity date. The proceeds from the term loans are used for general corporate and working capital purposes. The Company was entitled to make interest only payments until January 1, 2016. Commencing on January 1, 2016, and continuing on the first day of each calendar month thereafter, the Company is required to repay the advances made in twenty-four consecutive equal monthly installments. Principal payments coming due within twelve months have been classified as current in the accompanying balance sheet. The agreement is secured by a security interest in assets of the Company and its current and future subsidiaries, including a security interest in intellectual property proceeds, but excluding a current security interest in intellectual property. The agreement contains a liquidity covenant that requires that the Company maintain cash and cash equivalents in an amount equal or greater than eight times its monthly cash utilization, as well as customary representations (tested on a continual basis) and covenants that, subject to exceptions, restrict the Company’s ability to do the following things: declare dividends or redeem or repurchase equity interests; incur additional liens; make loans and investments; incur additional indebtedness; engage in mergers, acquisitions, and asset sales; transact with affiliates; undergo a change in control; add or change business locations; and engage in businesses that are not related to its existing business. As of December 31, 2015, the Company was in compliance with all covenants under this agreement. Upon repayment of the term loans, the Company is required to make a final payment to Silicon Valley Bank equal to 5.0% of the original principal amount of the term loans. This final payment totals $0.4 million and it has been classified as Other Liabilities on the accompanying balance sheet as of December 31, 2015. Debt obligations and the related interest rate were as follows (in thousands): Interest Rate at December 31, 2015 Maturity December 31, 2015 Loan Facility Tranche A % December 2017 $ Loan Facility Tranche B % December 2017 Total Debt $ Less Loan Discount Less Current Maturities Total Long Term Debt $ Warrants: In connection with funding of the first term loan for $6.0 million, the Company issued 68,996 warrants at an exercise price of $5.22 per share to Silicon Valley Bank and one of its affiliates. The Company valued these warrants at $3.86 per share utilizing the Black Scholes valuation model and the following assumptions: an expected dividend yield of 0%, an expected stock price volatility of 88.07%, a risk-free interest rate of 1.86%, and an expected life of 6.25 years. In connection with the funding of the second term loan for $2.0 million, the Company issued 32,609 warrants at an exercise price of $3.68 per share to Silicon Valley Bank and one of its affiliates. The Company valued these warrants at $2.71 per share utilizing the Black Scholes valuation model and the following assumptions: an expected dividend yield of 0%, an expected stock price volatility of 87.04%, a risk-free interest rate of 2.20%, and an expected life of 6.25 years. All warrants have a life of ten years and were fully vested at the date of grant. The value of these warrants was recorded as debt discount in the accompanying balance sheet and is being amortized to interest expense over the term of the debt agreement using the effective interest rate method. As of December 31, 2015, $201,000 of unamortized debt discount was netted against long-term debt in the accompanying condensed consolidated balance sheet.

Shareholder's Equity

Shareholder's Equity	12 Months Ended
	Dec. 31, 2015
Shareholder's Equity
Shareholder's Equity	Note 4—Shareholder’s Equity Stockholder Rights Plan On June 14, 2013, the Company adopted a stockholder rights plan (the “Rights Plan” ), which entitles the holders of the rights to purchase from the Company 1/1,000 th of a share of Series A Junior Participating Preferred Stock, par value $0.0001 per share, at a purchase price of $35.00 per share, as adjusted (a “Right” ), upon certain trigger events. In connection therewith, on June 14, 2013, the Company’s board of directors authorized 30,000 shares of Series A Junior Participating Preferred Stock and it declared a dividend of one Right per each share of common stock of the Company outstanding as of June 24, 2013. Each 1/1,000 th of a share of Series A Junior Participating Preferred Stock has terms that are substantially the economic and voting equivalent of one share of the Company’s common stock. However, until a Right is exercised or exchanged in accordance with the provisions of the Rights Plan, the holder thereof will have no rights as a stockholder of the Company, including, but not limited to, the right to vote for the election of directors or upon any matter submitted to stockholders of the Company. The Rights Plan has a three-year term and the board of directors may terminate the Rights Plan at any time (subject to the redemption of the Rights for a nominal value). The Rights may cause substantial dilution to a person or group (together with all affiliates and associates of such person or group and any person or group of persons acting in concert therewith) that acquires beneficial ownership of 15% or more of the Company’s stock on terms not approved by the board of directors or takes other specified actions. ATM Sales On March 21, 2014, the Company entered into a sales agreement (the “Sales Agreement”) with Cowen and Company LLC (“ Cowen ”). Under the Sales Agreement, the Company may sell from time to time, in “at the market” offerings, shares of its common stock registered under its currently effective registration statement on Form S-3. On March 21, 2014, the Company filed a prospectus supplement with the SEC in connection with the offering, relating to shares of its common stock having an aggregate offering price of up to $40.0 million. The Company pays Cowen a commission of up to 3.0% of the gross proceeds from the sale of any shares pursuant to the Sales Agreement. During 2014, the Company sold 23,120 shares of common stock for net proceeds of $0.1 million, after stock issuance costs of $32,000. In 2015, the Company sold 1,256,380 shares of common stock for net proceeds of $7.1 million after stock issuance costs of $0.2 million. As of December 31, 2015, the Company had a total of $32.6 million available for future sales under the Sales Agreement.

Stock-Based Compensation

Stock-Based Compensation	12 Months Ended
	Dec. 31, 2015
Stock-Based Compensation
Stock-Based Compensation	Note 5— Stock-Based Compensation Stock Options and Restricted Stock Awards The Company has various share-based compensation plans, including the Amended and Restated 2002 Stock Plan, the Second Amended and Restated 2011 Equity Incentive Plan, the 2013 Non-Employee Directors’ Equity Incentive Plan and the New-Hire Equity Incentive Plan (collectively, the “Plans” ). The Plans are designed to assist in attracting, motivating and retaining employees and directors and to recognize the importance of employees to the long-term performance and success of the Company. The Company has also granted stock options to certain non-employees outside of the Plans. The Company recognized share-based compensation expense related to grants of stock options, RSUs and common stock awards to employees, directors and consultants of $2.437 million, $3.085 million, and $3.604 million during the years ended December 31, 2015, 2014, and 2013, respectively. The following table summarizes the stock-based compensation expense which was recognized in the consolidated statements of operations for the years ended December 31: (Dollars in thousands) 2015 2014 2013 Selling, general and administrative $ $ $ Research and development Total $ $ $ The majority of the RSUs and options to purchase common stock vest on the anniversary of the date of grant, which ranges from one to four years. Share-based compensation expense related to these awards is recognized on a straight-line basis over the related vesting term in most cases, which generally is the service period. It is the Company’s policy to issue new shares upon the exercise of options. Stock Options : The following is a summary of the Plans’ stock option activity during the years ended December 31: 2015 2014 2013 Options Outstanding Weighted Average Exercise Price Options Outstanding Weighted Average Exercise Price Options Outstanding Weighted Average Exercise Price Beginning Balance $ $ $ Granted Exercised — — ) — — Forfeited/expired ) ) ) Outstanding at December 31 $ $ $ Exercisable at December 31 $ $ $ For options outstanding and exercisable at December 31, 2015, the weighted average remaining contractual life was 7.38 years and 8.07 years, respectively. The total intrinsic value, calculated as the closing stock price at year-end less the option exercise price, of options exercised during 2014 was $56,000. There were no option exercises in 2015. The total fair value of options that vested in 2015, 2014 and 2013 was $1.9 million, $1.8 million and $1.6 million, respectively, at the fair value of the options as of the date of grant. Valuation Assumptions : The fair value of each stock option is estimated at the grant date using the Black-Scholes option pricing model. The fair value of stock options under the Black-Scholes model requires management to make assumptions regarding projected employee stock option exercise behaviors, risk-free interest rates, volatility of the Company’s stock price, and expected dividends. The Company has not historically paid cash dividends to its stockholders, and currently does not anticipate paying any cash dividends in the foreseeable future. As a result the Company has assumed a dividend yield of 0%. The risk free interest rate is based upon the rates of U.S. Treasury bills with a term that approximates the expected life of the option. Since the Company has limited historical exercise data to reasonably estimate the expected life of its option awards, the expected life is calculated using a simplified method. Expected volatility is based on historical volatility of the Company’s stock. The following table provides the assumptions used in the Black-Scholes model: For the Years ended December 31 2015 2014 2013 Expected dividend yield % % % Risk-free interest rate % % % Expected volatility % % % Expected life (in years) The weighted-average fair value of stock options granted in 2015, 2014 and 2013 was $2.62, $4.05, and $5.54, respectively. As of December 31, 2015, the total compensation cost related to all non-vested stock option awards not yet recognized was $1.8 million and is expected to be recognized over the remaining weighted-average period of 2.3 years. Effective September 23, 2014, the Company redenominated certain outstanding stock options totaling 539,869 shares originally granted to non-Australia-based employees with an AU$ exercise price to the equivalent US$ exercise price, the Company’s functional currency. The redenomination was computed using the quoted currency exchange rate on September 23, 2014 and did not result in the recognition of any incremental stock option expense as a result of the modification. Restricted Stock Awards : The following table summarizes restricted stock award activity during 2015, 2014 and 2013: 2015 2014 2013 RSUs Weighted Average Grant Price RSUs Weighted Average Grant Price RSUs Weighted Average Grant Price Nonvested, beginning balance $ $ — $ — Granted Vested ) ) ) Forfeited ) ) — — Nonvested at December 31 $ $ $ During 2015, 2014, and 2013 employees tendered restricted stock units totaling 65,858, 70,161, and 9,779, respectively, to cover related payroll tax withholdings. Common Stock Issuances Fully vested common stock awards totaling 105,605 shares at a weighted average value of $11.32 per share were issued in the year ended December 31, 2013. Of these share awarded, 49,137 shares were tendered to the Company to cover related employee tax withholdings. There were no awards of fully vested common stock in 2015 or 2014. Warrants During the year ended December 31, 2014, 2,798 warrants were exercised at a price of AU$6.40 per share for total proceeds of $16,000 and 15,000 warrants were exercised at a price of AU$6.40 per share resulting in the net issuance of 5,397 shares of common stock. Warrants to purchase 297,843, 505,166, and 1,630,804 shares of common stock were outstanding at December 31, 2015, 2014 and 2013, respectively. As of December 31,2015, there were 297,843 warrants outstanding that were exercisable at prices ranging from $3.68 to $8.03 per share, and are exercisable over a period ranging from two months to 9.5 years.

Income Taxes

Income Taxes	12 Months Ended
	Dec. 31, 2015
Income Taxes
Income Taxes	Note 6—Income Taxes Domestic and foreign loss before income taxes, consists of the following: For the years ended December 31, (Dollars in thousands) 2015 2014 2013 Domestic $ ) $ ) $ ) Foreign ) ) ) Loss before income taxes $ ) $ ) $ ) The components of income tax benefit consist of the following: For the years ended December 31, (Dollars in thousands) 2015 2014 2013 Current: United States and state $ — $ — $ Foreign, net Deferred: United States and state — — — Foreign — — — Total income tax benefit $ $ $ Actual income tax benefit differs from statutory federal income tax benefit as follows: For the years ended December 31, (Dollars in thousands) 2015 2014 2013 Statutory federal income tax benefit $ $ $ State tax benefit, net of federal taxes — Foreign tax ) R&D tax credit Nondeductible/nontaxable items ) ) ) Other ) — ) Valuation allowance increase ) ) ) Total income tax benefit $ $ $ Deferred taxes consist of the following: As of (Dollars in thousands) December 31, 2015 December 31, 2014 Deferred tax assets: Current: Accrued leave $ $ Other accrued expenses Total current deferred tax asset Noncurrent: Stock based compensation Net operating loss carryforward Deferred rent Other R&D credit carryforward Total noncurrent deferred tax assets Total deferred tax assets $ $ Deferred tax liabilities: Current: $ — $ — Noncurrent: Fixed assets — ) Total deferred tax liabilities $ — $ ) Net deferred tax asset Less: valuation allowance ) ) Total $ — $ — As of December 31, 2015, the Company had net operating loss (“NOLs”) carryforwards of approximately $94.0 million for U.S. federal income tax purposes, which expire between 2024 and 2034, and NOLs in the Commonwealth of Australia of approximately AU$49.1 million which the Company can carry forward indefinitely. U.S. NOLs cannot be used to offset taxable income in foreign jurisdictions. In addition, future utilization of NOL carryforwards in the U.S. may be subject to certain limitations under Section 382 of the Internal Revenue Code. The Company received $135,000, $265,000, and $1.1 million fully refundable research and development tax credits in 2015, 2014 and 2013, respectively, related to qualified research and development expenditures of its Australian subsidiary for its tax years ended June 30, 2014, 2013, and 2012, respectively. The Company has not completed its Australian tax return for its Australian subsidiaries tax year ended June 30, 2015. As the Company cannot be reasonably assured of the amount or eligibility of the refundable research and development credit resulting from its Australian research and development activities, the Company has not reflected a benefit related to the research and development credit in its income tax provision for the year ended December 31, 2015. The Company provides for a valuation allowance when it is more likely than not that it will not realize a portion of the deferred tax assets. The Company has established a valuation allowance for U.S. and foreign deferred tax assets due to the uncertainty that enough taxable income will be generated in those taxing jurisdictions to utilize the assets. Therefore, the Company has not reflected any benefit of such deferred tax assets in the accompanying financial statements. For the years ended December 31, 2015 and 2014, the valuation allowance increased by $7.5 million and $5.1 million, respectively. The accounting guidance related to uncertain tax positions prescribes a recognition threshold and measurement attribute for recognition and measurement of a tax position taken or expected to be taken in a tax return. It also provides guidance on de-recognition, classification, interest and penalties, accounting in interim periods, disclosure and transition. The Company had no material uncertain tax positions as of December 31, 2015, 2014 or 2013. The Company recognizes interest and penalties on unrecognized tax benefits as well as interest received from favorable tax settlements within income tax expense. During the years ended December 31, 2015, 2014 and 2013, the Company recorded no accrued interest or penalties related to uncertain tax positions. The tax years ended December 31, 2012 through December 31, 2015 remain open to examination by the Internal Revenue Service. For the various states where we are subject to taxation, the fiscal tax years ended June 30, 2011 through December 31, 2015, remain open to examination. Additionally, the returns of the Company’s Australian and Irish subsidiary are subject to examination by tax authorities of those jurisdictions for the tax years ended and subsequent to June 30, 2011 and December 31, 2014, respectively.

Commitments and Contingencies

Commitments and Contingencies	12 Months Ended
	Dec. 31, 2015
Commitments and Contingencies.
Commitments and Contingencies	Note 7—Commitments and Contingencies Leases The Company leases office space under a non-cancelable operating lease that expires in March 2019. The lease contains provisions for future annual inflationary adjustments. Rent expense is recognized using the straight-line method over the term of the lease. The Company leases office equipment under non-cancelable operating leases that expire at various times through May 2016. Rent expense related to operating leases was approximately $261,000, $179,000, and $196,000 for the years ended December 31, 2015, 2014 and 2013, respectively. Future minimum lease payments under non-cancelable operating leases as of December 31, 2015, were approximately $198,000, $199,000, $195,000, $49,000, and $0 for each of the years ended December 31, 2016, through 2020, respectively. Employee Retirement Plan The Company has a 401(k) profit sharing plan that provides retirement benefit to substantially all full-time U.S. employees. Eligible employees may contribute a percentage of their annual compensation, subject to IRS limitations, with the Company matching a portion of the employee’s contributions at the discretion of the Company. Matching contributions totaled $147,000, $146,000 and $14,000 for the years ended December 31, 2015, 2014 and 2013, respectively.

Segment and Geographic Informat

Segment and Geographic Information	12 Months Ended
	Dec. 31, 2015
Segment and Geographic Information
Segment and Geographic Information	Note 8—Segment and Geographic Information The Company has one reportable segment, cardiac and coronary disease products. At December 31, 2015, long-lived assets were located primarily in the United States.

Quarterly Financial Data (unaud

Quarterly Financial Data (unaudited)	12 Months Ended
	Dec. 31, 2015
Quarterly Financial Data (unaudited)
Quarterly Financial Data (unaudited)	Note 9—Quarterly Financial Data (unaudited) Net Sales Operating Expenses Net Loss Basic and Diluted Loss Per Share (dollars in thousands, except per share data) 2015 First Quarter $ $ $ ) $ ) Second Quarter — ) ) Third Quarter — ) ) Fourth Quarter — ) ) Totals $ $ $ ) $ ) 2014 First Quarter $ $ $ ) $ ) Second Quarter ) ) Third Quarter ) ) Fourth Quarter ) ) Totals $ $ $ ) $ ) 2013 First Quarter $ — $ $ ) $ ) Second Quarter — ) ) Third Quarter ) ) Fourth Quarter — ) ) Totals $ $ $ ) $ )

Subsequent Events

Subsequent Events	12 Months Ended
	Dec. 31, 2015
Subsequent Events
Subsequent Events	Note 10—Subsequent Events On March 3, 2016, the Company announced that it is no longer enrolling patients into the COUNTER HF and OPTIONS HF studies and that it plans to pursue a new strategic direction, which includes seeking approval for a short term clinical study in which patients will remain on therapy for a shorter duration, making certain improvements to the C-Pulse System and implant procedure in connection therewith, and focusing additional resources on the development of a fully-implantable system.

Nature of Business and Signif17

Nature of Business and Significant Accounting Policies (Policies)	12 Months Ended
	Dec. 31, 2015
Nature of Business and Significant Accounting Policies
Nature of Business	Nature of Business Sunshine Heart, Inc. was founded in November 1999 and incorporated in Delaware in August 2002. The Company is headquartered in Eden Prairie, Minnesota and has a wholly owned subsidiary, Sunshine Heart Company Pty Limited, located in Clontarf, New South Wales, Australia and a wholly owned subsidiary, Sunshine Heart Ireland Limited, located in Dublin, Ireland. The Company is a medical device company developing innovative technologies for cardiac and coronary disease. The Company’s primary product, the C-Pulse System, is an implantable, non-blood contacting, heart assist therapy for the treatment of moderate to severe heart failure which can be implanted using a minimally invasive procedure. The C-Pulse System is designed to relieve the symptoms of heart failure through the use of counter-pulsation technology by enabling an increase in cardiac output, an increase in coronary blood flow, and a reduction in the heart’s pumping load. The Company has received approval from the US Food and Drug Administration ( “FDA” ) to conduct a U.S. feasibility clinical study with the C-Pulse System. Commencing February 16, 2012, the Company’s shares of common stock began trading on NASDAQ under the symbol “SSH.”
Going Concern	Going Concern The Company’s financial statements have been prepared and presented on a basis assuming it continues as a going concern. During the years ended December 31, 2015, 2014 and 2013, the Company incurred losses from operations and net cash outflows from operating activities as disclosed in the consolidated statements of operations and comprehensive loss and cash flows, respectively. At December 31, 2015, the Company had an accumulated deficit of $153.2 million and expects to incur losses for the foreseeable future. To date, the Company has been funded primarily by various equity and debt financings. Although the Company believes that it will be able to successfully fund its operations, there can be no assurance the Company will be able to do so or that the Company will ever operate profitably. The Company’s ability to continue as a going concern is dependent on the Company’s ability to raise additional capital based on the achievement of existing milestones as and when required. The Company expects to seek additional financing in 2016. Should future capital raising be unsuccessful, the Company may not be able to continue as a going concern. Furthermore, the ability of the Company to continue as a going concern is subject to the ability of the Company to develop and successfully commercialize the product being developed. If the Company is unable to obtain such funding of an amount and timing necessary to meet its future operational plans, or to successfully commercialize its intellectual property, the Company may be unable to continue as a going concern. No adjustments have been made relating to the recoverability and classification of recorded asset amounts and classification of liabilities that might be necessary should the Company not continue as a going concern.
Basis of Presentation	Basis of Presentation The accompanying consolidated financial statements include the accounts of Sunshine Heart, Inc. and its wholly owned subsidiaries, Sunshine Heart Company Pty Limited and Sunshine Heart Ireland Limited. All inter-company accounts and transactions between consolidated entities have been eliminated.
Use of Estimates	Use of Estimates The preparation of financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect the reported amounts and disclosures in the consolidated financial statements and accompanying notes. Actual results could differ from those estimates.
Fair Value of Financial Instruments	Fair Value of Financial Instruments The Company’s financial instruments consist of cash and cash equivalents, accounts receivable, accounts payable and accrued liabilities. The Company believes that the carrying amounts of the financial instruments approximate their respective current fair values due to their relatively short maturities. Pursuant to the requirements of Financial Accounting Standards Board (the “FASB” ) Accounting Standards Codification (the “ASC” ) Topic 820 “Fair Value Measurement,” the Company’s financial assets and liabilities measured at fair value on a recurring basis are classified and disclosed in one of the following three categories: · Level 1 - Financial instruments with unadjusted quoted prices listed on active market exchanges. · Level 2 - Financial instruments lacking unadjusted, quoted prices from active market exchanges, including over the counter traded financial instruments. The prices for the financial instruments are determined using prices for recently traded financial instruments with similar underlying terms as well as directly or indirectly observable inputs, such as interest rates and yield curves that are observable at commonly quoted intervals. · Level 3 - Financial instruments that are not actively traded on a market exchange. This category includes situations where there is little, if any, market activity for the financial instrument. The prices are determined using significant unobservable inputs or valuation techniques. All cash equivalents are considered Level 1 measurements for all periods presented. The Company does not have any financial instruments classified as Level 2 or Level 3 and there were no movements between these categories during the years ended December 31, 2015 and 2014.
Cash and Cash Equivalents	Cash and Cash Equivalents Cash and cash equivalents consist of cash and term deposits with original maturities of three months or less. The carrying value of these instruments approximate fair value. The balances, at times, may exceed federally insured limits. The Company has not experienced any losses on its cash and cash equivalents.
Accounts Receivable	Accounts Receivable Accounts receivable are unsecured, are recorded at net realizable value, and do not bear interest. The Company makes judgments as to its ability to collect outstanding receivables based upon significant patterns of uncollectability, historical experience, and managements’ evaluation of specific accounts and will provide an allowance for credit losses when collection becomes doubtful. The Company performs credit evaluations of its customers’ financial condition on an as-needed basis. Payment is generally due 30 days from the invoice date and accounts past 30 days are individually analyzed for collectability. When all collection efforts have been exhausted, the account is written off against the related allowance. No allowance for doubtful accounts was considered necessary as of December 31, 2015 and 2014.
Other Current Assets	Other Current Assets Other current assets represent prepayments and deposits made by the Company.
Property, Plant and Equipment	Property, Plant 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. Leasehold improvements are amortized using the straight-line method over the shorter of the lease term or the estimated useful life of the assets. Repairs and maintenance costs are expensed as incurred. The cost and accumulated depreciation of property, plant and equipment retired, or otherwise disposed of are removed from the related accounts, and any residual values are charged to expense. Depreciation expense has been calculated using the following estimated useful lives: Office furniture and equipment 5-15 years Computer software and equipment 3-4 years Laboratory and research equipment 3-15 years Production equipment 3-7 years Depreciation expense was $325, $277 and $185 for the years ended December 31, 2015, 2014 and 2013, respectively. Property and equipment are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset or asset group may not be recoverable. If the impairment tests indicate that the carrying value of the asset, or asset group is greater than the expected undiscounted cash flows to be generated by such asset or asset group further analysis is performed to determine the fair value of the asset or asset group. To the extent the fair value of the asset or asset group is less than its carrying value, an impairment loss is recognized equal to the amount the fair value of the asset or asset group exceeds its carrying amount. The Company generally measures fair value by considering sale prices for similar assets or asset groups, or by discounting estimated future cash flows from such assets or asset groups using an appropriate discount rate. Assets to be disposed of are carried at the lower of their carrying value or fair value less costs to sell. Considerable management judgment is necessary to estimate the fair value of assets or asset groups, and accordingly, actual results could vary significantly from such estimates. There have been no impairment losses recognized for the years ended December 31, 2015, 2014 or 2013.
Other Assets	Other Assets Other assets consist primarily of deferred financing fees, net of amortization, recorded in connection with the term loan with Silicon Valley Bank. Upon repayment of the term loans, the Company is required to make a final payment to Silicon Valley Bank equal to 5.0% of the original principal amount.
Revenue Recognition	Revenue Recognition The Company recognizes revenue when (i) persuasive evidence of a customer arrangement exists; (ii) the price is fixed or determinable and free of contingencies or uncertainties; (iii) collectability is reasonably assured; and (iv) product delivery has occurred, which is when product title transfers to the customer, or services have been rendered. Sales are not conditional based on customer acceptance provisions or installation obligations. The C-Pulse System is not approved for commercial sale. However, the FDA has assigned the C-Pulse System to a Category B designation, making it eligible for reimbursement at certain U.S. sites during the Company’s clinical studies. Consequently, the Company is able to invoice hospitals and clinics that are eligible for reimbursement by Medicare, Medicaid or private insurance companies. The Company’s revenue has consisted solely of sales of the C-Pulse System to hospitals and clinics who participate in the Company’s clinical studies per the terms of the clinical study contracts. For clinical study implant revenue, the product title generally transfers on the date the product is implanted. Product costs incurred for the Company’s clinical studies are deemed to be development costs and are expensed to research and development as incurred. Upon commercialization, product costs will be capitalized in inventory and recorded to cost of sales as the inventory is sold.
Foreign Currency Translation	Foreign Currency Translation Sales and expenses denominated in foreign currencies are translated at average exchange rates in effect throughout the year. Assets and liabilities of foreign operations are translated at period-end exchange rates with the impacts of foreign currency translation recognized to cumulative translation adjustment, a component of accumulated other comprehensive income . Foreign currency transactions gains and losses are included in other expense, net in the consolidated statements of operations and other comprehensive loss.
Stock-Based Compensation	Stock-Based Compensation The Company recognizes all share-based payments to employees and directors, including grants of stock options, restricted stock units (RSUs) and common stock awards in the income statement as an operating expense, based on their fair value. The Company’s stock awards use a graded vesting schedule. The Company recognizes the option expense over the requisite service period, which is generally the vesting period. The Company computes the estimated fair values of stock options and warrants using the Black-Scholes option pricing model. The closing market price of the Company’s common stock at the date of grant is used to calculate the fair value of restricted stock units and common stock awards. Stock-based compensation expense is based on awards ultimately expected to vest and is reduced for estimated forfeitures. Forfeitures are estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. Equity instruments issued to non-employees include RSUs, warrants or options to purchase shares of the Company’s common stock. These RSUs, warrants or options are either fully-vested and exercisable at the date of grant or vest over a certain period during which services are provided. The Company expenses the fair market value of fully vested awards at the time of grant, and of unvested awards over the period in which the related services are received. Unvested awards are remeasured to fair value until they vest. See Note 5 for further information regarding the assumptions used to calculate the fair value of share-based compensation.
Income Taxes	Income Taxes Deferred income taxes are provided on a liability method whereby deferred tax assets are recognized for deductible temporary differences and operating loss and tax credit carryforwards. Deferred tax liabilities are recognized for taxable temporary differences, which are the differences between the reported amounts of assets and liabilities and their tax bases. Deferred tax assets are reduced by a valuation allowance when, in the opinion of management, it is more likely than not that some portion or all of the deferred tax assets will not be realized. Deferred tax assets and liabilities are adjusted for the effects of changes in tax laws and rates on the date of enactment.
Net Loss per Share	Net Loss per Share B asic net loss attributable to common stockholders, on a per share basis, is computed by dividing income available to common stockholders (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 ( “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 and computed in accordance with the treasury stock method. In addition, in computing the dilutive effect of convertible securities, the numerator is adjusted to add back the after-tax amount of interest recognized in the period associated with any convertible debt. Shares reserved for outstanding stock warrants and options and restricted stock units totaling 2,302,257, 2,832,194, and 3,623,806 for the years ended December 31, 2015, 2014 and 2013, respectively, were excluded from the computation of loss per share as their effect was antidilutive due to the Company’s net loss in each of those years.
Research and Development	Research and Development Research and development expenses consist primarily of development personnel and non-employee contractor costs related to the development of new products and services, enhancement of existing products and services, quality assurance and testing. The Company incurred research and development expenses of $17.7 million, $16.9 million and $13.5 million for the years ended December 31, 2015, 2014 and 2013, respectively.
Recent Accounting Pronouncements	Recent Accounting Pronouncements In May 2014, the Financial Accounting Standards Board (FASB) issued amended revenue recognition guidance to clarify the principles for recognizing revenue from contracts with customers. The guidance requires an entity to recognize revenue to depict the transfer of goods or services to customers in an amount that reflects the consideration to which an entity expects to be entitled in exchange for those goods or services. The guidance also requires expanded disclosures relating to the nature, amount, timing, and uncertainty of revenue and cash flows arising from contracts with customers. Additionally, qualitative and quantitative disclosures are required about customer contracts, significant judgments and changes in judgments, and assets recognized from the costs to obtain or fulfill a contract. In August 2015, the FASB amended the guidance to defer the effective date by one year, so this guidance will be effective for the Company’s interim and annual periods beginning January 1, 2018. The Company is currently evaluating the impact that this standard will have on its business practices, financial condition, results of operations and disclosures. In August 2014, the FASB amended guidance relating to the presentation and disclosure of the uncertainties of an entity’s ability to continue as a going concern. This guidance explicitly requires management of a company to evaluate whether there is substantial doubt about a company’s ability to continue as a going concern and to provide related footnote disclosure in certain circumstances. This guidance is effective for the Company’s annual reporting periods ending after December 15, 2016, and for annual and interim periods beginning thereafter, with early adoption permitted. The Company is evaluating the impact that the adoption of this standard will have, if any, on its financial statements and disclosures. In April 2015, the FASB issued amended guidance concerning debt issuance costs in relation to a recognized debt liability to require it be presented in the balance sheet as a direct deduction from the carrying amount of that debt liability, consistent with debt discounts. This guidance is effective for the Company’s interim and annual reporting periods beginning January 1, 2016. Upon adoption of this standard, the Company will reclassify $121,000 of unamortized debt issuance costs currently classified as Other Current Assets and as Other Assets in the accompanying balance sheet as of December 31, 2015, to an offset of Current and Long-Term Debt. In November 2015, the FASB issued amended guidance concerning the classification of deferred taxes on the balance sheet to require that deferred tax assets and deferred tax liabilities be presented as noncurrent in a classified balance sheet. The amendment is effective for our annual and interim reporting periods beginning January 1, 2017, with early adoption permitted. The adoption of this standard will not have an impact on the Company’s consolidated financial statements as all deferred tax assets are fully reserved. In February 2016, the FASB issued updated guidance to improve financial reporting about leasing transactions. This guidance will require organizations that lease assets to recognize on the balance sheet the assets and liabilities for the rights and obligations created by those leases. This guidance is effective for the Company’s annual reporting period beginning January 1, 2020, and for interim periods beginning January 1, 2021. The Company is evaluating the impact that the adoption of this standard will have, if any, on its financial statements and disclosures. The Company evaluates events through the date the financial statements are filed for events requiring adjustment to or disclosure in the financial statements.

Nature of Business and Signif18

Nature of Business and Significant Accounting Policies (Tables)	12 Months Ended
	Dec. 31, 2015
Nature of Business and Significant Accounting Policies
Schedule of estimated useful lives	Office furniture and equipment 5-15 years Computer software and equipment 3-4 years Laboratory and research equipment 3-15 years Production equipment 3-7 years

Balance Sheet Information (Tabl

Balance Sheet Information (Tables)	12 Months Ended
	Dec. 31, 2015
Balance Sheet Information
Schedule of property, plant and equipment	(Dollars in thousands) December 31, 2015 December 31, 2014 Office Furniture & Fixtures $ $ Leasehold Improvements Software Production Equipment Computer Equipment Total Accumulated Depreciation ) ) $ $

Debt (Tables)

Debt (Tables)	12 Months Ended
	Dec. 31, 2015
Debt
Schedule of debt obligations and the related interest rate	Debt obligations and the related interest rate were as follows (in thousands): Interest Rate at December 31, 2015 Maturity December 31, 2015 Loan Facility Tranche A % December 2017 $ Loan Facility Tranche B % December 2017 Total Debt $ Less Loan Discount Less Current Maturities Total Long Term Debt $

Stock-Based Compensation (Table

Stock-Based Compensation (Tables)	12 Months Ended
	Dec. 31, 2015
Stock-Based Compensation
Summary of classification of stock-based compensation expense	(Dollars in thousands) 2015 2014 2013 Selling, general and administrative $ $ $ Research and development Total $ $ $
Summary of the Plan and non-Plan stock option activity	2015 2014 2013 Options Outstanding Weighted Average Exercise Price Options Outstanding Weighted Average Exercise Price Options Outstanding Weighted Average Exercise Price Beginning Balance $ $ $ Granted Exercised — — ) — — Forfeited/expired ) ) ) Outstanding at December 31 $ $ $ Exercisable at December 31 $ $ $
Schedule of weighted-average assumptions used in calculating the fair value of options granted	For the Years ended December 31 2015 2014 2013 Expected dividend yield % % % Risk-free interest rate % % % Expected volatility % % % Expected life (in years)
Summary of restricted stock award activity	2015 2014 2013 RSUs Weighted Average Grant Price RSUs Weighted Average Grant Price RSUs Weighted Average Grant Price Nonvested, beginning balance $ $ — $ — Granted Vested ) ) ) Forfeited ) ) — — Nonvested at December 31 $ $ $

Income Taxes (Tables)

Income Taxes (Tables)	12 Months Ended
	Dec. 31, 2015
Income Taxes
Schedule of domestic and foreign loss before income tax	For the years ended December 31, (Dollars in thousands) 2015 2014 2013 Domestic $ ) $ ) $ ) Foreign ) ) ) Loss before income taxes $ ) $ ) $ )
Schedule of components of income tax benefit	For the years ended December 31, (Dollars in thousands) 2015 2014 2013 Current: United States and state $ — $ — $ Foreign, net Deferred: United States and state — — — Foreign — — — Total income tax benefit $ $ $
Summary showing actual income tax benefit differing from statutory federal income tax benefit	For the years ended December 31, (Dollars in thousands) 2015 2014 2013 Statutory federal income tax benefit $ $ $ State tax benefit, net of federal taxes — Foreign tax ) R&D tax credit Nondeductible/nontaxable items ) ) ) Other ) — ) Valuation allowance increase ) ) ) Total income tax benefit $ $ $
Schedule of components of deferred taxes	As of (Dollars in thousands) December 31, 2015 December 31, 2014 Deferred tax assets: Current: Accrued leave $ $ Other accrued expenses Total current deferred tax asset Noncurrent: Stock based compensation Net operating loss carryforward Deferred rent Other R&D credit carryforward Total noncurrent deferred tax assets Total deferred tax assets $ $ Deferred tax liabilities: Current: $ — $ — Noncurrent: Fixed assets — ) Total deferred tax liabilities $ — $ ) Net deferred tax asset Less: valuation allowance ) ) Total $ — $ —

Quarterly Financial Data (una23

Quarterly Financial Data (unaudited) (Tables)	12 Months Ended
	Dec. 31, 2015
Quarterly Financial Data (unaudited)
Schedule of quarterly financial information (Unaudited)	Net Sales Operating Expenses Net Loss Basic and Diluted Loss Per Share (dollars in thousands, except per share data) 2015 First Quarter $ $ $ ) $ ) Second Quarter — ) ) Third Quarter — ) ) Fourth Quarter — ) ) Totals $ $ $ ) $ ) 2014 First Quarter $ $ $ ) $ ) Second Quarter ) ) Third Quarter ) ) Fourth Quarter ) ) Totals $ $ $ ) $ ) 2013 First Quarter $ — $ $ ) $ ) Second Quarter — ) ) Third Quarter ) ) Fourth Quarter — ) ) Totals $ $ $ ) $ )

Nature of Business and Signif24

Nature of Business and Significant Accounting Policies (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2015	Dec. 31, 2014	Dec. 31, 2013	Feb. 18, 2015
Going Concern
Accumulated deficit	$ 153,182	$ 126,599
Accounts Receivable
Period of payment due from the invoice date	30 days
Allowance for doubtful accounts	$ 0	0
Property, plant and equipment
Depreciation expense	325	277	$ 185
Impairment losses for long-lived assets	$ 0	$ 0	$ 0
Loan and Security Agreement with Silicon Valley Bank
Other Assets
Payment percentage of principal amount				5.00%
Office Furniture & Fixtures | Minimum
Property, plant and equipment
Estimated useful lives	5 years
Office Furniture & Fixtures | Maximum
Property, plant and equipment
Estimated useful lives	15 years
Computer Equipment | Minimum
Property, plant and equipment
Estimated useful lives	3 years
Computer Equipment | Maximum
Property, plant and equipment
Estimated useful lives	4 years
Laboratory and research equipment | Minimum
Property, plant and equipment
Estimated useful lives	3 years
Laboratory and research equipment | Maximum
Property, plant and equipment
Estimated useful lives	15 years
Production Equipment | Minimum
Property, plant and equipment
Estimated useful lives	3 years
Production Equipment | Maximum
Property, plant and equipment
Estimated useful lives	7 years

Nature of Business and Signif25

Nature of Business and Significant Accounting Polices - EPS/R&D (Details) - USD ($)	12 Months Ended
	Dec. 31, 2015	Dec. 31, 2014	Dec. 31, 2013	Jan. 01, 2016
Net Loss per Share
Shares reserved for outstanding stock warrants and options and restricted stock units excluded from the computation of loss per share due to their antidilutive effect	2,302,257	2,832,194	3,623,806
Research and Development
Research and Development Expense	$ 17,672,000	$ 16,874,000	$ 13,504,000
Accounting Standards update April 2015
Recent Accounting Pronouncements
Unamortized debt issuance costs (assets)				$ (121,000)
Unamortized debt issuance costs (liability)				$ 121,000

Balance Sheet Information (Deta

Balance Sheet Information (Details) - USD ($) $ in Thousands	Dec. 31, 2015	Dec. 31, 2014
Property, Plant and Equipment
Total	$ 1,645	$ 1,446
Accumulated Depreciation	(1,110)	(785)
Property, plant and equipment, net	535	661
Office Furniture & Fixtures
Property, Plant and Equipment
Total	269	229
Leasehold Improvements
Property, Plant and Equipment
Total	145	145
Software
Property, Plant and Equipment
Total	121	65
Production Equipment
Property, Plant and Equipment
Total	837	786
Computer Equipment
Property, Plant and Equipment
Total	$ 273	$ 221

Debt (Details)

Debt (Details)	Jan. 01, 2016installment	Dec. 08, 2015USD ($)	Dec. 08, 2015	Jun. 26, 2015USD ($)$ / sharesshares	Feb. 18, 2015USD ($)$ / sharesshares	Dec. 31, 2015USD ($)$ / shares
Debt Disclosure
Total borrowings outstanding						$ 8,000,000
Final payment liability of term loan						400,000
Unamortized debt discount						201,000
Warrants
Debt Disclosure
Term of warrants					10 years
Unamortized debt discount						201,000
Loan and Security Agreement with Silicon Valley Bank
Debt Disclosure
Fixed interest rate					7.00%
Total borrowings outstanding						8,000,000
Number of consecutive equal monthly installments of principal and interest repayment | installment	24
Payment percentage of principal amount					5.00%
Loan and Security Agreement with Silicon Valley Bank | Other liabilities
Debt Disclosure
Final payment liability of term loan						$ 400,000
Loan and Security Agreement with Silicon Valley Bank | Available at closing
Debt Disclosure
Proceeds received at closing					$ 6,000,000
Loan and Security Agreement with Silicon Valley Bank | Available upon announcement of FDA acceptance
Debt Disclosure
Loans and Security Agreement proceeds received upon the Company's announcement that the FDA has accepted its statistical Interim Analysis Plan				$ 2,000,000
Loan and Security Agreement with Silicon Valley Bank | Available upon enrollment of 100th patient in COUNTER HF study
Debt Disclosure
Loan And Security Agreement Proceeds To Be Received Upon The Company Enrolling Its 100TH Patient In The COUNTER HF Study					2,000,000
First Term Loan | Warrants
Debt Disclosure
Proceeds from loan					$ 6,000,000
Warrants issued | shares					68,996
Exercise price of warrants (in dollars per share) | $ / shares					$ 5.22
Value of warrants (in dollars per share) | $ / shares					$ 3.86
Expected dividend yield					0.00%
Expected stock price volatility					88.07%
Risk-free interest rate					1.86%
Expected warrant option life					6 years 3 months
Second Term Loan | Warrants
Debt Disclosure
Proceeds received at closing				$ 2,000,000
Warrants issued | shares				32,609
Exercise price of warrants (in dollars per share) | $ / shares				$ 3.68
Value of warrants (in dollars per share) | $ / shares				$ 2.71
Expected dividend yield				0.00%
Expected stock price volatility				87.04%
Risk-free interest rate				2.20%
Expected warrant option life				6 years 3 months
Maximum | Warrants
Debt Disclosure
Exercise price of warrants (in dollars per share) | $ / shares						$ 8.03
Maximum | Loan and Security Agreement with Silicon Valley Bank
Debt Disclosure
Proceeds from loan					$ 10,000,000
Minimum | Warrants
Debt Disclosure
Exercise price of warrants (in dollars per share) | $ / shares						$ 3.68
Minimum | Loan and Security Agreement with Silicon Valley Bank
Debt Disclosure
Net cash proceeds from the issuance and sale of equity securities		$ 20,000,000
Multiple required for cash and cash equivalents equal to or greater than monthly cash burn amount			8

Debt - Debt obligations and rel

Debt - Debt obligations and related interest rate (Details) $ in Thousands	Dec. 31, 2015USD ($)
Debt Disclosure
Total Debt	$ 8,000
Less Loan Discount	201
Current portion of long-term debt	3,858
Total Long Term Debt	$ 3,941
Loan Facility Tranche A
Debt Disclosure
Fixed interest rate	7.00%
Total Debt	$ 6,000
Loan Facility Tranche B
Debt Disclosure
Fixed interest rate	7.00%
Total Debt	$ 2,000

Shareholder's Equity (Details)

Shareholder's Equity (Details) - USD ($)	Mar. 21, 2014	Jun. 14, 2013	Dec. 31, 2015	Dec. 31, 2014	Dec. 31, 2013
Sales of common stocks
Proceeds, net of transaction costs			$ 7,055,000	$ 89,000	$ 57,566,000
Cowen
Sales of common stocks
Aggregate offering price of shares of common stock	$ 40,000,000
Percentage of commission the company pays from gross proceeds of any shares pursuant to the sales agreement	3.00%
Common stock sold (in shares)			1,256,380	23,120
Proceeds, net of transaction costs			$ 7,100,000	$ 100,000
Stock issuance cost			200,000	$ 32,000
Value of common stock available for future sale			$ 32,600,000
Series A junior participating preferred stock
Sales of common stocks
Par value of preferred stock that the holder of rights is entitled to purchase (in dollars per share)			$ 0.0001	$ 0.0001
Authorized shares			30,000	30,000
Rights Plan
Sales of common stocks
Term of plan		3 years
Minimum percentage of stock that may be required to be acquired by a person or group to cause substantial dilution		15.00%
Rights Plan | Series A junior participating preferred stock
Sales of common stocks
Number of shares of preferred stock that the holder is entitled against each right		0.001
Par value of preferred stock that the holder of rights is entitled to purchase (in dollars per share)		$ 0.0001
Purchase price (in dollars per share)		$ 35
Authorized shares		30,000
Dividend right declared per share of common stock (in shares)		1
Number of common stock for which their voting right is equivalent to voting right of 1/1,000th of a share of Series A Junior Participating Preferred Stock		1

Stock-Based Compensation - Comp

Stock-Based Compensation - Compensation Expense (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2015	Dec. 31, 2014	Dec. 31, 2013
Stock-based compensation
Compensation expense	$ 2,437	$ 3,085	$ 3,604
Selling, general and administrative expense.
Stock-based compensation
Compensation expense	1,612	2,241	2,722
Research and development expense.
Stock-based compensation
Compensation expense	$ 825	$ 844	$ 882

Stock-Based Compensation - Opti

Stock-Based Compensation - Options/RSU (Details) - USD ($)	12 Months Ended
	Dec. 31, 2015	Dec. 31, 2014	Dec. 31, 2013	Sep. 23, 2014
Additional disclosures
Number of shares of stock option outstanding redenominated to US$ exercise price				539,869
Minimum
Stock-based compensation
Vesting period	1 year
Maximum
Stock-based compensation
Vesting period	4 years
Stock Option
Options Outstanding
Outstanding at the beginning of the year (in shares)	2,170,493	1,886,579	1,113,244
Granted (in shares)	275,460	776,348	905,900
Exercised (in shares)	0	(16,580)
Forfeited/expired (in shares)	(452,879)	(475,854)	(132,565)
Outstanding at the end of the year (in shares)	1,993,074	2,170,493	1,886,579
Exercisable at the end of the year (in shares)	1,246,819	995,351	801,480
Weighted Average Exercise Price
Outstanding at the beginning of the year (in dollars per share)	$ 6.51	$ 8.80	$ 9.47
Granted (in dollars per share)	3.90	5.37	8.17
Exercised (in dollars per share)		5.88
Forfeited/expired (in dollars per share)	6.41	10.98	10.06
Outstanding at the end of the year (in dollars per share)	6.13	6.51	8.80
Exercisable at the end of the year (in dollars per share)	$ 6.72	$ 7.18	$ 8.95
Remaining Average Contractual Term
Outstanding at the end of the year	7 years 4 months 17 days
Exercisable at the end of the year	8 years 26 days
Aggregate Value
Total intrinsic value		$ 56,000
Total fair value, vested	$ 1,900,000	$ 1,800,000	$ 1,600,000
Additional disclosures
Weighted-average fair value of options granted (in dollars per share)	$ 2.62	$ 4.05	$ 5.54
Total unrecognized compensation costs related to non-vested stock option awards	$ 1,800,000
Unrecognized compensation costs related to non-vested stock option awards, recognition period	2 years 3 months 18 days
Weighted-average assumptions used in calculating the fair value of options granted
Expected dividend yield (as a percent)	0.00%	0.00%	0.00%
Risk-free interest rate (as a percent)	1.89%	2.12%	1.31%
Expected volatility (as a percent)	88.00%	91.00%	96.00%
Expected life	6 years 3 months	6 years 3 months	5 years 6 months
Restricted stock units
Restricted stock award activity
Nonvested beginning balance	156,535	84,128
Granted (in shares)	27,195	244,225	116,202
Vested (in shares)	(171,290)	(168,682)	(32,074)
Forfeited (in shares)	(1,100)	(3,136)
Nonvested ending balance	11,340	156,535	84,128
Restricted stock award activity weighted average grant price
Nonvested weighted average grant price beginning balance	$ 5.06	$ 11.32
Granted (in dollars per share)	4.29	5.07	$ 10.97
Vested (in dollar per share)	4.37	8.11	10.01
Forfeited (in dollars per share)	3.20	10.90	0
Nonvested weighted average grant price ending balance	$ 4.29	$ 5.06	$ 11.32
Award tendered (in shares)	65,858	70,161	9,779
Common stock awards
Restricted stock award activity
Vested (in shares)	0	0	(105,605)
Restricted stock award activity weighted average grant price
Granted (in dollars per share)			$ 11.32
Award tendered (in shares)			49,137

Stock-Based Compensation - Warr

Stock-Based Compensation - Warrants (Details)	12 Months Ended
	Dec. 31, 2015$ / sharesshares	Dec. 31, 2014AUD / sharesshares	Dec. 31, 2014USD ($)shares	Dec. 31, 2013shares
Exercise price of A$6.40
Warrants
Class of Warrant or Right Number of Securities Called by Exercised Warrants or Rights			2,798
Price of common stock per share in exercising warrants (in dollars per share) | AUD / shares		AUD 6.40
Total proceeds on exercise of warrants | $			$ 16,000
Number of shares of common stock purchased by exercising warrants in cashless exercise			15,000
Price of common stock per share in exercising warrants in cashless exercise (in dollars per share) | AUD / shares		AUD 6.40
Number of shares of common stock surrendered to fund cashless exercise			5,397
Warrants
Warrants
Warrants outstanding (in shares)	297,843	505,166		1,630,804
Warrants | Minimum
Warrants
Exercise price of warrants (in dollars per share) | $ / shares	$ 3.68
Period range, exercisable	2 months
Warrants | Maximum
Warrants
Exercise price of warrants (in dollars per share) | $ / shares	$ 8.03
Period range, exercisable	9 years 6 months

Income Taxes - Current_Non Curr

Income Taxes - Current/Non Current (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2015	Dec. 31, 2014	Dec. 31, 2013
Income Taxes
Domestic	$ (26,665)	$ (25,773)	$ (22,149)
Foreign	(42)	(63)	(822)
Loss before income taxes	(26,707)	(25,836)	(22,971)
Current:
United States and state			136
Foreign, net	124	249	1,077
Total income tax benefit	124	249	1,213
Income tax reconciliation
Statutory federal income tax benefit	9,066	8,784	7,810
State tax benefit, net of federal taxes	4		1,363
Foreign tax	3	23	(33)
R&D tax credit	135	265	1,213
Non deductible/nontaxable items	(186)	(283)	(367)
Other	(164)		(119)
Valuation allowance increase	(8,734)	(8,540)	(8,654)
Total income tax benefit	124	249	$ 1,213
Current:
Accrued leave	71	84
Other accrued expenses	163	97
Total current deferred tax asset	234	181
Noncurrent:
Stock based compensation	1,539	1,287
Net operating loss carryforward	44,462	37,248
Deferred rent	21	29
Other	52	54
R&D credits carryforward	531	531
Total noncurrent deferred tax assets	46,605	39,149
Total deferred tax assets	46,839	39,330
Noncurrent:
Fixed assets		(31)
Total deferred tax liabilities		(31)
Net deferred tax asset	46,839	39,299
Less: valuation allowance	$ (46,839)	$ (39,299)

Income Taxes - Carryforwards (D

Income Taxes - Carryforwards (Details) - Dec. 31, 2015 AUD in Millions, $ in Millions	AUD	USD ($)
United States
Operating loss carryforwards
Net operating loss (NOL) carryforwards | $		$ 94
Australian
Operating loss carryforwards
Net operating loss (NOL) carryforwards | AUD	AUD 49.1

Income Taxes - R&D Tax (Details

Income Taxes - R&D Tax (Details) - USD ($)	12 Months Ended
	Dec. 31, 2015	Dec. 31, 2014	Dec. 31, 2013
Income Taxes
Uncertain tax positions	$ 0	$ 0	$ 0
Interest and penalties related to uncertain tax positions accrued during the period	0	0	0
Tax credit carryforward
Income Tax Expense (Benefit)	(124,000)	(249,000)	(1,213,000)
Valuation Allowances and Reserves, Period Increase (Decrease)	7,500,000	5,100,000
Research and development tax credit | Australian subsidiary | Australian
Tax credit carryforward
Research and Development Tax Credit Received	$ 135,000	$ 265,000	$ 1,100,000

Income Taxes - Uncertain tax po

Income Taxes - Uncertain tax positions (Details) $ in Thousands, AUD in Millions	12 Months Ended
	Dec. 31, 2015USD ($)	Dec. 31, 2014USD ($)	Dec. 31, 2013USD ($)	Dec. 31, 2015AUD	Dec. 31, 2015USD ($)
Income Taxes
Uncertain tax positions		$ 0	$ 0		$ 0
Interest and penalties related to uncertain tax positions accrued during the period	$ 0	$ 0	$ 0
Australian
Operating loss carryforwards
Net operating loss (NOL) carryforwards | AUD				AUD 49.1

Commitments and Contingencies (

Commitments and Contingencies (Details) - USD ($)	12 Months Ended
	Dec. 31, 2015	Dec. 31, 2014	Dec. 31, 2013
Commitments and Contingencies.
Rent expense related to operating leases	$ 261,000	$ 179,000	$ 196,000
Future minimum lease payments
2,016	198,000
2,017	199,000
2,018	195,000
2,019	49,000
2,020	0
Employee Retirement Plan
Employer's matching contribution	$ 147,000	$ 146,000	$ 14,000

Segment and Geographic Inform38

Segment and Geographic Information (Details)	12 Months Ended
	Dec. 31, 2015item
Segment and Geographic Information
Number of reportable segments	1

Quarterly Financial Data (una39

Quarterly Financial Data (unaudited) (Deatails) - USD ($) $ / shares in Units, $ in Thousands	3 Months Ended												12 Months Ended
	Dec. 31, 2015	Sep. 30, 2015	Jun. 30, 2015	Mar. 31, 2015	Dec. 31, 2014	Sep. 30, 2014	Jun. 30, 2014	Mar. 31, 2014	Dec. 31, 2013	Sep. 30, 2013	Jun. 30, 2013	Mar. 31, 2013	Dec. 31, 2015	Dec. 31, 2014	Dec. 31, 2013
Quarterly Financial Data (unaudited)
Net sales				$ 59	$ 177	$ 59		$ 59		$ 59			$ 59	$ 295	$ 59
Operating Expenses	$ 6,354	$ 6,273	$ 6,331	7,051	6,833	6,169	$ 6,656	6,424	$ 6,995	6,233	$ 5,300	$ 4,402	26,017	26,082	22,930
Net Loss	$ (6,604)	$ (6,558)	$ (6,358)	$ (7,063)	$ (6,743)	$ (6,132)	$ (6,380)	$ (6,332)	$ (7,104)	$ (6,035)	$ (4,220)	$ (4,399)	$ (26,583)	$ (25,587)	$ (21,758)
Basic and Diluted Loss Per Share	$ (0.36)	$ (0.36)	$ (0.35)	$ (0.40)	$ (0.40)	$ (0.36)	$ (0.35)	$ (0.38)	$ (0.42)	$ (0.47)	$ (0.35)	$ (0.47)	$ (1.47)	$ (1.51)	$ (1.71)