Annual report pursuant to Section 13 and 15(d)

Going Concern

Going Concern
12 Months Ended
Dec. 31, 2019
Organization, Consolidation and Presentation of Financial Statements [Abstract]  
Going Concern

Note 2 – Going Concern


To date, the Company has generated minimal revenues, experienced negative operating cash flows and has incurred substantial operating losses from its activities. The Company expects operating costs will increase significantly as it incurs costs associated with commercialization activities related to the Pure-Vu System. Management expects the Company to continue to fund its operations primarily through utilization of its current financial resources, future product sales, and through the issuance of debt or equity.


The Company has financed its operations primarily through sales of equity-related securities. On December 13, 2019, the Company entered into a loan agreement for $8,000 (see Note 6). At December 31, 2019, the Company had an accumulated deficit of $84,464, total current assets of $30,167 and total current liabilities of $3,590 resulting in working capital of $26,577. For the years ended December 31, 2019 and 2018, the Company incurred a net loss of $23,086 and $22,257, respectively. At December 31, 2019, the Company had cash and cash equivalents, and investments of $28,731. Under the terms of the loan agreement, the Company must maintain unrestricted cash in accounts with Silicon Valley Bank of at least $10,000 (the "Liquidity Covenant"). The Company will need to raise additional capital or generate substantial revenue in order to ensure compliance with the Liquidity Covenant to support its development and commercialization efforts. If adequate funds are not available to the Company on a timely basis, or at all, it may breach the Liquidity Covenant, in which case, the Company would be required to immediately pledge to the bank and thereafter maintain in a separate account, unrestricted and unencumbered cash in an amount equal to the amount then outstanding under the loan agreement.


The Company's ability to continue as a going concern for the next twelve months from the issuance of the Company's Annual Report on Form 10K, depends on its ability to execute its business plan, increase revenue and reduce expenditures. Subsequent to year end, the Company adopted a cost reduction plan (the "2020 Plan") to better align the Company's cost structure with the resources required to more efficiently and effectively execute on its commercial strategy of creating a strong foundation in the market by establishing national and regional hospitals networks as Pure Vu reference centers. Most significantly, the 2020 Plan will result in the reduction of the Company's overall headcount by approximately 50%, including a material reduction of the Company's commercial team, the implementation of tighter expense controls, and the termination of the lease of the Company's planned corporate office facility in Norwood, Massachusetts. The 2020 Plan will be largely implemented in the second quarter of 2020.  Based on the Company's current business plan and pursuant to the implementation of its 2020 Plan, it believes the cash, cash equivalents and short-term investments balance as of December 31, 2019, will be sufficient to ensure compliance with the Liquidity Covenant into late fourth quarter of 2020, and meet its anticipated cash requirements into 2021. Such conditions raise substantial doubts about the Company's ability to continue as a going concern.


Management's plan, inclusive of the 2020 Plan, includes revenue generation through the sale of products, raising funds from outside investors and the successful implementation of cost cutting measures. However, there is no assurance that such sale of products will occur or that outside funding will be available to the Company, will be obtained on favorable terms or will provide the Company with sufficient capital to meet its objectives. These consolidated financial statements do not include any adjustments relating to the recoverability and classification of assets, carrying amounts or the amount and classification of liabilities that may be required should the Company be unable to continue as a going concern.