GOING CONCERN AND OTHER UNCERTAINTIES |
9 Months Ended |
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Sep. 30, 2024 | |
| Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
| GOING CONCERN AND OTHER UNCERTAINTIES | GOING CONCERN AND OTHER UNCERTAINTIES The Company is subject to a number of risks similar to those of early stage medical device companies, including dependence on key individuals and products, the inherent uncertainties with regulatory approvals, the difficulties inherent in the development of a commercial market, the potential need to obtain additional capital, competition from larger companies, other technology companies and other technologies.
The Company has incurred losses each year since inception and has experienced negative cash flows from operations in each year since inception. As of September 30, 2024 the Company has a cash and cash equivalents balance of approximately $5.8 million. Based on its current business plan assumptions and expected cash burn rate, the Company believes that the existing cash is insufficient to fund operations for the next twelve months following the issuance of these financial statements. These factors raise substantial doubt regarding the Company’s ability to continue as a going concern.
Therefore, the Company’s continued operations will depend on its ability to raise additional capital through various potential sources, such as equity and/or debt financings, strategic relationships until sufficient revenue can be generated to achieve positive cash flow from operations. The Company expects no material commercial revenue in 2024.
The Company continues to maintain strong financial discipline as it achieves critical R&D, clinical and regulatory milestones in advance of commercialization. Management believes the continued achievement of these milestones will provide the Company the ability to raise additional capital. Management can provide no assurance that such financing or strategic relationships will be available on acceptable terms, or at all, which would likely have a material adverse effect on the Company and its financial statements.
On May 2, 2024, the Company entered into a Sales Agreement (“PV Sales Agreement”) with Public Ventures, LLC, as sales agent (“Public Ventures”), pursuant to which the Company may sell up to an aggregate of approximately $17 million of shares of the Company’s common stock. There were 50,000 shares issued under the At The Market (“ATM”) during the nine months ended September 30, 2024. As of September 30, 2024, there was approximately $16.9 million available for issuance under the ATM. The accompanying unaudited condensed financial statements do not include any adjustments relating to the recoverability and classification of asset carrying amounts or the amount and classification of liabilities that may result should the Company be unable to continue as a going concern.
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