Quarterly report pursuant to Section 13 or 15(d)

LIQUIDITY, GOING CONCERN AND OTHER UNCERTAINTIES

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LIQUIDITY, GOING CONCERN AND OTHER UNCERTAINTIES
9 Months Ended
Sep. 30, 2022
Commitments and Contingencies Disclosure [Abstract]  
LIQUIDITY, GOING CONCERN AND OTHER UNCERTAINTIES LIQUIDITY, GOING CONCERN AND OTHER UNCERTAINTIES
The Company is subject to a number of risks similar to those of early stage companies, including dependence on key individuals and products, 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, 2022 and December 31, 2021, the Company had an accumulated deficit of approximately $18,474,000 and $9,224,000, respectively. Based on current business plan assumptions and the 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 condensed unaudited financial statements. These factors raise substantial doubt regarding the Company’s ability to continue as a going concern.

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 and revenue. Revenue is expected following FDA clearance of the Company’s initial two products. 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.

The condensed unaudited 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.
On January 30, 2020, the World Health Organization (“WHO”) announced a global health emergency, a result of coronavirus (“COVID-19 outbreak”) and the risks to the international community. In March 2020, the WHO classified the COVID-19 outbreak as a pandemic, based on the rapid increase in exposure globally. Developments such as social distancing and shelter-in-place directives were effected impacting the Company’s operations. While the restrictions have eased, the risk continues as new variants are being discovered, and although certain changes in telehealth benefits may be favorable to the Company, these disruptions may negatively impact the Company’s results of operations and liquidity beyond 2022