Failure to Satisfy Listing Rule Form 8 K

On November 7, 2024, the Company received a letter (the "Nasdaq Staff Deficiency Letter") from The Nasdaq Stock Market LLC ("Nasdaq") indicating that the Company's market value of its listed securities has been below the minimum $35,000,000 required for continued listing on the Nasdaq Capital Market, as set forth in Listing Rule 5550(b)(2) for the previous 30 consecutive trading days.

In accordance with the terms of the previously imposed "Mandatory Panel Monitor" as that term is defined in Nasdaq Listing Rule 5815(d)(4)(B), the Nasdaq Listing Qualifications Staff (the "Staff") did not grant the Company a grace period but rather issued a delist determination, which will be stayed if the Company exercises its right to appeal the Staff's determination, pursuant to the procedures set forth in the Nasdaq Listing Rule 5800 Series, by requesting a hearing and paying a non-refundable$20,000 fee.

The Company plans to timely file a request for a new hearing before the Nasdaq Hearings Panel (the "Panel"), which request will stay any further action by Nasdaq at least pending the issuance of the Panel's decision and the expiration of any extension that may be granted by the Panel to the Company as a result of the hearing.

The Company's common stock will remain listed and eligible to trade on Nasdaq pending the outcome of the hearing. There can be no assurance, however, that the Panel will grant the Company's request for continued listing or that the Company will evidence compliance with all applicable listing criteria prior to the expiration of any extension that may be granted by the Panel to do so.

Forward-Looking Statements

This Current Report on Form 8-Kcontains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this Current Report on Form 8-Kthat do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding the Company's ability to remain listed and eligible to trade on Nasdaq, as well as statements that include the words "expect," "intend," "plan", "believe", "project", "forecast", "estimate," "may," "should," "anticipate" and similar statements of a future or forward looking nature. These forward-looking statements are based on management's current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, (i) any inability to (a) realize anticipated benefits from commitments, contracts or products; (b) successfully execute strategic priorities; (c) bring products to market; (d) expand product usage or adoption; (e) obtain customer testimonials; (f) accurately predict growth assumptions; (g) realize anticipated revenues; (h) incur expected levels of operating expenses; or (ii) increase the number of high-risk patients at customer facilities; (iii) failure of early data to predict eventual outcomes; (iv) failure to make or obtain anticipated FDA filings or clearances within expected time frames or at all; or (iv) the factors discussed under Item 1A. "Risk Factors" in the company's Annual Report on Form 10-Kfor the year ended December 31, 2023, filed with the Commission on April 1, 2024 and other filings the company makes with Commission from time to time. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this Current Report on Form 8-K.While the Company may elect to update such forward-looking statements at some point in the future, unless required by law, it disclaims any obligation to do so, even if subsequent events cause its views to change. Thus, no one should assume that the Company's silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date of this Current Report on Form 8-K.