Ra Medical Systems Provides Update on its Annual Filings

Rhea-AI Summary

Ra Medical Systems (NYSE American: RMED) disclosed that its audited financial statements for the fiscal year ending December 31, 2021, included an audit report with a 'going concern' emphasis. This follows filings with the SEC on March 24, 2022, and an amended 10-K/A on July 7, 2022. No changes were made to previous filings. Ra Medical is known for its DABRA excimer laser and catheters used in vascular disease treatment, having received FDA and CE mark approvals for various applications. This information is mandated under NYSE American Company Guide Section 610(b).

Positive

• DABRA excimer laser and catheters are FDA approved for treating vascular diseases.
• The Company holds a CE mark for endovascular treatment of infrainguinal arteries.

Negative

• The audit report included a 'going concern' emphasis, indicating potential financial instability.

CARLSBAD, Calif.--(BUSINESS WIRE)-- Ra Medical Systems, Inc. (NYSE American: RMED) (“Ra Medical” or the “Company) announces that its audited consolidated financial statements for the fiscal year ended December 31, 2021 included in the Company’s Form 10-K filed with the Securities and Exchange Commission (SEC) on March 24, 2022 and Amended Form 10-K/A filed with the SEC on July 7, 2022 contained an audit report from its independent registered public accounting firm which included a going concern emphasis of matter paragraph. Release of this information is required by Section 610(b) of the NYSE American Company Guide. It does not represent any change or amendment to any of the Company’s filings for the fiscal year ended December 31, 2021.

About Ra Medical Systems

Ra Medical Systems manufactures the DABRA excimer laser and catheters for the treatment of certain vascular diseases. DABRA has been cleared by the FDA for crossing chronic total occlusions in patients with symptomatic infrainguinal lower extremity vascular disease and has an intended use for ablating a channel in occlusive peripheral vascular disease. In addition, DABRA has been granted CE mark clearance for the endovascular treatment of infrainguinal arteries via atherectomy and for crossing total occlusions.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements generally relate to future events or Ra Medical’s future financial or operating performance. In some cases, you can identify forward-looking statements because they contain words such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “could,” “intends,” “target,” “projects,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of these words or other similar terms or expressions that concern Ra Medical’s future expectations, strategy, plans or intentions.. Ra Medical’s expectations and beliefs regarding these matters may not materialize, and actual results in future periods are subject to risks and uncertainties that could cause actual results to differ materially from those projected or implied by such forward-looking statements. The potential risks and uncertainties which contribute to the uncertain nature of these statements include, among others, the other risks and uncertainties described in Ra Medical’s news releases and filings with the Securities and Exchange Commission. Information on these and additional risks, uncertainties, and other information affecting Ra Medical’s business and operating results is contained in Ra Medical’s Annual Report on Form 10-K for the year ended December 31, 2021 filed with the Securities and Exchange Commission on March 24, 2022, Ra Medical’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2022 filed with the Securities and Exchange Commission on May 16, 2022 and in its other filings with the Securities and Exchange Commission. The forward-looking statements in this press release are based on information available to Ra Medical as of the date hereof, and Ra Medical disclaims any obligation to update any forward-looking statements, except as required by law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220801005275/en/

Investor Relations Contact:

LHA Investor Relations

Jody Cain

310-691-7100

jcain@lhai.com

Source: Ra Medical Systems, Inc.

FAQ

What does the 'going concern' emphasis in RMED's audit report mean?

The 'going concern' emphasis indicates concerns regarding Ra Medical's ability to continue operations in the near future without financial support.

When did Ra Medical Systems file its audited financial statements?

Ra Medical filed its audited financial statements with the SEC on March 24, 2022, and an amended version on July 7, 2022.

What products does Ra Medical manufacture?

Ra Medical manufactures the DABRA excimer laser and catheters for the treatment of certain vascular diseases.

What regulatory approvals has the DABRA laser received?

The DABRA excimer laser has received FDA clearance and CE mark approval for various vascular treatments.

How does the 'going concern' opinion affect RMED's stock?

The 'going concern' opinion could lead to investor concerns regarding Ra Medical's financial health, potentially impacting RMED's stock performance.