RA MEDICAL SYSTEMS, INC. Ra Medical System’s Electrophysiology Division Has Increased Demand for its Non-invasive Mapping System

Directive transparence : information réglementée

24/07/2023 14:00

New Hospitals Approve Use of VIVO and Existing Customers Increase Utilization

FORT MILL, SC / ACCESSWIRE / July 24, 2023 / Ra Medical Systems, Inc. (NYSE/American:RMED) announced today that there is an increase in clinical adoption by hospitals for its VIVO system. The three-dimensional non-invasive mapping system is one of the product lines within the company's electrophysiology division, Catheter Precision, LLC. As previously announced, Catheter Precision recently expanded its sales and clinical support team in the United States as part of its full product launch in Q2 2023.

Included in the evaluations over the next few weeks are a number of hospitals including Staten Island University Hospital, Wellspan Hospital in York, PA, Our Lady of the Lake Hospital in Baton Rouge, LA, Valley Hospital in Ridgewood, NJ, and Cleveland Clinic Akron, as well as Cleveland Clinic, main campus in Cleveland, Ohio.

"In Q1 2023, we hired and trained new sales and clinical support employees in strategic locations across the US," said Patricia Kennedy, Chief Commercial Officer at Catheter Precision. "During Q2, we implemented our strategy of introducing and educating physicians and hospital staff about the benefits of using VIVO. Several notable accounts are currently reviewing VIVO, and we anticipate approvals in the coming months along with KOL support. Hospitals are increasingly leveraging technology to reduce costs, save time, and improve patient outcomes while simultaneously increasing margins and revenues."

"Clinical adoption and utilization are a critical part of our growth strategy," said David Jenkins, Interim CEO. "Not every product is approved for evaluation, and receiving approval means that the physicians and hospital staff see value in a product and the evaluation provides us the opportunity to demonstrate these values. Customers are recognizing the values and increasing their utilization of VIVO as evidenced by the increased orders in the consumable accessories."

About VIVO

Catheter Precision's VIVO™ (View Into Ventricular Onset), is a non-invasive 3D imaging system that enables physicians to identify the origin of ventricular arrhythmias pre-procedure, thereby streamlining workflow and reducing procedure time. VIVO has received marketing clearance from the U.S. FDA and has the CE mark.

About Ra Medical Systems

Ra Medical, and its wholly owned subsidiary Catheter Precision, is an innovative U.S.-based medical device company bringing new solutions to market to improve the treatment of cardiac arrhythmias.

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This communication contains forward-looking statements. Forward-looking statements can be identified by words such as "believe," "anticipate," "may," "might," "can," "could," "continue," "depends," "expect," "expand," "forecast," "intend," "predict," "plan," "rely," "should," "will," "may," "seek," or the negative of these terms and other similar expressions, although not all forward-looking statements contain these words. These forward-looking statements include, but are not limited to, our anticipated revenues during the second half of 2023, and the anticipated accounting for the merger with Catheter Precision. These forward-looking statements are subject to the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. The Company's expectations and beliefs regarding these matters may not materialize. Actual outcomes and results may differ materially from those contemplated by these forward-looking statements as a result of uncertainties, risks and changes in circumstances, including but not limited to risks and uncertainties included under the caption "Risk Factors" in the Company's Form 10-K filed with the SEC and available at www.sec.gov. These risks and uncertainties include, but aren't limited to, that we will not be able to reach profitability unless we are able to achieve our product expansion and growth goals, our research and development and commercialization efforts may depend on entering into agreements with corporate collaborators, we have entered into joint marketing agreements with respect to our products, and may enter into additional joint marketing agreements, that will reduce our revenues from product sales, royalty agreements with respect to our LockeT device will reduce any future profits from this product, if we experience significant disruptions in our information technology systems, our business may be adversely affected, litigation and other legal proceedings may adversely affect our business, if we make acquisitions or divestitures, we could encounter difficulties that harm our business, failure to attract and retain sufficient qualified personnel could also impede our growth, failure to maintain effective internal controls could cause our investors to lose confidence in us and adversely affect the market price of our common stock, if our internal controls are not effective, we may not be able to accurately report our financial results or prevent fraud, our revenues may depend on our customers' receipt of adequate reimbursement from private insurers and government sponsored healthcare programs, we may be unable to compete successfully with companies in our highly competitive industry, many of whom have substantially greater resources than we do, our future operating results depend upon our ability to obtain components in sufficient quantities on commercially reasonable terms or according to schedules, prices, quality and volumes that are acceptable to us, and suppliers may fail to deliver components, or we may be unable to manage these components effectively or obtain these components on such terms, if hospitals, physicians and patients do not accept our current and future products or if the market for indications for which any product candidate is approved is smaller than expected, we may be unable to generate significant revenue, if any, our medical device operations are subject to pervasive and continuing FDA regulatory requirements, our products may be subject to additional recalls, revocations or suspensions after receiving FDA or foreign approval or clearance, which could divert managerial and financial resources, harm our reputation, and adversely affect our business, changes in trade policies among the U.S. and other countries, in particular the imposition of new or higher tariffs, could place pressure on our average selling prices as our customers seek to offset the impact of increased tariffs on their own products, increased tariffs or the imposition of other barriers to international trade could have a material adverse effect on our revenues and operating results. In addition, our auditor's finalization of the accounting for the merger requires complex calculations and the input of outside advisors, and as a result, the final results of these calculations could differ from our current expectations. The risks and uncertainties described above may be amplified by the COVID-19 pandemic, which has caused significant economic uncertainty, or other pandemics, supply chain disruptions from the Ukraine war and otherwise, and ongoing volatility in the stock markets and the U.S. economy in general.

The forward-looking statements included in this communication are made only as of the date hereof. The Company assumes no obligation and does not intend to update these forward-looking statements, except as required by law.


At the Company

David Jenkins

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SOURCE: Ra Medical Systems, Inc.

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