RA MEDICAL SYSTEMS, INC. Ra Medical Systems Announces Milestone Achievement for Electrophysiology Division

Directive transparence : information réglementée

07/08/2023 14:00

Catheter Precision's VIVO System Has Been Utilized in over 1,000 Procedures

FORT MILL, SC / ACCESSWIRE / August 7, 2023 / Ra Medical Systems, Inc. (NYSE American:RMED) announced today that VIVO, the lead product for the electrophysiology division, has been used in more than 1000 ventricular ablation procedures. VIVO, which stands for View Into Ventricular Onset, enables physicians to learn more about patient specific anatomy and better help them plan the ablation procedure. As a result, VIVO aids in reducing overall procedure time benefitting physicians, hospitals and patients.

"I made a conscious decision to support a pre-commercial roll out with my own capital. I've invested well over $25mm at an average price of $3.20 in an effort to de-risk this opportunity. The one thousand procedure milestone is a major accomplishment for us as well as a confirmation of the need for VIVO in the EP Lab workflow," said David Jenkins, Interim CEO of Ra Medical Systems.

This past week cases were completed at Wellspan Hospital (York, Pennsylvania), Deborah Heart and Lung (Ridgewood, NJ), Penn Presbyterian (Philadelphia, PA), Overland Park Regional Medical Center (Overland Park, KS), Sutter Health (Sacramento, CA) and Heart Hospital of New Mexico (Albuquerque, NM) displaying a broad range of locations and stages of clinical adoption from first cases in an evaluation, first cases after recent purchase and long-time users over several years.

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 LockeT

Catheter Precision's LockeT is a suture retention device intended to assist in hemostasis after percutaneous venous punctures. LockeT is a Class 1 device registered with the FDA.

About Ra Medical Systems and Catheter Precision

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.

RMED previously announce that it will change it name to Catheter Precision, Inc. as of August 17, 2023. The trading symbol will change from RMED to VTAK effective as of the beginning of trading on August 18. VTAK is an anachronym for Ventricular Tachycardia, a fast heat beat of the ventricle, a disease that we assist in treating with our VIVO system.

Cautionary Note Regarding Forward-Looking Statements

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.

Forward Looking Statements


At the Company
David Jenkins

SOURCE: Ra Medical Systems, Inc.

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