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RA MEDICAL SYSTEMS, INC. RMED’s Electrophysiology Division Expands International Distribution

Directive transparence : information réglementée

03/07/2023 14:00

Prepares for the CE Mark and International Launch of LockeT in Third Quarter 2023

FORT MILL, SC / ACCESSWIRE / July 3, 2023 / Ra Medical Systems, Inc. (NYSE American:RMED) has announced that it has undertaken a strong effort to expand its distribution outside of the US. Last week RMED announced it has filed for the CE Mark on LockeT, its new device to assist in closure of percutaneous puncture sites. The effort to expand international distribution reflects the anticipated timing of the receipt of the LockeT CE Mark, which is expected during this third quarter. Most recently, the company entered into a distribution agreement with Medilynq for distribution of RMED's products in certain countries in the Middle East, including Saudi Arabia, Jordon, Oman, UAE, Qatar, and Kuwait. In conjunction with the kickoff of this area, Medilynq placed its first order for a VIVO system. Additionally, the company is working with Bioline, a new distributor in Spain, and recently attended a symposium/trade show in Spain exhibiting the company's products.

Following the Heart Rhythm Society symposium and trade show in May, on top of the EHRA meeting in April, RMED identified several international distributors who had an interest in its products. RMED also engaged the expertise of a consulting marketing company, to assist in identifying and managing distributors in areas of the world where it is currently not exposed such as parts of Asia, South America, Africa, and other European countries. To date, RMED is now in the process of working toward agreements in Mexico, Peru, Chile, and Brazil. In addition, discussions are advancing in Australia, Hong Kong, Thailand, and Malaysia.

Patricia Kennedy, Chief Commercial Officer of RMED's electrophysiology division, commented, "We are excited about all the components coming together for distribution in the various markets around the globe. Often it takes many years to put together the international distribution, but with the experienced team with which we are working, we are pushing forward quite rapidly. We are looking forward to the continued introduction of VIVO to new markets and excited about the opportunity with LockeT, in all the different market areas of electrophysiology, vascular surgery, and structural heart. We just introduced the Locket during the second quarter in the US, and already have several hospitals requesting to trial the product."

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

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. It is focused on developing groundbreaking technology for electrophysiology procedures by collaborating with physicians and continuously advancing its products.

Cautionary Note Regarding Forward-Looking Statements

This press release contains "forward-looking statements" which include, but are not limited to, the plans and expectations of the combined company regarding its search for a new, full-time chief executive. 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 challenges in the executive job market, and market and regulatory risks. Additional risks and uncertainties that could cause actual outcomes and results to differ materially from those contemplated by the forward-looking statements are included under the caption "Risk Factors" and elsewhere in the Company's Annual Report on Form 10-K filed on March 28, 2023. This document can be accessed on the Company's Investor Relations page at https://ir.ramed.com/ by clicking on the link titled "SEC Filings".

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.

CONTACTS:

At the Company
David Jenkins
973-691-2000
mhuck@catheterprecision.com

SOURCE: Ra Medical Systems, Inc.



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