RMED's Electrophysiology Division Submits Data for CE Mark on LockeT Expects to Receive CE Mark in Third Quarter, 2023
FORT MILL, SC / ACCESSWIRE / June 28, 2023 / Ra Medical Systems, Inc. (NYSE American:RMED) today announced that its Catheter Precision subsidiary has submitted to its European Notified Body the data necessary for determination of CE marking on its LockeT product. Recently the company concluded the final step of three-year shelf-life sterility testing which clears the pathway for achievement of the CE Mark.
"This is yet another milestone for us," commented David Jenkins, RMED's interim CEO. "We are excited about the opportunity for LockeT, not only in the US, but also internationally. We expect to receive the CE Mark on LockeT within the third quarter of this year, and with the CE Mark available, it opens the door for European countries and other countries as well. We believe the international market essentially doubles the market size above and beyond just the US market."
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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https://www.accesswire.com/764198/RMEDs-Electrophysiology-Division-Submits-Data-for-CE-Mark-on-LockeT-Expects-to-Receive-CE-Mark-in-Third-Quarter-2023
