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Ra Medical Systems Receives FDA 510(k) Clearance for the DABRA 2.0 Catheter

Wednesday, July 06, 2022

Ra Medical Systems, Inc., a medical device company focusing on developing its excimer laser system to treat vascular diseases, announces receipt of U.S. Food and Drug Administration 510(k) clearance for the Company’s DABRA 2.0 catheter as part of the DABRA Excimer Laser System. This next-generation DABRA catheter features enhancements including a braided overjacket design that’s intended to improve deliverability and kink resistance when navigating tortuous anatomy, as well as a six-month shelf life.

“While we are pleased to receive this regulatory clearance, it comes as our Board continues its evaluation of strategic alternatives to optimize our Company’s path forward in the current challenging economic environment,” said Will McGuire, Ra Medical Systems CEO. “As we have previously announced, the DABRA 2.0 catheter represents an interim step in our work to develop a guidewire-compatible version of the DABRA catheter, and at this time we have no plans to commercialize the DABRA 2.0.”

On May 16, 2022 Ra Medical Systems disclosed that its Board of Directors is reviewing strategic alternatives with the goal of maximizing shareholder value. In conjunction with this review, on June 6, 2022 the Company filed a report on Form 8-K with the Securities and Exchange Commission (SEC) announcing initiation of a reduction in force under which approximately 65% of the Company’s full-time employees were terminated. Non-terminated employees were offered conditional retention arrangements for a period of approximately 60 days from the date of the filing to allow for evaluation and monitoring of the Company’s near-term personnel needs based in part on the Company’s financial status and the Board’s review of strategic alternatives. The purpose of the reduction in force is to preserve capital with the goal of maximizing the opportunities available to the Company during the Board’s review of strategic alternatives.

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