Ra Medical Systems’ DABRA 2.0 Catheter Cleared by FDA as Company Explores Strategic Alternatives

July 5, 2022—Ra Medical Systems, Inc., which is focused on developing its excimer laser system to treat vascular diseases, announced FDA 510(k) clearance for the company’s DABRA 2.0 catheter as part of the DABRA excimer laser system. The next-generation DABRA catheter’s enhancements include a braided overjacket design intended to improve deliverability and kink resistance when navigating tortuous anatomy, as well as a 6-month shelf life.

In the press release, the company advised that on May 16, 2022, it disclosed that its Board of Directors is reviewing strategic alternatives with the goal of maximizing shareholder value.

On June 6, in conjunction with this review, the company filed a report on Form 8-K with the US Securities and Exchange Commission announcing the initiation of a reduction in force under which approximately 65% of the company’s full-time employees were terminated.

Nonterminated 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.

Will McGuire, CEO of Ra Medical Systems, commented in the company’s press release, “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.

“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.”