Ra Medical Systems DABRA Pivotal Atherectomy Clinical Trial Continues With Expanded Enrollment

February 18, 2022—Ra Medical Systems, Inc. announced an update of enrollment in its pivotal clinical trial to evaluate the safety and effectiveness of the company’s DABRA excimer laser system as an atherectomy device for the treatment of peripheral artery disease (PAD).

Patient enrollment has reached 95 patients. Additionally, the company advised that the FDA has approved an increase of enrollment from 100 to 125 patients.

According to the company, DABRA has been cleared by the FDA for crossing chronic total occlusions in patients with symptomatic infrainguinal lower extremity vascular disease and has an intended use for ablating a channel in occlusive peripheral vascular disease. The FDA defines atherectomy to include a prespecified improvement in luminal patency.

Ra Medical Systems advised that the open-label pivotal atherectomy clinical trial can enroll patients with symptoms of PAD (Rutherford class 2-5) at up to 10 sites.

The trial’s outcome measures include safety, acute technical success, and clinical success. The primary efficacy endpoint is the mean reduction in percent diameter stenosis in each patient’s primary lesion, as measured by angiography immediately after treatment with DABRA and before any adjunctive treatment. The trial’s safety and clinical success endpoints are major adverse events at 30 days postprocedure and incidence of primary target lesion revascularization at 6 months, stated Ra Medical Systems.

Will McGuire, CEO of Ra Medical Systems, stated in the company press release, “Our request to increase subject enrollment in the atherectomy trial was primarily due to subject fallout for follow-up visits during the ongoing COVID-19 pandemic. To this end, we are pleased the FDA has approved our protocol amendment.”

Mr. McGuire continued, “We are excited about the opening of two additional clinical sites in late 2021, both with lead investigators who are highly regarded interventional cardiologists, which brings the number of sites qualified for this trial to seven. We expect one additional site, also led by an interventional cardiologist thought leader, to be qualified in the near term. The opening of these new sites is encouraging, yet due to the pandemic, we are unable to provide a precise timeline for full enrollment.”

In conclusion, Mr. McGuire noted, “There is no question that obtaining FDA clearance for an atherectomy indication for the DABRA excimer laser system is among our top priorities. We significantly expand our addressable market with this clearance. A third-party research group estimates the value of the combined CTO and atherectomy markets in the United States at approximately $900 million for 2022, with atherectomy representing more than $700 million.”

In other company news, Ra Medical Systems announced on February 4 the pricing of an underwritten public offering of units for gross proceeds of approximately $12.0 million before deducting underwriting discounts and commissions and offering expenses.

The offering is comprised of (1) 9,535,000 units, priced at a public offering price of $0.50 per unit, with each unit consisting of one share of common stock, one warrant to purchase one share of common stock at an exercise price of $0.50 per share that expires on the first anniversary of the date of issuance (a “Series A Warrant”), and one warrant to purchase one share of common stock at an exercise price of $0.50 per share that expires on the seventh anniversary of the date of issuance (a “Series B Warrant”); and (2) 14,467,893 prefunded units, priced at a public offering price of $0.4999 per unit, with each unit consisting of one prefunded warrant to purchase one share of common stock at an exercise price of $0.0001 per share that expires on the twentieth anniversary of the date of issuance, one Series A Warrant, and one Series B Warrant.

The closing of the offering was expected to take place on or about February 8, 2022, subject to the satisfaction or waiver of customary closing conditions.