FDA Approves Ra Medical’s Atherectomy Clinical Study

Ra Medical Systems Inc., a medical device company focused on commercializing excimer laser systems to treat vascular and dermatological diseases, announces approval from the U.S. Food and Drug Administration (FDA) that the company has provided sufficient data to support initiating an investigational device exemption (IDE) to evaluate the safety and effectiveness of the DABRA excimer laser system for use as an atherectomy device for the treatment of peripheral vascular stenoses. In May 2017, DABRA received FDA 510(k) clearance for use in ablating a channel in occlusive peripheral vascular disease (PAD).
 
“We are delighted the FDA has granted this IDE allowing us to pursue an atherectomy indication for DABRA and anticipate enrolling the first patient into the trial in the next few months,” said Andrew Jackson, Ra Medical Systems chief financial officer and Interim CEO. “We believe DABRA produces minimal vascular trauma due to its unique use of photochemical ablation that dissolves plaque into its molecular components, which may make DABRA a preferred treatment. Atherectomy with mechanical devices can cause trauma to vessel walls, often resulting in restenosis or a return of the blockage months following the procedure.”
 
The multicenter, open-label trial will enroll up to 100 patients with symptoms of PAD (Rutherford Class 2-4). Outcome measures include safety, acute technical success and clinical success. The trial’s primary efficacy endpoint is the mean reduction in percent diameter stenosis in each patient’s primary lesion as measured by angiography immediately following treatment with DABRA, before any adjunctive treatment. Major adverse events at 30 days and incidence of primary target lesion revascularization (TLR) at six months will be the safety and clinical success endpoints.
 
DABRA is Ra Medical’s minimally invasive excimer laser system used by physicians as a tool in the endovascular treatment of vascular blockages resulting from lower extremity vascular disease, a form of PAD, both above and below the knee. DABRA reduces all four plaque types into their fundamental chemistry, such as proteins, lipids and other chemical compounds, eliminating blockages by essentially dissolving them without generating potentially harmful particulates. DABRA employs photochemical ablation, or the removal of arterial tissue by using photons to clear blockages by breaking the bonds of the obstructing plaque. Unlike many treatments for PAD that may damage the arterial wall, DABRA quickly and photochemically dissolves plaque with minimal vascular trauma.
 
The approval follows the appointment of Chris Folk, Ph.D., as vice president of Engineering. With more than 20 years of engineering experience primarily in medtech, Dr. Folk has led the design, development and engineering of novel medical devices with highly specific design requirements, leading to commercial success. In this newly created position, Dr. Folk will report to Jackson.
 
Folk served for the past four years at ViaCyte, a privately held regenerative medicine company, most recently as Engineering and Device Manufacturing Director. He was responsible for product development including the redesign of its lead product candidate PEC-Direct, a novel biologic-device replacement therapy for type 1 diabetes. Prior to ViaCyte, Dr. Folk spent three years as Device Strategy Principal Engineer at Amgen, where he evaluated and determined unmet drug delivery needs across the company’s entire portfolio and led internal device R&D programs to enable new routes and methods of drug delivery. Before that, Dr. Folk served for three years as Research & Development Manager for Covidien Neurovascular (formerly ev3) with responsibility for overseeing cross-functional teams that successfully launched three FDA 510(k)-cleared catheters to treat ischemic stroke and aneurysms. During his tenure, he managed the R&D team that created the first hypotube-based catheter for neurovascular access, allowing unprecedented torque and transmission of force.