Ra Medical Systems, Inc. (RMED) stock prices were up by 9.26% as of market close on May 7th 2021, bringing the price per share up to USD$4.13 at the end of the trading day.
DABRA Enrollment Progress
RMED recently announced an increase in enrolment for its pivotal clinical trial for DABRA, with a total of 42 subjects having been enrolled as of April 19th 2021. The trial is designed to evaluate the safety and efficacy of the DABRA laser system as an atherectomy device used in the treat of peripheral arterial disease (PAD).
DABRA Enrollment Status
The standing enrollment total is indicative of recent progress in the atherectomy trial, with 12 subjects having been updated since the previous trial update in March 2021. A running total of 5 clinical sites have thus far been cleared for enrollment in the study, while two additional sites are currently in varying stages of the qualification process.
501(k) FDA Clearance for DABRA
The U.S Drug and Food Administration granted 510(k) clearance to the DABRA excimer laser system in May 2017 for crossing chronic total occlusions (CTOs). The treatment is designed for the ablating of a channel in occlusive peripheral vascular disease in patients with symptomatic infrainguinallower extremity vascular disease.
U.S Market Value
Atherectomy, as defined by the U.S. FDA, includes a prespecified improvement to luminal patency. Third party research estimates have pegged the combined value of CTO and atherectomy markets in the U.S. alone to be roughly USD$900 million in 2021. Of this total, atherectomy represents a market of more than USD$750 million, as per the research estimates.
Atherectomy Trial Details
The open-label pivotal atherectomy clinical trial has an enrollment capacity of 100 subjects who exhibit symptoms of PAD, across a network of 10 enrollment sites. Among the outcome measures, safety, acute technical success and clinical success are primary objectives. The trial’s primary efficacy endpoint is the average decrease in percent diameter stenosis in each patient’s primary lesion. This is measured by angiograph immediately after treatment with DEBRA. The safety and clinical success endpoints for the trial are major adverse events at 30 days post-procedure and incidence of primary target lesion revascularization at 6 months post-procedure.
Future Outlook for RMED
With RMED’s progress in the atherectomy pivotal clinical trial, their proprietary DABRA treatment is on track towards commercialization. Such a significant addition to the company’s product portfolio is likely to usher in substantial and significant increases in shareholder value once it hits the market.