CARLSBAD, Calif.--(BUSINESS WIRE)--Ra Medical Systems, Inc. (NYSE American: RMED), a medical device company focused on developing its excimer laser system to treat vascular diseases, announces enrollment has reached 95 subjects in its pivotal clinical trial to evaluate the safety and effectiveness of the DABRA excimer laser system as an atherectomy device for the treatment of peripheral arterial disease (PAD). The company also announces approval from the U.S. Food and Drug Administration (FDA) to increase subject enrollment from 100 subjects to 125 subjects.
“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,” said Will McGuire, Ra Medical Systems CEO. “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.”
“There is no question that obtaining FDA clearance for an atherectomy indication for the DABRA excimer laser system is among our top priorities,” he added. “We significantly expand our addressable market with this clearance. A third-party research group estimates the value of the combined chronic total occlusion (CTO) and atherectomy markets in the U.S. at approximately $900 million for 2022, with atherectomy representing more than $700 million.”
DABRA has been cleared by the FDA for crossing CTOs 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.
The open-label pivotal atherectomy clinical trial can enroll subjects with symptoms of PAD (Rutherford Class 2-5) at up to 10 sites. 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 and before any adjunctive treatment. The trial’s safety and clinical success endpoints are major adverse events at 30 days post-procedure and incidence of primary target lesion revascularization at six months.
About Ra Medical Systems
Ra Medical Systems manufactures the DABRA excimer laser and catheters for the treatment of certain vascular diseases. DABRA has been granted CE mark clearance for the endovascular treatment of infrainguinal arteries via atherectomy and for crossing total occlusions. DABRA excimer lasers and catheters are manufactured in a 32,000-square-foot facility located in Carlsbad, California. The vertically integrated facility is ISO 13485 certified and is licensed by the State of California to manufacture sterile, single-use catheters in clean room environments.
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This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements generally relate to future events or Ra Medical’s future financial or operating performance. In some cases, you can identify forward-looking statements because they contain words such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “could,” “intends,” “target,” “projects,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of these words or other similar terms or expressions that concern Ra Medical’s future expectations, strategy, plans or intentions. Forward-looking statements in this press release include, but are not limited to, statements concerning or implying future financial performance, anticipated product performance and functionality of our products, and industry trends and growth opportunities affecting Ra Medical, in particular statements relating to Ra Medical’s support catheters, their functionality and functionality in combination with the DABRA ablation catheters, and the potential range of solutions for and commercialization of the DABRA liquid core ablation catheters.. Ra Medical’s expectations and beliefs regarding these matters may not materialize, and actual results in future periods are subject to risks and uncertainties that could cause actual results to differ materially from those projected or implied by such forward-looking statements. The potential risks and uncertainties which contribute to the uncertain nature of these statements include, among others, challenges inherent in developing, manufacturing, launching, marketing, and selling new products; risks associated with acceptance of DABRA, and procedures performed using the device by physicians, payors, and other third parties; development and acceptance of new products or product enhancements; clinical and statistical verification of the benefits achieved via the use of Ra Medical’s products; the results from our clinical trials, which may not support intended indications or may require Ra Medical to conduct additional clinical trials or modify ongoing clinical trials; challenges related to commencement, patient enrollment, completion, an analysis of clinical trials; Ra Medical’s ability to manage operating expenses; Ra Medical’s ability to effectively manage inventory; Ra Medical’s ability to recruit and retain management and key personnel; Ra Medical’s need to comply with complex and evolving laws and regulations; intense and increasing competition and consolidation in Ra Medical’s industry; the impact of rapid technological change; costs and adverse results in any ongoing or future legal proceedings; adverse outcome of regulatory inspections; impacts from public health crises, such as the Covid-19 pandemic, or natural disasters; and the other risks and uncertainties described in Ra Medical’s news releases and filings with the Securities and Exchange Commission. Information on these and additional risks, uncertainties, and other information affecting Ra Medical’s business and operating results is contained in Ra Medical’s Annual Report on Form 10-K for the year ended December 31, 2020 and in its other filings with the Securities and Exchange Commission. Additional information is also set forth in Ra Medical’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2021, filed with the Securities and Exchange Commission. The forward-looking statements in this press release are based on information available to Ra Medical as of the date hereof, and Ra Medical disclaims any obligation to update any forward-looking statements, except as required by law.
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