Ra Medical Systems Hosts Summit with Vascular Physicians to Monitor Progress on Next-Generation DABRA Catheter Design
Ra Medical Systems, Inc. (NYSE: RMED) has announced a one-day DABRA Summit aimed at gathering input for the next-generation DABRA catheters. Attendees include principal investigators and clinical coordinators from the DABRA pivotal atherectomy trial, focusing on product design enhancements and best practices for patient enrollment. With five clinical sites open for patient enrollment, Ra Medical is prioritizing improvements in their DABRA catheter and advancing the atherectomy trial. The DABRA system is designed to treat vascular blockages caused by lower extremity vascular disease.
- DABRA Summit will gather critical input on next-generation catheter design.
- Patient enrollment has commenced at five clinical sites for the atherectomy trial.
- Focus on enhancing product features to meet physician expectations.
- Clinical trial results may require additional studies or modifications.
- Risks associated with the acceptance of new products by physicians and payors.
CARLSBAD, Calif.--(BUSINESS WIRE)--Ra Medical Systems, Inc. (NYSE: RMED), a medical device company focused on commercializing excimer laser systems to treat vascular and dermatological diseases, announces a one-day DABRA Summit, during which participants will have the opportunity to provide input on the design features and enhancements for the Company’s next-generation DABRA catheters. Principal investigators and study coordinators from Ra Medical’s DABRA pivotal atherectomy clinical trial will also meet to share with one another insights on best practices.
“Convening this DABRA Summit with leaders in the field of vascular surgery, interventional radiology and interventional cardiology demonstrates our progress in engineering the next-generation DABRA catheter. This hands-on workshop will allow us to incorporate input on the usability and performance features we are building into our next-generation DABRA catheters,” said Will McGuire, Ra Medical Systems CEO. “We are highly focused on providing an enhanced product that exceeds their expectations.
“We also will be meeting with the clinical investigators for the atherectomy trial. With patient enrollment now open in five clinical sites, we will use this forum to share best practices in driving successful enrollment, patient outcomes and subject retention,” he added. “Making improvements and enhancements to our DABRA catheter along with advancing the atherectomy trial are our top priorities, and these meetings are expected to provide critical information to support our success.”
DABRA is Ra Medical’s 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 peripheral artery disease.
About Ra Medical Systems
Ra Medical Systems commercializes excimer lasers and catheters for the treatment of vascular and dermatological diseases. In May 2017 the DABRA excimer laser system received FDA 510(k) clearance in the U.S. for crossing chronic total occlusions, or CTOs, in patients with symptomatic infrainguinal lower extremity vascular disease with an intended use for ablating a channel in occlusive peripheral vascular disease. The Pharos excimer laser system is FDA-cleared and is used as a tool in the treatment of psoriasis, vitiligo, atopic dermatitis and leukoderma. DABRA and Pharos are both based on Ra Medical’s core excimer laser technology platform and deploy similar mechanisms of action. Ra Medical manufactures DABRA and Pharos excimer lasers and catheters in a 32,000-square-foot facility located in Carlsbad, Calif. The vertically integrated facility is ISO 13485 certified and is licensed by the State of California to manufacture sterile, single-use catheters in controlled environments.
Cautionary Note Regarding Forward Looking Statements
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 regarding the timing and potential outcome of the DABRA atherectomy clinical study. 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 Pharos and procedures performed using such devices 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; 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. 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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