CARLSBAD, Calif.--(BUSINESS WIRE)--Ra Medical Systems, Inc. (NYSE: RMED), a medical device company focusing on commercializing excimer laser systems to treat vascular and dermatological diseases, announces the appointment of Chris Folk, PhD, as Vice President of Engineering, effective January 13, 2020. 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 Andrew Jackson, Ra Medical Systems Interim CEO and CFO.
“Chris is an experienced leader, engineer and inventor who brings to Ra Medical highly relevant expertise in engineering transformational products and bringing game-changing medical devices to market,” said Mr. Jackson. “He has managed teams responsible for more than 20 device development programs at firms ranging from startups to multinationals. Notably, Chris has significant experience with catheters from his years at Covidien Neurovascular/ev3, where he led the commercial launch of three 510(k) catheters. We view his appointment as a significant step in improving the design and manufacturing of the DABRA catheter to enhance its consistency and extend its shelf life.”
“I have a particular passion for innovative medical devices, whether being developed from scratch or improving an existing design, and I see the clear advantages of photoablation over competing technologies for the treatment of peripheral artery disease,” said Dr. Folk. “This is an exciting opportunity for my colleagues and me to identify design and manufacturing solutions that enhance the existing products while concurrently developing new and next generation product offerings. I’m delighted to join the Ra Medical team at this critical juncture as we work toward a successful future with a differentiated product line.”
Dr. 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.
Earlier in his career he was Senior Design and Applications Engineer-Medical Devices for Microfabrica Corporation, a designer and manufacturer of micromachine devices, where he was the technical manager for NIH-funded minimally invasive heart surgery research and co-invented the device published as the first all-micro electro-mechanical system (MEMS) medical devices surgical tool. He began his career in the Technical Leadership Program at General Electric, a world leader in the design and manufacture of commercial and military jet engines, leading a team developing the high-pressure engine core for an advanced military prototype.
Dr. Folk holds 10 issued patents with more than a dozen pending. He has coauthored articles published in the peer-reviewed journals Circulation: Cardiovascular Interventions, International Journal of Robotics Research, Rapid Prototyping Journal and Journal of American College of Cardiology.
Dr. Folk holds a BS in Aerospace Engineering from the University of Notre Dame, an MS in Engineering Mechanics from the University of Cincinnati and a PhD in Aerospace Engineering from the University of California, Los Angeles.
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 laser system and single-use DABRA catheter received FDA 510(k) clearance in the U.S. as a device 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. 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 Ra Medical’s business strategy, including its plans to improve the consistency and shelf life of its DABRA catheters, as well as developing new and next generation product offerings. 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, 2018 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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