ReFlow Medical, Inc.

SAN CLEMENTE, Calif.--(BUSINESS WIRE)-- Reflow Medical, Inc., a developer of innovative devices focused on cardiovascular disease, announces the first patient enrollments in “A pilot study of the Drug-Eluting Coronary Spur™ StEnt as a Primary trEatment for in-stent Restenosis (ISR) of the CORONARY arteries” (DEEPER CORONARY, NCT06117150). ISR is a common clinical problem that can generate significant health care costs and is often associated with an increased risk of death and rehospitalization. Known as the Coronary Sirolimus-Eluting Retrievable Scaffold System, or “Spur Elute,” this unique clinical solution is intended to treat patients with coronary ISR by transferring a proprietary sirolimus drug formulation to the diseased lesion without leaving a permanent metallic implant behind. The study is approved to enroll a total of 10 patients at up to three centers in New Zealand. Principal Investigator Prof. Scott Harding, M.D., is an interventional cardiologist specializing in the treatment of complex coronary disease at Wellington Hospital in Wellington, New Zealand. He shared his experience with the Spur Elute, saying, “It’s exciting to take part in the study of this novel platform, which has the potential to successfully treat patients suffering from in-stent restenosis.” William Lombardi, M.D., and Kathleen E. Kearney, M.D., interventional cardiologists at the UW Medicine Heart Institute in Seattle, Washington, were in attendance at the first enrollment. “Being able to deliver anti-proliferative drugs while maintaining blood flow can be a crucial element for treating ISR patients,” said Dr. Lombardi, who is the Director of the Complex Coronary Program at the Institute. The Spur Elute is a novel device whose Retrievable Scaffold Therapy (RST) creates channels to increase uptake of antiproliferative drugs, while dilating the arterial lumen to maximize gain during the procedure. The system is then removed, without leaving anything behind. “These enrollments take us one step closer to enabling physicians to utilize the Spur platform for treating patients with cardiovascular disease, and ISR in particular,” said Isa Rizk, CEO and Co-Founder of Reflow Medical, Inc. “We are so proud of the entire team and grateful to our external CRO, Mobius Medical, for reaching this milestone.” The pilot study of the Spur Elute for accessing and treating ISR follows last year’s successful introduction of the Reflow coraCatheters™ line for complex percutaneous coronary interventions (PCI). About Reflow Medical, Inc. Reflow Medical, Inc. focuses on empowering physicians through the design and development of innovative and effective technologies for cardiovascular disease. The Reflow portfolio includes products designed for use in treating cardiovascular disease in the coronary and peripheral vasculature.

SAN CLEMENTE, Calif.--(BUSINESS WIRE)-- Reflow Medical, Inc., a developer of innovative devices focused on cardiovascular disease, announces completion of enrollment in the DEEPER REVEAL clinical trial (NCT05358353) to evaluate the Reflow Spur™ Stent. Designated a Breakthrough Device by the FDA, the Spur is a unique clinical solution intended to provide stent-like results while leaving no metal behind. The study enrolled 130 patients in over 35 clinical centers in the U.S. This press release features multimedia. View the full release here: Spur Retrievable Scaffold Therapy (RST) features a retrievable stent with radially self-expanding spikes designed to treat the diseased vessel wall without leaving anything behind. (Graphic: Business Wire) “The steady rate of enrollment, along with the level of support from so many centers, has been impressive. The response reflects the huge unmet need for treatment options for CLTI,” said Dr. S. Jay Mathews, MD, MS, FACC, FSCAI, one of the Lead Principal Investigators and Cath Lab Director at Bradenton Cardiology/Manatee Memorial Hospital in Bradenton, Florida. He continued, “We’re looking forward to next steps in working with the FDA to bring this technology to our patients.” Dr. Mahmood K. Razavi, MD, FSIR, FSVM, one of the lead PIs and the Director of the Clinical Trials and Research Center at St. Joseph Heart & Vascular Center in Orange, California, commented, “As a physician who has worked with Reflow, I have followed the clinical data generated from the EU trials, which are very promising. I’m looking forward to seeing the final clinical data from the DEEPER REVEAL trial.” The prospective, single-arm, multicenter study will examine the efficacy and safety of the Spur Stent for the treatment of vascular lesions in the infrapopliteal arteries below the knee. A novel device intended for use in patients with critical limb-threatening ischemia (CLTI), this Retrievable Scaffold Therapy (RST) features a retrievable stent with radially self-expanding spikes that treat the diseased vessel wall without leaving anything behind. Teo Jimenez, Senior VP of R&D at Reflow Medical, commented on completion of enrollment in the DEEPER REVEAL study: “We want to thank everyone who has partnered with us in completing this enrollment. Our next step is to gather the necessary follow-up data on our path to U.S. approval.” About Reflow Medical, Inc. Reflow Medical, Inc. focuses on empowering physicians through the design and development of innovative and effective technologies for cardiovascular disease. The Reflow portfolio includes products designed for use in treating cardiovascular disease in the coronary arteries, as well as the peripheral vasculature.

The Bare temporary spur stent system, known as Retrievable Stent Therapy (RST), together with a commercially available drug-coated balloon (DCB), is indicated for the treatment of restenotic lesions in the infrapopliteal arteries to enhance drug absorption The Bare temporary spur stent system provides stent-like results. (Credit: Business Wire) US-based medical equipment manufacturer Reflow Medical has received the CE mark for its Bare temporary spur stent system to treat a type of Below-the-Knee (BtK) lesions. The Bare temporary spur stent system is a unique clinical solution, known as Retrievable Stent Therapy (RST), which provides stent-like results while leaving no metal behind. It is a self-expanding stent, designed with radial spikes to create channels in the vessel wall to enhance drug absorption and reduce recoil. The system, together with a commercially available drug-coated balloon (DCB), is indicated for the treatment of restenotic lesions in the infrapopliteal arteries to enhance drug absorption. Reflow Medical co-founder and CEO Isa Rizk said: “Earning the CE Mark is a huge milestone for the company. It enables us to offer a clinically validated solution to an unmet need in a major disease area. “Our next goal is to expand our organisation to commercialise this breakthrough technology and serve the needs of physicians and their patients in countries accepting this certification.” The treatment using the Bare temporary spur stent system, followed by DCB, is said to reduce clinically driven target lesion revascularisation (CD-TLR). It would also improve wound healing, reduce recoil, and improve vessel patency through one year, compared to historical treatment outcomes with plain balloon angioplasty or a DCB alone. Reflow Medical said its Bare temporary spur stent system was approved as a Class 2a medical device under the European Union (EU) Medical Device Regulation (MDR). The EU MDR is a stringent process that requires manufacturers to provide substantial evidence supporting the performance and safety of the device. DEEPER OUS clinical trial principal investigator Thomas Zeller said: “The device performance and clinical study data for patients suffering from CLTI has been quite impressive.” DEEPER LIMUS clinical trial principal investigator Marianne Brodmann said: “We have found that the Spur allows us to treat patients with (BTK) disease using stent therapy, without the long-term risk of a stent implant.”