R3 Vascular, Inc.

R3 Vascular said the proceeds would support its pivotal clinical trial in patients with severe vessel blockages below-the-knee, including people facing potential amputation. On the heels of a groundbreaking FDA approval for a major medtech, a Silicon Valley startup is shaping up to be a possible competitor.  R3 Vascular recently raised $87 million in venture capital cash to support work on its bioresorbable, drug-eluting stent designed for peripheral artery disease—in addition to tapping a new president and CEO. The company said the proceeds would support its pivotal clinical trial in patients with severe vessel blockages below the knee, including people facing the potential loss of the limb, as well as help scale up its manufacturing base. Going forward, R3 Vascular will be led by Christopher Owens, who previously served as chief of the intrauterine fibroid ablation developer Gynesonics—and also formerly led IDEV Technologies, maker of a metal stent for reopening the larger arteries of the thigh, which was acquired by Abbott back in 2013. He takes over from R3 Vascular’s founder, Kamal Ramzipoor, who will become chief technology officer. Now Owens will have to contend with Abbott once again. The devicemaker claimed an FDA green light late last month for its own dissolving scaffold in severe below-the-knee cases of peripheral artery disease, known as chronic limb-threatening ischemia.  Before that, the standard of care has relied almost solely upon balloon angioplasty, as no stents or drug-coated balloons had been approved by the FDA to help the small, twisting vessels of the lower leg stay open over time. Abbott’s everolimus-eluting Esprit BTK system marked the company’s return to bioresorbable implants—after its Absorb coronary stent was taken off the market about a year after its approval in 2016, following slow sales and concerns over safety compared to metal stents.  R3 Vascular’s Magnitude implant, meanwhile, delivers a dose of the immunosuppressant sirolimus.  “R3 Vascular scaffolds strike a critical balance between strength and flexibility which has enabled designs that are thinner and stronger in a wide range of diameters and lengths suitable to effectively treat complex below-the-knee lesions,” Ramzipoor said in a statement. “We strive to become the new standard of care for PAD interventions.” The Mountain View, California-based company’s series B round was led by affiliates of Deerfield Management, and joined by previous backers including 415 Capital. Deerfield’s David Neustaedter and Michael Hurley took seats on its board of directors. “R3 Vascular’s novel bioresorbable scaffolds encompass a world-class polymer and scaffold design that drives significant next-generation advantages with our technology,” said Owens. “This significant financing is also a testament to the belief in our evolutionary bioresorbable scaffold technology to provide treatment for this significant and growing problem of below-the-knee PAD.”

“Clinical development of our bioresorbable sirolimus-eluting scaffold for treating peripheral arterial disease (PAD) is proceeding ahead of schedule and achieving outstanding procedural results,” said Kamal Ramzipoor, CEO of R3 Vascular. MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)-- R3 Vascular Inc. today reported the successful initiation of its First-in-Human clinical study evaluating the technical and clinical performance of the R3 Vascular MAGNITUDE® Bioresorbable Sirolimus-Eluting Scaffold (BRS) in patients suffering of Critical Limb Ischemia (CLI) due to occlusive below the knee (BTK) arterial disease. The R3 Vascular platform incorporates an innovative scaffold design and bioresorbable polymer technology resulting in biomechanical performance comparable to metallic stents. The MAGNITUDE BRS, specifically designed to balance mechanical strength and flexibility uses a novel bioresorbable polymer that provides the structural support needed in this complex vascular territory. At a 98-micron strut thickness across all its usable range of diameters, the MAGNITUDE BRS device is the thinnest BRS ever tested in this clinical setting. “Given the dire and unmet clinical need of patients presenting with CLI undergoing BTK revascularization, we are extremely pleased by the rapid progression of our program,” said R3 Vascular CEO Kamal Ramzipoor. “Our MAGNITUDE BRS is well-positioned to improve the clinical outcomes of these patients by providing temporary mechanical support and sustained drug delivery while reducing the well-established complications associated with permanent implants.” “In this early clinical experience, we successfully tested the deliverability and mechanical performance of the MAGNITUDE BRS. Post-procedural angiographic and duplex ultrasound data confirms the mechanical properties and ‘stent-like’ results of the MAGNITUDE BRS device in presence of a high-disease burden. We are looking forward to expanding the patient population cohort and following the clinical results over time,” said Dr. Marianne Brodman, Professor and Head, Clinical Division of Medical University of Graz, Austria. Dr. Juan F. Granada, a strategic advisor to R3 Vascular, added: “In BTK intervention, the prevention of vessel recoil following balloon dilatation is key to prevent negative remodeling and maintain vessel patency over time. BRS offer the best of both worlds by providing vessel support while it is needed and allowing the opportunity for future re-interventions, which is important in this type of patients. The successful validation of this technology may finally offer an effective and durable way to treat patients with this complex medical condition.”. About R3 Vascular Inc. R3 Vascular is a privately held, early-stage medical device company that has created a novel technology platform for developing and manufacturing fully bioresorbable vascular scaffolds with a sirolimus coating for treatment of PAD below the knee. The R3 Vascular platform combines the best of both worlds of below-the-knee (BTK) therapy, designed to deliver the ‘stent-like’ support of a scaffold along with the anti-inflammatory result of sirolimus, but ‘disappearing’ over time as the vessel heals. R3 Vascular is headquartered in Mountain View, Calif., USA, with additional operations in Munich, Germany.