R3 Vascular Announces First Patient Treated in ELITE-BTK Pivotal Trial for Below-the-Knee PAD Using MAGNITUDE® Drug Eluting Bioresorbable Scaffold

MOUNTAIN VIEW, Calif., April 22, 2025 (GLOBE NEWSWIRE) — R3 Vascular Inc., a medical device company dedicated to developing and providing novel, best-in-class bioresorbable scaffolds for treating peripheral arterial disease (PAD), is pleased to announce that the first patient in its ELITE-BTK pivotal trial was treated by Dr. Brian DeRubertis, FACS, Chief of the Division of Vascular & Endovascular Surgery at New York-Presbyterian and Weill Cornell Medicine in New York City. The trial evaluates R3 Vascular’s next generation drug eluting bioresorbable scaffold, MAGNITUDE®, for below-the-knee (BTK) PAD, which according to the American Heart Association affects more than 200 million people globally, and 10 to 12 million in the U.S. older than the age of 40. The most common type of PAD affects the lower-extremity where blood flow is reduced to the legs and feet. Each year, approximately 150,000 leg amputations are performed in the U.S. alone.      

“The treatment of the first patient in our ELITE-BTK pivotal trial by distinguished vascular surgeon and researcher Dr. Brian DeRubertis is a significant milestone as we commence our effort to fully demonstrate the efficacy and safety of our next generation MAGNITUDE scaffold,” said Christopher M. Owens, President and Chief Executive Officer of R3 Vascular. “Moving forward we look to accelerate enrollment, paving the way for a PMA market application with the FDA.”

Dr. DeRubertis commented on the importance of the ELITE-BTK pivotal trial, saying, “I am honored to have enrolled the first two patients in R3 Vascular’s ELITE-BTK pivotal trial, primarily because this type of technology has been needed by our patients for years.  I have spent much of my career researching novel devices for vascular disease, including bioresorbable scaffolds, and while there have been some recent successes in the BTK PAD trial landscape, there remain significant unmet needs in this area. We expect the results of this important trial will reveal MAGNITUDE’s unique potential to further advance treatment and improve patient outcomes for patients with vascular disease.”

“The start of this trial marks the continuation of our journey in providing a ground-breaking technology for patients who have suffered from this debilitating disease for many years without effective therapeutic options,” said Kamal Ramzipoor, Founder and Chief Technology Officer of R3 Vascular. “MAGNITUDE is a next generation bioresorbable scaffold with the potential to address one of the greatest needs for patients suffering from Chronic Limb-Threatening Ischemia due to below-the-knee PAD. R3 Vascular’s novel bioresorbable scaffolds are made from a unique, ultra-high molecular weight polylactic acid polymer. This polymer, combined with the company’s scaffold design and proprietary processing technology allow for superior biomechanical properties with strength and ductility. We believe these properties will drive extremely positive outcomes, especially long-term for real-world patients. We look forward to advancing our product through its clinical development with the ultimate goal of having a market leading position.”

As an active researcher, Dr. DeRubertis has participated in more than 15 clinical research studies as a Site or National Principal Investigator, many of which focus on the challenging area of BTK disease. He has published more than 70 articles in peer-reviewed journals, as well as more than 15 book chapters. As frequent speaker, he has presented original research at over 35 regional and national academic conferences and has been an invited speaker at numerous national and international symposia delivering over 350 presentations at these conferences.

About R3 Vascular Inc.
R3 Vascular is a privately-held medical device company that has developed a novel technology platform for the next generation of fully bioresorbable drug eluting sirolimus coated vascular scaffolds. These are designed to deliver the ‘stent-like’ support of a scaffold along with the anti-inflammatory and anti-proliferative result of sirolimus, but ‘disappearing’ over time as the vessel heals. R3 Vascular is headquartered in Mountain View, California. More information can be found at www.r3vascular.com.         

Media Contact:
David Gutierrez, Dresner Corporate Services, (312) 780-7204, [email protected]

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