R3 Vascular Inc. has achieved significant milestones in the development of its MAGNITUDE Drug Eluting Next Generation Bioresorbable Scaffold for treating below-the-knee peripheral arterial disease (PAD). The company announced it has received WCG Institutional Review Board (IRB) approval for the ELITE-BTK Pivotal Trial and Category B approval from the Centers for Medicare & Medicaid Services (CMS). These approvals pave the way for accelerated clinical trials and Medicare coverage, potentially transforming treatment options for millions suffering from PAD.
The IRB approval allows the ELITE-BTK trial to proceed at institutions utilizing WCG IRB as their central review board within the United States. CMS Category B approval ensures that Medicare will cover the investigational device, related items, and services during the trial, reducing the financial burden on patients participating in the study.
Significance of Approvals
Christopher M. Owens, President and CEO of R3 Vascular, stated that these approvals validate the potential of R3 Vascular’s technology and will accelerate the enrollment of the ELITE-BTK Pivotal Trial. Josh Smale, Vice President of Global Clinical and Scientific Affairs, highlighted that these approvals enable rapid progress in investigational site activation, bringing them closer to enrolling the first subject.
Physician Perspective
Eric A. Secemsky, M.D., MSc, Director of Vascular Intervention at Beth Israel Deaconess Medical Center and lead investigator for the ELITE-BTK pivotal trial, expressed enthusiasm for the novel design of R3 Vascular's scaffold. He believes it has the potential to transform the field of peripheral interventions and is eager to assess its impact on patient outcomes.
About the MAGNITUDE Scaffold and ELITE-BTK Trial
The MAGNITUDE scaffold is designed to provide stent-like support with the anti-inflammatory and anti-proliferative benefits of sirolimus, while gradually dissolving as the vessel heals. The ELITE-BTK trial aims to evaluate the safety and efficacy of the MAGNITUDE scaffold in patients with below-the-knee PAD.
Market Context
Peripheral Arterial Disease affects an estimated 8-12 million people in the U.S., impacting one in 20 Americans over the age of 50, according to the National Institutes of Health. The global peripheral vascular device market was valued at $12.9 billion in 2023 and is projected to reach $17.4 billion by 2030, with significant growth expected in the below-the-knee segment.
R3 Vascular's progress is further supported by its $87 million Series B financing round, which will fund the ELITE-BTK IDE pivotal trial, additional research and development, global regulatory submissions, manufacturing scale-up, and initial commercialization efforts.
