Medical 21 Secures Approval for Pioneering Clinical Study in Spain

Medical 21, Inc. has received regulatory approval in Spain under the European Union Medical Device Regulation (EU MDR) to launch its first-in-human clinical study, known as the MAVERICS Coronary Revascularization Study. This significant milestone allows the Minneapolis-based medical technology company to evaluate its next-generation synthetic small-diameter bypass graft, the MAVERICS graft.

The MAVERICS graft represents a novel approach to coronary artery bypass grafting (CABG) by offering a regenerative vascular scaffold designed to address the persistent challenges of creating durable small-diameter conduits. The graft’s innovative design incorporates an absorbable polymeric scaffold combined with a nitinol wire frame. This structure not only provides early mechanical support but is also intended to facilitate the patient’s natural healing process.

By promoting cellular infiltration, neovascularization, and the gradual formation of native vascular tissue, the MAVERICS graft aims to serve as a reliable alternative to traditional harvested vessels. This advancement is expected to streamline CABG procedures, reduce complications associated with vessel harvesting, and expand revascularization options for patients requiring bypass surgery.

Dr. Manny Villafaña, Ph.D. Sc., the Chief Executive Officer of Medical 21, expressed enthusiasm about the approval. “We are pleased to have received all necessary regulatory clearances in Spain to begin our first-in-human study,” he stated. “This milestone marks an important step forward in validating the clinical potential of the MAVERICS graft and advancing our mission to transform coronary bypass surgery. For decades, surgeons have faced limitations in available conduit quality and quantity. The MAVERICS graft is designed to address these longstanding challenges, and we are eager to begin assessing its safety, performance, and biological integration in patients.”

The MAVERICS graft is classified as an investigational device and has not yet received approval for commercial sale from the U.S. Food and Drug Administration (FDA) or any other regulatory authority, highlighting the importance of this clinical study in the development process.

About Medical 21, Inc.

Medical 21, Inc. is dedicated to reshaping cardiac bypass surgery through innovative technology. The company is advancing its MAVERICS regenerative platform, which includes its first product, the MAVERICS coronary graft. This small-diameter vascular conduit is designed to eliminate the need for vessel harvesting in CABG procedures, thus potentially improving patient outcomes.

The company is headquartered in Minneapolis, Minnesota, and continues to focus on developing groundbreaking solutions in the field of cardiac surgery.

This announcement reflects a significant step in the ongoing evolution of medical technologies aimed at improving surgical outcomes and patient care. The clinical study will play a critical role in determining the efficacy and safety of the MAVERICS graft, paving the way for future innovations in the treatment of coronary artery disease.

For further information about Medical 21, Inc. and its initiatives, visit www.Medical21.com.