Medical 21, Inc. Launches First Human Trial for Innovative Coronary Graft

Medical 21, Inc., a medical technology firm based in Minneapolis, has received regulatory approval to begin its first-in-human clinical trial for a novel coronary bypass graft in Spain. This trial, named the MAVERICS Coronary Revascularization Study, marks a significant milestone for the company and its innovative approach to coronary artery bypass grafting (CABG).

On December 15, 2025, the company announced that it had obtained necessary regulatory clearance under the European Union Medical Device Regulation (EU MDR). The MAVERICS graft is designed to overcome the challenges associated with small-diameter conduits used in CABG procedures. This next-generation graft features an absorbable polymeric scaffold combined with a nitinol wire frame, providing both immediate mechanical support and a structure that promotes natural healing.

Advancements in Coronary Bypass Surgery

The design of the MAVERICS graft aims to enhance cellular infiltration, neovascularization, and the gradual formation of natural vascular tissue. By offering a consistent and readily available alternative to harvested vessels, the graft seeks to streamline CABG procedures, minimize complications related to vessel harvesting, and expand revascularization options for patients.

Dr. Manny Villafaña, Chief Executive Officer of Medical 21, expressed enthusiasm about the regulatory approval. He stated, “We are pleased to have received all necessary regulatory clearances in Spain to begin our first-in-human study. 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.” He elaborated that the graft addresses longstanding challenges surgeons face in terms of conduit quality and availability.

As an investigational device, the MAVERICS graft has not yet received approval for commercial sale from the U.S. Food and Drug Administration (FDA) or any other regulatory authority. The company aims to gather comprehensive data on the safety, performance, and biological integration of the graft as it moves forward with this clinical trial.

About Medical 21, Inc.

Medical 21, Inc. is committed to reshaping cardiac bypass surgery through innovative technology. The MAVERICS regenerative platform represents the company’s first product, designed specifically to eliminate the need for vessel harvesting during CABG. The company is headquartered in Minneapolis, Minnesota, and focuses on advancing the future of cardiac care.

This announcement not only signifies a leap forward for Medical 21, Inc. but also holds the potential to impact countless patients requiring coronary bypass surgery. As the clinical trial progresses, the medical community will be attentive to the outcomes and what they may mean for the future of cardiac interventions.

For further information on Medical 21, Inc. and the MAVERICS graft, visit www.Medical21.com.