Medical 21, Inc. Announces Regulatory Approval to Initiate First-in-Human Clinical Study in Spain

Regulatory clearance enables launch of the MAVERICS Coronary Revascularization Study, advancing evaluation of the Company's next-generation synthetic small-diameter bypass graft.

MINNEAPOLIS, Dec. 15, 2025 /PRNewswire/ -- Medical 21, Inc., a private medical technology company developing a novel regenerative small-diameter coronary bypass graft, today announced that it has received regulatory approval in Spain under the European Union Medical Device Regulation (EU MDR) to initiate the Company's first-in-human, multicenter clinical trial of the MAVERICS graft, the MAVERICS Coronary Revascularization Study.

The MAVERICS graft is a next-generation regenerative vascular scaffold engineered to address the long-standing challenge of creating durable, small-diameter conduits for coronary artery bypass grafting (CABG). Its design integrates an absorbable polymeric scaffold with a nitinol wire frame, combining early mechanical support with a structure intended to guide the patient's natural healing process. The scaffold architecture is designed to encourage cellular infiltration, neovascularization, and the gradual formation of native vascular tissue. By providing a consistent, readily available alternative to harvested vessels, the MAVERICS graft aims to streamline CABG procedures, reduce harvest-related morbidity, and broaden revascularization options for patients requiring coronary bypass surgery.

"We are pleased to have received all necessary regulatory clearances in Spain to begin our first-in-human study," said Dr. Manny Villafaña, Ph.D. Sc., Chief Executive Officer of Medical 21. "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 an investigational device and has not been approved for commercial sale by the U.S. Food and Drug Administration (FDA) or any other regulatory authority.

About Medical 21, Inc. 
Medical 21, Inc. is a medical technology company dedicated to reshaping the future of cardiac bypass surgery. The Company is advancing its MAVERICS regenerative platform, with its first product—the MAVERICS coronary graft—designed as a small-diameter vascular conduit intended to eliminate the need for vessel harvesting in CABG procedures. Medical 21 is headquartered in Minneapolis, Minnesota.

Forward-Looking Statements
This press release contains forward-looking statements regarding the development, clinical evaluation, and regulatory review of the MAVERICS graft. These statements are based on current expectations and are subject to risks and uncertainties that could cause actual results to differ materially, including risks related to the initiation and progress of the first-in-human study, the interpretation of clinical data, and the timing or outcome of regulatory interactions. Medical 21 undertakes no obligation to update forward-looking statements except as required by law.

For additional information about Medical 21, Inc., please visit www.Medical21.com.

Medical 21 Investor Contact:
Andrea Sweeney
VP Business Administration
[email protected]
+1-612-429-7630

SOURCE Medical 21, Inc.