St. Jude Medical founder Manny Villafaña draws on his experience developing a new medical device to offer insights for innovators in the medical device sector. His approach emphasizes real-world clinical needs and patient-centered design principles. Villafaña highlights how early surgeon feedback shaped the device’s development trajectory.
Oct 2026Medical Design and OutsourcingNews article
Manny Villafaña and Medical 21 introduce a regenerative artificial artery designed for coronary artery bypass grafting (CABG). The device represents Villafaña’s largest project to date, following his past sales of medical device companies totaling $67 billion. This innovation aims to address limitations in current vascular graft solutions.
Aug 2026Medical Design and OutsourcingNews article
Medical 21, a Minneapolis-based developer of synthetic regenerative grafts for coronary bypass surgery, files for a $25 million initial public offering. The company plans to raise capital by selling 2.3 million shares at a proposed price range of $10 to $... per share. The filing marks a key step toward public market entry for its regenerative medical technology.
Medical 21 has begun its first-in-human clinical trial of the **Maverics graft**, a regenerative small-diameter coronary bypass graft, under the **MAVERICS study**. The trial, approved by Spain’s EU MDR, marks the first multicentre test of this novel device. The graft aims to address limitations in traditional bypass procedures by leveraging regenerative technology.