Medical 21, Inc.

Medical 21, Inc. is a developmental-stage medical technology company founded in 2016, focused on revolutionizing coronary artery bypass grafting (CABG) surgery with its flagship investigational product, the MAVERICS small-diameter synthetic regenerative graft. MAVERICS is designed as an alternative conduit to harvested autologous vessels, potentially simplifying CABG procedures and reducing patient morbidity from vessel harvesting incisions. The graft utilizes a resorbable synthetic polymer scaffold with nitinol wire support, engineered for cellular integration and natural healing without foreign body rejection. The company conducts development and manufacturing in a leased Minnesota facility and holds intellectual property covering scaffold design, materials, and manufacturing. Medical 21 has received regulatory approval in Spain for a first-in-human early feasibility study (EFS) trial enrolling approximately ten patients, with human studies anticipated to begin in Q1 2026; U.S. IDE submission is targeted for Q2 2027 following additional GLP ovine studies and testing. Financially, the company reported net losses of $10.2 million for 2025 and $11.4 million for 2024, with $1.8 million in cash as of December 31, 2025 and an accumulated deficit of $60.6 million. It is offering 2,272,727 shares of common stock at an assumed $11.00 per share (midpoint), expecting net proceeds of $22.8 million to fund first-in-human clinical trials, animal studies, regulatory activities, product development, and working capital. Medical 21 is going public to raise capital addressing its going concern uncertainty and advancing MAVERICS toward FDA approval and commercialization in the $400,000 U.S. annual CABG market.

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