Founded at the Cleveland Clinic, the company named Marwan Berrada-Sounni as CEO to lead its investigational Subvalvular Spacer therapy for functional mitral regurgitation into its next phase of clinical evaluation.

SANTA CLARA, Calif., Sept. 29, 2026 /PRNewswire/ — Mitria Medical, an early-stage, structural heart company developing a next-generation transcatheter solution for mitral valve repair, today announced a partnership with T45 Labs, a Silicon Valley medtech incubator focused on minimally invasive cardiovascular technologies. Mitria is developing the Subvalvular Spacer (SVS), an investigational transcatheter mitral valve repair therapy for functional mitral regurgitation (FMR). The company also announced that Marwan Berrada-Sounni will serve as Chief Executive Officer (CEO) in addition to his current role as Founder and Managing Partner of T45 Labs. T45 Labs will support the company across product development, financing, operations, and clinical and regulatory strategy.

“We are thrilled to have Mitria join the T45 portfolio. The differentiated mitral repair technology has demonstrated a meaningful early clinical experience to address the limitations of edge-to-edge valve repair, potentially expanding treatment options for patients with functional mitral regurgitation,” said Berrada-Sounni, Founder and Managing Partner of T45 Labs. “The Cleveland Clinic Innovations program nurtured the promising SVS technology, and we look forward to advancing the development and clinical evaluation backed by T45 Labs’ hands-on operating model, cardiovascular expertise, and company development acumen.”

To date, six patients have received the SVS implant, with early clinical experience presented at four structural heart conferences, including the Transcatheter Cardiovascular Therapeutics (TCT) Conference, New York Valves, the American Association for Thoracic Surgery’s Mitral Conclave, and Miami Valves. Co-inventors, Samir Kapadia, MD, Chair of the Department of Cardiovascular Medicine at Cleveland Clinic, and Jose Navia, MD, Vice Chief of the Heart, Vascular & Thoracic Institute at Cleveland Clinic Florida, performed the first U.S. implantation at Cleveland Clinic under the FDA’s Single Patient Expanded Access Program.

Mitral regurgitation is one of the most common heart valve diseases globally. In patients with FMR, heart remodeling distorts the valve and prevents proper closure due to displaced papillary muscles and leaflet tethering. The resulting backward flow places additional volume load on the heart and can further worsen heart failure. For many patients, anatomical considerations make today’s transcatheter treatment options unsuitable.

The Subvalvular Spacer is an investigational device and is not available for commercial sale.

About Mitria Medical
Mitria Medical, a T45 Labs portfolio company, is developing the Subvalvular Spacer (SVS), an investigational transcatheter mitral valve repair (TMVr) therapy for secondary or functional mitral regurgitation (FMR). The SVS is a nitinol braid implant designed to support the displaced posterior leaflet, preserve anterior leaflet motion, improve leaflet coaptation, and reduce mitral regurgitation while maintaining native valve opening. The company is advancing the SVS as a minimally invasive solution for a wide range of mitral valve anatomies, while preserving future treatment options.

About T45 Labs
T45 Labs is a Silicon Valley-based medtech incubator that builds and funds acquisition-ready cardiovascular companies. Through the T45 Fund series, the firm provides hands-on operational support to advance minimally invasive technologies through key clinical and regulatory milestones, reducing development risk at each stage. The current T45 portfolio includes Advanced NanoTherapies, a dual-drug-coated balloon technology, VahatiCor a coronary sinus reducer therapy, NuevoSono, an intravascular ultrasound technology, and now Mitria Medical, in the structural heart market.

For more information about the firm and its portfolio, please visit: t45labs.com

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SOURCE T45 Labs