Mitria Medical, an early-stage, structural heart company developing a next-generation transcatheter solution for mitral valve repair, has 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 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 has also announced that Marwan Berrada-Sounni will serve as 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 programme 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, chair of the Department of Cardiovascular Medicine at Cleveland Clinic (Cleveland, USA), and Jose Navia, vice chief of the Heart, Vascular & Thoracic Institute at Cleveland Clinic Florida (Weston, USA), performed the first US implantation at Cleveland Clinic under the US Food and Drug Administration (FDA) Single Patient Expanded Access programme.
The Subvalvular Spacer is an investigational device and is not available for commercial sale.
