Mitralign

Mitralign, Inc. operated as a venture-backed medical device company, establishing its headquarters near Boston, in Tewksbury, Massachusetts. Founded in 2003 by Rick Geoffrion, the company focused on developing minimally invasive, catheter-based technologies for treating structural heart diseases, specifically functional mitral regurgitation (FMR) and tricuspid regurgitation (TR). Geoffrion, who also served as CEO, guided the company through significant funding rounds and clinical milestones. The company successfully raised substantial capital over its lifetime, amounting to $142 million across 11 rounds from 22 investors, including prominent names like Medtronic, Forbion, and Oxford Bioscience Partners.

The company's core business revolved around providing interventional cardiologists with less invasive alternatives to open-heart surgery. Its business model was centered on the development, clinical validation, and commercialization of its proprietary device platforms. Mitralign developed the Mitralign Percutaneous Annuloplasty System (MPAS), a direct transcatheter annuloplasty system designed to repair the mitral valve by reducing the size of the valve annulus through tissue plication. This system involved a retrograde femoral approach to place implants into the posterior mitral annulus, which were then cinched together to remodel the valve. A significant achievement came in February 2016, when the MPAS received CE Mark approval in the European Union for treating FMR, allowing for its commercialization in the EU. The company also developed the Trialign System, which applied the same technological platform to address TR. This system received an Investigational Device Exemption (IDE) from the U.S. FDA in 2015 to begin an early feasibility study, known as the SCOUT study.

In March 2019, Mitralign's journey as a standalone entity concluded when Edwards Lifesciences, a global leader in structural heart innovations, acquired certain assets of the company for an undisclosed amount. The acquisition included Mitralign's intellectual property and its associated clinical and regulatory experience, aligning with Edwards' strategy to strengthen its portfolio in the transcatheter mitral and tricuspid therapy space. Prior to the acquisition, Mitralign's products were for investigational use in the United States and not commercially available. Following the acquisition, the company is no longer active as an independent entity.