Mitralign develops direct transcatheter mitral and tricuspid valve repair systems, including the Trialign System and the Mitralign Percutaneous Annuloplasty System (MPAS). MPAS received CE mark approval in February for the treatment of functional mitral regurgitation (FMR). The Trialign System is currently enrolling patients in an early feasibility IDE study in the US and is not approved for sale or distribution. With $39.8 million raised to date in a Series E equity financing, the company plans to pursue US and CE regulatory approval for Trialign while preparing for commercial launch of MPAS in Europe. The funding will be used to accelerate clinical trials in both the United States and Europe and to expand the company’s tricuspid clinical data set. Mitralign is a venture-backed medical innovation company located near Boston, Massachusetts. Mitralign makes the Mitralign System, a catheter-delivered device that deploys pairs of anchors which are cinched together to restore the mitral valve's shape in patients with functional mitral regurgitation. The company completed enrollment of 61 FMR patients in a European clinical trial and is collecting follow-up data for a CE Mark submission. Management said it will continue to enroll patients in active clinical studies to accrue additional data for the medical community. Mitralign expects to report results from the trial before the end of 2014. Financially, the Tewksbury, Mass.-based company raised about $8.1 million in a recent equity round and previously closed a $35 million Series D in May 2012. Mitralign has developed a catheter-based, percutaneous direct annuloplasty system intended to repair functional mitral regurgitation by reducing mitral annulus size and bringing leaflets closer together. The system delivers a pair of surgical implants into the mitral annulus via catheter; the implants are cinched and can be customized in location, extent of cinching, and number to suit patient anatomy. The company is conducting clinical studies to evaluate the technology for first-line percutaneous and trans-apical treatment of FMR and is completing a CE Mark study. Proceeds from the financing will support completing the CE Mark study, securing the CE Mark, and initiating sales in the EU. The press release cites a large addressable market, noting more than 2.5 million people in the U.S. with moderate or severe FMR and an expectation from an investor that a PMVR market could exceed $1 billion. Mitralign was founded by the Accelerated Technologies (ATI) medical device incubator and is based in Tewksbury, Massachusetts. Mitralign develops a catheter-based mitral valve repair device intended to treat mitral regurgitation in patients with congestive heart failure. The company is advancing development of its mitral valve repair technology and is using external financing to support operations. Mitralign secured a $5m senior secured credit facility to provide working capital as it progresses device development. The financing was provided by GE Capital, Healthcare Financial Services. Leadership emphasized the lender's industry expertise and fit with the company's needs. The company is based in Tewksbury, Massachusetts.

Total raised

$88M

Funding rounds

4

Latest round

Series E

Latest activity

May 2016