Mitralign, which is looking to commercialize its namesake mitral valve treatment and pursue regulatory nods for its Trialign tricuspid valve device, said it raised nearly $10 million.
The $9.8 million funding, of a hoped-for $30.2 million, came from 19 unnamed investors beginning last September, the Tewksbury, Mass.-based company said in a regulatory filing. Mitralign raised a $40 million Series E round in May 2016.
The Mitralign and Trialign devices are designed to use wire and catheters to implant polyester anchors within the annulus of the mitral and tricuspid valves. The anchors are then cinched together to reduce valve circumference, creating a functional valve. The Mitralign valve won CE Mark approval in the European Union in February 2016; clinical programs are under way in Europe and the U.S. for Trialign.
Last November, the company touted “clinically meaningful” one-year results from the 30-patient Scout early feasibility trial for Trialign in the U.S. The study’s primary endpoint is technical success at 30 days, with a secondary outcome of safety and performance endpoints measured at discharge, 1, 3, 6, 12 and 24 months, according to ClinicalTrials.gov.
After a year 90% of patients were in New York Heart Assn. Class I/II and showed “sustained improvement” in Minnesota Living with Heart Failure Score, from 49.6 to 19.2. Participants in the single-arm study also showed a 21% improvement in 6-minute walk test, from 236.5 to 285.4, and a 21.6% reduction in proximal isovelocity surface area/effective regurgitant orifice area and a 17.1% improvement in left ventricle outflow tract stroke volume, Mitralign said.
Mitralign is also running the Scout II program aiming for Trialign CE Mark approval. The company is backed by a mix of venture capital and strategic medical device investors, including Forbion Capital Partners, Orchestra Medical Ventures, Oxford Bioscience Partners, Triathlon Medical Ventures, Medtronic (NYSE:MDT) and Johnson & Johnson(NYSE:JNJ).
Steve MacMillan took over as CEO of Hologic in 2013, drawing on his experience at medtech titans like Stryker and Johnson & Johnson. Since then, Hologic has grown into a $3 billion business.
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