Tricuspid, mitral valve repair startup raises $40M to back regulatory approvals, launch

Using the Mitralign Percutaneous Annuloplasty System to repair a mitral valve--Screenshot courtesy of Mitralign

Mitralign has raised $39.8 million in a Series E round to help it get U.S. and EU approvals for its tricuspid valve repair system and to launch its mitral valve repair system in Europe. Transcatheter mitral valve repair and replacement were white-hot areas of strategic investment last year as major med techs worked to anticipate the best follow-up play to the massive success of transcatheter aortic valve replacement (TAVR).

The tricuspid valve seems lined up to be the next major spot of R&D interest in transcatheter cardiac valve tech. Early this year, another startup, 4Tech, led by former execs from Medtronic and huge mitral valve takeout Twelve, got $29 million to work on transcatheter tricuspid valve repair. And rather than highlight its mitral valve offeringMitralign is putting the emphasis on its tricuspid system.

"The funding reinforces the importance of developing distinctly new tricuspid treatment options and it validates our transcatheter valve repair platform strategy," said Mitralign CEO Rick Geoffrion in a statement. "The capital will be used to accelerate clinical trials both in the United States and in Europe for the Trialign System and support our leadership in the tricuspid space. We look forward to the approaching completion of the SCOUT early feasibility study in the US and the initiation of the SCOUT II Study to support the CE Mark in Europe as we expand our tricuspid clinical data set."

SCOUT is the Tewksbury, MA-based startup's early feasibility study to examine its Percutaneous Tricuspid Valve Annuloplasty System. It's slated to have final primary outcome data in May 2018, according to Clinicaltrials.gov. The company's Mitralign Percutaneous Annuloplasty System has a CE mark.

For now, valve repair and replacement efforts each seem to have their place, offering specific benefits in particular indications. Research has sought to prove the superiority of one over the other with mixed results.

Mitralign notes that for moderate to severe tricuspid regurgitation patients, of which there are at least 1.6 million in the U.S., 90% of them are offered repair rather than replacement. Current procedures are conducted with standard surgery, but minimally invasive transcatheter tech is up next. The startup also notes that at least half of patients with mitral regurgitation also have moderate to severe tricuspid regurgitation.

Given the nonexistent med tech IPO market, it's not too surprising that Mitralign opted for a sizable late-stage venture round. The investors in this financing were not disclosed. But several heavy hitters joined its $35 million Series D in 2012, including strategic investors Medtronic ($MDT) and Johnson & Johnson Development Corporation.

That round was led by Forbion Capital Partners with participation from Saints Venture Capital, Oxford Bioscience Partners, Triathlon Medical Ventures, Orchestra Medical Ventures, Oakwood Medical Investors, Palisade Capital Management and Giza Venture Capital.

- here is the announcement

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