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THE TAPE

FDA panel backs GRAIL's Galleri on a 6 to 4 effectiveness vote TriSalus clears TriNav Advance, its fourth pressure-enabled infusion device Anaconda Biomed raises $56M to finish a 327-patient stroke trial FDA issues an early alert on Impella controllers that miss purge cassettes HighLife raises 80 million euros for a mitral valve CE marked in January Xenix Medical clears the Riva Anchor for sacroiliac fusion at the base of a lumbar construct Dialybrid raises 15 million euros as its silk polyurethane dialysis graft reaches a first patient CMS posts preliminary 2027 lab rates and cuts more than 1,100 test codes FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US FDA panel backs GRAIL's Galleri on a 6 to 4 effectiveness vote TriSalus clears TriNav Advance, its fourth pressure-enabled infusion device Anaconda Biomed raises $56M to finish a 327-patient stroke trial FDA issues an early alert on Impella controllers that miss purge cassettes HighLife raises 80 million euros for a mitral valve CE marked in January Xenix Medical clears the Riva Anchor for sacroiliac fusion at the base of a lumbar construct Dialybrid raises 15 million euros as its silk polyurethane dialysis graft reaches a first patient CMS posts preliminary 2027 lab rates and cuts more than 1,100 test codes FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US

Financing

HighLife raises 80 million euros for a mitral valve CE marked in January

MedDevice Startups Staff · 2 days ago · 2 min read · Via HighLife

HighLife raised 80 million euros, more than $90M, in a round announced September 22. Andera Partners, Sofinnova Partners, Supernova Invest and Merieux Equity Partners co-led.

The European Investment Bank, BNP Paribas Developpement, Capricorn Partners, Critical Path Ventures, Pro Benefis Familiae and SPRIM Global Investments joined, with returning investors USVP, Sectoral and VI Partners.

The company's transcatheter mitral valve replacement system won a CE mark in January 2026, and the Clarity Valve followed in July. The indication covers symptomatic moderate to severe or severe mitral regurgitation in patients who are not surgical candidates. The money funds a US approval trial and commercial expansion in Europe.

HighLife was founded in 2010, runs from Paris and keeps a facility in Irvine, California. Sixteen years from founding to a CE mark is ordinary for a structural heart implant, and the US approval is still a full trial away.

Questions & Answers

How much did HighLife raise in September 2026?

HighLife announced a financing round of 80 million euros, more than $90M, on September 22, 2026. Andera Partners, Sofinnova Partners, Supernova Invest and Merieux Equity Partners co-led.

Does the HighLife transcatheter mitral valve have a CE mark?

Yes. HighLife received a CE mark for its transcatheter mitral valve replacement system in January 2026, and a CE mark for the Clarity Valve in July 2026. The device is not FDA approved and remains investigational in the United States.

Which patients is the HighLife TMVR system intended for?

The HighLife transcatheter mitral valve replacement system treats symptomatic moderate to severe or severe mitral valve regurgitation in patients who are not suitable for surgery.

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