HighLife raises €80M to fund US heart-valve trial and European rollout

What's the deal? Paris-based MedTech company HighLife has raised €80 million (about $91.8 million) in a late-stage round to expand across Europe and advance its US clinical program. Andera PartnersDealroom has a profile for this one. Try Dealroom →, Sofinnova Partners, Supernova InvestDealroom has a profile for this one. Try Dealroom →, and Mérieux Equity PartnersDealroom has a profile for this one. Try Dealroom → co-led the round.

Who else joined? New backers included the European Investment Bank, BNP Paribas DéveloppementDealroom has a profile for this one. Try Dealroom →, Capricorn PartnersDealroom has a profile for this one. Try Dealroom →, Critical Path VenturesDealroom has a profile for this one. Try Dealroom →, Pro Benefis Familiae, and SPRIM Global InvestmentsDealroom has a profile for this one. Try Dealroom →. Existing investors USVP, SectoralDealroom has a profile for this one. Try Dealroom →, and VI PartnersDealroom has a profile for this one. Try Dealroom → also participated.

What does it do? Founded in 2010, HighLife builds transcatheter systems for structural heart disease. Its Transcatheter Mitral Valve Replacement (TMVR) system treats patients with severe mitral regurgitation who cannot undergo surgery or other repair options.

Why now? The round follows two regulatory milestones this year. HighLife won CE Mark approval for its TMVR system in January, letting it start a limited European release and its US pivotal study; in July it secured CE Mark approval for the Clarity Valve, designed to reduce a key barrier to adoption.

What's the endgame? The capital funds commercial expansion across Europe and the US pivotal clinical study. Chief executive officer Stefan Pilz called the financing "an important milestone as HighLife continues to build momentum toward establishing its technology as a new treatment option."

The signal: Investors are betting the field is at a turning point. "We believe transcatheter mitral valve replacement is reaching a critical inflection point," said Rémi Spagnol, partner at co-lead Supernova Invest. The round ranks among the largest late-stage deep tech deals in France, sitting in the top 1% of 82 comparable rounds on record.

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