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HighLife, a Paris-based MedTech company developing transcatheter solutions for structural heart disease, has closed a financing round of more than $90 million (€80 million). The round was co-led by Andera Partners, Sofinnova Partners, Supernova Invest, and Mérieux Equity Partners, with participation from new investors including the European Investment Bank, BNP Paribas Développement, Capricorn Partners, Critical Path Ventures, Pro Benefis Familiae, SPRIM Global Investments, and an undisclosed global strategic investor, alongside existing backers USVP, Sectoral, and VI Partners.
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The capital will fund commercial expansion of HighLife's Transcatheter Mitral Valve Replacement (TMVR) system across Europe and advance its US pivotal clinical study. The company received CE Mark approval for the TMVR system in January, enabling a limited European market release while its US pivotal trial got underway, and received a second CE Mark in July for the Clarity Valve, a next-generation design intended to further reduce left ventricular outflow tract (LVOT) obstruction risk, historically a primary barrier to TMVR adoption.
The HighLife system uses a valve-in-ring design, implanting both a subannular ring and valve percutaneously to mimic the surgical gold standard of annuloplasty ring plus valve replacement, for patients with moderate-severe or severe mitral regurgitation who are not candidates for surgical repair or edge-to-edge repair.
For HighLife, the round supports parallel execution across two fronts: scaling commercially in Europe while pursuing US regulatory approval. For the broader MedTech space, it reflects continued investor confidence in transcatheter mitral valve replacement as a maturing category, an area long constrained by anatomical complexity and adoption barriers like LVOT obstruction that newer device generations are working to resolve.
CEO Stefan Pilz called the round "an important milestone" in establishing the technology as a new treatment option for patients with limited alternatives.
