HighLife Raises Over $90M to Advance TMVR System Through U.S. Pivotal Study and European Expansion
HighLife, a Paris-based MedTech company focused on transcatheter solutions for structural heart disease, has announced the completion of a financing round of over $90 million (€80 million) to accelerate the commercial expansion of its Transcatheter Mitral Valve Replacement (TMVR) system across Europe and advance its U.S. clinical development program.
The fundraise was co-led by Andera Partners, Sofinnova Partners, Supernova Invest, and Mérieux Equity Partners. New investors joining the round included the European Investment Bank, BNP Paribas Développement, Capricorn Partners, Critical Path Ventures, Pro Benefis Familiae, SPRIM Global Investments, and a global strategic investor, alongside existing investors USVP, Sectoral, and VI Partners.
HighLife has achieved significant regulatory and clinical milestones this year. In January, the company received CE Mark approval for its TMVR system, enabling the start of a limited market release in Europe while also initiating its U.S. pivotal clinical study. In July, HighLife received CE Mark approval for the Clarity Valve, its next-generation valve purpose-built to further mitigate left ventricular outflow tract obstruction risk, the primary barrier to adoption for TMVR. Together, these milestones strengthen HighLife’s ability to expand treatment access for patients with limited therapeutic options.
The HighLife TMVR System consists of a valve-in-ring concept, with both ring and valve implanted percutaneously, mimicking the surgical gold standard of annuloplasty ring plus valve. It is intended for the treatment of adult patients suffering from symptomatic moderate-severe or severe mitral valve regurgitation who are deemed unsuitable for surgical repair or replacement and transcatheter edge-to-edge repair by a multi-disciplinary heart team.
Stefan Pilz, Chief Executive Officer of HighLife, said the financing represents an important milestone as the company continues to build momentum toward establishing its technology as a new treatment option for patients suffering from mitral regurgitation who have limited therapeutic alternatives. Pilz noted that the funding will support HighLife’s strategic roadmap by accelerating commercial expansion across Europe, advancing its pivotal clinical study, and strengthening the organization to support long-term growth.
Rémi Spagnol, Partner at Supernova Invest, said that TMVR is reaching a critical inflection point and that with differentiated technology, a highly experienced team, and a strong financial foundation, HighLife is well positioned to establish itself as a global leader in this new therapeutic approach.
Jose Calle Gordo, Chairman of the Board, said the strength of the financing reflects strong investor confidence in the company’s leadership, strategy, and technology. Calle Gordo noted that HighLife has built a strong foundation and is well positioned to execute its next phase of growth to treat patients who have no other option today.
