HighLife Medical, a Paris-based medical technology company developing transcatheter treatments for structural heart disease, has raised more than $90 million (€80 million) in financing to advance its U.S. clinical development program and accelerate commercial expansion in Europe. The funding round was co-led by Andera Partners, Sofinnova Partners, Supernova Invest, and Mérieux Equity Partners, with participation from new and existing investors.
Additional new investors include the European Investment Bank, BNP Paribas Développement, Capricorn Partners, Critical Path Ventures, Pro Benefis Familiae, SPRIM Global Investments, and a global strategic investor. Existing investors USVP, Sectoral, and VI Partners also participated in the round.
The financing will support HighLife’s efforts to expand access to its Transcatheter Mitral Valve Replacement (TMVR) system, which is designed to treat patients suffering from significant mitral regurgitation who are not suitable candidates for traditional surgery or transcatheter edge-to-edge repair.
Mitral regurgitation occurs when the heart’s mitral valve does not close properly, allowing blood to flow backward within the heart. Patients with severe forms of the condition may experience symptoms and complications that require valve repair or replacement.
HighLife’s technology uses a transfemoral valve-in-ring approach, enabling physicians to implant both a supporting ring and a replacement valve through a catheter-based procedure.
The system is designed to reproduce aspects of conventional surgical mitral valve replacement while offering a less invasive treatment approach for patients with limited therapeutic options.
HighLife achieved several regulatory and clinical milestones during 2026. In January, the company received CE Mark approval for its TMVR system, allowing it to begin a limited commercial release in Europe while also initiating its pivotal clinical study in the United States.
In July, the company received CE Mark approval for its next-generation Clarity Valve, which was developed to further reduce the risk of left ventricular outflow tract obstruction, a significant challenge associated with transcatheter mitral valve replacement procedures.
The latest financing will support the company’s European commercial expansion, advance its U.S. pivotal study, and strengthen its organization as it prepares for additional growth.
Founded in 2010, HighLife is headquartered in Paris and also operates a U.S. facility in Irvine, California. Its TMVR and Clarity systems have received CE Mark approval but remain investigational and are not approved for commercial sale in the United States.
KEY QUOTES:
“This financing represents an important milestone as HighLife continues to build momentum toward establishing its technology as a new treatment option for patients suffering from mitral regurgitation who have limited therapeutic alternatives. It 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.”
Stefan Pilz, CEO of HighLife Medical
“We believe transcatheter mitral valve replacement is reaching a critical inflection point. With differentiated technology, a highly experienced team and a strong financial foundation, we believe HighLife is particularly well positioned to establish itself as a global leader in this new therapeutic approach.”
Rémi Spagnol, Partner at Supernova Invest
“The strength of this financing reflects strong investor confidence in the leadership of the company, its strategy and winning technology. HighLife has built a strong foundation, and we believe the company is well positioned to execute its next phase of growth to treat patients who have no other option today.”
Jose Calle Gordo, Chairman of HighLife Medical
