HighLife SAS, a French medical technology company specializing in transcatheter solutions for structural heart disease, has raised more than 90 million dollars, equivalent to nearly 80 million euros. The Paris based company announced the successful completion of its financing round on Tuesday. The new capital will support commercial expansion in Europe and the continuation of clinical development in the United States.
Funding Round and Investors
The financing round was co-led by Andera Partners, Sofinnova Partners, Supernova Invest and Mérieux Equity Partners. Additional participants included 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 took part in the round.
European Regulatory Milestones
In January, HighLife received CE Mark approval for its Transcatheter Mitral Valve Replacement system, enabling the start of a limited market release in Europe. This authorization is required before a medical device can be commercialized within the European Union. The approval allowed the company to begin a targeted commercial launch while continuing its clinical work.
Next Generation Valve Approval
In July, HighLife received CE Mark approval for the Clarity Valve, its next generation mitral valve. The device is specifically designed to further reduce the risk of left ventricular outflow tract obstruction, which is a primary barrier to broader adoption of transcatheter mitral valve replacement. This milestone strengthens the company's ability to expand access for patients with limited therapeutic options.
Clinical Development in the United States
Alongside its European commercialization, HighLife has advanced its clinical program in the United States, where it began a pivotal clinical study. The company also operates a site in Irvine, California, supporting its American development activities. The newly raised capital will help accelerate this study and strengthen the organization for long term growth.
Technology and Patient Population
The HighLife TMVR system uses a valve in ring concept that mimics the surgical gold standard of an annuloplasty ring combined with a valve. Both components are implanted percutaneously through a catheter introduced via the femoral artery. It is intended for adult patients with symptomatic moderate to severe or severe mitral valve regurgitation who are considered unsuitable for surgery or transcatheter edge-to-edge repair.
Leadership and Investor Perspectives
Chief Executive Officer Stefan Pilz described the financing as an important milestone for building momentum toward a new treatment option for patients with limited alternatives. Rémi Spagnol, partner at Supernova Invest, said transcatheter mitral valve replacement is reaching a critical inflection point and that HighLife is well positioned to become a global leader. Chairman Jose Calle Gordo added that the strength of the financing reflects investor confidence in the company's leadership, strategy and technology.
French MedTech Landscape
HighLife is part of a group of French companies dedicated to cardiovascular medical devices. Other players include Carvolix, which focuses on heart valve replacement and stroke treatment, as well as CorWave and Fineheart, which develop cardiac pumps. The sector has also seen restructuring, with the former artificial heart pioneer Carmat continuing its activity under a new entity after being liquidated as a listed company earlier this year.
With more than 90 million dollars in new funding, HighLife is positioned to accelerate both its commercial rollout in Europe and its pivotal clinical study in the United States. The company's recent CE Mark approvals and next generation valve technology provide a foundation for expanding treatment options for patients with mitral regurgitation. The financing also underscores investor confidence in the company's ability to address a challenging clinical need in structural heart disease.