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September 24, 2026
HighLife Raises Financing to Advance Its TMVR Program
KEY TAKEAWAYS
- HighLife completed an €80 million financing round to support European commercialization and United States clinical development of its TMVR technology.
- The HighLife TMVR system received CE Mark approval in January 2026, followed by CE Mark approval of the Clarity valve in August.
- The company is initiating its United States pivotal study after receiving FDA investigational device exemption approval in June 2024.
September 24, 2026—HighLife SAS, which is headquartered in Paris, France, and focused on transcatheter solutions for structural heart disease, announced the completion of a €80 million financing round.
According to the company, the capital will accelerate HighLife’s commercial expansion across Europe and advance its clinical development program in the United States.
HighLife advised that regulatory and clinical milestones achieved in 2026 included the following:
- In January, the company announced CE Mark approval for its transcatheter mitral valve replacement (TMVR) system, enabling the start of a limited market release in Europe.
- The company also was initiating its United States pivotal clinical study, which received an FDA investigational device exemption in June 2024.
- In August 2026, HighLife announced CE Mark approval for the Clarity valve for its TMVR system that is designed to mitigate left ventricular outflow tract obstruction risk.
The company stated that the HighLife TMVR system is composed of a valve-in-ring concept, both ring and valve being implanted percutaneously. It is intended for the treatment of adult patients with symptomatic moderate-severe or severe mitral valve regurgitation who are deemed unsuitable for surgical repair/replacement and transcatheter edge-to-edge repair by a multidisciplinary heart team.
HighLife advised that the financing was co-led by Andera Partners, Sofinnova Partners, Supernova Invest, and Mérieux Equity Partners. Other existing investors included USVP, Sectoral, and VI Partners. New investors included the European Investment Bank, BNP Paribas Développement, Capricorn Partners, Critical Path Ventures, Pro Benefis Familiae, and SPRIM Global Investments Ltd.
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