HighLife

HighLife is a French medical device company focused on the development of transcatheter solutions for heart valve disease, with a particular emphasis on mitral regurgitation (MR), the most common valvular abnormality worldwide. The company was founded in 2010 in Paris by a multidisciplinary team of engineers, heart surgeons and interventional cardiologists: Georg Börtlein, Malek Nasr, Prof. Rüdiger Lange and Dr. Nicolo Piazza. Its mission is to deliver innovative, safe and effective treatment options that transform outcomes for patients living with mitral regurgitation. HighLife's flagship technology is the HighLife TSMVR (Trans-septal Mitral Valve Replacement) solution, a proprietary transcatheter mitral valve replacement system intended for the treatment of moderate to severe mitral regurgitation. The system is designed to be implanted in a beating heart, preserving the native valve structure and respecting the surrounding anatomy — a distinctive alternative in the TMVR space. The company manufactures its valves at a facility in Irvine, California, and operates across multiple geographies including Europe, the United States and Australia. It also has a license agreement with Peijia Medical in China. HighLife has achieved several regulatory and clinical milestones. Its TMVR solution received CE Mark approval, and the technology has been granted breakthrough device designation in the United States. In 2026 the company received CE Mark approval for its TMVR solution and subsequently for the Clarity Valve, a next-generation valve for the HighLife TMVR system. In September 2026 HighLife raised more than $90 million to start its US pivotal study and accelerate commercial expansion in Europe. The company continues to partner with physicians and clinicians to improve treatment outcomes for an extended patient population.

HighLife was founded in 2010 in Paris, France, by a multidisciplinary team of medical experts and innovators: Georg Börtlein (engineer), Malek Nasr (engineer), Prof. Rüdiger Lange (heart surgeon) and Dr. Nicolo Piazza (interventional cardiologist). The company was established with a mission to deliver innovative treatment options to patients suffering from heart valve diseases, with a specific focus on mitral regurgitation — the most common valvular abnormality worldwide. Soon after device development began, HighLife expanded with a facility in Irvine, California, where its valves are manufactured. After years of research and development, the company developed a transcatheter procedure in response to unmet treatment needs for patients with moderate to severe mitral regurgitation. Its proprietary HighLife valve technology is implanted in a beating heart, preserving the native valve structure and respecting the surrounding anatomy — a distinctive approach in the transcatheter mitral valve replacement (TMVR) space. HighLife's TMVR technology has received CE Mark approval as well as breakthrough device designation in the United States. The company also entered a license agreement with Peijia Medical in China, extending its reach into the Chinese market. HighLife is operational in multiple geographies across Europe, the United States and Australia. In 2026 the company reached several significant milestones. On January 26, 2026, HighLife received CE Mark approval for its TMVR solution. On August 27, 2026, it received CE Mark approval for the Clarity Valve, the next-generation valve for the HighLife TMVR system. On September 22, 2026, HighLife announced it had raised more than $90 million to start its US pivotal study and accelerate commercial expansion in Europe. The company continues to partner with physicians and clinicians to improve treatment outcomes in an extended patient population.

• 2026

  HighLife receives CE Mark approval for its TMVR solution (January 26).

• 2026

  HighLife receives CE Mark approval for the Clarity Valve, the next-generation valve for the HighLife TMVR system (August 27).

• 2026

  HighLife raises $90+ million to start its US pivotal study and accelerate commercial expansion in Europe (September 22).

• 2010

  HighLife founded in Paris, France, by Georg Börtlein, Malek Nasr, Prof. Rüdiger Lange and Dr. Nicolo Piazza.

• Company expands with a valve manufacturing facility in Irvine, California.

• HighLife TMVR technology receives breakthrough device designation in the United States.

• HighLife enters a license agreement with Peijia Medical in China.

Innovative transcatheter mitral valve replacement technology addressing unmet needs in moderate to severe mitral regurgitation.

• HighLife TSMVR System

  A trans-septal mitral valve replacement solution intended for the treatment of moderate to severe mitral regurgitation, implanted in a beating heart while preserving the native valve structure.

• Clarity Valve

  The next-generation valve for the HighLife TMVR system, which received CE Mark approval in 2026.

1. 1HighLife Medicalhighlifemedical.com
2. 2About HighLife Medical - Our Mission and Expertisehighlifemedical.com
3. 3HighLife (France) - Wikidatawikidata.org