Paris, April 7, 2025 – HighLife SAS, a leading MedTech company focusing on the development of a unique Trans-septal Mitral Valve Replacement (“TMVR”) system to treat patients suffering from moderate to severe mitral regurgitation (MR), announced today that that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to its TMVR solution.

The FDA’s Breakthrough Device Program is designed to speed up the development and review of devices that offer substantial improvement over current treatments or diagnostics for serious conditions and address unmet medical needs. This designation provides companies with access to more frequent interactions with the FDA, facilitating a faster path to approval and the potential for earlier access to innovative medical devices for patients and healthcare providers.

Stefan Pilz, Chief Executive Officer of HighLife, said "We are honored to receive the breakthrough device designation by the FDA. HighLife has made significant clinical progress and is addressing a huge unmet clinical need. This designation recognizes the potential of HighLife to become the standard of care in mitral regurgitation treatment once FDA approved and deployed."

Mitral Regurgitation is a growing public health concern, affecting over 2% of the total population(1). It refers to a condition in which the valve between the heart’s left chambers (the mitral valve) does not close completely, allowing blood to leak back across it, rather than continuing to supply the organs with oxygenated blood. Without proper treatment, severe Mitral Regurgitation can cause major heart problems or even lead to heart failure. Limited treatment options are available for many patients at high surgical risk, TMVR solutions offer a less invasive alternative to traditional open-heart surgery.

The HighLife technology is under investigation in clinical studies in Europe, Asia-Pacific and the USA. The company received an IDE approval from the FDA to initiate a US Pivotal study.

About HighLife

HighLife SAS, headquartered in Paris, France, with facilities in Irvine, California, is a pre-commercial stage company. It is focused on the development of a novel transcatheter replacement system for treating mitral regurgitation.  The TMVR solution developed by HighLife consists of a valve-in-ring concept, both ring and valve being implanted percutaneously. The technology is implanted in a simple, 3-step procedure. The valve is deployed in a beating heart, reducing trauma to the patients. It is currently evaluated in clinical studies across three continents.  HighLife is backed by international investors: Sofinnova Partners, Andera Partners, VI Partners, USVP and Sectoral Asset Management. For more information, visit https://www.highlifemedical.com/

About Vi Partners

Vi Partners is the longest-established venture capital firm in Switzerland. For over 20 years, Vi Partners has supported innovative technology and healthcare companies, investing over CHF 350 million in 72 startups. Vi Partners-managed funds are backed by some of Switzerland’s most prominent companies and institutions, including ETH Zurich, ABB, Bühler, Credit Suisse, Hilti, McKinsey, Nestlé, Schindler, Sulzer, Suva, and ZKB, as well as the European Investment Fund and many other institutional investors.