HighLife granted US FDA Breakthrough Device Designation for its TMVR solution

Paris – April 7, 2025 – HighLife SAS, a leading MedTech company focusing on the development of a novel Trans-septal Mitral Valve Replacement (“TMVR”) system to treat patients suffering from moderate to severe Mitral Regurgitation (MR), announced today 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, CEO 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 population1. 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, TSMVR 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 precommercial stage company. It is focused on the development of a novel transcatheter replacement system for treating mitral regurgitation.

The TSMVR 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.

1 Burden of valvular heart diseases: a population base study. Nkomo VT et al.

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/

Caution: The HighLife Valves are investigational devices and not for sale in any geography.

Contact:

HighLife Medical

Amina Benkabou

abenkabou@highlifemed.com

Tel : +33 (0)1 72 32 21 2