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.