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HighLife is a technology company.
HighLife develops a proprietary transcatheter valve technology for treating mitral regurgitation, offering an innovative replacement system designed to be implanted in a beating heart. This advanced procedure preserves the native valve structure while respecting the surrounding anatomy, providing a safe and effective treatment option for patients with heart valve diseases. The company is dedicated to transforming patient outcomes through its minimally invasive approach to addressing moderate to severe mitral regurgitation.
The company was founded in Paris, France, in 2010 by a multidisciplinary team including engineers Georg Börtlein and Malek Nasr, heart surgeon Professor Rüdiger Lange, and interventional cardiologist Dr. Nicolo Piazza. Georg Börtlein brought significant prior experience in transcatheter valve technology, having co-founded CoreValve, which was later acquired by Medtronic. The founders united with the insight to address the unmet treatment needs for mitral regurgitation patients through novel device development.
HighLife’s solution targets patients worldwide suffering from moderate to severe mitral regurgitation. The company's vision centers on delivering innovative treatment options globally, actively partnering with physicians and clinicians to continuously improve outcomes for an expanded patient population. With its technology currently undergoing clinical trials across Europe, the USA, and Australia, HighLife aims to fulfill a significant global medical need.
HighLife has raised $50.0M across 2 funding rounds.
HighLife has raised $50.0M in total across 2 funding rounds.
HighLife has raised $50.0M in total across 2 funding rounds.
HighLife's investors include Olivier Litzka, Casey Tansey, Soffinova Partners, Jose Calle Gordo, Sectoral Asset Management, LivaNova.
HighLife SAS is a Paris-based medtech company founded in 2010, specializing in a novel transcatheter mitral valve replacement (TMVR) system for treating moderate to severe mitral regurgitation (MR), a condition affecting over 2% of the population where the mitral valve leaks blood backward, risking heart failure.[1][4] The technology enables a less invasive, beating-heart procedure via trans-septal access, reducing patient trauma compared to open-heart surgery, and targets high-risk patients with limited options.[1][4] Backed by Sofinnova Partners as a lead investor, HighLife serves cardiologists and patients globally, with ongoing clinical trials in Europe, Asia-Pacific, and the US, including FDA IDE approval for a pivotal study and Breakthrough Device Designation in April 2025, signaling potential to become a standard of care.[1][4]
The company demonstrates strong growth momentum: ISO 13485 certification, a new CEO (Stefan Pilz), Chief Medical Officer appointment (Prof. Stephen Brecker), a Large Annulus Valve launch, and FDA Breakthrough status expediting development and review for unmet needs.[1][4]
HighLife SAS was established in 2010 as an early-stage medtech venture, headquartered in Paris with offices in Irvine, California, focused from inception on pioneering transcatheter solutions for mitral regurgitation.[1] Key details on founders are not specified in available sources, but the company's emergence aligns with advances in minimally invasive cardiac interventions, addressing gaps in treatments for high-surgical-risk patients.[1][4] Pivotal early traction includes investment from Sofinnova Partners' Capital and MD Start strategies, which support medtech accelerators and groundbreaking therapies.[1]
Clinical progress accelerated with IDE approval for a US pivotal study, leadership hires like CEO Stefan Pilz and CMO Prof. Stephen Brecker, and the 2025 FDA Breakthrough Device Designation, validating its novel TMVR system's potential.[1][4]
HighLife rides the wave of transcatheter heart valve innovations, expanding from aortic (TAVR) to mitral (TMVR) therapies amid rising MR prevalence due to aging populations and improved diagnostics.[4] Timing is ideal: MR affects millions with few options for inoperable patients, and TMVR addresses this unmet need less invasively, potentially reducing heart failure burdens.[1][4] Market forces like FDA prioritization via Breakthrough Designation and global trials favor rapid adoption, influencing the ecosystem by setting TMVR standards and attracting investment in structural heart medtech, backed by leaders like Sofinnova.[1][4]
HighLife is poised for FDA approval post-pivotal US trial, potentially launching as a TMVR leader by late 2020s, with trends like AI-guided implants and expanded indications shaping growth.[4] Its influence may evolve to dominate high-risk MR treatments, partnering with hospitals worldwide and inspiring next-gen devices, cementing its role in transforming cardiac care from HighLife's innovative origins.[1][4]
HighLife has raised $50.0M across 2 funding rounds. Most recently, it raised $36.0M Series B in January 2019.
| Date | Round | Lead Investors | Other Investors |
|---|---|---|---|
| Jan 1, 2019 | $36.0M Series B | Olivier Litzka, Casey Tansey | Soffinova Partners, Jose Calle Gordo, Sectoral Asset Management |
| Oct 1, 2017 | $14.0M Series A | Soffinova Partners | LivaNova |