About HighLife: Our Company and Vision for the Future
Our Company
HighLife is driven by a mission to deliver innovative treatment options to patients suffering from heart valve diseases. In particular, our company is dedicated to the development of innovative solutions that provide safe and effective treatment options focusing on the transformation of patient outcomes for people living with Mitral Regurgitation.
The company 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). Soon after device development started, the company expanded with a facility in Irvine, California, where the valves are manufactured.
After years of research & development, HighLife medical has developed a transcatheter procedure in response to today’s unmet treatment needs for patients with moderate to severe Mitral Regurgitation. In a groundbreaking approach to treating this condition, the proprietary HighLife valve technology is implanted in a beating heart, preserving the native valve structure and respecting the surrounding anatomy.
Our goal is to deliver this transcatheter treatment to eligible patients around the world, meeting grossly underserved needs. By partnering with physicians and clinicians, we are constantly improving treatment outcomes in an extended patient population.
HighLife is now operational in multiple geographies in Europe, the USA and Australia, where the technology is being assessed in clinical trials. HighLife also has a license agreement with Peijia Medical in China.
Meet our team
Jose Calle Gordo
ChairmanJose (Pepe) Calle Gordo is a global medical device executive with over 35 years of business and management experience. Currently Jose is an operating partner at Valiance, a venture growth investment firm in London. He also serves as non-executive board member at SMT medical, JenaValve, FEOPs, LungPacer and Laminate Medical.
Before joining HighLife as Chairman he served as CEO of Biosensors International, an interventional cardiology company. Previously he held several leadership roles at Abbott Vascular and Guidant where he led the commercialization of Mitraclip and the development and commercialization of the drug eluting stent Xience Program. Jose started his career at Eli Lilly where he had a number of commercial roles with growing responsibility in the field of cardiac devices.
Jose is a Spanish national and currently lives with his family in the UK. Jose Calle Gordo holds an electrical engineering degree (MSc) from the Universidad Politecnica de Madrid, Spain.
Stefan Pilz
CEOStefan Pilz brings more than 20 years of experience in commercial leadership roles in the field of interventional cardiology and heart surgery. Before joining HighLife, Stefan held several leadership positions at Johnson & Johnson, Abiomed, HeartWare and Biotronik, building and managing high performing teams.
Most recently, he was Chief Commercial Officer at Abiomed, now part of Johnson & Johnson Med Tech, overseeing the global commercial organization where he was responsible for the growth strategy, geographic expansion and market development in the US, Europe, Middle East and Asia. After a successful merger with Johnon & Johnson in December 2022 Stefan led and completed the integration of Abiomed’s commercial organization.
Prior to Abiomed, Stefan led the European commercial organization and distribution partners for HeartWare, which was successfully acquired by Medtronic in 2016. Stefan initiated his MedTech career at Biotronik where he held various global and regional roles within the commercial, marketing and business development organizations.
Stefan holds a Master Degree in Mechanical Engineering and Business Studies from BHT University Berlin.
Georg Börtlein
FounderGeorg Börtlein graduated in 1991 as a mechanical engineer from Ecole Centrale Paris (France). He started his career in the banking industry where he developed a strong financial background. In 1998, he joined a cardiac surgeon and started several medtech ventures.
Among those, he co-founded CoreValve in 2001 to develop a trans-catheter aortic valve replacement technology (TAVR). The company was acquired by Medtronic in 2009 for $700+ million.
In 2010, he joined a cardiac surgeon and an interventional cardiologist to form HighLife developing a trans-septal mitral valve replacement technology (TSMVR).
Olivier Litzka
Board MemberDr. Litzka is partner at Andera Partners. He joined the Life Sciences Team of Paris based Andera Partners (formerly Edmond de Rothschild Investment Partners) in 2006, and since then contributed to grow the firm to a leading European Venture Capital player in the sector. Before that, he worked from 2000 to 2006 with 3i in its Venture Life Sciences team, initially based in Munich, then in Paris. Prior to that, Olivier was a consultant with Mercer Management Consulting in Munich and Paris.
Olivier holds a PhD in Biology from the Munich Institute for Genetics and Microbiology and has performed his scientific research in Munich and Oxford University.
Malek Nasr
VP Therapy Development and Co-founderMalek Nasr co-founded HighLife with Georg Börtlein in 2010. He now serves as Vice President for Therapy Development, leading Clinical Support, Physician training and Marketing for HighLife.
When creating the company, Malek first led the product development from the very early concept stage, through iterative prototyping of mitral valve repair then replacement prototypes, to the preclinical proof-of-concept of the HighLife System in animal models. While leading R&D and production teams for HighLife, Malek adapted the devices to human anatomies and was heavily involved in initiating the First in Human and the first implantations. He then established the clinical procedure with proctors and global Key Opinion Leaders.
Malek holds a Biomedical Engineering degree from UTC (Université de Technologie de Compiègne), France.
Stephen Brecker
Chief Medical OfficerProf. Brecker brings over 30 years of extensive clinical and leadership experience in both general and interventional cardiology. Prof. Brecker is Consultant Cardiologist at Mayo Clinic Healthcare in London, UK and holds Honorary Consultant Cardiologist status at St. George’s University Hospitals NHS Foundation Trust. He has held numerous leadership positions at St. George's Hospital, including Chief of Cardiology Clinical Academic Group and Director of the Cardiac Catheterization Laboratories. Prof. Brecker has been active in research and education throughout his career, participated in numerous innovations in the Cardiology field and developed an interventional guidewire for use in transcatheter procedures now used by physicians worldwide. Prof. Brecker has published numerous books and book chapters and has more than 175 peer-review publications.
Steve Backer
Chief Operations OfficerSteve Backer joined HighLife as Chief Operations Officer in January 2020. He provides leadership for both the Research and Development and Global Supply Chain organizations. Steve has over 25 years of experience in the medical device industry and brings a wealth of expertise across multiple functions and technologies.
Prior to HighLife, Steve spent more than 20 years in various technical and leadership roles at Edwards Lifesciences Corporation. His most recent position at Edwards was in the Global Supply Chain organization as the Senior Director, Pilot Manufacturing.
Steve earned his Bachelor of Science in Mechanical Engineering from the University of California, Los Angeles (UCLA). He also holds an MBA from The Marshall School of Business at the University of Southern California (USC).
Margaret Kayo
VP Regulatory AffairsMargaret Kayo joined HighLife Medical in 2018 and serves as the Vice President of Regulatory affairs. Dr. Kayo has extensive experience in management of complex global products.
She has a demonstrated record of developing innovative solutions to challenging regulatory hurdles taking early development programs through market approval and commercialization in multiple jurisdictions across five continents.
Margaret holds an MBA from the University of California-Irvine, where she focused on strategy, and BSc, MSc, and PhD degrees from the University of Florida Materials Sciences and Engineering Department, with her dissertation research centered on drug delivery from and novel surface modification of implantable biomaterials.
Margaret also currently serves as the Vice Chair of the Executive Advisory Board at University of Florida’s Materials Sciences and Engineering Department.
Martin Rothman
Board MemberEx-VP Medical Affairs Medtronic, interventional cardiologist.
Dr. Rothman was Vice President of medical affairs for coronary, structural heart and renal denervation, for Medtronic, based in Santa Rosa (CA), from 2010 to his retirement. He was involved in the development of the renal denervation program and the innovative Spyral™ renal denervation catheter, TAVR, and the Medtronic percutaneous mitral regurgitation program, including Twelve and development of its Intrepid TMVR product and associated clinical strategy.
Dr. Rothman trained as an interventional cardiologist in Bart Hospital Trust, UK. Then, as a world-renowned interventional cardiologist, he worked for the UK National Health Service for almost 40 years, with the last decade spent as director of cardiac research and development at the London Chest Hospital. He developed its interventional cardiology training program and was responsible for training about one-third of all the interventional cardiologists practicing in the UK today. He has also been a leading investigator in research involving drug-eluting coronary stents and cardiac stem-cell treatment, and helped develop intravascular ultrasound technology.
Antoine Papiernik
Board MemberAntoine Papiernik is Chairman and Managing Partner at Sofinnova Partners, which he joined in 1997. Antoine actively invests for the firm's Capital Funds. He has been an initial investor and active board member in several public companies, including Actelion, ProQR, Shockwave Medical, NovusPharma (sold to CTI), and Movetis (sold to Shire). Trade sale successes include CoreValve (sold to Medtronic), Fovea (sold to Sanofi Aventis), Ethical Oncology Science (EOS, sold to Clovis Oncology) and Recor Medical (sold to Otsuka). He has also invested in and is a board member of private companies Reflexion Medical, Tissium, PiCardia, SafeHeal, Noema Therapeutics, May Health, Highlife and Inspirna (formerly Rgenix). Antoine has an MBA from the Wharton School of Business, University of Pennsylvania. He has been selected twice for the Forbes Midas List, an annual ranking recognizing the world’s top venture capital investors. Antoine is one of the few European and life science investors on the prestigious list.
Eric Simon
VP of Quality AssuranceEric, a U.S. Marine Corps veteran, joined HighLife Medical in 2019 and serves as the Vice President of Quality Assurance. He brings over 20 years of experience in Quality, Regulatory Affairs, Operations and R&D. He previously served as the Head of Regulatory Affairs and Quality Assurance for Sonendo and has served in various Quality and Engineering roles for Medtronic, Abbott Vascular, and Guidant where he played a key role in the development and manufacturing of the XienceTM Drug Eluting Stent.
Eric holds a BS in Manufacturing Design Engineering from National University, a MS in Regulatory Affairs from Northeastern University, and a Certificate in Pharmaceutical Engineering from California State University, Fullerton.
Casey Tansey
Board MemberCasey is General Partner at USVP. He brings over 25 years of entrepreneurial, early-stage medical device and seasoned operating experience.
Casey's passion is to strive for delivery of medical services with less trauma to the patient and improved quality of life. Innovations shaping this trend include minimally-invasive technologies. During his tenure as CEO and President of Epicor Medical from 2001 to 2004, Casey, along with a dedicated team, pioneered a minimally-invasive treatment for atrial fibrillation and transformed the company into a recognized market leader, and he led Epicor's acquisition by St. Jude Medical.
Prior to Epicor, Casey was CEO and President of Heartport, a public company that helped pioneer minimally-invasive cardiac surgery which is now a Johnson & Johnson company. Before that, he was with Baxter Edward's Cardiovascular Division for nearly ten years, holding various sales and marketing positions. During his tenure at Baxter, Casey was involved in launching innovative heart valve products that have grown to be the market leaders.