About HighLife: Our Company and Vision for the Future

Stefan 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 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).

Malek 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.

Prof. 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 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 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.

Eric, 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.