Protembis Forms Scientific Advisory Board of Leading Heart Experts
Protembis, a privately-held cardiovascular medical device company, has announced the establishment of a Scientific Advisory Board (SAB) to provide strategic guidance and expert counsel on scientific and clinical matters. The SAB will assist in shaping the company’s overarching scientific direction, advising on emerging trends, and contributing to strategic planning.
The newly formed SAB consists of four internationally recognized interventional cardiologists who have played a significant role in advancing cerebral embolic protection (CEP) in transcatheter aortic valve replacement (TAVR). The distinguished members include Dr. Martin Leon, Dr. Anita Asgar, Dr. Samir Kapadia, and Dr. Nicolas van Mieghem.
Dr. Martin Leon, who will chair the SAB, is a Professor of Medicine at Columbia University Irving Medical Center in New York. He is also the Chief Innovation Officer and Director of the Cardiovascular Data Science Center for the Division of Cardiology. Throughout his career, Dr. Leon has been a key figure in shaping interventional cardiovascular medicine, having contributed to over 50 clinical trials and co-authored more than 1,550 publications. He has also directed or co-directed over 100 international educational programs in interventional cardiology. His contributions have earned him ten international career achievement awards and an honorary degree from the University of Athens.
Expressing his enthusiasm for the new role, Dr. Leon stated, “I have been impressed by the Protembis management and their innovative U.S. pivotal clinical trial design that utilizes MRI endpoints. I am looking forward to collaborating with the other members of the SAB to advise on the technology’s future evolution as the field of TAVR expands into lower-risk, asymptomatic, and younger patients.”
Dr. Anita Asgar, another key member of the SAB, has recently transitioned from the Montreal Institute of Cardiology, where she was the medical director of the structural heart program, to her current role as associate professor and medical director for structural and interventional cardiology at Northwestern Medicine in Evanston/Chicago, USA. With nearly 200 scientific papers published in peer-reviewed journals, Dr. Asgar’s research primarily focuses on valvular heart disease treatment and cost-effectiveness analyses.
Dr. Samir Kapadia serves as chairman of cardiology in the Robert and Suzanne Tomsich Department of Cardiovascular Medicine in Cleveland. He is a renowned expert in interventional cardiology, having contributed over 800 articles to peer-reviewed medical journals and authored more than 80 book chapters in medical textbooks. As the editor-in-chief for the Textbook of Interventional Cardiology, Dr. Kapadia is widely regarded as a leader in the field. He played a critical role in designing and executing key CEP trials, serving as Co-Principal Investigator of the Sentinel IDE trial (Boston Scientific) and Principal Investigator of the PROTECTED TAVR Trial. He is also affiliated with the American College of Cardiology, European Society of Cardiology, Society of Vascular Medicine, American Heart Association, and Society of Thoracic Surgery.
Dr. Nicolas van Mieghem, a professor of medicine and director of interventional cardiology at the Thoraxcenter Erasmus University Medical Center in Rotterdam, brings extensive expertise in coronary and transcatheter valve technologies. He has authored and co-authored over 500 scientific papers in peer-reviewed journals, including nearly 30 publications specific to CEP. Dr. van Mieghem was the Principal Investigator of the MISTRAL-C European Trial for the Sentinel™ device and has been actively involved in multiple ongoing international trials. He is a fellow of both the European Society of Cardiology and the American College of Cardiology.
Commenting on the formation of the SAB, Protembis Co-Chief Executive Officers Karl von Mangoldt and Conrad Rasmus expressed their enthusiasm: “We are pleased to announce the creation of this SAB with such a roster of globally recognized thought leaders. To be able to cooperate closely with the members and to benefit from their extensive clinical and strategic knowledge is a privilege. Their guidance will be critical as we map our strategic path forward.”
Protembis is currently conducting the PROTEMBO Pivotal IDE Trial (NCT05873816), designed to demonstrate the superiority of the ProtEmbo® System in reducing new cerebral lesion volume as assessed by Diffusion-Weighted MRI. This innovative trial follows a unique approach by randomizing ProtEmbo against a hybrid control group—half of the patients receive no CEP, while the other half receive the Sentinel™ device. The trial is being led by Dr. Roxana Mehran (Mount Sinai, NY, USA) as the Chair of the Study Executive Committee, with global Co-Principal Investigators Dr. Susheel Kodali (New York Presbyterian Hospital, NY, USA), Dr. Raj Makkar (Cedars Sinai, Los Angeles, CA, USA), and Dr. Stephan Haussig (Herzzentrum, Dresden, Germany).
As the field of TAVR continues to evolve, expanding into lower-risk and younger patient populations, Protembis is committed to refining its CEP technology and strengthening its research efforts. The newly formed SAB will play a crucial role in advising on the company’s ongoing clinical trials, product development, and strategic initiatives, ensuring that Protembis remains at the forefront of innovation in cardiovascular medicine. The company’s commitment to advancing CEP technologies is reflected in its strategic collaborations with world-renowned experts, reinforcing its position as a leader in the field.
The expertise brought in by the SAB members will significantly impact the company’s approach to improving patient outcomes, refining procedural safety, and optimizing long-term efficacy in TAVR procedures. With its continued focus on innovation and clinical excellence, Protembis is poised to make substantial contributions to the field of interventional cardiology, ultimately benefiting patients worldwide.
In conclusion, the establishment of the Scientific Advisory Board marks a significant milestone for Protembis. With the guidance of leading experts, the company is well-positioned to navigate the evolving landscape of cardiovascular interventions, particularly in the realm of cerebral embolic protection. The ongoing PROTEMBO Pivotal IDE Trial and future strategic initiatives will further solidify Protembis’ commitment to advancing medical technologies that enhance patient safety and improve clinical outcomes.
