Protembis Announces Formation of New Scientific Advisory Board Comprised of World-Renowned Structural Heart Experts

Protembis, a privately-held emerging cardiovascular medical device company, announced today the establishment of a Scientific Advisory Board (SAB) to provide objective advice and contribute to the strategic plans of the company. Specifically, the SAB will provide overarching scientific and clinical strategic guidance, advise on emerging trends and opportunities, and provide expert counsel on scientific and clinical matters.

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The SAB will be comprised of four internationally recognized interventional cardiologists, who have made significant contributions to the understanding of the role for cerebral embolic protection (CEP) in transcatheter aortic valve replacement (TAVR): Dr Martin Leon MD, Dr Anita Asgar MD, Dr Samir Kapadia MD, and Dr Nicolas van Mieghem MD.

The SAB is chaired by Dr Martin Leon, Professor of Medicine at New York’s Columbia University Irving Medical Center and Chief Innovation Officer and the Director of the Cardiovascular Data Science Center for the Division of Cardiology. Dr. Leon has played a pivotal role in shaping the field of interventional cardiovascular medicine through his involvement in over 50 clinical trials. He has co-authored over 1550 publications and has directed or co-directed over 100 international educational programs focused on interventional cardiology. Dr. Leon's significant contributions to the medical community have been recognized with 10 international career achievement awards, and he has been awarded an honorary degree from the University of Athens.

“I have been impressed by the Protembis management and their innovative US 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,” said SAB Chair Dr Martin Leon.

Having recently moved from the Montreal Institute of Cardiology where she was medical director of the structural heart program, Dr Anita Asgar is an associate professor and the medical director for structural and interventional cardiology at Northwestern Medicine in Evanston/Chicago, USA. She has published and co-authored almost 200 scientific papers in peer-reviewed journals. Her research interests include the treatment and management of valvular heart disease and cost-effectiveness analyses.

Dr Samir Kapadia is chairman of cardiology in the Robert and Suzanne Tomsich Department of Cardiovascular Medicine in Cleveland. He is the author of more than 80 book chapters in medical textbooks on his specialty interests, and he has authored more than 800 articles in peer reviewed medical journals on his clinical experience. He is editor in chief for the Textbook of Interventional Cardiology. Dr Kapadia has been instrumental in the design and execution of the seminal CEP trials as the Co-Principal Investigator of the Sentinel IDE trial (Boston Scientific, Marlborough, MA, USA) and Principal Investigator of the PROTECTED TAVR Trial. Dr Kapadia is a fellow of the American College of Cardiology, European Society of Cardiology, Society of Vascular Medicine, and a member of the American Heart Association and Society of Thoracic Surgery.

Dr Nicolas Van Mieghem is a professor of medicine and the director of interventional cardiology at the Thoraxcenter Erasmus University Medical Center in Rotterdam. He has published and co-authored over 500 scientific papers in peer-reviewed journals. He was the Principal Investigator of the MISTRAL-C European Trial of the Sentinel™ device and has been author or co-author on almost 30 publications specifically in the field of CEP. He is a principal investigator and steering committee member in multiple ongoing international trials evaluating various coronary and transcatheter valve technologies. Dr Van Mieghem is a fellow of the European Society of Cardiology and the American College of Cardiology.

“We are pleased to announce the creation of this SAB with such a roster of global recognized thought leaders,” said Protembis Co-Chief Executive Officers Karl von Mangoldt and Conrad Rasmus. “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 enrolling patients in the PROTEMBO Pivotal IDE Trial (NCT05873816), which aims to show that the ProtEmbo^® System is superior to contemporary practice in reducing new cerebral lesion volume when assessed by Diffusion-Weighted MRI. The novel trial randomizes ProtEmbo against a hybrid control group: half receiving no CEP and half receiving the Sentinel™ device. The trial is led by Dr Roxana Mehran (Mount Sinai, NY, USA) as the Chair of the Study Executive Committee, with 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 Global Co-Principal Investigators.

About Protembis

Protembis is a privately-held emerging medical device company that has developed the ProtEmbo^® Cerebral Protection System. The company strives to provide a simple and reliable solution to protect patients from brain injury during left-sided heart procedures, improving patient quality of life and reducing overall healthcare costs associated with brain injury. The ProtEmbo^® System is currently undergoing clinical investigations.

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