Protembis has announced the enrolment of the first patient in the PROTEMBO investigational device exemption (IDE) pivotal trial, investigating transcatheter aortic valve implantation (TAVI) procedures with the Protembo cerebral embolic protection (CEP) system.
The randomised trial will enrol between 250‒500 patients undergoing TAVI in the USA and Europe with the Protembo system. The device is designed to provide three-vessel coverage of the cerebral arteries.
The PROTEMBO study aims to show superiority of the Protembo System against a hybrid control group: half receiving no cerebral embolic protection and half receiving the Sentinel (Boston Scientific) device.
The primary diffusion-weighted magnetic resonance imaging (DW-MRI) efficacy endpoint will use a novel adaptive statistical approach that includes pre-specified interim analyses with the possibility of early study completion in the instance of superiority. The primary safety endpoint is the rate of major adverse cardiac and cerebrovascular events (MACCE) assessed at 30 days.
The trial will be led by Susheel Kodali (New York Presbyterian Hospital, New York, USA), Raj Makkar (Cedars Sinai, Los Angeles, USA) and Stephan Haussig (Herzzentrum, Dresden, Germany), as the designated global co-principal investigators, with Roxana Mehran (Mount Sinai, New York, USA) as the chair of the study executive committee.
“The novel adaptive statistical design of this clinical study will answer several important unanswered questions about the role of three-vessel cerebral protection in reducing new lesions in all areas of the brain,” said Mehran. “The results will give the physician community increased confidence in offering patients cerebral protection when they undergo their TAVI procedures.”
“We are proud to be the first centre to enrol a patient into this innovative international study,” said Kodali. “The requirement for DW-MRI assessment means that we will be able to accurately quantify the fundamental effect of the technology on reducing the size and frequency of new cerebral lesions, which are very common during the TAVI procedure.”
“We are delighted to announce that the first patient has been enrolled in the trial, and that we are executing a cadenced plan to activate the other investigational sites in the next few months. We would like to express our gratitude to the teams at the sites for the hard work that each has invested in the study startup phase. This significant progress reflects the close collaboration between our study executive committee, our clinical research organisation, and core lab partners in planning this complex trial,” said Karl von Mangoldt and Conrad Rasmus co-CEOs of Protembis.
The Protembo cerebral protection system is an intra-aortic filter device that protects the entire brain from embolic material liberated during TAVI. It is a low-profile non thrombogenic system that shields all cerebral vessels, delivered through the left radial artery.
The company has also announced the completion of a €30 million Series B financing round co-led by a European consortium of VC investors including Sweden-based Segulah Medical Acceleration, Italy-based XGEN Venture, and Germany-based TechVision Fund. Other investors include Coparion, several large family offices, angel investors and a multinational medical device strategic.
“We are delighted to announce the completion of the round and would like to thank our existing investors as well as the new investors for their trust and confidence.”, said Von Mangoldt and Rasmus. “It reflects the fact that the field of cerebral embolic protection is buoyant, and that future growth will be driven by younger and lower risk patients who have zero tolerance for brain injury risk when selecting to undergo transcatheter aortic valve replacement.”
Additionally, Protembis has added Keith D Dawkins to its board of directors. Dawkins has more than 35 years’ experience in the cardiovascular environment. With over 20 years as a practicing interventional cardiologist in the UK he has held research roles as a Fulbright Scholar at Stanford University, served as president of the British Cardiovascular Intervention Society, and authored more than 750 academic publications and presentations. Dawkins has been the chief medical officer (CMO) of Shockwave since 2019, and this was preceded by his role as global CMO at Boston Scientific where he held senior positions since 2008. He also serves as a member of the boards of Ventric Health and JenaValve Technology, as well as chairman of InnovHeart.
