Protembis to Sponsor Breakfast Symposium at TCT 2024
Protembis receives €20 million backing from the European Investment Bank
First Patient Enrolled in the PROTEMBO IDE Pivotal Trial
Protembis Completes €30M Financing and Adds Keith D. Dawkins to Board
European PROTEMBO C Trial Published in EuroIntervention Journal
FDA Approval of Pivotal Investigational Device Exemption (IDE) Study
Professor J Mocco to Join Protembis’ Board of Directors
Azin Parhizgar To Chair Protembis’ New Board of Directors
Protembis announces completion of 20 cases in European CE mark study
Protembis Successfully Closes $ 10 Million Series A Financing
Taking place at 6:30am on Monday October 28th during the TCT Congress, Protembis will sponsor a breakfast symposium co-Chaired by Dr Roxana Mehran (Mt Sinai Hospital, New York) and Dr Samir Kapadia (Cleveland Clinic, Cleveland). The faculty will present and discuss the current understanding of new brain injury that occurs during TAVR, the landscape of CEP devices, and the optimal clinical trial pathway to demonstrate safety and efficacy. It will be supplemented through informed panellist discussion and will also show two cases where the ProtEmbo CPS has been used to mitigate brain injury in the ongoing international randomised clinical trial.
About TCT
Founded by Dr. Martin B. Leon, the Transcatheter Cardiovascular Therapeutics® (TCT®) conference is the annual scientific symposium of the Cardiovascular Research Foundation® (CRF®) and the world’s foremost educational forum specializing in interventional cardiovascular medicine. Debuting as a small gathering of 150 in 1988, TCT® now attracts thousands of attendees from around the world. Every year, TCT® features major medical research breakthroughs and gathers leading researchers and clinicians from around the world to present and discuss the latest evidence-based research. The end goal: improving the survival and quality of life of patients suffering from heart and vascular disease.
The program directors, in collaboration with 40+ world-renowned thought leaders, have designed a comprehensive program to foster engagement and interactive case-based learning with a diverse lineup of faculty in multiple disciplines.
Contact:
Press contacts
EIB: Donata Riedel, d.riedel@eib.org,
tel.: +49 30 590 04 79-0, mobile: +49 151 14659021
Website: www.eib.org/press — Press Office: +352 4379 21000 — press@eib.org
Protembis GmbH
Conrad Rasmus & Karl von Mangoldt
+49(0)241 9903 3622
management[at]protembis.com
www.protembis.com
The European Investment Bank (EIB) is providing €20 million in venture-debt financing to German medical-technology company Protembis to develop a next-generation device for protecting the brains of patients who undergo certain heart treatments.
The funding is to support clinical trials, research, development and market access for the “ProtEmbo®” cerebral embolic protection system. ProtEmbo® is a filter device that deflects embolic material away from arteries to the brain during left-sided heart procedures including transcatheter aortic valve replacement (TAVR), countering risks including stroke and cognitive decline.
“This agreement demonstrates our commitment to supporting companies such as Protembis that aim to improve the health and well-being of European citizens. Their innovative technology, developed in Europe, will save patients who have to undergo heart surgery, from suffering grave side effects like cerebral embolic events”, said EIB Vice-President Nicola Beer.
The EIB accord with Protembis is supported by the InvestEU programme to trigger more than €372 billion in additional investment in new technologies until 2027. The deal is aligned with the InvestEU objective of promoting research, development and innovation.
“We are pleased to announce the signature of this agreement with the EIB,” said Protembis Co-Chief Executive Officers Karl von Mangoldt and Conrad Rasmus. “We would like to recognise the hard work, skill and professionalism of the EIB team while thanking our existing investors and our board for their unwavering belief in the benefits of this additional financing facility.”
TAVR is an x-ray guided procedure to replace an aortic valve that has narrowed and doesn’t open fully. TAVR is minimally invasive, meaning it uses smaller incisions than open-heart valve surgery. Globally, around 430,000 patients with severe aortic stenosis are expected to be treated with TAVR by 2025.
A significant complication of TAVR is the risk of dislodging debris that lines the aortic arch and the old aortic valve. This debris can travel to the brain via three major arteries that originate in the roof of the aortic arch. It can block the smaller vessels in the brain and create lesions, which may cause stroke or contribute to acceleration of cognitive decline.
ProtEmbo® is inserted during TAVR via the artery in the left wrist, and lines the roof of the aortic arch, shielding the brain from the dislodged debris.
In March 2024, Protembis completed a €30 million Series B financing round to advance a pivotal FDA approved Investigational Device Exemption study called the ProtEmbo® trial. The trial will enrol between 250 and 500 patients undergoing TAVR in Europe and the US. The study aims to show the superiority of ProtEmbo® by randomising against a hybrid control group: half of this control-group receiving no protection and half receiving the current predicate system called “Sentinel”.
Background information
The European Investment Bank (EIB) is the long-term lending institution of the European Union owned by its Member States. It makes long-term finance available for sound investment in order to contribute towards EU policy goals. Its key priorities are climate and the environment, development, innovation and skills, SMEs, infrastructure, and cohesion. It works closely with other EU institutions to foster European integration, promote the development of the European Union and support EU policies in more than 140 countries worldwide.
The InvestEU programme provides the European Union with crucial long-term funding by leveraging substantial private and public funds in support of a sustainable recovery. It also helps mobilise private investments for the European Union’s policy priorities, such as the European Green Deal and the digital transition. The InvestEU programme brings together under one roof the multitude of EU financial instruments currently available to support investment in the European Union, making funding for investment projects in Europe simpler, more efficient and more flexible. The programme consists of three components: the InvestEU Fund, the InvestEU Advisory Hub and the InvestEU Portal. The InvestEU Fund is implemented through financial partners that will invest in projects using the EU budget guarantee of €26.2 billion. The entire budget guarantee will back the investment projects of the implementing partners, increase their risk-bearing capacity and thus mobilise at least €372 billion in additional investment.
About ProtEmbo® and Protembis
The ProtEmbo® Cerebral Protection System is an intra-aortic filter device that protects the entire brain from embolic material liberated during transcatheter aortic valve replacement (TAVR). It is a low-profile non thrombogenic system that shields all cerebral vessels, delivered through the left radial artery for optimal placement and stability. This is an ideal access site enabling physicians to avoid interference with TAVR equipment typically delivered through the femoral artery.
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 during such procedures. The ProtEmbo® System is currently undergoing clinical investigations.
Contact:
Press contacts
EIB: Donata Riedel, d.riedel@eib.org,
tel.: +49 30 590 04 79-0, mobile: +49 151 14659021
Website: www.eib.org/press — Press Office: +352 4379 21000 — press@eib.org
Protembis GmbH
Conrad Rasmus & Karl von Mangoldt
+49(0)241 9903 3622
management[at]protembis.com
www.protembis.com
Protembis GmbH (Protembis) a privately-held emerging cardiovascular medical device company, announced today the enrollment of the first patient in the PROTEMBO Investigational Device Exemption (IDE) Pivotal Trial (NCT05873816). The trial will enroll between 250-500 randomized patients undergoing transcatheter aortic valve replacement (TAVR) in the USA and Europe with the ProtEmbo® System, an innovative next generation cerebral embolic protection device (CEP) providing complete 3-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 CEP and half receiving the Sentinel™ CEP (Boston Scientific, Marlborough, MA, USA), which covers just two of the three cerebral arteries that originate from the aortic arch. 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 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 designated Global Co-Principal Investigators, with Dr Roxana Mehran (Mount Sinai, NY, 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 Dr Mehran. “The results will give the physician community increased confidence in offering patients cerebral protection when they undergo their TAVR procedures”.
“We are proud to be the first center to enroll a patient into this innovative international study.”, said Dr 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 TAVR 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 organization, and core lab partners in planning this complex trial.”, said Karl von Mangoldt and Conrad Rasmus Co-CEOs of Protembis.
About ProtEmbo® and Protembis
The ProtEmbo® Cerebral Protection System is an intra-aortic filter device that protects the entire brain from embolic material liberated during transcatheter aortic valve replacement (TAVR). It is a low-profile non thrombogenic system that shields all cerebral vessels, delivered through the left radial artery for optimal placement and stability. This is an ideal access site enabling physicians to avoid interference with TAVR equipment typically delivered through the femoral artery.
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 during such procedures. The ProtEmbo® System is currently undergoing clinical investigations.
Contact:
Protembis GmbH
Conrad Rasmus & Karl von Mangoldt
+49(0)241 9903 3622
management[at]protembis.com
www.protembis.com
Protembis GmbH (Protembis), a privately-held emerging cardiovascular medical device company, announced today the completion of a € 30 million Series B financing round to support the enrollment of the PROTEMBO Investigational Device Exemption (IDE) Pivotal Trial (NCT05873816). The funding round was structured in two separate capital increases which have both been completed. It was 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 Karl von Mangoldt and Conrad Rasmus Co-CEOs of Protembis. “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 is proud to announce the addition of Keith D. Dawkins, MD, to the Board of Directors. Dr 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. Dr Dawkins has been the Chief Medical Officer (CMO) of Shockwave (NASDAQ:SWAV) since 2019, and this was preceded by his role as Global CMO at Boston Scientific (NYSE:BSX) where he held senior positions since 2008. He also serves as a member of the boards of Ventric Health LLC and JenaValve Technology Inc., as well as Chairman of InnovHeart s.r.l. Dr Dawkins will contribute his significant expertise to the clinical strategies of Protembis and the pre-commercial programs as the IDE study reaches its conclusion.
“To have such a visionary leader as Dr Dawkins join our Board of Directors is an exciting indication of the opportunities that cerebral embolic protection holds for future transcatheter therapies. We look forward to close collaboration as the field develops and our superiority trial gains momentum.”, said Azin Parhizgar, PhD, Chairwoman of the Board of Directors.
“As a long-term believer in the need to protect the brain from all new lesions during transcatheter aortic valve replacement, I am very pleased to join Protembis.”, said Dr Dawkins. “The ProtEmbo System and the clinical trial design are both novel and I am confident that they will be highly disruptive to the field of cerebral embolic protection, removing or mitigating many of the current issues that concern the physician community”.
About Protembis
The ProtEmbo® Cerebral Protection System is an intra-aortic filter device that protects the entire brain from embolic material liberated during transcatheter aortic valve replacement (TAVR). It is a low-profile non thrombogenic system that shields all cerebral vessels, delivered through the left radial artery for optimal placement and stability. This is an ideal access site enabling physicians to avoid interference with TAVR equipment typically delivered through the femoral artery.
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 during such procedures. The ProtEmbo® System is currently undergoing clinical investigations.
Contact:
Protembis GmbH
Conrad Rasmus & Karl von Mangoldt
+49(0)241 9903 3622
management[at]protembis.com
Protembis are proud to announce the publication of the final results from the European trial of the second generation ProtEmbo Cerebral Embolic Protection system. The study successfully demonstrated the safety of the system and its ability to reduce the burden of new cerebral lesions in patients undergoing Transcatheter Aortic Valve Replacement (TAVR) relative to historical data.
The study enrolled 64-patients and was run in 10 hospitals in Germany, Poland, and Latvia. Some key findings include:
- The incidence of MACCE in the enrolled population at 30-days was 4.7% (3/64), meeting the predefined Performance Goal (PG) for the primary safety endpoint (upper limit of 95% CI: 12.9% vs PG 25%; p=0.0001).
- Technical success was achieved in 95% of patients in whom the procedure was attempted (intention-to-treat population), achieving the predefined PG for the primary performance endpoint (lower limit of 95% CI: 86.3% vs PG 75.0%; p=0.0002).
- There were no patients who experienced a clinical stroke amongst those who received full procedural protection with ProtEmbo.
- Complete cerebral coverage was reported in 98.2% of patients; In the group of 51 patients who underwent baseline and acute follow-up Magnetic Resonance Imaging (MRI), 76.5% of patients were free of single lesions >150 mm³, and 94.1% were free of single lesions >350 mm³.
- The average time for device deployment was 4.7±4.4 minutes, and 84% of patients did not receive additional contrast for delivery of the ProtEmbo.
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 during such procedures. The ProtEmbo® System is currently undergoing clinical investigations and has not yet been approved for commercial use by a regulatory authority.
Contact:
Protembis GmbH
Conrad Rasmus & Karl von Mangoldt
Co-CEOs & Co-Founders
+49(0)241 9903 3622
management[at]protembis.com
Protembis GmbH (Protembis) a privately-held emerging cardiovascular medical device company, announced today the FDA has approved the PROTEMBO Pivotal IDE Trial (NCT05873816). The trial will recruit between 250-500 randomized patients undergoing TAVR in the USA and Europe with the next generation ProtEmbo’s complete 3-vessel cerebral artery protection aiming to show superiority against a hybrid control group: half receiving no CEP and half receiving the Sentinel CEP (Boston Scientific, Minneapolis, USA), which covers just two of the three cerebral arteries that originate from the aortic arch. The primary DW-MRI efficacy endpoint will use a novel adaptive statistical approach that includes pre-specified interim analyses with the possibility of early termination in the instance of superiority. The primary safety endpoint is the rate of major adverse cardiac and cerebrovascular events (MACCE) assessed at 30-days, with stroke neurologists adjudicating the neurological events.
“We are excited to embark on this landmark trial as it is the only randomized trial in the space that is designed to examine the superior effectiveness of a next generation CEP technology to the current standard of care.” Says Dr Roxana Mehran (Mount Sinai, New York) Chair of the Study Executive Committee. The trial will be led by Dr Susheel Kodali (New York Presbyterian Hospital, NYC), Dr Raj Makkar (Cedars Sinai, Los Angeles) and Dr Stephan Haussig (Dresden Herzzentrum, Dresden, Germany), as the designated Global Co-Principal Investigators.
“We are delighted to announce that the pivotal IDE trial has been approved by the US FDA. The Protembis team is working hard with our investigational sites, which are high volume TAVR centers and world-renowned academic centers of excellence, to ensure study activation is achieved expeditiously. The significant progress made reflects the close collaboration between our Global Steering Committee, our clinical research organization, and core lab partners in planning this complex trial.”, said Karl von Mangoldt and Conrad Rasmus Co-CEOs of Protembis.
In addition, Protembis has announced the acceptance of three ProtEmbo related presentations for the upcoming TCT Congress in San Francisco, USA (October 23-26). Firstly, the results of the ProtEmbo-C European CE-Mark clinical trial will be presented by Dr Darren Mylotte (Galway, Ireland). “On behalf of the ProtEmbo-C investigators, I am proud to present the final data, which demonstrates that ProtEmbo has the potential to offer a next generation device that is safe and intuitive. It covers all three cerebral vessels without interaction with the TAVR systems by leveraging a very low profile in the aortic arch with a robust anchoring mechanism, and it significantly reduces large clinically meaningful new cerebral lesions” says Dr Mylotte.
This presentation will be preceded, in the same dedicated CEP session, by the exploratory secondary endpoint DW-MRI data of the ProtEmbo-C trial presented by Dr Tobias Schmidt (Luebeck, Germany). Finally, to round out the scientific program for Protembis, there will be a Challenging Case presentation during the TCT Masters Session by Dr Felix Hofmann (Giessen, Germany) demonstrating the use of ProtEmbo to protect the brain of a patient who underwent a procedure to remove mitral vegetation.
About ProtEmbo and Protembis
The ProtEmbo System is an intra-aortic filter device that protects the entire brain from embolic material liberated during the TAVR procedure. It is a low-profile non thrombogenic system that shields all cerebral vessels, delivered through the left radial artery for optimal placement and stability. This is an ideal access site enabling physicians to avoid interference with TAVR equipment which is typically delivered through the femoral artery.
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 during such procedures. The ProtEmbo System is currently undergoing clinical investigations.
Contact:
Protembis GmbH
Conrad Rasmus & Karl von Mangoldt
Co-CEOs & Co-Founders
+49(0)241 9903 3622
management[at]protembis.com
Aachen, Germany, August 29, 2023 – Protembis GmbH (Protembis) a privately-held emerging cardiovascular medical device company, announced today the appointment of Professor J Mocco MD, MS, FAANS, FAHA of Icahn School of Medicine at Mount Sinai, NY, USA as an independent member of their Board of Directors.
Professor J MoccoProfessor Mocco brings a wealth of clinical and academic experience as the Kalmon D. Post Professor and Senior Vice Chair of the Department of Neurological Surgery at Mount Sinai and is the immediate past President of the Society of Neurointerventional Surgery. Over his distinguished medical career spanning more than 20 years, he has authorship credits on over 600 publications. He is an editorial board member of Stroke since 2015 and has served or is serving as an associate editor of other journals including Neurosurgery, the Journal of Neurointerventional Surgery, and ISNR Stroke.
In his new role on the Board of Protembis, Professor Mocco will offer insights into the strategic direction of the company with his deep knowledge and clinical insights of endovascular stroke diagnosis and management. He will offer guidance on clinical strategies and new product development.
“I have been impressed by the Protembis team’s achievements in developing an elegant system to mitigate cerebral infarction risk during Transcatheter Aortic Valve Replacement” says Professor Mocco. He continues: “Their adaptive IDE clinical trial strategy is both rigorous and innovative. I am excited to offer my insights and guidance to the Board as this field evolves to treat future aortic stenosis patients who will have zero tolerance for brain injury as a potential procedural complication”.
Protembis has recently received FDA approval to conduct an IDE study aimed at demonstrating safety and efficacy of the ProtEmbo® Cerebral Protection System (“ProtEmbo”) during transcatheter aortic valve replacement (“TAVR”). The ProtEmbo® System is an intra-aortic filter device that protects the entire brain from embolic material liberated during the TAVR procedure. It is a low-profile system that shields all cerebral vessels, delivered through the left radial artery for optimal placement and stability. This is an ideal access site enabling physicians to avoid interference with TAVR equipment which is typically delivered through the femoral artery. The IDE study is designed as a multicenter randomized controlled trial in the USA and Europe.
“To have such an eminent expert with deep experience in the field of stroke joining our Board, is a strong indication of the Protembis solution for cerebral embolic protection’s impact in the future of TAVR” say Karl von Mangoldt and Conrad Rasmus Co-CEOs of Protembis. “I am delighted to welcome Professor Mocco to the Board of Protembis and to have his insights and strategic guidance as we generate confirmatory clinical data and further advance the field of cerebral embolic protection with the ProtEmbo System for complete cerebral protection” adds Dr Azin Parhizgar, Chairwoman of the Protembis Board of Directors.
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 during such procedures. The ProtEmbo® System is currently undergoing clinical investigations.
Contact:
Protembis GmbH
Conrad Rasmus & Karl von Mangoldt
Co-CEOs & Co-Founders
+49(0)241 9903 3622
management[at]protembis.com
Protembis GmbH, a privately-held emerging cardiovascular medical device company, announced today the appointment of highly experienced and successful serial entrepreneur and medical device executive Azin Parhizgar (Ph.D.) as an Independent Member and Chairwoman of the Board of Directors.
Azin remains committed to the embolic protection field after her recent successes with Claret Medical. During her five years as President and CEO of Claret, she nurtured the company from its infancy to successful revenue generation with commercial sales in the U.S., Europe and other markets leading to a successful $270 million exit of the company to Boston Scientific Corporation.
Azin is currently also the Chairwoman of CVPath Institute, a Senior Venture Partner at 415 Capital, and a Board member at InnovHeart, CroíValve, Soundbite Medical Solutions, Moray Medical, among others. Prior to Claret Medical, Azin served as the COO of Conor Medsystems, which led to the acquisition of the company by Johnson & Johnson. Previously she held the position of Executive VP for Arterial Vascular Engineering (AVE), which was acquired by Medtronic.
She spent two years at Medtronic post-merger expanding her roles and responsibilities leading to her position as Executive VP of Emerging Ventures and New Technologies. Azin received both her Ph.D. in Cell, Gene and Tissue Engineering and her M.Sc. in Biomechanical Engineering and Artificial Organ Design from Brown University.
“It is both exciting and an honor for us that Azin has chosen to lead our Board of Directors as new Chairwoman,” said Karl von Mangoldt and Conrad Rasmus, Co-CEOs of Protembis. “Azin continues to be committed to this space and brings incredible experience in the field of embolic protection and medical devices to Protembis. We are delighted to have Azin’s insights and strategic advice as we generate additional clinical data and advance the development of the ProtEmbo System.”
“I have watched Protembis’ successes and this space over the past years. I am convinced that there is a need for a simple and effective next generation complete cerebral protection system” notes Azin Parhizgar. “Protembis has developed an intuitive and differentiated technology, and I am very much looking forward to joining this great group of people to support the company’s continued success and value creation.”
Protembis plans to conduct an IDE study aimed at demonstrating safety and efficacy of the ProtEmbo® Cerebral Protection System (“ProtEmbo”) during transcatheter aortic valve replacement (“TAVR”). The ProtEmbo® System is an intra-aortic filter device that deflects embolic material away from the brain during TAVR. It is a low-profile system which is delivered through the left radial artery for optimal placement and stability. This is an ideal access site enabling physicians to avoid interference with TAVR equipment which is typically delivered through the femoral artery. The IDE study is designed as a multicenter randomized controlled trial in the USA and Europe.
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 during such procedures. The ProtEmbo® System is currently undergoing clinical investigations and has not yet been approved for commercial use by a regulatory authority.
Contact:
Protembis GmbH
Conrad Rasmus & Karl von Mangoldt
Co-CEOs & Co-Founders
+49(0)241 9903 3622
management[at]protembis.com
Protembis GmbH, a privately held emerging medical device company, announced today the successful completion of 20 clinical cases in its European regulatory study of the ProtEmbo® Cerebral Protection System. The ProtEmbo® System is an intra-aortic filter device that deflects embolic material away from the brain during transcatheter aortic valve replacement (TAVR). The device is a low profile system which is delivered through the left radial artery, an ideal access site enabling physicians to avoid interference with TAVR equipment, typically delivered through the femoral artery.
Nikos Werner, M.D., Professor of Medicine, Head of Cardiology at the Heart Center Trier, Germany, and Principal Investigator in Germany commented: “Embolic protection in TAVR procedures has been shown to be effective in reducing the ischemic burden in the brain, but physicians look forward to next generation devices that are easy to use, cover all three potential access arteries to the brain, and can be simply and rapidly deployed without interfering with the TAVR procedure. The initial procedures with the ProtEmbo® System are very promising in this regard and show that the device can fulfil all of these criteria, with even smaller pores allowing effective protection of the brain.”
This new generation of the ProtEmbo® System has an improved frame shape and a dedicated ergonomic handle to facilitate push-pull and torque of the device during deployment and retrieval. The filter, using 60 micron pores, is self-positioning in the aortic arch across all three major cerebral arteries, maintaining blood flow to the brain. The filter surface is heparin-coated to avoid clot formation.
Dariusz Jagielak, M.D., Professor of Medicine, and his team at Medical University of Gdansk, Poland, have performed more than ten procedures with the device. He commented: “Recently, we presented the very first-in-human case at the PCR Valves e-Course in which the ProtEmbo® System was able to protect all three cerebral vessels from debris migration in a challenging TAVR procedure. Using the ProtEmbo® System is very intuitive because it is self-positioning across all three cerebral vessels and does not interfere with TAVR devices and accessories used during the procedure.”
Eberhard Grube, M.D., Professor of Medicine, Head of Center of Innovative Interventions in Cardiology at University Hospital Bonn, Germany, Consulting Professor at Stanford University School of Medicine and Clinical Advisor to Protembis, commented: “The ProtEmbo® System has shown to be intuitively designed for seamless integration into the TAVR workflow. I am excited about this device because it offers a simple and elegant solution for reducing the risk of stroke during TAVR.”
Co-CEOs of Protembis, Conrad Rasmus and Karl von Mangoldt, are pleased with the progress of the study and commented: “We believe that the full coverage cerebral protection of the ProtEmbo® System from even extremely small particles in combination with outstanding simplicity enabling rapid and easy deployment will offer physicians significant advantages over existing technologies.“
The objective of the European trial (PROTEMBO C Trial, NCT04618718) is to assess the safety and performance of the ProtEmbo® System used for embolic protection during TAVR compared to historical data. The trial is designed as a multi-center, single-arm study in 60 patients with severe symptomatic native aortic valve stenosis indicated for TAVR. Patients will undergo MRI assessments to evaluate the efficacy of the ProtEmbo® System.
About Protembis
Protembis is a privately-held, emerging medical device company that has developed the ProtEmbo® Cerebral Protection System. The company strives to offer 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 during those procedures.
Contact:
Protembis GmbH
Conrad Rasmus & Karl von Mangoldt
Co-CEOs & Co-Founders
+49(0)241 9903 3622
info[at]protembis.com
www.protembis.com
The Managing Directors and founders of Protembis GmbH, Karl von Mangoldt and Conrad Rasmus, have successfully closed a Series A financing round in a structured process.
A syndicate consisting of the US listed medical technology company Abiomed Inc., the Seed Fonds III for the region of Aachen and Mönchengladbach GmbH & Co. KG, coparion GmbH & Co. KG, as well as renowned family offices and internationally experienced angel investors, has invested in the Aachen-based medical technology startup Protembis GmbH. The company is developing a novel and innovative cerebral protection system that is designed to minimize the risk of stroke and other neurological injury, particularly during catheter-based heart valve implantations. Protembis has raised a total of $ 10 million in an oversubscribed Series A financing round and expects to bring its product to market maturity with this round.
ProtEmbo® Minimizes the Risk of Particle Migration to the Brain During Interventional Heart Procedures
Protembis has developed the „ProtEmbo® Cerebral Protection System“ – also called the „ProtEmbo®“ – to minimize the risk of stroke and other neurological injury in heart valve interventions. Nowadays, the calcified native aortic valve can be replaced by an artificial heart valve, which is advanced via a catheter into the left ventricle, i.e. to the site of the calcified native valve. This procedure is called transcatheter aortic valve implantation (also called „TAVI“ or „TAVR“). The heart valve prosthesis is opened, presses the old and defective native valve against the vessel wall and thus takes over its function. TAVI is a quicker and less invasive procedure and is conducted while the heart is beating; it is associated with less pain and a shorter hospital stay than the alternative open-heart surgery.
In both methods, however, there is a risk that calcific debris from the native heart valve or aorta is detached and then migrates to the brain via the bloodstream, where it can cause stroke or other neurological complications. The drugs used before, during and shortly after the heart valve procedure do not provide complete protection against this risk.
„Literally every TAVI intervention leads to particle migration to the brain“ says Karl von Mangoldt, co-managing director and co-founder of Protembis. „Recent clinical studies have shown that up to 9 percent of TAVI patients suffer a stroke“ adds Conrad Rasmus, also co-managing director and co-founder of Protembis. The Protembis team wants to minimize this risk with its novel device. The ProtEmbo® is a catheter-based filter device which is advanced intuitively, safely and quickly via the radial artery of the left arm before the start of a TAVI procedure and removed again at the end of the procedure in order to prevent the migration of particles to the brain. The permeable material of the filter covers all arteries leading to the brain while allowing free passage of blood cells and blocking even the smallest embolic particles. The filter is coated with heparin to prevent it from clotting during the procedure, as well as prevent thrombus formation on the filter surface. „Patient safety should always be our top priority,” says Dr. Thorsten Siess, Chief Technology Officer at Abiomed. “We see great potential in Protembis‘ technology to make TAVI neurologically safer and thus enable TAVI to be used in an even larger patient population“.
High Market Potential
„We see enormous potential for Protembis in this rapidly growing market segment, due to the demographic development and the associated increase in the number of minimally invasive heart valve interventions – and concomitant cerebral protection procedures“ says Markus Krückemeier, Managing Director of the management company of Seed Fonds III Aachen und Mönchengladbach. „The evidence for the clinical need and potential benefit of cerebral protection during TAVI has grown significantly in recent years – Protembis therefore addresses a strong clinical need“ adds Dr. Sebastian Pünzeler, Investment Manager at coparion.
ProtEmbo® has Already Been Successfully Used in Human Studies
Protembis has already successfully demonstrated the initial safety and feasibility of the ProtEmbo® in a first-in-human clinical study – the effectiveness of the technology was also shown. „We plan to conduct further clinical studies in renowned heart centers in Europe and the U.S.A. and want to bring the ProtEmbo® to market as quickly as possible“ says Oliver Schumacher, Chief Technology Officer at Protembis.
Contact
Protembis GmbH
Conrad Rasmus & Karl von Mangoldt
Co-CEOs & Co-Founders
+49(0)241 9903 3622
info[at]protembis.com
www.protembis.com