AdjuCor GmbH has successfully completed the world's First-in-Human clinical trial for its reBEAT extravascular cardiac support system, a groundbreaking device that supports the heart by gently squeezing it from the outside without making contact with the blood. This milestone, supported by a grant from the European Innovation Council (EIC), demonstrated the device's safety and initial feasibility at three renowned European hospitals. The study's principal investigators were impressed with the system's ease of implantation, its positive impact on cardiac output, and its potential to reduce complications like stroke and bleeding, which are common with traditional devices. This successful trial represents a major step forward for AdjuCor, paving the way for a crucial U.S. study to evaluate reBEAT's effectiveness as a bridge to heart transplantation for up to 30 days.
MUNICH, Aug. 5, 2025 /PRNewswire-PRWeb/ -- AdjuCor GmbH, a leading innovator in advanced heart failure solutions, today announced the successful conclusion of its world's First-in-Human (FIH) clinical trial for the groundbreaking reBEAT extravascular cardiac support system, i.e. the reBEAT implant gently squeezes the heart from the outside, in synchrony with its natural rhythm. The study, designed to demonstrate the safety and initial feasibility of the reBEAT device, was conducted across three internationally renowned cardiac centers in Europe.
Patients in the study successfully underwent the reBEAT study procedure, involving the implantation and operation of the device, and evaluating short term support. This milestone represents a significant step forward for AdjuCor's unique technology, which aims to transform mechanical circulatory support by offering a non-blood-contacting, pulsatile, minimally invasive solution.
This project was generously supported with a grant from the European Innovation Council (EIC), underscoring the EIC's commitment to fostering breakthrough innovations that address critical healthcare challenges and have the potential for global impact.
"We are extremely satisfied with the clinical data from the reBEAT FIH study," said Stephan Schueler, M.D., Ph.D., Principal Investigator from NHS Newcastle upon Tyne Freeman Hospital in the UK. "This is an incredibly important step, providing invaluable insights and paving the way for the final crucial phase of clinical testing. There is no blood contact, avoiding the need for anticoagulation. The reBEAT device is pulsatile, allows biventricular support and is available in all heart sizes – great outlook for future trials. The potential for this extravascular technology to make a real difference for heart failure patients is immense."
Bastian Schmack, M.D., Ph.D., Principal Investigator from Hannover Medical School in Germany, commented on the procedural aspects, stating, "The reBEAT device's ease of implantation is truly remarkable. This simplicity will enable a small access site implantation like a mini-thoracotomy; it has the potential to shake things up significantly in the mechanical circulatory support space, offering a much-needed alternative to current approaches."
Christian Møller, M.D., Ph.D., Principal Investigator from Rigshospitalet in Copenhagen, highlighted advantages that this type of cardiac support holds: "We were particularly impressed by the immediate changes in cardiac output and improvement of AV valve function assessed by Echo. Combined with the ability to normalize interventricular balance, it presents a significant advantage. We foresee that this minimally invasive approach will enable patients to be mobilized much quicker, leading to faster discharge from the ICU and an improved recovery experience."
"This successful multicenter FIH trial is a landmark achievement for extravascular cardiac support," added Stephen Wildhirt, M.D., Ph.D., CEO & Co-Founder of AdjuCor GmbH. "The robust 30- and 60-day preclinical large animal data, combined with the invaluable clinical insights gained from this early feasibility study, decisively clears the way for our upcoming U.S. trial. This next study will focus on bridging patients to transplantation for up to 30 days, further validating reBEAT's potential to address critical unmet needs in advanced heart failure."
About AdjuCor GmbH and reBEAT
AdjuCor GmbH is the pioneering Medtech developer and manufacturer of the reBEAT cardiac support system, an innovative extravascular device designed to provide mechanical circulatory support to patients with advanced heart failure. Unlike traditional mechanical circulatory support devices, reBEAT operates externally to the blood flow, preventing direct blood contact. This unique feature holds significant potential to reduce common and severe complications such as stroke, bleeding, and infection, thereby improving patient outcomes and quality of life while addressing a severely underserved market in cardiac care.
About EIC
The European Innovation Council (EIC) is Europe's flagship innovation program that provides funding and support for high-impact projects in the fields of technology and innovation. The EIC supports projects with the potential to create jobs, improve quality of life, and drive economic growth.
Disclaimer
Co-funded by the European Union. Views and opinions expressed are, however, those of the author(s) only and do not necessarily reflect those of the European Union or granting authority. Neither the European Union nor the granting authority can be held responsible for them.
Media Contact
Dr. Hamman de Vaal, AdjuCor GmbH, 49 (0)89262049600, [email protected], www.adjucor.com
SOURCE AdjuCor GmbH
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