Latest news with #WilliamCohn
Business Wire
06-08-2025
- Business
- Business Wire
BiVACOR Total Artificial Heart Accepted into FDA's Total Product Life Cycle (TAP) Program
HUNTINGTON BEACH, Calif.--(BUSINESS WIRE)--BiVACOR, Inc., a clinical-stage medical device company developing the world's first titanium Total Artificial Heart (TAH), today announced that its TAH System has been accepted into the U.S. Food and Drug Administration's (FDA) prestigious Total Product Life Cycle (TPLC) Advisory Program, also known as the TAP program. This milestone further solidifies BiVACOR's collaboration with the FDA following the TAH's earlier recognition this year as a Breakthrough Device. This isn't just a vote of confidence in BiVACOR, it's a vote of confidence in the future of heart replacement technology. The TAP program gives us the opportunity to collaborate with the FDA at a level that aligns with urgency and magnitude of our mission. Share The TAP program is a transformative FDA initiative designed to accelerate the development and patient access to high-impact medical technologies. Entry into the program provides BiVACOR with proactive, strategic engagement with the FDA throughout the entire product life cycle, from development to commercialization, supporting more efficient, risk-informed decision-making. TAP participation is reserved for breakthrough-designated devices with the potential to significantly improve patient outcomes for serious or life-threatening conditions. 'Acceptance into the TAP program marks a major milestone not just for BiVACOR, but for the field of mechanical circulatory support as a whole,' said Daniel Timms, Founder and Chief Technology Officer of BiVACOR. 'The BiVACOR TAH has the potential to fundamentally redefine the standard of care for patients with end-stage heart failure. TAP access gives us a powerful framework for working hand-in-hand with the FDA to bring this technology to the patients who need it most.' The BiVACOR TAH is intended for use as a bridge to transplant in adults with severe, irreversible biventricular or univentricular heart failure, particularly for patients who cannot be treated with traditional left ventricular assist devices (LVADs). The system employs a magnetically levitated centrifugal pump, inspired by space and industrial technologies, which provides continuous, pulsatile, and physiologically responsive cardiac support. The FDA's acceptance letter to BiVACOR emphasized that the TAP program's inclusion reflects the agency's confidence in the technology's potential to transform clinical practice. As part of the program, BiVACOR will receive more regulatory guidance, earlier identification of scientific and evidentiary gaps, and greater coordination among stakeholders, including payers and patient advocacy groups. 'This isn't just a vote of confidence in BiVACOR, it's a vote of confidence in the future of heart replacement technology,' said William Cohn, MD, BiVACOR Chief Medical Officer and renowned cardiac surgeon. 'The TAP program gives us the opportunity to collaborate with the FDA at a level that aligns with the urgency and magnitude of our mission to bring a durable, fully implantable artificial heart to patients with no other options.' The TAP program was established as part of the FDA's efforts to modernize device development oversight and ensure the U.S. remains at the forefront of medical innovation. The program currently operates as a pilot under the Center for Devices and Radiological Health (CDRH), with acceptance based on strict criteria outlined in the Federal Register (87 FR 61605). BiVACOR's participation in TAP follows several recent milestones for the company, including its first-in-human implant as a bridge to support a patient awaiting a cardiac transplant. The company is now progressing toward expanded clinical trials in the U.S. and internationally. For more information on the FDA's TAP program, visit: Participation in the FDA's Total Product Life Cycle Advisory Program (TAP) does not imply FDA approval, clearance, or authorization. Inclusion in the TAP Pilot does not guarantee future marketing authorization or a regulatory outcome. The BiVACOR TAH is currently used as an investigational device and is not approved for commercial use. About BiVACOR BiVACOR ® is a clinical-stage medical device company developing a fully implantable, magnetically levitated Total Artificial Heart for long-term support of patients with end-stage biventricular heart failure. Founded by biomedical engineer Daniel Timms, PhD, and backed by leading experts in cardiovascular medicine including Dr. William E. Cohn and Dr. O.H. (Bud) Frazier, the company is conducting an FDA-approved Early Feasibility Study in the U.S. Headquartered in Huntington Beach, CA, with clinical operations in Houston and engineering offices in Gold Coast, Australia, BiVACOR is committed to addressing the global shortage of donor hearts through advanced, scalable technology. Learn more at
Yahoo
30-05-2025
- Business
- Yahoo
BiVACOR's Total Artificial Heart Receives FDA Breakthrough Device Designation
Clinical-stage company earns key regulatory milestone as it advances a first-of-its-kind heart replacement system toward wider use. HUNTINGTON BEACH, Calif., May 30, 2025--(BUSINESS WIRE)--BiVACOR, a clinical-stage medical device company developing the world's first titanium Total Artificial Heart (TAH), today announced that its device has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). The designation supports the BiVACOR TAH as a bridge to transplant (BTT) for adults with severe biventricular or univentricular heart failure where current treatments, including LVADs, are not viable. The FDA's Breakthrough Device program is reserved for technologies that may significantly improve outcomes for patients with life-threatening or irreversibly debilitating conditions. It offers priority regulatory interaction and accelerated pathways to approval. "This is more than a regulatory milestone. It's a validation of a concept we've spent decades proving that a fully implantable, total artificial heart isn't just possible, it's necessary," said Daniel Timms, PhD, Founder and Chief Technology Officer of BiVACOR. "Patients with biventricular failure have been overlooked for too long. The early results from our clinical trial show that we can give them a second chance, without the compromises of older technologies. The Breakthrough Device Designation puts us on a faster track to deliver exactly that." The milestone follows the first phase of BiVACOR's FDA Early Feasibility Study, where five patients in the U.S. received the TAH between July and November 2024. Based on positive safety and performance data, the FDA approved the expansion of the trial to include 15 additional patients starting later this year. BiVACOR's device represents a new category in artificial heart technology. Compact enough to fit most men and women, the TAH uses magnetic levitation, similar to maglev trains, to suspend a single dual-sided rotor. This rotor simultaneously powers the right and left circulatory systems, mimicking the natural heartbeat without valves or mechanical wear points. Its simplified design allows for pulsatile flow, large blood gaps to reduce trauma, and long-term durability. "We've seen every kind of artificial heart technology over the last four decades, but this is the first system I've encountered that combines engineering elegance, efficiency, and safety with true clinical viability," said William Cohn, MD, BiVACOR Chief Medical Officer and heart surgeon at the Texas Heart Institute. "The early results are remarkable with no strokes, no device-related complications, and a safety profile unlike anything in this space. With Breakthrough status in hand, we're entering the next phase with the wind at our backs and real momentum to bring this to more patients." Heart failure affects more than 6 million Americans, and thousands of patients each year progress to irreversible biventricular failure. However, the number of available donor hearts remains stagnant, with fewer than 4,500 transplants performed annually in the U.S. BiVACOR is targeting this critical gap with a durable artificial replacement engineered for eventual long-term support. The BiVACOR TAH is currently investigational and not approved for commercial use. About BiVACOR BiVACOR® is a clinical-stage medical device company developing a fully implantable, magnetically levitated Total Artificial Heart for long-term support of patients with end-stage biventricular heart failure. Founded by biomedical engineer Daniel Timms, PhD, and backed by leading experts in cardiovascular medicine including Dr. William E. Cohn and Dr. O.H. (Bud) Frazier, the company is conducting an FDA-approved Early Feasibility Study in the U.S. Headquartered in Huntington Beach, CA, with clinical operations in Houston and engineering offices in Gold Coast, Australia, BiVACOR is committed to addressing the global shortage of donor hearts through advanced, scalable technology. Learn more at View source version on Contacts Media Contact: Dana SummersPenman PRdana@
Business Wire
30-05-2025
- Business
- Business Wire
BiVACOR's Total Artificial Heart Receives FDA Breakthrough Device Designation
HUNTINGTON BEACH, Calif.--(BUSINESS WIRE)--BiVACOR, a clinical-stage medical device company developing the world's first titanium Total Artificial Heart (TAH), today announced that its device has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). 'This is more than a regulatory milestone. It's a validation of a concept we've spent decades proving that a fully implantable, total artificial heart isn't just possible, it's necessary,' said Daniel Timms, PhD, Founder and CTO of BiVACOR Share The designation supports the BiVACOR TAH as a bridge to transplant (BTT) for adults with severe biventricular or univentricular heart failure where current treatments, including LVADs, are not viable. The FDA's Breakthrough Device program is reserved for technologies that may significantly improve outcomes for patients with life-threatening or irreversibly debilitating conditions. It offers priority regulatory interaction and accelerated pathways to approval. 'This is more than a regulatory milestone. It's a validation of a concept we've spent decades proving that a fully implantable, total artificial heart isn't just possible, it's necessary,' said Daniel Timms, PhD, Founder and Chief Technology Officer of BiVACOR. 'Patients with biventricular failure have been overlooked for too long. The early results from our clinical trial show that we can give them a second chance, without the compromises of older technologies. The Breakthrough Device Designation puts us on a faster track to deliver exactly that.' The milestone follows the first phase of BiVACOR's FDA Early Feasibility Study, where five patients in the U.S. received the TAH between July and November 2024. Based on positive safety and performance data, the FDA approved the expansion of the trial to include 15 additional patients starting later this year. BiVACOR's device represents a new category in artificial heart technology. Compact enough to fit most men and women, the TAH uses magnetic levitation, similar to maglev trains, to suspend a single dual-sided rotor. This rotor simultaneously powers the right and left circulatory systems, mimicking the natural heartbeat without valves or mechanical wear points. Its simplified design allows for pulsatile flow, large blood gaps to reduce trauma, and long-term durability. 'We've seen every kind of artificial heart technology over the last four decades, but this is the first system I've encountered that combines engineering elegance, efficiency, and safety with true clinical viability,' said William Cohn, MD, BiVACOR Chief Medical Officer and heart surgeon at the Texas Heart Institute. 'The early results are remarkable with no strokes, no device-related complications, and a safety profile unlike anything in this space. With Breakthrough status in hand, we're entering the next phase with the wind at our backs and real momentum to bring this to more patients.' Heart failure affects more than 6 million Americans, and thousands of patients each year progress to irreversible biventricular failure. However, the number of available donor hearts remains stagnant, with fewer than 4,500 transplants performed annually in the U.S. BiVACOR is targeting this critical gap with a durable artificial replacement engineered for eventual long-term support. The BiVACOR TAH is currently investigational and not approved for commercial use. About BiVACOR BiVACOR® is a clinical-stage medical device company developing a fully implantable, magnetically levitated Total Artificial Heart for long-term support of patients with end-stage biventricular heart failure. Founded by biomedical engineer Daniel Timms, PhD, and backed by leading experts in cardiovascular medicine including Dr. William E. Cohn and Dr. O.H. (Bud) Frazier, the company is conducting an FDA-approved Early Feasibility Study in the U.S. Headquartered in Huntington Beach, CA, with clinical operations in Houston and engineering offices in Gold Coast, Australia, BiVACOR is committed to addressing the global shortage of donor hearts through advanced, scalable technology. Learn more at
