Latest news with #DanielTimms
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
Associated Press
30-05-2025
- Health
- Associated Press
BiVACOR's Total Artificial Heart Receives FDA Breakthrough Device Designation
HUNTINGTON BEACH, Calif.--(BUSINESS WIRE)--May 30, 2025-- 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 CONTACT: Media Contact: Dana Summers Penman PR [email protected] KEYWORD: CALIFORNIA UNITED STATES NORTH AMERICA INDUSTRY KEYWORD: CARDIOLOGY BIOTECHNOLOGY FDA HEALTH GENERAL HEALTH HEALTH TECHNOLOGY OTHER SCIENCE MEDICAL DEVICES RESEARCH SCIENCE CLINICAL TRIALS SOURCE: BiVACOR Copyright Business Wire 2025. PUB: 05/30/2025 11:40 AM/DISC: 05/30/2025 11:38 AM
Time Magazine
08-05-2025
- Health
- Time Magazine
Daniel Timms
As a kid growing up in Australia, Daniel Timms shared a passion with his father, a plumber, for building fishponds behind their house, tinkering with how to recycle the water. Years later, his father needed a heart transplant and was struggling with a mechanical valve prone to breaking down while waiting for one. Father and son—who was by then a bioengineering student—realized a better implant design was sitting in their backyard. 'The pond pumps are basically spinning discs,' Timms says—a simpler, more resilient machinery to circulate blood than most implants use. They built prototypes of their improved implant—which they called an artificial heart—on their kitchen table, and Timms continued to improve the design over his career as an engineer. Since mid-2024, people have reaped the benefits through an early FDA-approved study based in the U.S. and simultaneous studies in Australia. In March, an Australian man lived a record 105 days with Timms's device, called the BiVACOR Total Artificial Heart, before receiving a heart transplant. 'It's a paradigm shift,' says Timms, BiVACOR's founder and chief technical officer. A magnetic field levitates the disc, eliminating friction and degradation, so he believes it could potentially become a permanent fix, not just a stopgap measure before a transplant. Plus, clotting and infection are less likely compared to previous types. With over 6 million Americans suffering heart failure—and fewer than 4,500 getting heart transplants annually—it's anticipated that more than 20 patients will have received Timms' device over the course of 2025 in three countries, including the U.S. The goal is to use the artificial heart beyond experimental trials, in regular treatment. Timms's father passed away before he could see this progress. 'We knew we probably couldn't finish it in time for him,' Timms says. 'We worked tirelessly, but not just for him. It was for everyone.'
Yahoo
18-03-2025
- Health
- Yahoo
A Man Lived Over 100 Days With a Titanium Heart. What If He's the Future of Medicine?
"Hearst Magazines and Yahoo may earn commission or revenue on some items through these links." Millions of people around the world suffer from heart failure with not nearly enough donors to go around. A new life-saving titanium device called the BiVACOR Total Artificial Heart (TAH) recently kept a patient alive for more than 100 days while awaiting a donor heart. Although designed as a stop-gap device for would-be heart donor recipients, the titanium heart could be a future permanent heart replacement for those too old or sick to undergo a transplant. Being a man with a heart of stone isn't usually a compliment, but a heart of titanium, on the other hand, might just save your life. At least that's true for one particular Australian man who lived with an artificial titanium heart while waiting for a match for a heart transplant. According to St. Vincent's Hospital Sydney in Australia, the man eventually received that heart and is recovering well. The patient was the sixth person to ever receive the BiVACOR Total Artificial Heart (TAH), the first to do so in Australia, and also the first to live with the device for more than a month, but he didn't stop there—his titanium ticker was pumping blood for more than 100 days. That's particularly impressive as the mechanical device was initially designed as a stopgap measure as patients with heart failure wait for a donor heart—and those waiting lists can be to Nature, 7 million adults live with heart failure in the U.S. alone yet only 4,500 heart transplants were performed in 2023. That leaves many millions across the globe in need of short-term solutions while waiting for a heart, and it appears BiVACOR can help in the most severe circumstances. The five previous trials of the device, all in the United States, also were successes though they featured earlier versions of the device that weren't designed for at-home support. The first device was implanted on July 9, 2024, at The Texas Heart Institute. 'Utilizing advanced MAGLEV technology, our TAH brings us one step closer to providing a desperately needed option for people with end-stage heart failure who require support while waiting for a heart transplant,' Daniel Timms, the CTO of BiVACOR, said after the successful implantation in July. Suitable for most men and women, this small device uses a titanium biventricular rotary pump that, as Timms describes, contains a magnetically levitated rotor that pumps blood and therefore replaces the need for the failing heart's ventricles. This MAGLEV technology ensures that there's no wear-and tear of the device, a defect that could prove fatal for someone relying on the titanium heart, or incidences of blood trauma.[WHOEVER TOP EDITS, READ THAT LAST SENTENCE. DOESNT THAT NOT MAKE SENSE? FEEL WE CAN JUST CUT] The TAH is currently only a short-term solution for those with heart failure, but that may not always be the case. In some cases, patients who are too old or sick for a transplant could use the BiVACOR TAH as a permanent replacement. However, Nature notes that the device still needs to go through trials for such an application. 'Many end-stage heart disease patients are actually too sick to qualify for heart transplants,' heart surgeon Jacob N. Schroder, surgical director of Advanced Heart Failure at Duke, who performed the second BiVACOR TAH operation in November 2024, said in a press statement. 'Current technologies are effective for some patients but still leave others without options. Having another way to bridge a path to transplant would fill a tremendous void and truly be a lifesaver.' For now, BiVACOR TAH is only accessible in clinical trials approved by the FDA, and the Australian implantation is part of Monash University's Artificial Heart Frontiers Program that aims to commercialize life-saving heart failure devices. BiVACOR TAH isn't quite like the flexible membranes that made up replacement hearts in the past, but its six-for-six winning streak certainly has cardiologists and surgeons around the world taking notice. You Might Also Like The Do's and Don'ts of Using Painter's Tape The Best Portable BBQ Grills for Cooking Anywhere Can a Smart Watch Prolong Your Life?
