Latest news with #BiVACOR
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
23-04-2025
- Health
- Yahoo
He tried to save his father by building an artifical heart. His creation could replace organ transplants
Gary Timms had suffered from slowly progressive heart failure for more than five years. But in the end, his passing aged 55 was swift and cruel. 'It was very fast, you know, like from the admission to the ICU, and then it was just… very, very quick,' his son Daniel says, his voice halting briefly. What comforts Daniel is the fact that his plumber father – 'a real tinkerer' – had helped him for the duration of his illness on a biomedical engineering PhD project that would one day turn near-death for people facing a similar fate into a second life. The father-and-son duo had worked tirelessly at their family home in Brisbane, Queensland, to make a prototype of what would eventually become the first durable total artificial heart, a mechanical blood pump made from titanium. The device, made by Daniel's company BiVACOR, with the only metal that isn't rejected by the body, made global headlines last month when it transpired that a recipient in Sydney had become the world's first person to be discharged from hospital with the device in situ. He lived with the device for more than 100 days before undergoing surgery to receive a donated human heart replacement. As part of an initial human feasibility study, five heart failure patients in the United States had already previously received the devices – the first procedure took place in Texas last July – but had remained in hospital until a donor heart could be transplanted. 'This patient went home [until his donor heart became available] and was able to be a normal guy, walking the streets of Sydney with a lunch box in his backpack, so yes, it was pretty, pretty good,' Timms says casually. Pretty good indeed, yet something of a humble understatement. Speaking on the run, during a visit with his BiVACOR senior team to a hospital in Taiwan to discuss this new device, fast-talking Timms, 46, is flying high in a blaze of medical glory but he's had no time to celebrate. The striking inventor had already been hailed as a 'medtech heartthrob' when named as a finalist in the 2021 Global Australian Awards – and now, he's fast becoming a household name. 'I think we're just immersed in it so much that it's hard for us to kind of step aside and go, 'wow',' he says. In his most candid and detailed interview yet about his father's key practical input into their invention – and his heartbreaking premature death in 2006 – Timms discloses how they would take over the family home with all sorts of metals, wires and plastics as they worked together on developing the early prototypes. 'I wanted to work on inventing something for my PhD that could even save my father's life [after his initial heart attack in 2001] and he was equally committed and excited.' His mother, Karen, and older brother, Darren, were 'supportive' but Timms admits 'it was really annoying for them'. 'I mean, we're taking over the kitchen and using the oven to mould PVC.' Their winning combination of skills made the project excel: while his father concentrated on the mechanics of the project, the more academically focused Daniel pored over 'at least' 500 medical studies and reports on heart transplants and the devices that were already being used. He learnt that while artificial devices had been used in the past, they largely supported only one part of the heart. 'We were able to learn what the limitations were and what we can do to improve on that. 'Dad had pumps and pipes and everything in the backyard, pumping water around the pool, and those pumps have this spinning disc inside them. 'That's also how they pump [pool] waterfalls and slow them down… and it's also how jet skis work. So it's kind of like, 'Oh, well, why can't we use that kind of approach for the body as well? It's just another system, right?'' Developing the early concept was just the start of an arduous 25-year journey, however; it has taken the past 10 years alone to seek regulatory approval, investment and also trust from the transplant medical community: 'We first sought approval from the FDA [Food and Drug Administration] on purpose as it has the strictest standards.' During the 'calm but tense' operations of each of the six 'very brave' first batch of patients, Timms has been in the theatre himself, overseeing the device being implanted and ensuring it works, alongside a huge medical team. Dr Paul Jansz, the lead heart transplant surgeon for the Australian procedure at St Vincent's Hospital in Sydney, speaks of his deep admiration for Timms and shared the vital point in the operation when the device was implanted. 'There's always a sort of lump in your throat as you're cutting the heart out, because that's a seminal moment,' he says. 'Once it [the BiVACOR device] worked, it worked very well, and it immediately supported his circulation.' As for the patient, a man from New South Wales in his 40s, who has not been named, his clinical presentation after the surgery exceeded expectations. 'Before the surgery, he could barely walk across the room, so he was almost bed-bound,' Dr Jansz explains. 'Patients like this are on a precipice and can go either way; they can just collapse and arrest, or in this case we get them an artificial heart transplant using a device like this one and their kidneys start working better, their liver starts working better.' As a result, the patients are in more robust health to have their donor heart transplant, when the call comes. But using the device simply as a stopgap is not the end goal for ambitious Timms. His aim is for this device to be used for life and to completely replace the need for donor hearts, along with the precariously long waiting lists. While the 600g device is too large for babies and small children, their widespread approval could potentially decrease the anxiety of parents knowing their child will need to be retransplanted as teenagers or young adults. 'This trial is just a stepping stone to that goal,' he says. 'Ultimately, patients will come to the hospital and get this device and then they don't come back; they have the device for the rest of their life and that will be incredible.' Timms, who says he's so focused on his work that he has no time for hobbies or even a personal life, hopes that by as early as next year, the current trial of 20 patients (and the further trials that will be required) could expand to more countries, including the UK, depending on regulations and funding. There is certainly the need: according to the British Heart Foundation, there are more than 7.6 million people living with heart and circulatory diseases in the UK. Tragically, the deeply cherished loved one who Timms says could have benefited from the device is no longer here. Thankfully, amid his hectic schedule, he's been able to read regular text messages from his mother, Karen, back home in Australia, which remind him of his father's lasting legacy; the lives already saved thanks to his early input. 'She tells me how proud my father would be, and that means a lot… But I know deep down he'd also be saying, 'You've done six, Daniel, but keep your head down and don't get ahead of yourself – there are still many things to do.'' Broaden your horizons with award-winning British journalism. Try The Telegraph free for 1 month with unlimited access to our award-winning website, exclusive app, money-saving offers and more.
