Latest news with #TAH
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
02-06-2025
- Business
- Yahoo
Third Age Health Services (NZSE:TAH) Is Increasing Its Dividend To NZ$0.0398
Third Age Health Services Limited (NZSE:TAH) has announced that it will be increasing its dividend from last year's comparable payment on the 26th of June to NZ$0.0398. This will take the dividend yield to an attractive 3.1%, providing a nice boost to shareholder returns. We've found 21 US stocks that are forecast to pay a dividend yield of over 6% next year. See the full list for free. Impressive dividend yields are good, but this doesn't matter much if the payments can't be sustained. The last dividend was quite easily covered by Third Age Health Services' earnings. This indicates that a lot of the earnings are being reinvested into the business, with the aim of fueling growth. If the trend of the last few years continues, EPS will grow by 17.2% over the next 12 months. Assuming the dividend continues along recent trends, we think the payout ratio could be 59% by next year, which is in a pretty sustainable range. See our latest analysis for Third Age Health Services The track record isn't the longest, but we are already seeing a bit of instability in the payments. The annual payment during the last 4 years was NZ$0.0391 in 2021, and the most recent fiscal year payment was NZ$0.101. This implies that the company grew its distributions at a yearly rate of about 27% over that duration. Third Age Health Services has grown distributions at a rapid rate despite cutting the dividend at least once in the past. Companies that cut once often cut again, so we would be cautious about buying this stock solely for the dividend income. Growing earnings per share could be a mitigating factor when considering the past fluctuations in the dividend. We are encouraged to see that Third Age Health Services has grown earnings per share at 17% per year over the past five years. Shareholders are getting plenty of the earnings returned to them, which combined with strong growth makes this quite appealing. In summary, it is always positive to see the dividend being increased, and we are particularly pleased with its overall sustainability. Earnings are easily covering distributions, and the company is generating plenty of cash. All of these factors considered, we think this has solid potential as a dividend stock. Market movements attest to how highly valued a consistent dividend policy is compared to one which is more unpredictable. Still, investors need to consider a host of other factors, apart from dividend payments, when analysing a company. Taking the debate a bit further, we've identified 1 warning sign for Third Age Health Services that investors need to be conscious of moving forward. If you are a dividend investor, you might also want to look at our curated list of high yield dividend stocks. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
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
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?
