Latest news with #Trial
Business Wire
2 days ago
- Health
- Business Wire
Foldax Announces Positive One-Year Data on TRIA Mitral Valve
SALT LAKE CITY--(BUSINESS WIRE)--Foldax® Inc., a leader in the development of innovative polymer heart valves, today announced compelling one-year results from the India Clinical Trial of the TRIA™ Mitral Valve, showing a good safety profile, sustained hemodynamic performance, and statistically significant improvement in patient quality of life. These are the first one-year outcomes ever presented for a multicenter clinical study of a polymer heart valve worldwide. Results were presented today at New York Valves 2025, the annual conference organized by the Cardiovascular Research Foundation (CRF), and concurrently published in the Journal of the American College of Cardiology (JACC). 'It is exciting to see the positive clinical outcomes associated with this novel polymer valve.' Isaac George, M.D., Surgical Director of the Heart Valve Center at Columbia University. Share Key one-year results from the trial showed: No valve-related mortality or reinterventions >50% reduction in mean gradient (9.7 mmHg to 4.5 mmHg) and >90% increase in effective orifice area (0.9 cm² to 1.5 cm²), the highest reported in similar surgical mitral valve studies 24-point improvement in KCCQ score (57.5 to 81.9) and 65% increase in Six-Minute Walk Test distance (298.1 m to 494.8 m), indicating significant improvement in quality of life The prospective, multicenter trial enrolled 67 patients aged 19 to 67 across eight sites in India, with an average age of 42. Notably, 64% were women, and of these, nearly half were of childbearing age, a significantly larger percentage than typically seen in clinical studies. Seventy-three percent of patients had rheumatic heart disease. 'It is exciting to see the positive clinical outcomes associated with this novel polymer valve,' said Isaac George, M.D., Surgical Director of the Heart Valve Center at Columbia University. 'This new type of valve sets out to reimagine how a device can address clinical needs that are underserved by current valve solutions.' 'I am proud to be the principal investigator in India for this groundbreaking trial and represent the highly esteemed clinical investigators who participated in the study,' said Kaushal Pandey, M.D., Principal Investigator of the TRIA Mitral Valve India Clinical Trial and Cardiac Surgeon at P.D. Hinduja Hospital in Mumbai. 'The TRIA Mitral Valve provides hope for Indian patients—including younger patients and many women of childbearing age—for whom current valve options often fall short.' Foldax's vision for its novel polymer heart valves is to address the limitations of tissue and mechanical options by making its valves durable, with the future goal of avoiding a requirement for lifelong anticoagulation. TRIA valves incorporate a proprietary polymer—LifePolymer™ —formulated to be calcium-resistant, biostable and biocompatible. The novel polymer material enables TRIA valves to be robotically produced, which is designed to increase manufacturing efficiency and maximize product quality and precision. 'These results validate our strategy of taking heart valve therapy to a new level by bringing innovation to a platform of products that will help patients globally,' said Ken Charhut, CEO of Foldax. The Journal of the American College of Cardiology (JACC) publication can be viewed at: *The TRIA Mitral Valve is approved for use in India by CDSCO. The TRIA Mitral Valve is for investigational use only and is not available for commercial sale in the U.S. Headquartered in Salt Lake City, Utah, Foldax is reinventing every aspect of the heart valve—from material to design to manufacturing—to develop surgical and transcatheter valves with the potential to last a lifetime, addressing limitations of tissue and mechanical valves. Foldax investors include Angel Physicians Fund, Biostar Capital, Caltech, Glenview Capital, Kairos Ventures, Memorial Care Innovation Fund and Sayan Bioventures. For more information on the TRIA Mitral Valve and Foldax's commitment to revolutionizing heart valve care, visit
Yahoo
7 days ago
- Entertainment
- Yahoo
Johnny Depp Says He Has 'No Regrets' About Amber Heard Trial & Was A 'Crash Test Dummy For #MeToo'
In a sprawling interview with The Times U.K., Johnny Depp claimed he was a 'crash test dummy for #MeToo,' reflecting on his protracted legal battle with actress and ex-wife Amber Heard. 'My comeback? Honestly? I didn't go anywhere,' he said. 'If I had the chance to split I would never come back.' More from Deadline Sick Juror Throws Sean Combs Trial Off Tight Schedule; No Decision Yet If Diddy Will Testify Tyler Perry Slams $260M Sexual Assault Suit By 'The Oval' Actor As A "Scam" Another Harvey Weinstein Rape Retrial Could Start This Fall, Judge Says; Current Case Ends In Mistrial As Jury Foreman Won't Return To Deliberations - Update The Pirates of the Caribbean star, who classified his ousting from Hollywood as a 'boycott,' praised the San Sebastián International Film Festival for sticking with him through 'all the hit pieces, the bullsh–.' In 2021, the fest awarded him the prestigious Donostia, its highest accolade, and last year, his second directorial effort, Modi: Three Days on the Wing of Madness, garnered a long-standing ovation by the crowd. 'No, I have no regrets about anything — because, truly, what can we do about last week's dinner? Not a f—ing thing,' he said of the much-publicized court trial with Heard. In 2022, Depp and Heard engaged in a contentious court battle during which a jury unanimously found he was defamed. After Heard filed an appeal of the verdict, the two announced separately that the case had been settled with the money paid by Heard going to charity. The case stemmed from a 2018 Washington Post op-ed in which Heard said she was a survivor of domestic violence without mentioning Depp's name. Throughout the media circus that ensued during the live-streamed trial, Heard — who wields considerably less power as a woman who is not as well-known nor cherished as veteran Depp — was largely raked over the coals both online and by Depp's fans who lined the doors outside the courtroom, receiving death threats. Studies conducted by a research firm also indicated the overwhelming hatred she experienced on social media was not entirely human-generated. The Virginia battle also followed a separate libel case in the U.K. over The Sun's calling Depp a 'wife beater.' The judge sided with the publication in 2020, after which Depp was asked to resign from Warner Bros.' Fantastic Beasts franchise, with the judge finding that the 'great majority of alleged assaults of Ms. Heard by Mr. Depp have been proved.' When asked why he pursued the public trial in the U.S., Depp answered: 'Look, it had gone far enough. I knew I'd have to semi-eviscerate myself. Everyone was saying, 'It'll go away!' But I can't trust that. What will go away? The fiction pawned around the f—ing globe? No it won't. If I don't try to represent the truth it will be like I've actually committed the acts I am accused of. And my kids will have to live with it. Their kids. Kids that I've met in hospitals. So the night before the trial in Virginia I didn't feel nervous. If I don't have to memorize lines, if you're just speaking the truth? Roll the dice.' He continued, 'Look, none of this was going to be easy, but I didn't care. I thought, 'I'll fight until the bitter f—ing end.' And if I end up pumping gas? That's all right. I've done that before.' Depp also claimed his experience predated #MeToo, and that's why people failed to support him. However, activist Tarana Burke's hashtag and movement were founded in 2006, later moving to the entertainment industry space circa 2017, the same year the New York Times and The New Yorker published exposés on now-disgraced mogul Harvey Weinstein. 'I'll tell you what hurts. There are people, and I'm thinking of three, who did me dirty. Those people were at my kids' parties. Throwing them in the air. And, look, I understand people who could not stand up [for me] because the most frightening thing to them was making the right choice,' he said. 'I was pre-#MeToo. I was like a crash test dummy for #MeToo. It was before Harvey Weinstein. And I sponged it, took it all in. And so I wanted from the hundreds of people I've met in that industry to see who was playing it safe. Better go woke!' Since 2022, the actor hasn't really gone gently into that good night — hence the disagreement with the term 'comeback.' That year, he made a surprise appearance at the MTV Video Music Awards; later on, he embarked on a 2023 European tour with band Hollywood Vampires and was seen in Savage X Fenty's fashion show. More recently, he is set to reunite with Pirates of the Caribbean co-star Penelope Cruz in Lionsgate's upcoming Day Drinker, also featuring Madelyn Cline. Additionally, filming for Terry Gilliam's Carnival: At the End of Days, opposite Adam Driver, Jeff Bridges and Jason Momoa was scheduled to commence in April. Best of Deadline Sean 'Diddy' Combs Sex-Trafficking Trial Updates: Cassie Ventura's Testimony, $10M Hotel Settlement, Drugs, Violence, & The Feds A Full Timeline Of Blake Lively & Justin Baldoni's 'It Ends With Us' Feud In Court, Online & In The Media 'Poker Face' Season 2 Guest Stars: From Katie Holmes To Simon Hellberg
CTV News
13-06-2025
- CTV News
Closing arguments in Adam Drake trial underway
Closing arguments in Adam Drake trial underway Crown prosecutors told a jury Adam Drake should be found guilty of second-degree murder in the death of Pat Stay.
Yahoo
21-05-2025
- Health
- Yahoo
EuroPCR 2025: Late-Breaking Data Demonstrate Sustained Significantly Lower Event Rates With Elixir Medical's DynamX Bioadaptor Over Drug-Eluting Stent Through Three Years
Paris, May 21, 2025 (GLOBE NEWSWIRE) -- —Sustained durability of treatment effect with significantly lower TLF rates (2.7% versus 7.2%, p=0.030) with DynamX® compared to DES— —Significantly lower rate of Cardiac Death (0.5% versus 3.2%, p=0.033) with DynamX® compared to DES— Paris – May 21, 2025 – Elixir Medical, a developer of transformative technologies to treat cardiovascular and peripheral disease, today announced three-year results from the large 445-patient BIOADAPTOR Randomized Controlled (1:1) Trial (RCT), comparing the DynamX® Coronary Bioadaptor System to standard of care Resolute OnyxTM Drug-Eluting Stent (DES) from 34 centers in Japan, Europe, and New Zealand. The results demonstrate sustained very low adverse events and durability of clinical outcomes with DynamX® bioadaptor in target lesion failure (TLF) and Cardiovascular Death (CVD) compared to non-plateauing increase in adverse events in the DES arm. The data were presented at a late-breaking clinical session during the EuroPCR 2025 conference in Paris. Clinical results show sustained significant reduction of device-oriented adverse events with DynamX® bioadaptor over the drug-eluting stent at three years: Significant reduction in TLF rate (2.7% versus 7.2%; p=0.030) demonstrating the durability of DynamX® treatment through three years of follow-up. The significant reduction in TLF was driven by low adverse events across all components of the composite endpoint with DynamX® compared to DES, respectively: Significantly lower Cardiovascular Death (0.5% versus 3.2%, p=0.033) Target Vessel Myocardial Infarction (0.9% versus 1.8%) Ischemia-Driven Target Lesion Revascularization (1.4% versus 2.7%) Reduction in adverse events amplified in Left Anterior Descending (LAD) artery lesions: Significantly lower TLF rate in LAD lesions (2.7% versus 10.6%; p=0.019) consistent with bioadaptor mechanism of action of restoring vessel function in this hemodynamically critical coronary vessel as reported previously in the imaging subgroup at 12 months1. 'These three-year results from the BIOADAPTOR RCT demonstrate that DynamX bioadaptor provides for a new class of treatment—with significant clinical benefit from six months when the bioadaptor mechanism of action is activated and sustained through long-term follow-up, including the hard clinical endpoint of cardiovascular death,' said Shigeru Saito, M.D., director of the Division of Cardiology and Catheterization Laboratory at Shonan Kamakura General Hospital in Kamakura, Japan. 'We also see the heightened importance of restoring hemodynamic modulation in the LAD vessel demonstrated by the large difference in clinical events in LAD lesions between the two treatment arms.' The DynamX bioadaptor is differentiated from the current therapies, having a novel mechanism of action designed to return vessel health through three distinct phases of adapting in the body to restore vessel biology. In the locked phase during the implant, the bioadaptor opens the artery and restores blood flow. Unique to bioadaptor, after six months the implant unlocks, separates into three helical strands, releasing the vessel and providing dynamic support to maintain the established blood flow lumen. The continued adaptive dynamic support helps return vessel hemodynamic modulation through restoration of pulsatility and adaptive blood flow volume and has also shown evidence of plaque stabilization and regression in the lesion. 'With these results, we are pleased to demonstrate that restoring hemodynamic modulation of the artery translates to lasting clinical outcomes, elevating the level of care for patients,' said Motasim Sirhan, CEO of Elixir Medical. 'With the three-year BIOADAPTOR-RCT data presented today, and the results from the 2,400 patient INIFINITY-SWEDEHEART RCT published in The Lancet, we have shown consistently across multiple trials significantly lower, plateauing clinical events after six months with DynamX® bioadaptor compared to DES, validating the benefit of our transformative technology.' About BIOADAPTOR RCT TrialThe BIOADAPTOR RCT is an international, single-blind, randomized controlled (1:1) trial comparing a sirolimus-eluting bioadaptor with a contemporary zotarolimus-eluting stent in 445 patients in 34 centers in Japan, Europe, and New Zealand. Both arms had large randomized multi-modality imaging subgroups of 50 patients each to document standard effectiveness benchmarks of establishing and maintaining artery flow lumen measured by percent diameter stenosis (%DS) and late lumen loss (LLL), and the new effectiveness benchmarks of restoring artery hemodynamic modulation, including pulsatility, vessel compliance, adaptive flow volume, and plaque stabilization and regression. Clinical follow-up will continue through five years. BIOADAPTOR RCT trial is the third trial of Elixir Medical's robust DynamX® bioadaptor clinical evidence program consisting of nine company-sponsored and investigator-initiated studies involving over 9,000 patients, including INFINITY SWEDEHEART RCT (n=2400) and a global BIO-RESTORE registry with a target enrollment of up to 5,000 patients. About DynamX Coronary Bioadaptor SystemThe DynamX® bioadaptor is the first coronary implant technology designed to restore coronary artery hemodynamic modulation as demonstrated by restored vessel pulsatility, compliance, and adaptive increase in blood flow volume, and providing plaque stabilization and regression. With its unique mechanism of action (MOA), it addresses the shortcomings of drug-eluting stents and bioresorbable scaffolds (BRS) with remarkably low clinical event rates that showed a plateau from six months through three-year clinical follow-up. The DynamX® Coronary Bioadaptor System is CE-marked. The DynamX® Sirolimus Eluting Coronary Bioadaptor System is an investigational device. Limited by Federal (or United States) law to investigational use. About Elixir MedicalElixir Medical Corporation, a privately held company based in Milpitas, California, develops disruptive platforms to treat coronary and peripheral artery disease. Our transformative technologies have multiple applications across the cardiovascular space capable of delivering improved clinical outcomes for millions of patients. Elixir Medical was named to Fast Company's prestigious list of the World's Most Innovative Companies of 2025. Visit us at and on LinkedIn. Media ContactRichard LaermerRLM PRelixir@ 741-5106 X 216 1 Saito S et al. 12-Months Outcomes BIODAPTOR-RCT. The Lancet eClinicalMedicine. 2023;65: in to access your portfolio
Yahoo
21-05-2025
- Health
- Yahoo
EuroPCR 2025: Late-Breaking Data Demonstrate Sustained Significantly Lower Event Rates With Elixir Medical's DynamX Bioadaptor Over Drug-Eluting Stent Through Three Years
Paris, May 21, 2025 (GLOBE NEWSWIRE) -- —Sustained durability of treatment effect with significantly lower TLF rates (2.7% versus 7.2%, p=0.030) with DynamX® compared to DES— —Significantly lower rate of Cardiac Death (0.5% versus 3.2%, p=0.033) with DynamX® compared to DES— Paris – May 21, 2025 – Elixir Medical, a developer of transformative technologies to treat cardiovascular and peripheral disease, today announced three-year results from the large 445-patient BIOADAPTOR Randomized Controlled (1:1) Trial (RCT), comparing the DynamX® Coronary Bioadaptor System to standard of care Resolute OnyxTM Drug-Eluting Stent (DES) from 34 centers in Japan, Europe, and New Zealand. The results demonstrate sustained very low adverse events and durability of clinical outcomes with DynamX® bioadaptor in target lesion failure (TLF) and Cardiovascular Death (CVD) compared to non-plateauing increase in adverse events in the DES arm. The data were presented at a late-breaking clinical session during the EuroPCR 2025 conference in Paris. Clinical results show sustained significant reduction of device-oriented adverse events with DynamX® bioadaptor over the drug-eluting stent at three years: Significant reduction in TLF rate (2.7% versus 7.2%; p=0.030) demonstrating the durability of DynamX® treatment through three years of follow-up. The significant reduction in TLF was driven by low adverse events across all components of the composite endpoint with DynamX® compared to DES, respectively: Significantly lower Cardiovascular Death (0.5% versus 3.2%, p=0.033) Target Vessel Myocardial Infarction (0.9% versus 1.8%) Ischemia-Driven Target Lesion Revascularization (1.4% versus 2.7%) Reduction in adverse events amplified in Left Anterior Descending (LAD) artery lesions: Significantly lower TLF rate in LAD lesions (2.7% versus 10.6%; p=0.019) consistent with bioadaptor mechanism of action of restoring vessel function in this hemodynamically critical coronary vessel as reported previously in the imaging subgroup at 12 months1. 'These three-year results from the BIOADAPTOR RCT demonstrate that DynamX bioadaptor provides for a new class of treatment—with significant clinical benefit from six months when the bioadaptor mechanism of action is activated and sustained through long-term follow-up, including the hard clinical endpoint of cardiovascular death,' said Shigeru Saito, M.D., director of the Division of Cardiology and Catheterization Laboratory at Shonan Kamakura General Hospital in Kamakura, Japan. 'We also see the heightened importance of restoring hemodynamic modulation in the LAD vessel demonstrated by the large difference in clinical events in LAD lesions between the two treatment arms.' The DynamX bioadaptor is differentiated from the current therapies, having a novel mechanism of action designed to return vessel health through three distinct phases of adapting in the body to restore vessel biology. In the locked phase during the implant, the bioadaptor opens the artery and restores blood flow. Unique to bioadaptor, after six months the implant unlocks, separates into three helical strands, releasing the vessel and providing dynamic support to maintain the established blood flow lumen. The continued adaptive dynamic support helps return vessel hemodynamic modulation through restoration of pulsatility and adaptive blood flow volume and has also shown evidence of plaque stabilization and regression in the lesion. 'With these results, we are pleased to demonstrate that restoring hemodynamic modulation of the artery translates to lasting clinical outcomes, elevating the level of care for patients,' said Motasim Sirhan, CEO of Elixir Medical. 'With the three-year BIOADAPTOR-RCT data presented today, and the results from the 2,400 patient INIFINITY-SWEDEHEART RCT published in The Lancet, we have shown consistently across multiple trials significantly lower, plateauing clinical events after six months with DynamX® bioadaptor compared to DES, validating the benefit of our transformative technology.' About BIOADAPTOR RCT TrialThe BIOADAPTOR RCT is an international, single-blind, randomized controlled (1:1) trial comparing a sirolimus-eluting bioadaptor with a contemporary zotarolimus-eluting stent in 445 patients in 34 centers in Japan, Europe, and New Zealand. Both arms had large randomized multi-modality imaging subgroups of 50 patients each to document standard effectiveness benchmarks of establishing and maintaining artery flow lumen measured by percent diameter stenosis (%DS) and late lumen loss (LLL), and the new effectiveness benchmarks of restoring artery hemodynamic modulation, including pulsatility, vessel compliance, adaptive flow volume, and plaque stabilization and regression. Clinical follow-up will continue through five years. BIOADAPTOR RCT trial is the third trial of Elixir Medical's robust DynamX® bioadaptor clinical evidence program consisting of nine company-sponsored and investigator-initiated studies involving over 9,000 patients, including INFINITY SWEDEHEART RCT (n=2400) and a global BIO-RESTORE registry with a target enrollment of up to 5,000 patients. About DynamX Coronary Bioadaptor SystemThe DynamX® bioadaptor is the first coronary implant technology designed to restore coronary artery hemodynamic modulation as demonstrated by restored vessel pulsatility, compliance, and adaptive increase in blood flow volume, and providing plaque stabilization and regression. With its unique mechanism of action (MOA), it addresses the shortcomings of drug-eluting stents and bioresorbable scaffolds (BRS) with remarkably low clinical event rates that showed a plateau from six months through three-year clinical follow-up. The DynamX® Coronary Bioadaptor System is CE-marked. The DynamX® Sirolimus Eluting Coronary Bioadaptor System is an investigational device. Limited by Federal (or United States) law to investigational use. About Elixir MedicalElixir Medical Corporation, a privately held company based in Milpitas, California, develops disruptive platforms to treat coronary and peripheral artery disease. Our transformative technologies have multiple applications across the cardiovascular space capable of delivering improved clinical outcomes for millions of patients. Elixir Medical was named to Fast Company's prestigious list of the World's Most Innovative Companies of 2025. Visit us at and on LinkedIn. Media ContactRichard LaermerRLM PRelixir@ 741-5106 X 216 1 Saito S et al. 12-Months Outcomes BIODAPTOR-RCT. The Lancet eClinicalMedicine. 2023;65: 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
