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 www.elixirmedical.com and on LinkedIn. Media ContactRichard LaermerRLM PRelixir@rlmpr.com(212) 741-5106 X 216 1 Saito S et al. 12-Months Outcomes BIODAPTOR-RCT. The Lancet eClinicalMedicine. 2023;65:102304.
