Paris, France, May 19, 2026 (GLOBE NEWSWIRE) — Significantly lower TLF rates (2.8% versus 7.8%, p=0.020) with DynamX® compared to Resolute Onyx DES with no new events in bioadaptor arm between 3 and 4 years
88% reduction in Cardiovascular Death (0.5% versus 3.7%, p=0.020) with DynamX® compared to DES
PARIS – May 19, 2026 – Elixir Medical, a developer of transformative technologies to treat cardiovascular and peripheral disease, today announced four-year results from the large 445-patient BIOADAPTOR Randomized Controlled Trial (RCT), comparing the DynamX® Coronary Bioadaptor System to standard of care Resolute Onyx™ Drug-Eluting Stent (DES) at 34 centers in Japan, Europe, and New Zealand. The data were presented at a late-breaking clinical trial session during the EuroPCR 2026 conference in Paris.
“Interventional cardiologists typically use a drug-eluting stent (DES) during percutaneous coronary intervention (PCI) to open the heart blockage and keep the artery open. These interlocked mesh-like tubes, however, permanently cage the artery, limiting its function and contributing to an annual 2-3% increase in adverse clinical events over time,” – said Professor Stefan Verheye, M.D., Ph.D., interventional cardiologist at ZNA Cardiovascular Center in Antwerp, Belgium and leading DynamX® investigator. “The bioadaptor is a new type of unlocking, adaptive implant designed to keep the artery open while restoring normal vessel function, its compliance and pulsatility.”
Late-breaking four-year results presented at EuroPCR highlight durable clinical outcomes with the DynamX® bioadaptor, with no new target lesion failure (TLF) or cardiovascular death (CVD) events observed between years three and four, maintaining a very low plateauing rate of adverse events compared to the continued annual increase seen with DES.
DynamX® demonstrated a 66% lower TLF rate (2.8% versus 7.8%; p=0.020) compared to DES, reflecting significant clinical benefit and long-term durability of PCI treatment with bioadaptor. The TLF reduction was driven by improvement across all components of the device-related combined endpoint, including:
- 88% lower cardiovascular death (0.5% versus 3.7%, p=0.020), a statistically significant reduction
- Numerically lower target vessel myocardial infarction (0.9% versus 1.8%)
- Numerically lower clinically driven target lesion revascularization (1.4% versus 2.8%)
These findings highlight a key differentiation of the bioadaptor implant from drug-eluting stents: while DES outcomes continue to accrue adverse events over time, DynamX® demonstrates stabilization of event rates following restoration of vessel function at 6 months post-procedure.
Substantial clinical improvement was also observed in the left anterior descending (LAD) artery, with TLF rates dramatically lower with DynamX® compared to DES (2.7% versus 10.6%; p=0.021), potentially reflecting an amplified impact of restoring vessel function in this hemodynamically critical coronary vessel responsible for about 50% of heart blood supply.
“The DynamX® bioadaptor represents a significant advancement in PCI by providing functional restoration of the artery,” – remarked Shigeru Saito, M.D., trial principal investigator and director of the Division of Cardiology and Catheterization Laboratory at Shonan Kamakura General Hospital in Kamakura, Japan. “Furthermore, the significant finding in reducing cardiovascular mortality marks a major achievement in how we treat cardiovascular disease and improve patient outcomes.”
PCI procedures have been successful at improving the conductance of blood through diseased, blocked coronary arteries. Stents establish luminal diameter and improve the acute mechanical result of PCI compared to balloon angioplasty. However, DES do not restore the physiology of the vessel wall because they create rigid scaffolding. This constrains vessel elasticity and prevents return to a more normal, pulsatile function.
The DynamX® bioadaptor first achieves the initial objective of opening the artery in establishing luminal diameter to improve blood flow. Unlike DES, it transitions to a different structure following an initial period of healing where it unlocks and provides the essential radial dynamic support to the diseased artery, allowing the treated segment to recover pulsatility and compliance.
“The four-year BIOADAPTOR-RCT data presented today, and the results from the 2,400 patient INIFINITY-SWEDEHEART RCT have shown consistently across multiple randomized clinical trials significantly lower, plateauing clinical events with DynamX® bioadaptor compared to DES treatment, demonstrating the clear benefit of restoring a key function of arteries, hemodynamic modulation, with this breakthrough technology.” – said Motasim Sirhan, CEO of Elixir Medical.
About BIOADAPTOR RCT Trial
The 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 part of Elixir Medical’s robust DynamX® bioadaptor clinical evidence program consisting of nine company-sponsored and investigator-initiated studies involving over 9,000 patients.
About DynamX® Sirolimus Eluting Coronary Bioadaptor System
The 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 four-year clinical follow-up.
The DynamX® Sirolimus Eluting 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 Medical
Elixir 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 Contact:
Richard Laermer
RLM PR
elixir@rlmpr.com
(212) 741-5106 X 216
