Elixir Medical Corp.

Coronary stents were first developed in the mid 1980s, revolutionizing coronary artery disease treatment for patients. While stents are still used in patients today, only incremental developments in their technology have been made over the last 30 to 40 years. One company, Elixir Medical, is trying to change that. The company focuses on re-imagining how new medical technologies will breathe new life into vascular interventions, reshaping the space for decades to come, and developing disruptive platforms to treat coronary and peripheral artery disease. Elixir’s newest device, the DynamX Bioadaptor, aims to not only improve clogged arteries for patients, but over time actually make the artery stronger. The novel scaffolding device is readily available in Europe and parts of Asia, it is currently undergoing FDA testing in the U.S. Vinayak Bhat, COO of Elixir Medical , connected with MD+DI about the adverse events rates of traditional coronary stents, how the DynamX Bioadaptor differs from conventional stents and what vessel restoration means for aging patients and long-term health outcomes, and ongoing pre-clinical and clinical trials of the device. Can you explain in practical terms how the DynamX Bioadaptor's "vessel restoration" mechanism works differently from traditional stents? Bhat: When plaque builds up in the arteries with coronary artery disease, stents have done a great job in terms of restoring blood flow to these coronary arteries. But what it does not necessarily do is restore the entire functionality of the heart. When the heart pumps blood into the aorta to go across the entire body, the first exit it takes is towards the coronary arteries. So it supplies blood there first before it goes to the brain or rest of the body. Like on an airplane, they say if the mask drops down, even if you love your child more than yourself, you first put the mask on yourself and then on the child. It is the same way here. Nature has designed the coronary arteries in a certain way and the functions, there is hemodynamic modulation in the heartbeat, and with every beat the vessel expands and contracts, there are sheer stressors, which are the communication channel for cells to respond to the changes. So the functionality of the arteries is not just to pass blood, but also do all of these other things in terms of modulation for the entire functionality of the coronary structure. When we put in a stent, like we have been doing for the last 30+ years, you restore blood flow but take away the natural ability of arteries to expand and contract with every heart beat. That is the important functionality of the vessel. This has an impact on clinical events down the line. What we have designed with the Bioadaptor is an implant that is three coils held together by a bioresorbable polymer coating. You implant it in the coronary artery when there is a lesion. Six months after implantation, for the first six months it works like a stent to restore blood flow, but once that job is done, the bioresorbable polymer coating is gone and these coils unlock from each other, allowing restoration of the arteries. With every heartbeat, now the vessel expands and contracts like it's supposed to do. Because of that, you have an impact on the plaque that is behind, there is no compliance mismatch. All of these have an important function in terms of reducing coronary events down the line. Currently with traditional stents, every year after the first year, there is a 2-3% chance of clinical events. Events like repeat heart attack, hospitalization, etc. By restoring the functionality by treating it with a Bioadaptor, we have impacted and made a change to that. And now we have clinical data to essentially prove that, from randomized clinical studies. With over 35 patents behind this technology, what were the most critical engineering breakthroughs that enabled this scaffolding approach? What technical challenges did you have to overcome? Bhat: We had the good fortune of being around for two decades in this space. We have developed stents, fully bio dissolvable scaffolds, and we have a unique group of individuals with medical backgrounds, strong technical backgrounds, drug delivery and polymer science experts, so if you look at problem statements holistically and then come up with solutions that can address the root cause of the issue. So when we set out to develop the Bioadaptor, it took us over 100 iterations just in terms of coming up with the right configuration to ensure that the restoration will be clinically similar to what a natural coronary artery gets. So all of these iterations on the bench, and we develop multiple versions. One version that can unlock within three months, one version that can unlock within six months, really to have an understanding of what it takes to ensure restoring of the natural modulation of the artery. Over multiple iterations, a huge challenge was being in a space that has so many stents with just incremental iterations. To take that function and create a new category of device was a pretty interesting challenge. We went about doing the development on the bench, development in preclinical trials, then moving on to multiple clinical studies where we were looking at proof of concept mechanistically to show that it would work. Only then did we go on to do not one, but two randomized clinical studies in two different geographies to show the effect of this device on patients. What does the long-term safety profile look like for the DynamX Bioadaptor beyond the six-month landmark analysis? Bhat: We have now two first-in-man smaller studies, 50 patients each. After that, we did a 450 patient randomized clinical study, which now has 3-year follow up data. After that, we did a 2,400 patient randomized study in much sicker patients. Those patients now have a 2-year follow up. Long term data now shows not just safety but excellent efficacy of the Bioadaptor as compared to the traditional standard of care. The second study showed superiority in a landmark analysis. The first study showed an over 50% reduction in clinical events at three years. The second study showed the same. So two independent randomized studies showing a significant impact in terms of superior outcomes. Now, long-term data gives us great confidence in new technology. In addition to these new studies, we have also conducted a post-market, 5,000 patient global study which is ongoing. A lot  of physicians are doing their own studies with the device. There is a wealth of data in terms of long-term safety on the Bioadaptor in addition to efficacy. What's the adoption experience been like in European and Asian markets? Bhat: When we initially started with the Bioadaptor, every physician who looks at it says it makes a lot of sense. When nature wants the vessel to hemodynamically modulate, we should be using devices that essentially mimic that. But, they were not really certain that just by making these changes we would impact, because traditional stents have been around for the last 30 years and people felt that that was as good as it can get. They thought these other clinical events we were seeing were just disease progression. Initially there was hesitation, but as there is more clinical data that comes out, the adoption has been excellent. We have tens of thousands of patients in the Middle East and Europe who have been treated. In Asia, patients have a say in which devices they get. A lot of patients come into physicians saying they want our Bioadaptor. They want a device that has long-term benefits. So it is getting a lot of traction moving in that direction. What does the competitive landscape look like? How are established stent manufacturers responding to this disruptive technology? Bhat: The competitive landscape as we entered the market, we didn't want to compete with the stent as just another product with incremental value. Now that we have clinical data showing superiority, we are positioning ourselves as a premium product from a pricing and outcomes perspective. We have no direct competitors to what the Bioadaptor can do. There are 20 to 30 companies that work in the drug-eluting stent space, and we are not necessarily competing with them, but creating a new category of therapy for patients. When it comes to value, the value of the Bioadaptor is for all patients that have coronary artery disease. Given this is a premium product, in many cases, physicians are using the Bioadaptor for more complex cases. Is there anything else you would like to expand on? Bhat: Elixir is uniquely positioned, and FDA has given us breakthrough device designation for the Bioadaptor. FDA has been very collaborative, and very impressed with our innovation in a space that has been dormant for a long time. We are working very closely with them to try and bring this technology to U.S. patients as soon as possible, so this is very exciting for us as an organization and a company. Before you implant the device,  you need to treat calcification. We have created a simple yet innovative mechanism based on physics principles where without requiring an external energy source, we can crack the calcium, even in the arteries, and then implant the Bioadaptor. So that is also another technology that Elixir has developed. And traction in terms of the takeoff of this product is looking really good. It is exciting times for the organization.

Elixir Medical reported clinical results for its DynamX bioadaptor, a coronary implant designed to restore a blood vessel’s natural movement and function. The Milpitas, CA-based company presented the results at the Transcatheter Cardiovascular Therapeutics  Conference 2025 in San Francisco. Results showed the DynamX bioadaptor achieved a 48% reduction in Target Lesion Failure (TLF) endpoint – encompassing reductions in cardiac death, target vessel myocardial infarction, and ischemia-driven target lesion revascularization – from six months through two years ( HR: 0.52 [0.29–0.93], p=0.027 ) in prespecified landmark superiority analysis. “The INFINITY-SWEDEHEART long-term landmark results confirm our trial design hypothesis, demonstrating separation of the event curves for TLF at six months and maintaining consistency up to two years with a reduction of TLF by 48%. Our data validates the unique property of the bioadaptor of restoring coronary physiology after unlocking after half a year, which translates into improved clinical outcomes long-term,” said Principal Investigator David Erlinge, MD, PhD, Head of the Cardiology Department at Lund University, Lund, Sweden. The Dynamx bioadaptor, which has received FDA’s Breakthrough Device Designation, has been shown in randomized controlled trials to safely and effectively open vessels while reducing stent-related adverse events. The differentiator is that the bioadaptor becomes flexible within the first six months after implantation. It unlocks and enables the coronary arteries to resume their function of being able to expand, pulsate, and move freely in response to normal hemodynamic flow in the coronary arteries. The Bioadaptor is made of three helical strands that are temporarily connected by a bioresorbable polymer, which is the glue that holds them together to enable implantation and delivery of the Bioadaptor into the coronary artery with a balloon catheter. In addition to delivering the DynamX bioadaptor’s results, presentations from multiple leading physicians investigating and demonstrating successful clinical outcomes with Elixir Medical technologies garnered a heavy podium presence each day at the TCT Conference. From October 25th through the 28th, investigators are unveiling new clinical and case performance data regarding the company’s LithiX Hertz Contact Intravascular Lithotripsy (HC-IVL) device while leading the discussion on topics like Is It Time to Move Beyond Stents for Lasting Patient Outcomes? and The Rebirth of Novel Technologies for Coronary PCI.

WASHINGTON--( BUSINESS WIRE )-- Elixir Medical , a developer of disruptive technologies to treat cardiovascular disease, today announced positive six-month data from the PINNACLE I study evaluating the safety and performance of its LithiX™ Hertz Contact (HC) Intravascular Lithotripsy System (IVL) for the treatment of moderate to severely calcified coronary artery lesions demonstrating safety and efficacy. The data were presented at Transcatheter Cardiovascular Therapeutics ® (TCT ® ), the annual scientific symposium of the Cardiovascular Research Foundation ® (CRF ® ). “The cardiology community has long sought solutions that can better treat patients with calcified lesions to achieve optimal PCI outcomes,” said Johan Bennett, M.D., study principal investigator and director of CTO/CHIP program at the University Hospital Leuven in Leuven, Belgium. “The six-month PINNACLE I data are a strong validation of LithiX IVL’s mechanism of action that can safely fragment calcium across a range of complex morphologies without trauma to the soft tissue and can be easily integrated into standard PCI procedure workflow without the need for an energy source.” LithiX data results demonstrate: 98.3% clinical success (primary effectiveness and safety endpoint) with 100% angiographic success across a range of moderate to severe calcium morphologies < 30% residual diameter stenosis was achieved in 100% of the lesions No procedural angiographic complications, including no severe dissections, perforation, or abrupt closure post-stenting Excellent safety and efficacy with only one peri-procedural non-Q-wave myocardial infarction resulting in a 1.7% TLF event rate through 6 months An intravascular imaging sub-study using optical coherence tomography (OCT) was conducted to accurately assess lesion complexity and calcium fragmentation effectiveness of LithiX IVL across a range of complex calcium morphologies. OCT sub-study results demonstrate LithiX IVL treatment effect across a broad range of lesions: In eccentric lesions with 184.38 (± 56.42) degrees of maximum continuous calcium arc with calcium nodules present in 33.3% of lesions: 84.6% of eccentric lesions had documented fractures and 61.5% of lesions with two or more fractures with 0.76 mm (±0.28 mm) average fracture depth and 0.51 mm (±0.23 mm) average fracture width 97.86% stent expansion at Maximum Calcium Site (MCS) and 101.38% stent expansion at Minimum Stent Area (MSA) site In concentric lesions with 317.47 (± 22.51) degrees of maximum continuous calcium arc with calcium nodules present in 29.4% of lesions: 94.7% of lesions had documented fractures and 84.2% of lesions with two or more fractures with 0.85 mm (±0.36 mm) average fracture depth and 0.75 mm (± 0.29 mm) average fracture width 106.58% stent expansion at MCS and 93.95% stent expansion at MSA site “We developed LithiX to improve the IVL treatment of calcified lesions with shorter procedure times and effectiveness across a broad range of calcified lesions, and we’re delighted with the PINNACLE I study outcomes demonstrating its sustained safety and effectiveness,” said Motasim Sirhan, CEO of Elixir Medical. “Our team is committed to developing transformative cardiovascular technologies that deliver improved physician experiences and most importantly, better clinical outcomes for patients.” The novel LithiX Hertz Contact IVL system is the first non-energy based IVL technology designed to fragment moderate to severe calcified lesions resistant to optimal stent expansion. 1 The LithiX IVL mechanism of action is based on the physics principle of Hertz Contact Stress propagating the required discrete forces to fragment calcium without causing vessel injury, without the need for energy source or capital equipment, and positively impacting PCI procedure workflow with short procedure times and simpler learning curve. ​​About the PINNACLE I Trial PINNACLE I is a prospective, multicenter, single-arm clinical study evaluating the safety, effectiveness, and performance of the LithiX Hertz Contact Intravascular Lithotripsy (IVL) System for the treatment of calcified lesions. The trial includes 60 patients across seven sites in Belgium and the Netherlands. An imaging subset of 32 patients underwent intravascular imaging assessment by OCT. About LithiX Hertz Contact Intravascular Lithotripsy System LithiX Hertz Contact IVL System is a transcatheter device comprising multiple discrete metal hemispheres incorporated on a semi-compliant balloon. The system is designed to deliver calcium fragmentation in a broad range of moderate to severe calcium morphologies by creating multiple discrete focal stress forces across hemisphere contact points. Using this unique mechanism of action, the LithiX Hertz Contact IVL System aims to improve treatment of moderate to severe calcified lesions without requiring an external power source, positively impacting PCI procedure safety, effectiveness, and workflow. The LithiX IVL System is not approved for sale in the U.S. 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 with vascular disease. Visit us at www.elixirmedical.com and on LinkedIn and X . 1 Cialdella P, Sergi SC, Zimbardo G, Donahue M, Talarico GP, Lombardi d’Aquino UM, Di Fusco P, Calò L. Calcified coronary lesions. Eur Heart J Suppl. 2023 Apr 26;25(Suppl C):C68-C73. doi: 10.1093/eurheartjsupp/suad009. PMID: 37125323; PMCID: PMC10132609.