Elixir Medical is committed to transforming care of patients with heart and vascular disease through innovation. Pulse 2.0 interviewed Elixir Medical founder and CEO Motasim Sirhan to learn more about the company.
Motasim Sirhan’s Background
What is Motasim Sirhan’s background? Sirhan said:
“I am an engineer by training, and I started my career with Guidant Corporation working on catheter systems and other interventional cardiology technologies. I left Guidant to pursue the entrepreneurial route to found and successfully exit Avantec Vascular. Elixir Medical was established 15 years ago with a mission of disrupting cardiovascular care to deliver superior long-term outcomes.”
Formation Of The Company
How did the idea for the company come together? Sirhan shared:
“It has always bothered me that with stents, regardless of generation, we have not been able to improve outcomes beyond one year of the procedure, and they continue to accrue at a constant 2-3% annual adverse events rate attributed to stent failure. By leveraging my prior work in the space and bringing together the best engineers across the disciplines of implant design, polymer science, and pharmacology, we set out to build a solution that does what stents don’t – not just treat the symptom of atherosclerosis, which is the artery blockage, but also restore vessel function and have it work more like a healthy vessel.”
Favorite Memory
What has been your favorite memory working for the company so far? Sirhan reflected:
“The journey of Elixir Medical over the last 15 years has not been an easy one. We had to make pivots in our technologies to develop the product and the platform that is going through the clinical and regulatory pathway today – the bioadaptor implant (DynamX).”
“One of my favorite memories is when we began reading out the results from our randomized controlled trials and demonstrating significant 80%-plus reductions in adverse events compared to best-in-class drug-eluting stents, and the reaction from our investigators and research partners has been nothing short of amazement. Improvements of such magnitude and consistency repeated in two separate randomized controlled trials conducted in different geographies and increasingly complex patient populations – this is exactly what we’ve been working towards.”
Core Products
What are the company’s core products and features? Sirhan explained:
“The bioadaptor implant, which I just mentioned, is our main technology platform. It is being developed under the brand DynamX for coronary use to treat coronary artery disease (CAD) and DynamX BTK for peripheral vascular disease. The bioadaptor is designed to repair the vessel wall by restoring the hemodynamic modulation of the artery; improving cyclic pulsatility, vasomotion, and adaptive remodeling; and restoring the native 3D vessel geometry and motion, as demonstrated by a large body of preclinical and clinical evidence.”
“The bioadaptor is comprised of three separate 71 μm cobalt-chromium (CoCr) helical implants that are temporarily locked and held together by a bioresorbable polymer coating at delivery. After the resorption of the polymer coating over 6 months, the helical strands separate, augmenting the arterial tissue biomechanics by providing a dynamic structural support mechanism. From a biological perspective, the bioadaptor design mimics native collagen fibers that are helically arranged within the vessel wall, providing the dynamic structural support essential for maintaining physiological vasomotion (i.e., rotational, radial, axial motion), as well as the cholesterol metabolism of the vessel wall.”
“Our next platform technology is designed for treatment of calcified lesions and thus improves the acute lumen gain following an implant [such as a bioadaptor]. It is a lithotripsy catheter called LithiX Hertz Contact IVL system. Lithotripsy systems to fragment calcium in vessel walls is a hot space, with the recent acquisitions of Shockwave by Johnson and Johnson and Bolt Medical by Boston Scientific. Lithotripsy can be achieved by creating stresses and fractures in the calcium with the help of an energy source to generate pressure waves or through creation of mechanically derived stresses and pressure waves (as it is in our technology) using the physics principle of Hertz Contact Stress.”
“The LithiX design is as elegant in its simplicity as it is effective. We are able to fragment calcium without the use of an external energy source, which simplifies procedure workflow, saves time, and reduces radiation exposure for physician and patient, all while achieving the ultimate end goal of enabling >90% implant expansion.”
Challenges Faced
What challenges have Sirhan and the team face in building the company? Sirhan acknowledged:
“Developing Class III medical devices is a complex process and requires expertise, agility, and perseverance to take technology from an idea to a functioning device and all the way through clinical and regulatory phases. We’ve had our share of challenges, including the need to pivot from completely bioresorbable implants to the bioadaptor once we learned the importance of providing dynamic support to the vessel to aid in its recovery. I am extremely proud of our team for having successfully completed this journey.”
Evolution Of The Company’s Technology
How has the company’s technology evolved? Sirhan noted:
“Speaking of the bioadaptor platform, it’s a completely novel concept of vessel treatment and achieving percutaneous coronary interventions (PCI) outcomes. The technology went through over 150 iterations on the bench before advancing into animal and human trials. And now we are successfully treating patients around the world.”
Significant Milestones
What have been some of the company’s most significant milestones? Sirhan cited:
“We’ve had many milestones along the way. Three recent ones are very exciting. First, the publication of our first RCT trial results (BIOADAPTOR-RCT) and demonstrating through intravascular imaging the impact of bioadaptor mechanism of action compared to stents, never-before-seen evidence of restored vessel function, and then being able to demonstrate the difference in patient hard clinical outcomes. Second, achieving the Breakthrough Designation by the FDA, which recognizes the novelty of the technology and its potential for substantial safety and efficacy benefit vs. existing standard of care. Third, the readout and publication in The Lancet of results from our largest 2,400-patient RCT (INFINITY-SWEDEHEART) and effectively replicating the safety and superior efficacy observed in BIOADAPTOR-RCT. Consistency and superior magnitude of reducing stent failure event rates after 6 months, when the bioadaptor mechanism of action activates, is groundbreaking.”
Customer Success Stories
When asking Sirhan about customer success stories, he highlighted:
“We are proud to have positively impacted thousands of patients around the world. One patient’s story I heard recently particularly resonated with me. It is of a young man who suffered a heart attack at the early age of 33. His artery was treated minimally invasively with DynamX. Knowing that he has a long life ahead of him, we are thrilled that DynamX dramatically reduces the likelihood of a repeat procedure or heart attack compared to standard treatment, giving this young man more worry-free years. Also, the fact that the bioadaptor returns vessel function and allows the blood flow to adapt with cardiac load and heart rate should lead to a fuller and more active life for this patient.”
Funding
When asking Sirhan about the company’s funding details, he revealed:
“Elixir Medical is a privately held company, and we are extremely grateful for the longstanding support of our lead investor, a global PE firm. Together with our lead investor, we will be raising our final pre-IPO funding round in the first half of 2025.”
Total Addressable Market
What total addressable market (TAM) size is the company pursuing? Sirhan assessed:
“Even as a premium technology, we are well-positioned to disrupt the very large multibillion-dollar global percutaneous coronary interventions (PCI) market. Around 7 million procedures are performed globally every year, with over 80% utilizing drug-eluting stents. Around 30% of procedures have calcified lesions that could be a target for pre-treatment with LithiX.”
“In addition, given the novel mechanism of action of DynamX, there is also an opportunity to conduct clinical trials and expand future indications to an additional 10-15 million patients with heart disease who are at risk of experiencing a myocardial infarction and are not being treated today.”
Differentiation From The Competition
What differentiates the company from its competition? Sirhan affirmed:
“It is our focus and ability to be nimble and disruptive. We are not bound by legacy standards or approaches to R&D. Large med techs are constrained by the need to risk-manage their portfolio, and thus the innovation is largely iterative to the existing portfolio and way of doing things. By being focused, we can exert intense effort to understand the root problem, like we did with understanding the need to restore vessel function. We then apply our diverse expertise to develop truly disruptive innovations. DynamX bioadaptor and LithiX HC-IVL are such examples.”
Future Company Goals
What are some of the company’s future company goals? Sirhan concluded:
“Our upcoming goals are to initiate clinical trials for DynamX and LithiX in the U.S. to enter the market as soon as possible and to secure regulatory approval and reimbursement for DynamX in Japan this year.”
