A revolution in heart disease treatment
Cardiovascular disease affects 315 million people globally and is the world's leading cause of death. For the past quarter-century, it has been standard practice for heart surgeons to treat this by inserting small, mesh tubes called stents to widen or unblock patients' coronary arteries to restore blood flow. Unfortunately, many of those patients experienced additional issues—from blood clots to heart attacks—within years, sometimes months, of the procedure.
That's where DynamX, a new vascular technology from Elixir Medical, comes in. Like traditional stents, DynamX is minimally invasive and expands arteries to promote blood flow, but their unique design also enables them to restore arteries' natural defense mechanisms, helping patients avoid life-threatening events or costly and dangerous repeat procedures. The technology's promise to allow cardiac patients to heal more completely and live full, productive lives earned Elixir a spot as one of Fast Company 's 2025 Most Innovative Companies.
Novel technology, proven effectiveness
Traditional stents solve heart patients' immediate, critical need for restoring arterial blood flow. However, because they don't heal the arteries themselves, about half of patients re-experience an adverse medical event within 10 years, says Motasim Sirhan, Elixir founder and CEO.
DynamX is different. After six months, Elixir's implant transforms into an essential part of the artery itself as its mesh tube unlocks, freeing and reinforcing the artery's wall. The implant then gradually restores and adapts to the blood vessel's natural pulsing motion. 'You need to address the disease where it's originating, not the just symptoms of it,' Sirhan says. 'This is the first technology to do that.'
In the spring and fall of 2024, Elixir announced the results of a pair of large, international randomized clinical trials that demonstrate DynamX's favorable results. Patients with these implants had 65% fewer serious heart events and 78% fewer issues in the left anterior descending artery—which is critical for heart function as it supplies 50% of blood to the heart—than patients with traditional stent implants.
Last year, recognizing DynamX's promise, the U.S. Food and Drug Administration granted Elixir 'Breakthrough Device Designation' (BDD) on two applications of its DynamX technology: to treat heart artery blockage and serious artery blockages in the leg below the knee. BDD accelerates the review and approval process for novel technologies that may provide more effective treatment of life-threatening diseases and conditions.
Patient-focused solutions
As they developed DynamX, the company's researchers never lost sight of the seriousness and scale of the problem they were addressing. Many people begin to have cardiac issues in their 50s and 60s, requiring them to undergo multiple procedures. Patients often miss a substantial amount of work and sometimes can't participate fully in family activities. As Sirhan puts it, these hardships—on top of the millions or cardiac deaths annually—are 'not acceptable.'
Elixir's innovative solution is the product of a multidisciplinary team of experts in physics, biology, chemistry, engineering, and other fields. The researchers addressed the challenge from different perspectives but with a singular mission: serving patients. 'What was important for us,' Sirhan says, 'was being able to make a difference in patient treatment and to not be fazed by the difficulty of the mission.'
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Cardiovascular disease affects 315 million people globally and is the world's leading cause of death. For the past quarter-century, it has been standard practice for heart surgeons to treat this by inserting small, mesh tubes called stents to widen or unblock patients' coronary arteries to restore blood flow. Unfortunately, many of those patients experienced additional issues—from blood clots to heart attacks—within years, sometimes months, of the procedure. That's where DynamX, a new vascular technology from Elixir Medical, comes in. Like traditional stents, DynamX is minimally invasive and expands arteries to promote blood flow, but their unique design also enables them to restore arteries' natural defense mechanisms, helping patients avoid life-threatening events or costly and dangerous repeat procedures. The technology's promise to allow cardiac patients to heal more completely and live full, productive lives earned Elixir a spot as one of Fast Company 's 2025 Most Innovative Companies. Novel technology, proven effectiveness Traditional stents solve heart patients' immediate, critical need for restoring arterial blood flow. However, because they don't heal the arteries themselves, about half of patients re-experience an adverse medical event within 10 years, says Motasim Sirhan, Elixir founder and CEO. DynamX is different. After six months, Elixir's implant transforms into an essential part of the artery itself as its mesh tube unlocks, freeing and reinforcing the artery's wall. The implant then gradually restores and adapts to the blood vessel's natural pulsing motion. 'You need to address the disease where it's originating, not the just symptoms of it,' Sirhan says. 'This is the first technology to do that.' In the spring and fall of 2024, Elixir announced the results of a pair of large, international randomized clinical trials that demonstrate DynamX's favorable results. Patients with these implants had 65% fewer serious heart events and 78% fewer issues in the left anterior descending artery—which is critical for heart function as it supplies 50% of blood to the heart—than patients with traditional stent implants. Last year, recognizing DynamX's promise, the U.S. Food and Drug Administration granted Elixir 'Breakthrough Device Designation' (BDD) on two applications of its DynamX technology: to treat heart artery blockage and serious artery blockages in the leg below the knee. BDD accelerates the review and approval process for novel technologies that may provide more effective treatment of life-threatening diseases and conditions. Patient-focused solutions As they developed DynamX, the company's researchers never lost sight of the seriousness and scale of the problem they were addressing. Many people begin to have cardiac issues in their 50s and 60s, requiring them to undergo multiple procedures. Patients often miss a substantial amount of work and sometimes can't participate fully in family activities. As Sirhan puts it, these hardships—on top of the millions or cardiac deaths annually—are 'not acceptable.' Elixir's innovative solution is the product of a multidisciplinary team of experts in physics, biology, chemistry, engineering, and other fields. The researchers addressed the challenge from different perspectives but with a singular mission: serving patients. 'What was important for us,' Sirhan says, 'was being able to make a difference in patient treatment and to not be fazed by the difficulty of the mission.'
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About Orchestra BioMed Orchestra BioMed (Nasdaq: OBIO) is a biomedical innovation company accelerating high-impact technologies to patients through risk-reward sharing partnerships with leading medical device companies. Orchestra BioMed's partnership-enabled business model focuses on forging strategic collaborations with leading medical device companies to drive successful global commercialization of products it develops. Orchestra BioMed's lead product candidate is AVIM therapy for the treatment of hypertension, the leading risk factor for death worldwide. Orchestra BioMed is also developing Virtue SAB for the treatment of atherosclerotic artery disease, the leading cause of mortality worldwide. Orchestra BioMed has a strategic collaboration with Medtronic, one of the largest medical device companies in the world, for development and commercialization of AVIM therapy for the treatment of hypertension in pacemaker-indicated patients, and a strategic partnership with Terumo, a global leader in medical technology, for development and commercialization of Virtue SAB for the treatment of artery disease. The Company has received four Breakthrough Device Designations from the U.S. FDA across these two core programs, reflecting the significant potential of its technologies to address high unmet needs in cardiovascular care. For further information about Orchestra BioMed, please visit , and follow us on LinkedIn . References to Websites and Social Media Platforms References to information included on, or accessible through, websites and social media platforms do not constitute incorporation by reference of the information contained at or available through such websites or social media platforms, and you should not consider such information to be part of this press release. About AVIM Therapy AVIM therapy is an investigational therapy compatible with standard dual-chamber pacemakers designed to substantially and persistently lower blood pressure. It has been evaluated in pilot studies in patients with hypertension who are also indicated for a pacemaker. MODERATO II, a double-blind, randomized pilot study, showed that patients treated with AVIM therapy experienced net reductions of 8.1 mmHg in 24-hour ambulatory systolic blood pressure (aSBP) and 12.3 mmHg in office systolic blood pressure (oSBP) at six months when compared to control patients. In addition to reducing blood pressure, clinical results using AVIM therapy demonstrate improvements in cardiac function and hemodynamics. The BACKBEAT (BradycArdia paCemaKer with atrioventricular interval modulation for Blood prEssure treAtmenT) global pivotal study will further evaluate the safety and efficacy of AVIM therapy in lowering blood pressure in patients who have systolic blood pressure above target despite anti-hypertensive medication and who are indicated for or have recently received a dual-chamber cardiac pacemaker. AVIM therapy has been granted Breakthrough Device Designation by the FDA for the treatment of uncontrolled hypertension in patients who have increased cardiovascular risk. Forward-Looking Statements Certain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as 'believe,' 'may,' 'will,' 'estimate,' 'continue,' 'anticipate,' 'intend,' 'expect,' 'should,' 'would,' 'plan,' 'predict,' 'potential,' 'seem,' 'seek,' 'future,' 'outlook' and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements relating to the enrollment, implementation and design of the Company's planned and ongoing pivotal trials, realizing the clinical and commercial value of the Company's product candidates, the potential safety and efficacy of the Company's product candidates, and the ability of the Company's partnerships to accelerate clinical development. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of the Company's management and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as and must not be relied on as a guarantee, an assurance, a prediction, or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and may differ from assumptions. Many actual events and circumstances are beyond the control of the Company. These forward-looking statements are subject to a number of risks and uncertainties, including changes in domestic and foreign business, market, financial, political, and legal conditions; risks related to regulatory approval of the Company's commercial product candidates and ongoing regulation of the Company's product candidates, if approved; the timing of, and the Company's ability to achieve expected regulatory and business milestones; the impact of competitive products and product candidates; and the risk factors discussed under the heading 'Item 1A. Risk Factors' in the Company's Annual Report on Form 10-K for the year ended December 31, 2024, which was filed with the SEC on March 31, 2025 and the risk factor discussed under the heading 'Item 1A. Risk Factors' in the Company's Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2025, which was filed with the SEC on May 12, 2025. The Company operates in a very competitive and rapidly changing environment. New risks emerge from time to time. Given these risks and uncertainties, the Company cautions against placing undue reliance on these forward-looking statements, which only speak as of the date of this press release. The Company does not plan and undertakes no obligation to update any of the forward-looking statements made herein, except as required by law. Investor ContactSilas NewcombOrchestra BioMed [email protected]
