Elixir Medical Announces Outstanding 24-month Data for DynamX Coronary Bioadaptor System, Demonstrating Strong Safety With No Target Lesion Revascularization, Myocardial Infarction or Thrombosis Through 24 Months

Successful DynamX Bioadaptor Live Case Presented at Singapore Live

MILPITAS, Calif.–(BUSINESS WIRE)–#BeyondDES—Elixir Medical, a developer of innovative, drug-eluting cardiovascular devices, today announced the 24-month clinical results for the DynamX� Coronary Bioadaptor System, the first drug-eluting coronary artery implant that adapts to vessel physiology. The results were presented at the 30^th Annual Live Interventions in Vascular Endotherapy conference organized by the National Heart Centre of Singapore (Singapore LIVE).

The DynamX Bioadaptor is a metal implant with a drug-eluting bioresorbable polymer coating, having a radial strength similar to DES. Over six months, the polymer coating dissolves, uncaging the bioadaptor and freeing the artery to move with the natural expansion and contraction of the artery, unlike DES. This has been shown to (a) maintain the ability for positive adaptive remodeling, (b) restore vessel function, and (c) allow for the vessel’s return towards baseline angulation.¹

Dr. Antonio Colombo, MD, co-principal investigator of the study, Professor of Cardiology at Humanitas Medical School, Senior Consultant in Interventional Cardiology at Humanitas Research Hospital, Rossano, Milan, and Director of the Cardiac Catheterization Laboratory in Columbus Hospital, Milan, Italy, presented the 24-month results from the clinical study demonstrating:

• Excellent safety profile for the bioadaptor
• No target vessel revascularization (TVR) through 24 months
• No myocardial infarction (MI) through 24 months
• No device thrombosis through 24 months

Dr. Colombo said, “Coronary arteries naturally have the ability to expand with disease progression in order to maintain blood flow to the heart. Drug-eluting stents cage the coronary arteries and hinder this physiological response. DynamX is the first metallic coronary artery implant to demonstrate positive adaptive remodeling of the vessel. At 24 months, the bioadaptor continued to show no thrombosis, no MI, and no target vessel revascularization, which demonstrates a strong safety profile and excellent performance.”

The bioadaptor is designed to address the two to three percent major adverse cardiac event rate that occur with drug-eluting stents each year without plateau.^2,3 The rigid design of a DES constrains, or cages, natural artery movement, restricting its natural ability to accommodate disease progression. This has been associated with major adverse cardiac events (MACE).⁴ Long-term studies have shown adverse event rates associated with DES of 20 percent at five years² and 40 to 50 percent at 10 years.³ Clinical studies have demonstrated that a DES prevents positive adaptive remodeling,⁵ inhibits vessel compliance and dilation in response to the body’s changing blood flow needs,^6,7 and causes vessel straightening, which has been associated with increased MACE.⁸

Studies have shown that the DynamX Bioadaptor improves vessel function⁸ in several ways. It enables the vessel to accommodate disease progression and achieve positive adaptive remodeling by increasing vessel area and maintaining lumen diameter, which preserves blood flow to the heart. DynamX restores vessel function and allows for normal vessel pulsatility and motion, enabling it to provide more blood flow in response to the body’s needs during physical activity. It also allows the vessel to return to baseline angulation, which may reduce adverse events.

Prof. Lim Soo Teik, Deputy Medical Director and Senior Consultant, Department of Cardiology, and Director of the Cardiac Catheterisation Laboratory, National Heart Centre Singapore, performed a live case on a young patient with triple vessel disease during Singapore Live. Prof. Lim said, “DynamX Bioadaptor has demonstrated excellent clinical results, and performed well in the procedure presented at the Singapore LIVE conference. We are hopeful that allowing the artery to expand, preserving blood flow, and restoring artery motion may result in better outcomes for our patients.”

“The 24-month clinical results presented this week demonstrate the sustained excellent clinical safety and effectiveness of the DynamX Bioadaptor,” said Motasim Sirhan, Elixir Medical CEO. “Additionally, Elixir’s DynamX Bioadaptor is the only technology designed to accommodate disease progression, improve blood flow to the heart, and reduce stresses on the artery. By creating a coronary artery device that allows the restoration of normal vessel function, we expect to demonstrate a continued reduction in clinical events over time.”

About Elixir Medical

Elixir Medical Corporation, a privately-funded company based in Milpitas, California, develops next-generation platforms to treat coronary artery disease that are designed to restore the adaptive remodeling and pulsatile motion capabilities of the blood vessel. The company’s mission is to transform the care of patients with heart and vascular disease through innovation.

The DynamX Coronary Bioadaptor System is CE Mark approved. Not available for sale in the USA.

1. Verheye S, Vrolix M, Montorfano M, Zivelonghi C, Giannini F, Bedogni F, et al. Twelve-month clinical and imaging outcomes of the uncaging coronary DynamX bioadaptor. EuroIntervention 2020;16;e974-e981
2. Iqbal J, Serruys PW, Silber S, et al. Comparison of zotarolimus- and everolimus-eluting coronary stents: final 5-year report of the RESOLUTE all-comers trial. Circ Cardiovasc Interv. 2015;8(6):e002230. doi:10.1161/CIRCINTERVENTIONS.114.002230
3. Kufner S, Joner M, Thannheimer A, Hoppmann P, Ibrahim T, Mayer K, et al. Ten-year clinical outcomes from a trial of three limus-eluting stents with different polymer coatings in patients with coronary artery disease: results from the ISAR-TEST 4 randomized trial. Circulation. 2019; 139:325–333. doi: 10.1161/CIRCULATIONAHA.118.038065.
4. Stone GW, Kimura T, Gao R, et al. Time-Varying Outcomes With the Absorb Bioresorbable Vascular Scaffold During 5-Year Follow-up: A Systematic Meta-analysis and Individual Patient Data Pooled Study. JAMA Cardiol. 2019;4(12):1261–1269. doi:10.1001/jamacardio.2019.4101
5. Nakamura M, Yock PG, Bonneau HN, et al. Impact of peri-stent remodeling on restenosis: a volumetric intravascular ultrasound study. Circulation. 2001;103(17):2130-2132. doi:10.1161/01.cir.103.17.2130
6. Maier, W, Windercker, S, Kung, A, et al. Exercise-Induced Coronary Artery Vasodilation Is Not Impaired by Stent Placement. Circulation. 2002; 105(20): 2373-2377. doi: 10.1161/01.cir.0000016360.97819.44
7. Hamilos, M, Sarma, J, Ostojic, M, et al. (2008). Interference of Drug-Eluting Stents With Endothelium-Dependent Coronary Vasomotion Evidence for Device-Specific Responses. Circulation. Cardiovascular interventions. 1. 193-200. 10.1161/CIRCINTERVENTIONS.108.797928.
8. Gyöngyösi M, Yang P, Khorsand A, Glogar D. Longitudinal straightening effect of stents is an additional predictor for major adverse cardiac events. Austrian Wiktor Stent Study Group and European Paragon Stent Investigators. J Am Coll Cardiol. 2000;35(6):1580-1589. doi:10.1016/s0735-1097(00)00570-2

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