Elixir Medical Submits IPO Prospectus Following FDA Breakthrough Designation for DynamX™, the World’s First Dynamic Coronary Bioadaptor

Jun 28, 2024 09:10 CST Updated 09:10

Elixir Medical

Medical Device R&D and Manufacturing Company

Source: Heart Future; Editor: Sophia

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Heart Future

Recently，Elixir Medical Announced, itsNovel Bioadaptive ImplantsDynamx Sirolimus-Eluting Coronary Bioadaptable SystemAlreadyObtained in the United StatesFDA Breakthrough DeviceTitle。

DynamX™ is the first dynamic coronary artery implant technology that canPolymer absorption exceeds 6 monthsSubsequently, the stent framework lock is released while maintaining dynamic support for the blood vessel.It can deliver the acute performance of a drug-eluting stent (DES) while offering the advantage of restoring vascular function.。

This Breakthrough DeviceUsed forImproving coronary artery lumen diameter, restoring hemodynamic regulation, and reducingPatients with symptomatic ischemic heart disease caused by newly developed primary coronary artery lesionsPlaque Progression，Providing Potential New Treatment Options for Patients with Coronary Artery Disease。

# Research and Development Background

To date, the use of drug-eluting stents for interventional treatment of coronary artery disease has been able to establish blood flow through angiography. However, althoughTraditional drug-eluting stents have good safety and performance, butWhile traditional stent implantation avoids elastic recoil, it also affects the adaptive remodeling, rotation, and angulation of coronary vessels.。Adverse events related to stents increase steadily at a rate of 2%-3% per year after the first year, reaching 20% after 5 years and 50% after 10 years.。

For more than two years, the use of stents has been the main reason for the annual increase in the rate of non-platform-related events. However, relevant data on the use of bioresorbable scaffold technology shows,Even after stent reabsorption, non-platform event rates continue to occur.，There are still limitations such as excessive stent thickness and poor performance in the acute phase.。Therefore, a more innovative approach is needed to restore vascular vitality.

DynamX™ Sirolimus-Eluting Bioadaptor is an innovatively designed scaffold,Its design balances acute-phase clinical performance with bioresorbable properties.，It is expected to solve the above-mentioned shortcomings of current PCI devices and has good application potential.。

# About DynamX

DynamX Bioadaptor Implant has a novel design and mechanism of action, designed toThrough Three Different StagesRestore diseased vessels to a more normal state.

After implantation, the locked phaseEstablish maximum flow cavity and restore blood flow,To treat the symptoms of coronary artery disease (CAD).
The uniqueness of the bioimplant lies in the second phase, which occurs after the Bio-adaptor is encapsulated by tissue and the absorbable polymer coating is reabsorbed. This allows Bio-adapto Helical Chain Can Unlock and SeparateAnd Release,And allow blood vessels to grow and adapt to maintain the established blood flow cavity.
The third stage is also the most unique stage.，Providing Adaptive Dynamic Support for Containers Through Detached Helical Lines。This restores vascular vitality and hemodynamic regulation by restoring pulsatility, compliance, adaptive blood flow, as well as plaque stabilization and regression.

# Latest Clinical Data

In May 2024, EuroPCR 2024 announced the latest two-year BIOADAPTOR RCT data,The 12-month results of the study demonstratedSafety and Efficacy of Dynam。

This study is an international, multicenter, controlled, single-blind, randomized controlled trial, with a total of445 patients from 34 medical centersAmong them, 50% of the patients are from Germany, Belgium, and New Zealand, and 50% are from Japan. These patients were randomly assigned in a 1:1 ratio,223 patients received DynamX treatment, and 222 patients received Resolute Onyx DES treatment.。

Primary Endpoint Event: Target Lesion Failure (TLF) rate at 24 months, defined as the composite outcome of cardiovascular death, target vessel-related myocardial infarction (TV-MI), and clinically driven target lesion revascularization (TLR).

Angiographic Endpoint: Acute phase, late lumen loss rate (%LLL), diameter stenosis rate at post-operation and follow-up, and changes in vascular angle.

Intravascular Imaging Endpoint: Malapposition, stent coverage, neointimal hyperplasia (NIH) thickness, and vessel pulsatility rate.

▲ Research Flowchart

Primary Endpoint Event: Follow-up for 24 months,DynamX GroupTLF Incidence RateCompared with the Resolute Onyx group (2.3% vs. 5.5%, P=0.093)Reduced by 59%, and there is a trend that the gap increases over time.

▲K-M Survival Curves of Two Groups Over 2-Year Follow-Up

Follow-up at 24 months, compared with the Resolute Onyx group,The TLF rate in the DynamX group decreased by 65%.（1.9% vs 5.5%;p=0.046）, while the incidence rates of CVD, TVMI, and TLR were all significantly reduced.

▲Incidence Rates of TLF, CVD, TVMI, and TLR at 2-Year Follow-Up Between Two Groups

For lesions with a higher risk of restenosis, DynamX outperforms Resolute Onyx.Compared with the Resolute Onyx group, the incidence of TLF in the DynamX group significantly decreased in left anterior descending artery lesions, small vessel lesions, and long lesions, particularly in small vessel and long lesions.TLF Incidence Rate is 0。

▲Incidence of TLF in the Two Groups with Left Anterior Descending Artery Lesions, Small Vessel Lesions, and Long Lesions

Imaging Endpoint：There was no difference in the immediate postoperative vascular diameter stenosis rate between the DynamX group and the Resolute Onyx group.，which were 9.6±3.8 and 10.2±5.2 (P=0.773), respectively.After 12 months of follow-up, the rate of vascular diameter stenosis in the DynamX group was significantly lower than that in the Resolute Onyx group.(12.7±5.4 vs. 17.3±10.0, P=0.051); The DynamX group showed higher changes in luminal area during the cardiac cycle (7.5% vs. 2.7%, P<0.001) and coronary blood flow (16.75% vs. 5.2%, P<0.001) compared to the Resolute Onyx group.

▲Immediate Vascular Stenosis Rate After Surgery in Two Groups; Incidence of Vascular Stenosis, Vascular Lumen Area, and Coronary Blood Flow Ratio at 12-Month Follow-Up

DynamX GroupTotal Plaque Volume of All Lesions(3% [SD 19] vs. 12% [SD 24] (P=0.032) andPlaque Volume in Lipid-Rich Lesions（-9% [SD 18] vs. 10% [SD 18]，P=0.008）Significantly smaller thanResolute Onyx Group.

▲Comparison of Plaque Volume in All Lesions and Lipid-Rich Lesions Between Two Groups

Research Conclusion：DynamX The bioadaptor further reduced the TLF rate compared to traditional drug-eluting stents and hasMay become a new standard of treatment, thereby establishing a new therapy for patients with coronary atherosclerotic heart disease.

# About Elixir Medical

Elixir Medical Corporation is a medical device company located in California, USA.Developing the Next-Generation Platform for Treating Coronary and Peripheral Artery Diseases, aiming to restore the adaptive remodeling and pulsatile movement ability of blood vessels. The company's mission is to transform the care of patients with heart and vascular diseases through innovation.

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