Elixir Medical Submits IPO Filing for DynamX BTK System – the First Vascular Adaptive Below-the-Knee Stent with FDA Breakthrough Device Designation

Mar 24, 2024 11:40 CST Updated 11:40

Elixir Medical

Medical Device R&D and Manufacturing Company

Source: Heart Future; Editor: Li Yuanming

Reprint Requirements: If the source of the article is indicated at the beginning of the text, it can be reprinted directly.

Heart Future

Recently,Cardiovascular Healthcare Company Elixir MedicalAnnounced, itsDynamX BTK SystemObtainFDA "Breakthrough Device" DesignationDynamX BTK isThe First ModelPeripheral Artery Stents Designed to Adapt to Vascular Physiology, used forTreatment of infrapopliteal vascular stenosis or occlusion in patients with chronic limb disease，The stentCE Certified。

CEO of Elixir Medical CorporationMotasim SirhanRepresentation: "DevelopmentDynamX BTK SystemIt is to change the treatment of coronary artery and peripheral artery diseases. We thank the FDA for our treatment of CLTI patients.Below-the-Knee Atherosclerotic Disease (BTK)The innovation and its recognition of the potential impact on patients with vascular diseases."

# Product Development Background

CLTI (Chronic Limb Threatening Ischemia), also known as CLI (Critical Limb Ischemia), is aMore severe peripheral artery disease (PAD) is associated with high mortality and morbidity rates and also consumes substantial healthcare resources.. This disease severely impairs limb blood flow and microcirculation function, leading to rest pain, ischemic ulcers, and gangrene.

Data shows,The amputation rate for CLTI patients is as high as 40% within six months, with nearly 50% of major amputations occurring without prior diagnostic evaluation.25% of CLTI patients will die within 1 year, and 60% of patients will die within 5 years.。

Currently, BTK diseaseIntracavitary treatment methods includePlain Balloon Angioplasty (POBA), DCB (Drug-Coated Balloon), DES (Drug-Eluting Stent), Debulkingetc., butThere are certain limitations, satisfactory therapeutic effects cannot be achieved.

Among them, POBA cannot counteract early vascular elastic recoil and long-term intimal hyperplasia; DCB also cannot counteract elastic recoil, cannot prevent the formation of dissections, and inappropriate sizing can affect drug delivery rates; although debulking can serve as an excellent vessel preparation tool, there is no clear evidence supporting its use as a definitive treatment method.The efficacy of DES in treating short-segment BTK lesions is certain, but the issue of stent retention still cannot be avoided., itsCan serve as a transitional product for novel bioresorbable drug-eluting stents.

Since drug-eluting stents (DES) need to be permanently placed and fixed in the coronary arteries to prevent their expansion due to disease progression, thisCan lead to thrombosis, neointimal hyperplasia, and inflammatory response., while the stent locks the coronary artery willCausing blood vessels to lose positive remodeling, physiological contraction, and dilation capabilities, reducing blood flow and oxygen supply in the myocardium.

To address the issues associated with traditional drug-eluting stents (DES), bioresorbable scaffolds (BVS) are undoubtedly the optimal solution. However, due to insufficient raw material performance, the applicability of bioresorbable scaffolds (BVS) remains relatively limited.Cannot truly replace traditional drug-eluting stents (DES).

Elixir Medical has come up with a completely new stent structure., which refers to this new type of stent as the Bioadaptable System (DynamX).DynamX is the first coronary artery stent designed to adapt to vascular physiology.Can adapt to this physiological dilation and contraction of the coronary arteryThis stent also features a drug-eluting bioabsorbable polymer coating, which supports the coronary arteries during the healing process, similar to traditional drug-eluting stents.

However, unlike traditional drug-eluting stents, after six months, the polymer coating dissolves, allowing the stent structure to loosen but maintaining longitudinal continuity.Allowing it to move freely with the natural expansion and contraction of the artery, thereby maintaining active adaptive remodeling capability and restoring vascular function.。

DynamX Coronary Bioadaption System

▲Image source: Company's official website

DynamX Coronary Bioadaption SystemIt is a coronary artery implantation technology,Aimed at releasing the stent to unseal the blood vessel, to maintain the normal function of the blood vessel through the supporting effect of percutaneous coronary intervention (PCI) on the diseased vessel after the procedure.DynamX BTK is the first peripheral artery stent designed to adapt to vascular physiology.CE certified.

It solvesDrug-Eluting Stent (DES)AndBioresorbable Scaffold (BRS)The defect, andLower incidence of adverse clinical events。

As an adaptive device,DynamX BTK SystemSystemCan support patients' BTK vessels after PCI or other interventions.Once it is no longer needed, it unlocks and "releases" the blood vessel, while continuing to provide additional support as the healing process progresses.

According to Elixir Medical,DynamX Restores Vascular Movement and Function While Increasing Blood Flow。

▲Image source: Company's official website

# Clinical Trial Results

The BIOADAPTOR RCT trial is the third trial in Elixir Medical's DynamX Bioadaptor System clinical evidence program, which consists of multiple clinical trials.Involving more than 9,000 patients, including the INFINITY SWEDEHEART RCT (n=2400) which completed registration in July, and the global BIO-RESTORE registry targeting up to 5000 registered patients.

In this study, regarding the primary endpoint,DynamX Achieved Non-Inferiority Endpoint, showing acute-phase performance similar to that of traditional stents.At 12 months,DynamX is non-inferior to DES in target lesion failure (TLF) rate (1.8% vs. 2.8%, p<0.001).Among the various components of TLF, the DynamX group had no cardiac deaths, and both groups exhibited very low rates of target vessel myocardial infarction and target lesion revascularization.

▲Primary Endpoint of the Trial (Source: Company's Official Website)

In terms of secondary endpoints,The imaging evaluation of DynamX is more outstanding, including the restoration of vascular motility and function.. The imaging endpoint at 12 months showedDynamX The卓越有效性, such as the restoration of vascular compliance and cyclic pulsatility (7.5% vs. 2.7%, p<0.001), late lumen loss (0.09±0.34mm vs. 0.25±0.39mm, p=0.038), etc.

Compared with DES,DynamX Shows Superior Lumen Patency at 12 Months, with diameter stenosis percentages of 12.7% and 17.3% (p=0.05), respectively. Moreover, subgroups such as anterior descending artery lesions (12.1% vs. 19.0%), small vessels (13.0% vs. 18.3%), and long lesions (13.0% vs. 22.9%) all showed statistical significance.

▲Secondary Endpoint of the Trial (Source: Company's Official Website)

Not only that, but against the backdrop of over 90% of patients in both research groups taking lipid-lowering medications, at 12 months,Compared with a 10% increase in plaque in the DES group, DynamX reduced plaque volume by 9%., which suggests a certain synergistic effect between DynamX in restoring vascular motility and function and the systemic use of lipid-lowering drugs. However, better evaluation of DynamX's role in different populations is needed in the future to achieve more clinical benefits.

▲Test Results (Source: Company Official Website)

# Comparison of Products in the Same Track

A few days ago,German cardiovascular company BiotronikAnnounced that its independently developedFreesolve™ Below-the-Knee Resorbable Magnesium Scaffold (BTK RMS) Receives FDA "Breakthrough Device" Designation。FDA Breakthrough Designation! Bioabsorbable Magnesium Stent for Below-the-Knee

Freesolve™ RMS, which officially received CE certification in February 2024, has been launched in Europe and is mainly used for the treatment of coronary artery disease.

In 2016, Biotronik launchedThe second-generation absorbable magnesium alloy stent Magmaris® has become the world's first marketed absorbable metal stent.。

Based on the excellent clinical performance of Magmaris® RMS,Elixir Medical has further optimized Magmaris® RMS, leading to the birth of the third-generation Freesolve™ RMS.。

Freesolve™ RMS builds on the technology of Magmaris® RMS and incorporates several technical improvements to meet the needs of interventional cardiologists and achieve better patient outcomes, aiming to provide a superior stent treatment option for patients with coronary artery disease.

▲Freesolve™ Stent Product Image (Image source: Company's official website)

This stent is based on the BIOmag® magnesium alloy and the proven Orsiro® drug-eluting stent (DES) coating technology, offering verified safety, improved deliverability, optimal performance, and vascular support during and after implantation.

▲Vascular support function of the Freesolve™ stent (Image source: company's official website)

These characteristics of Freesolve™ RMS can provide special value in BTK intervention.In BTK interventions, stents can resist vascular recoil in the short term, but ultimately vascular implants are not necessary.。

Elixir Medical Corporation plans to launch the product in major European markets such as Germany and Switzerland within 2024, and actively initiate post-marketing clinical studies to further evaluate the long-term efficacy and safety of the stent.

# About Elixir Medical

Elixir Medical Corporation is a medical device company located in California, USA, developing next-generation platforms for the treatment of coronary and peripheral artery diseases, aiming to restore vascular adaptive remodeling and pulsatile motion capabilities. The company's mission is to transform care for patients with heart and vascular diseases through innovation.

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