AtaCor Medical Submits IPO Prospectus for Atala: A Universal Extravascular Lead Compatible with All Marketed ICDs, Enabling Transvenous-Free Defibrillation

Mar 29, 2025 22:15 CST Updated 22:15

AtaCor Medical

Cardiac Pacemaker Developer

AtaCor MedicalAnnouncing its compatibility with extravascular leads---AtalaCompletion of the First Clinical (ASCEND EV) Enrollment.

ASCEND EV is a prospective, non-randomized international study designed to evaluate the safety and effectiveness of the AtaCor integrated extravascular implantable cardioverter defibrillator (EV-ICD) used in conjunction with mainstream commercially available transvenous ICDs.

PI Evaluation

"The initial cases are impressive, and I look forward to continuing to monitor clinical progress as more patients receive treatment. The extravascular solution allows physicians to deliver critical treatment while maintaining cardiac integrity. AtaCor's innovative design represents an exciting technological advancement with the potential to elevate cardiac rhythm management standards. These first cases are impressive, and I look forward to continuing to monitor clinical progress as more patients receive treatment."

---Shephal Doshi Providence Saint John's Health Center

Executive Evaluation

"The company is committed to revolutionizing cardiac rhythm management technology and safeguarding heart integrity for future cardiac care needs. We are thrilled to have successfully completed the first phase of case implants, a significant milestone in validating Atala. Thanks to the hard work of the entire team and the professional contributions of our clinical partners, we look forward to adding more clinical research centers in the coming months."

---Martin Burke Chief Medical Officer of AtaCor Medical

If cardiac arrest occurs, the heart will lose its pumping ability.Force, leading to largeIschemia and hypoxia in the brain and vital organs throughout the body, posing a critical threatLife.At this point, timely defibrillation treatment is required to help the patient restore their normal heart rhythm.However, due to the sudden onset, it is difficult to find an automated external defibrillator (AED) for timely treatment within a short period. Once the optimal treatment window is missed, patients often die within one to several hours.According to statistics, every year in ChinaOccurrenceSudden Cardiac DeathThe number of deaths exceeds 540,000, while the success rate of out-of-hospital rescue is less than 1%.

The implantable cardioverter defibrillator (ICD) can solve this tricky problem. By implanting a miniaturized defibrillator into the patient’s body, it provides 24-hour continuous monitoring of the heart condition and swiftly delivers defibrillation in the event of cardiac arrest, akin to providing the patient with a "cardiac bulletproof vest." Despite the conventionalImplantable HeartImplantable Cardioverter Defibrillator (ICD) can help patients in a timely mannerDefibrillation saves patients' lives, but traditional ICDs have two major drawbacks:Damage and infection of the lead.Since the leads are adhered to the heart and veins, lead extraction is not an easy task (many centers do not perform it). The severe complication rate of percutaneous lead extraction is 1-2%, with a mortality rate of 0.1%. Additionally, for pediatric and adolescent patients, growth and development are unavoidable issues, and multiple surgeries significantly increase the risk of infection.Probability。

To solve through blood vesselsLead issues, mainstream companies are actively addressingExtravascular defibrillator. Currently, only Medtronic's Aurora EV-ICD extravascular defibrillator has received FDA approval for market release.Aurora EV-ICD is a systematic product, whichDefibrillators and extravascular leads are highly bound, and patients can only purchase them as a whole. AndAtaCor MedicalExtravascular LeadAtalaIs a product that can be compatibleAll marketedTransvenous ICDs can be used for both ICD transplant patients and those requiring ICD implantation.AtalaIt only needs to be implanted into the patient's body through minimally invasive surgery to connect to the ICD for use.

Atala

AtalaIt is a revolutionary EV-ICD lead that is compatible with all marketed products.Transvenous ICD.AtalaCan be mentionedProviding reliable sensing, pacing, and shock therapy to treat life-threatening arrhythmias, while avoiding entry into the heart and vascular system to reduce unnecessary complications.

Advantages of Atala over Traditional Leads

Unlike subcutaneous ICDs that cannot provide anti-tachycardia pacing (ATP) therapy, Atala achieves both ATP and shock therapy through a single lead and a single procedure.
AtalaSpecifically designed to enhance patient comfort, it is compatible with smaller and thinner commercially available transvenous ICDs (compared to subcutaneous ICDs). This feature not only improves the aesthetic appearance and comfort after device implantation but also significantly reduces pain perception during ATP therapy.
AtalaTaking Cardiac Rhythm Management to the Next Level --- Its proprietary design features optimize the implantation process of extravascular ICD leads while seamlessly integrating ATP and shock therapy through commercially available transvenous ICDs.

Atala Demonstration

AtaCor Medical

Atacor MedicalAtaCor Medical, Inc. is an innovative medical device company dedicated to transforming cardiac rhythm management through novel extravascular catheters and deployment systems, aiming to eliminate the risks, costs, and drawbacks associated with traditional transvenous leads.