AtaCor Medical Enrolls First Patients in its ASCEND EV Clinical Study

• The novel design of AtaCor's EV-ICD Atala™ lead aims to provide reliable sensing, antitachycardia pacing (ATP), and shock therapies through an extravascular approach
• Initial cases demonstrated successful sensing and defibrillation of induced ventricular fibrillation with the Atala™ lead, across a range of commercially available ICDs
• Study marks the first permanent implantation of the company's EV-ICD Lead System for the treatment of life-threatening ventricular tachyarrhythmias

SAN CLEMENTE, Calif., March 24, 2025 /PRNewswire/ -- AtaCor Medical, Inc., a privately-held medical device company focused on transforming cardiac rhythm management, announced today that it has initiated its ASCEND EV study. The prospective, non-randomized international study aims to evaluate the safety and performance of AtaCor's all-in-one Extravascular Implantable Cardioverter Defibrillator (EV-ICD) Lead System in combination with leading commercially available transvenous ICDs. The initial cases were performed at a single clinical site and demonstrated successful sensing and defibrillation of induced ventricular fibrillation using the Atala™ lead in connection to a range of commercially available ICDs.

"Extravascular solutions allow physicians to deliver critical therapy while maintaining the integrity of the heart," commented Dr. Shephal Doshi, ASCEND EV study investigator and Executive Director of the Heart and Vascular Institute, Providence Saint John's Health Center & Cardiac Electrophysiology at the Pacific Heart Institute/Cedars Sinai. "AtaCor's innovative design is an exciting advancement with the potential to elevate the standard for cardiac rhythm management. I am impressed by these first cases, and I look forward to following the clinical progress as more patients are treated."

The AtaCor EV-ICD Lead System aims to deliver life-saving ICD benefits without the complications associated with transvenous leads or the pacing discomfort associated with other extravascular ICD systems. The all-in-one system facilitates both antitachycardia pacing (ATP) and shock delivery from a single lead and with one procedure – all without entering the heart or vascular system. Implanted via a streamlined parasternal approach, the system is designed for compatibility with commercially available transvenous ICDs and will accommodate either a lateral or left-pectoral pulse generator pocket placement.

"AtaCor is committed to revolutionizing cardiac rhythm management and protecting the integrity of the heart for future cardiac care needs. We are thrilled to have successfully completed this first round of cases, a critical step towards validating AtaCor's Atala™ lead," stated Dr. Martin Burke, Chief Medical Officer of AtaCor Medical. "Thank you to the entire AtaCor team for their tireless efforts and our physician partners for their invaluable expertise to achieve this important milestone. We look forward to adding additional clinical sites in the coming months."

The AtaCor EV-ICD Lead System is under development exclusively for investigational use and is not approved for sale in any geography.

ABOUT ATACOR MEDICAL
AtaCor is committed to transforming cardiac rhythm management with novel extravascular leads and deployment systems designed to eliminate the risks, costs, and drawbacks associated with traditional transvenous leads. To learn more, please visit www.atacor.com.

SOURCE AtaCor Medical Inc.