AtaCor Medical has announced up to $75m in financing to support a pivotal study of its extravascular implantable cardioverter-defibrillator (EV-ICD) system.
The US Food and Drug Administration (FDA) study of the system is intended to evaluate the system for treating life-threatening ventricular tachyarrhythmias.
AtaCor’s EV-ICD system comprises the Atala lead and an implantable pulse generator.
The Atala lead is inserted through a left parasternal incision, with electrodes positioned against the pericardium, avoiding placement in the heart or vasculature.
Placed in a subcutaneous device pocket, the pulse generator is said to provide a new approach to EV-ICD systems by reducing the risks associated with traditional intravascular or intracardiac leads.
AtaCor Medical CEO Rick Sanghera said: “There is a clear and growing need for extravascular ICD systems that combine a straightforward implant procedure with the ability to deliver the full spectrum of tachyarrhythmia therapies using a small pulse generator.
“AtaCor is poised to meet that need. We are proud to close this financing round and excited to initiate our pivotal trial next year.”
Recently, AtaCor completed enrolment for its ASCEND EV Pilot Study, with initial findings to be presented at the Asia-Pacific Heart Rhythm Society meeting in Japan next month.
Building on the study results, the company plans to initiate the ALARION EV Pivotal Study in Europe and the US in 2026.
This study will evaluate the efficacy and safety of the parasternal EV-ICD system to support global regulatory submissions.
AtaCor is currently developing the EV-ICD Lead System for investigational use only.
AtaCor Board of Directors’ chair Maria Berkman said: “The AtaCor team is developing a meaningful solution for patients, while protecting the integrity of the heart for future interventions.
“The board is delighted to see this infusion of capital in support of AtaCor's pivotal trial, bringing this important technology one step closer to the bedside.”
In April last year, AtaCor raised $28m in a Series C financing round led by Arboretum Ventures to advance its extravascular ICD and pacing solutions.
