CoreMap, Inc. Receives U.S. FDA Investigational Device Exemption (IDE) Approval for INvENI Map-Guided AF Ablation Study

/EIN News/ -- BURLINGTON, Mass., May 28, 2025 (GLOBE NEWSWIRE) -- CoreMap today announced it has received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to extend the INvENI clinical study into the U.S. This study is designed to evaluate the safety and effectiveness of the proprietary CoreMap™ Endocardial Electrophysiology (EP) Mapping System in patients with persistent Atrial Fibrillation (AF) and long-standing persistent AF. To date, CoreMap has demonstrated safety and acute effectiveness of its EP Mapping system in over 50 patients.

Dr. Vivek Reddy, the Helmsley Trust Professor of Medicine at the Icahn School of Medicine at Mount Sinai and Principal Investigator of this US IDE commented: “CoreMap’s novel AF mapping catheter and signal processing algorithms are able to identify AF driver regions not discernible in prior AF mapping attempts. I believe strongly that ablation strategies based on patient-specific electrical activation, patterns, rather than a blind anatomic approach, will improve outcomes for patients with AF. I am excited to begin enrolling patients in the U.S.”

Earlier this month at a renowned New York City hospital, the Company conducted Compassionate Use cases guiding pulsed field ablation in patients with recurrent AF that had been unresponsive to multiple prior mapping and ablation procedures using commercially available technology.

About CoreMap

CoreMap’s cofounders Dr. Peter Spector, a clinical electrophysiologist, and CEO Sarah Kalil, an industry veteran, founded the Company to improve outcomes for the millions of people affected by AF. The company’s micro-electrode technology and novel algorithms address today’s limitations in AF mapping—low spatial resolution and inadequate signal density.

The CoreMap EP Mapping System is a next-generation EP platform intended to guide patient specific AF ablation using ultra-high resolution endocardial mapping, recording hundreds of thousands of electrical activations during a single AF map. The CoreMap Invenio™ EP Mapping Catheter features a dense array of micro-scale electrodes capable of capturing highly localized, high-fidelity electrograms with minimal fractionation. This patented breakthrough catheter design enables the use of novel algorithms to identify drivers of AF and support precise, targeted ablation strategies.

About the INvENI Study

The INvENI study is a multi-phase, multi-center clinical trial that began enrollment in July of 2024 at Na Homolce Hospital in the Czech Republic under Principal Investigator Professor Petr Neuzil. Phase 1 of the study assessed acute safety in 14 patients. Phase 2 demonstrated acute safety and effectiveness in 15 patients receiving CoreMap-guided tailored ablation. Phase 3 is a randomized controlled study evaluating the effectiveness of CoreMap-guided ablation in de novo persistent AF patients. The treatment group will undergo pulmonary vein isolation (PVI) plus CoreMap-guided ablation targeting AF drivers, while the control group will receive standard-of-care PVI and Posterior Wall Isolation (PWI). Patients will be followed for 12 months to assess freedom from AF, atrial tachycardia, and atrial flutter recurrence.

“This IDE approval marks a major milestone for CoreMap as we expand our clinical research into the U.S.,” said Sarah Kalil, CEO and Co-founder of CoreMap. “We are encouraged by our clinical data as we seek to transform treatment for AF patients globally and look forward to building on the strong safety and effectiveness data already demonstrated in Europe.”

For more information about the INvENI study or CoreMap’s technology, please visit www.coremapmedical.com.

Contact:
investorrelations@coremapmedical.com