Milestone highlights growing multicenter experience with Recross Cardio’s novel PFO Sealing System

NEW YORK, Oct. 5, 2026 /PRNewswire/ — Recross Cardio Inc., a structural heart company pioneering novel membrane-based technologies for lifelong septal management, today announced the treatment of the 25th subject in the PROTEA-PFO clinical program evaluating the Recross PFO Sealing System.

The milestone marks an important advancement in the clinical evaluation of Recross’ membrane-based sealing platform, with subjects enrolled across investigational sites in the United States and Europe. The program is designed to assess the initial safety and preliminary performance of the Recross PFO Seal in subjects who have had a prior ischemic stroke due to presumed paradoxical embolism. Building on the first enrolment in the Early Feasibility Study, Recross has expanded its clinical experience across multiple physicians and healthcare institutions. To date, the program includes 15 subjects treated in the United States and 10 subjects treated in Serbia, demonstrating growing physician experience with the company’s novel membrane-based approach to septal sealing.

Dr. Carey Kimmelstiel, Director of Interventional Cardiology at Tufts Medical Center, Professor of Medicine at Tufts University School of Medicine, and National Co-Principal Investigator of the study, added:

“As our experience with PFO closure evolves, we continue looking for technologies that not only achieve effective closure but also consider the subjects’ needs over their lifetime. The Recross system offers a novel approach while maintaining a familiar transcatheter workflow. Reaching 25 treated subjects across multiple centers is an important milestone in understanding the performance of this technology.”

Dr. Mihajlo Farkic, Principal Investigator at National Institute for Heart and Blood Vessels “Dedinje” in Belgrade, Serbia, commented:

“We are proud to have contributed to the continued progress of the study. Our early experience has demonstrated that the device can be implanted efficiently and has shown promising acute sealing performance. Continued clinical experience across multiple centers will be important to further understand the potential of this technology and the way we approach PFO closure.”

The Recross PFO Sealing System is the first clinical application of Recross’ proprietary membrane-based septal sealing platform. The technology is designed to provide a conformable, low-profile approach to septal sealing with minimal permanent implant footprint.

Dr. Gilberto Melnick, Co-Founder and Clinical Advisor at Recross Cardio, commented:

“The idea behind the Recross technology stemmed from the belief that septal therapies should evolve beyond closure toward lifelong septal management. Our goal has not only been to seal a septal defect, but also to better consider the patient’s long-term journey. The clinical insights gained through the PROTEA-PFO program continue to help shape and refine that vision.”

“This achievement reflects meaningful progress not only for the PROTEA-PFO study, but for the broader Recross mission,” said Tom Gerhardt, Chief Executive Officer of Recross Cardio. “The growing experience across multiple centers and physicians provides valuable clinical insight into our membrane-based approach to septal sealing. We remain focused on generating the evidence needed to advance our platform and evaluate its potential across PFO, ASD and iASD.”

About the PROTEA-PFO Clinical Program

PROTEA-PFO is a prospective, multicenter clinical program evaluating the safety and performance of the Recross PFO Sealing System for transcatheter closure of patent foramen ovale in subjects at risk of recurrent ischemic stroke. The program represents the first clinical evaluation of Recross’ membrane-based septal sealing technology. The study is being conducted at leading centers in the United States and Europe. The company plans to continue generating clinical evidence to support development of its septal sealing platform. For more information, please visit clinicaltrials.gov/study/NCT07172464 (United States) or clinicaltrials.gov/study/NCT07698951 (Outside the United States)

About Recross Cardio

Recross Cardio is a structural heart company developing novel membrane-based septal sealing technologies. Its membrane-based platform is being evaluated for structural heart applications including patent foramen ovale (PFO), atrial septal defect (ASD) and iatrogenic atrial septal defect (iASD), with the goal of supporting lifelong septal management.

CAUTION – Investigational device. Limited by Federal (or United States) law to investigational use.  Exclusively for Clinical Investigation and not for Commercial Use.

For additional information, visit www.recrosscardio.com.

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SOURCE Recross Cardio Inc