Recross Cardio’s Global PROTEA-PFO Clinical Program Marks Enrollment Milestone

October 12, 2026—Recross Cardio Inc., a structural heart company developing membrane-based technologies for septal management, announced that enrollment has reached 25 patients in the PROTEA-PFO clinical program evaluating the company’s patent foramen ovale (PFO) sealing system. The Recross technology is designed to provide a conformable, low-profile approach to septal sealing with minimal permanent implant footprint, noted the press release.

According to the company, the prospective, multicenter PROTEA-PFO program is evaluating the initial safety and performance of the Recross system for transcatheter closure of PFO in patients at risk of recurrent ischemic stroke. Patients enrolled in the study have had a previous ischemic stroke caused by presumed paradoxical embolism.

The program includes the PROTEO-PFO early feasibility study evaluating percutaneous repair of the atrial septum with the Recross PFO system in the United States and the PROTEA-PFO OUS, evaluating the device outside the United States.

In December 2025, Recross Cardio announced commencement of the PROTEA-PFO early feasibility study with the first clinical implantation of the Recross PFO device.

Since then, Recross has expanded its clinical experience across multiple physicians and health care institutions. To date, the program has enrolled and treated 15 patients in the United States and 10 patients treated in Serbia.

Carey Kimmelstiel, MD, Director of Interventional Cardiology at Tufts Medical Center and Professor of Medicine at Tufts University School of Medicine in Boston, Massachusetts, serves as National Co-Principal Investigator of the United States study.

“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,” commented Dr. Kimmelstiel in the company’s press release. “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.”

Mihajlo Farkic, MD, who is Principal Investigator for the OUS study at National Institute for Heart and Blood Vessels “Dedinje” in Belgrade, Serbia, added, “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.”