NOBLES MEDICAL TECHNOLOGY II ANNOUNCES FDA APPROVAL TO RESTART NOBLESTITCH™ CLINICAL TRIAL

LAS VEGAS, Oct. 7, 2025 /PRNewswire/ -- Nobles Medical Technology II, a pioneering leader in innovative cardiovascular closure solutions, today announced that the U.S. Food and Drug Administration (FDA) has granted approval to restart its pivotal NobleStitch™ clinical trial, marking an important milestone in the development of the first device-free, suture-mediated system for closing patent formaen ovale (PFO) for reduction of recurrent cryptogenic stroke.

The clinical trial, originally designed to evaluate the safety and efficacy of the NobleStitch EL™ system for patent foramen ovale (PFO) closure, was proactively paused by Chairman and CEO Dr. Anthony Nobles to ensure the highest standards of safety, transparency, and scientific rigor. With FDA approval now confirmed, the company will move forward with renewed momentum to reinitiate enrollment and continue gathering critical data in support of its expanded indication of its' FDA cleared suture-mediated, non-device closure platform.

This development directly follows the recent publication of a pivotal peer-reviewed study in the Journal of the American College of Cardiology: Advances (September 2025 edition)¹. The findings demonstrate strong clinical rationale for suture-based closure strategies and reinforce the unique potential of the NobleStitch™ technology to establish new standards of care by eliminating permanent implants, reducing metal and nickel exposure, and expanding long-term patient safety.

"We are thrilled to restart the NobleStitch™ clinical trial with the support of the FDA's decision," said Dr. Anthony Nobles, Chairman and CEO of Nobles Medical Technology II. "This decision reflects confidence in our technology, our trial design, and our commitment to advancing safer, more effective solutions for patients suffering from cryptogenic stroke and other PFO-related conditions. We paused the trial to make a more robust protocol and data collection. The recently published data validates what we have long believed—that a suture-mediated, non-implant approach represents the future of PFO closure. The completion of the trial and upcoming PMA submission should provide additional scientific evidence of the safety and efficacy of the NobleStitch™. The company is also pleased to announce the addition of Rush University Medical Center as a new clinical site, under the direction of Dr. Josh Murphy, a leading expert in PFO closure.".

The company expects to resume patient enrollment in Q4 2025 and anticipates submitting a Pre-Market Approval (PMA) application upon completion of the pivotal study.

The NobleStitch EL™ system leverages a proprietary percutaneous suturing technique to close intracardiac defects without leaving behind a permanent device. This approach may reduce complications associated with conventional metal mesh occluders, including nickel hypersensitivity and late device-related adverse events. Nobles Medical Technology II remains committed to completing the clinical trial with robust data collection to support regulatory submissions and future widespread adoption.

FOR FURTHER INFORMATION, VISIT www.noblesmed2.com AND HeartStitch.com.

ABOUT NOBLESTITCH™ AND HEARTSTITCH, INC.
NobleStitch™ IS A PATENTED SUTURE-MEDIATED CARDIOVASCULAR CLOSURE SYSTEM OFFERING A DEVICE-FREE ALTERNATIVE FOR STRUCTURAL HEART DEFECTS. HEARTSTITCH, INC. IS ITS EXCLUSIVE GLOBAL DISTRIBUTOR, COMMITTED TO ADVANCING PATIENT CARE THROUGH INNOVATION.
NobleStitch™ IS MANUFACTURED AND DISTRIBUTED BY HEARTSTITCH, INC.
THE NOBLESTITCH EL™ IS FDA CLEARED IN THE USA FOR CARDIOVASCULAR SUTURING AND CE MARKED IN THE EU FOR CARDIOVASCULAR SUTURING PFO CLOSURE. THE NOBLESTITCH EL™ IS COVERED BY SEVERAL US AND INTERNATIONAL PATENTS (VISIT www.noblesmed2.com).

MEDIA CONTACT:
[email protected]

SOURCE HeartStitch® Inc.

¹ https://www.jacc.org/doi/full/10.1016/j.jacadv.2025.101991 

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