Nobles Gains FDA Approval to Restart NobleStitch Clinical Trial

October 10, 2025—Nobles Medical Technology II announced that the FDA has granted approval to restart the company’s pivotal clinical trial for its NobleStitch, which is a device-free, suture-mediated system for closing patent foramen ovale (PFO) for the reduction of recurrent cryptogenic stroke.

The company expects to resume patient enrollment in Q4 2025 and anticipates submitting a premarket approval application upon completion of the pivotal study.

Nobles stated that the clinical trial was originally designed to evaluate the safety and efficacy of the NobleStitch EL system for PFO closure. The company noted that it paused the trial to ensure standards of safety, transparency, and scientific rigor.

With FDA approval confirmed, the company advised it will reinitiate enrollment and continue gathering data in support of its expanded indication of its NobleStitch EL platform, which is FDA cleared for cardiovascular suturing. In Europe, the device has received CE Mark approval for cardiovascular suturing PFO closure.

NobleStitch is manufactured and distributed by HeartStitch, Inc. Both HeartStitch and Nobles Medical Technology II were founded and are led by Anthony Nobles, PhD.

HeartStitch recently announced that long-term clinical results from a study of a large cohort of patients evaluating the NobleStitch system for PFO closure were published by Professor Achille Gaspardone, MD, et al in JACC: Advances.

In the current press release, Nobles Medical Technology II stated that the findings by Gaspardone et al demonstrated strong clinical rationale for suture-based closure strategies and reinforce the 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.