Cleveland, OH – August 27, 2025 – Checkpoint Surgical, Inc., a leader in intraoperative nerve care and regeneration, today announced the first in-human use of its Investigational Nerve Regeneration System Regen10® in the company’s ongoing FASTR-TEN clinical trial, marking a pivotal step forward in advancing treatment options for patients with peripheral nerve injuries.
The multicenter, double-blinded, randomized, controlled trial, Evaluating Therapeutic Electrical Stimulation to Improve Nerve Healing After Surgical Repair of Digital Nerve Injuries (FASTR‑TEN), is designed to assess the safety and potential clinical benefit of delivering brief, targeted electrical stimulation to injured peripheral nerves at the time of surgical repair.
“Regen10® pioneers a new standard in supporting nerve recovery through advanced regenerative technology,” said Dr. Amy Moore, Professor and Chair of the Department of Plastic and Reconstructive Surgery at The Ohio State University Wexner Medical Center. “With its use in the FASTR-TEN study, we are taking a major step toward studying its impact on accelerating nerve regeneration and improving patient outcomes.”
FASTR-TEN marks Checkpoint Surgical’s third major clinical trial evaluating regenerative electrostimulation to enhance nerve recovery, further underscoring the company’s leadership in advancing transformative technologies for nerve repair and regeneration. The FASTR-TEN study is enrolling patients at leading academic and medical institutions across the U.S., with additional sites expected to join in the coming months.
The Regen10® Nerve Regeneration System builds upon the established CHECKPOINT BEST® (Brief Electrical Stimulation Therapy) platform, which received Breakthrough Device designation from the FDA. Checkpoint Surgical recently received an FDA Investigational Device Exemption (IDE) for the use of the device in the FASTR-TEN study.
To learn more about FASTR-TEN, visit https://clinicaltrials.gov/study/NCT06867185.
About
Checkpoint Surgical
Checkpoint Surgical, Inc. is a
privately held medical device company headquartered in Cleveland, Ohio.
Dedicated to advancing intraoperative nerve care and regeneration, the company
develops innovative solutions designed to protect and assess nerves, as well as
accelerate nerve regeneration, during surgical procedures. For more
information, visit www.checkpointsurgical.com.
The Regen10®
device is currently available for investigational use only.
0136-MKT-165-A
