Actuated Medical Celebrates First Human Use of GripTract-GI Endoscopic Tissue Manipulator and FDA 510(k) Clearance for its Upper GI Model

BELLEFONTE, Pa. - Rezul -- Actuated Medical is thrilled to announce the first clinical case of its FDA cleared and patented GripTract-GI endoscopic tissue manipulator. This achievement demonstrates the company's ongoing commitment to advancing minimally invasive medical technologies and improving patient outcomes.

Molham Abdulsamad, MD, FACP, performed an advanced endoscopic procedure called endoscopic submucosal dissection (ESD) during which he leveraged GripTract's innovative design to assist in improving visualization to successfully remove a large complex polyp from a patient's lower gastrointestinal (GI) tract. A notable moment occurred when Dr. Abdulsamad commented to his team, "That's what you want to see," as one of GripTract's fingers provided traction while the other maintained countertraction—allowing for a broad visualization of the resection plane and facilitating a safer, more effective procedure.

In addition to this groundbreaking case, Actuated Medical is proud to announce that GripTract received its third FDA clearance, which adds an upper GI model that further expands its portfolio to provide solutions across the entire GI tract.

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"These two milestones, achieved on the same day, reflect several years of rigorous development by a dedicated team focused on improving patient outcomes," said Maureen L. Mulvihill, CEO of Actuated Medical. "ESD is a very challenging procedure to master, so better tools like GripTract are necessary to make this procedure available for more patients.  GripTract's development was partially supported by a NIH-NIDDK (National Institutes of Health – National Institute of Diabetes and Kidney Diseases) SBIR (Small Business Innovation Research) project. Thanks to NIH, GripTract was available for this patient and many more to follow."

GripTract is being manufactured in central Pennsylvania in Actuated Medical's FDA compliant facility.

About Actuated Medical, Inc.

Actuated Medical is a medical technology innovator that is pioneering motion-based solutions to address critical, unmet clinical needs in gastroenterology and neurology. The team is committed to delivering transformative products that empower healthcare professionals to achieve greater precision, enhance efficiency, and drive better patient outcomes while reducing healthcare costs. The company's technologies are backed by a strategic path to commercialization with multiple exit opportunities, supported by invaluable feedback from industry leaders. Actuated holds 45 issued U.S. and international patents, 9 FDA 510(k) clearances, 5 Investigational Device Exemptions (IDEs), 33 pre-submissions, and has completed or is conducting 8 clinical studies. Actuated has been honored with two Small Business Administration (SBA) Tibbetts Awards for SBIR commercialization excellence (2014 & 2020).  Actuated operates out of a state-of-the-art 20,000 sq. ft. facility in central Pennsylvania and is certified with ISO 13485 and as a Woman-Owned Small Business (WOSB), reflecting its steadfast commitment to quality and innovation. actuatedmedical.com

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For media inquiries, please contact Maureen L. Mulvihill, Ph.D. by phone at 814-355-0003 or email at info@actuatedmedical.com.

Additional information can be found by visiting:
ActuatedMedical.com
ActuatedNeuroscience.com
TubeClear.com
GripTract.com