Polyganics, a medical technology company developing, manufacturing and commercialising bioresorbable medical devices, has announced treatment of the first patients in its first-in-human study for ACTISEAL, its liver and pancreas sealant patch.
via Shutterstock
First patients treated in first-in-human trial for ACTISEAL
The ‘SHIELDS’ trial is a prospective, multi-centre study, evaluating the safety and performance of ACTISEAL in reducing fluid leakage following elective hepato-pancreato-biliary (HPB) surgery. The trial will involve 80 adult patients, enrolled and treated across seven renowned European clinical centres.
Despite post-operative fluid leakage being one of the most common complications of HPB procedures, with potentially life-threatening consequences, there are currently no clinically effective treatment options available. As a result of this high unmet need, combined with Polyganics’ convincing research data, the US FDA awarded the Company’s Liver and Pancreas Sealant Patch a Breakthrough Device Designation in 2018.
ACTISEAL functions both as a sealant, withstanding the impact of aggressive bile and pancreatic fluids, and a hemostat, controlling mild-to-moderate bleeding. The easy-to-use, 100% synthetic device is optimised to adhere to and seal the treated tissue throughout the critical healing period following HPB surgery. After this it degrades safely within the body.
Professor Dr Med. Dr Jakob Izbicki, Chairman of the Department of General, Visceral and Thoracic Surgery, Surgeon-in-Chief at University Medical Center Hamburg-Eppendorf (UKE), Polyganics’ development partner for ACTISEAL, and Principal Investigator of the study, said: “There is a clear and urgent need for a device capable of effectively controlling fluid leakage following HPB surgery. Such post-operative leakage represents a high burden to both patients’ well-being and our healthcare system. I applaud Polyganics for responding directly to the demands of surgeons and needs of patients with ACTISEAL. The initiation of the first-in-human study is a significant step towards reducing leakage associated complications, which adversely affect surgical success and patient outcomes”.
Rudy Mareel, CEO of Polyganics, added: “As the first product to enter the clinic from our General Surgery portfolio, ACTISEAL is spearheading Polyganics’ expansion into this challenging field. The patch is key to our strategy to increase the strength and breadth of our offering by diversifying our pipeline of bioresorbable tissue support, repair and regeneration devices. This announcement adds to the string of varied successes Polyganics has enjoyed since inception across product development, R&D, manufacturing and commercialisation.”