First Patients Treated in Trial for Liver and Pancreas Sealant Patch

Polyganics, a medical technology company developing, manufacturing and commercializing bioresorbable medical devices, announced treatment of the first patients in its first-in-human study for  ACTISEAL, its Liver and Pancreas Sealant Patch.
 
The ‘SHIELDS’ trial is a prospective, multicenter 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 centers.
 
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 U.S. Food and Drug Administration (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 percent synthetic device is optimized to adhere to and seal the treated tissue throughout the critical healing period following HPB surgery. After this it degrades safely within the body.
 
Prof. 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 commented: “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 commercialization.”
 
Fluid leakage is a common complication of hepato-pancreato-biliary (HPB) procedures and represents a significant healthcare burden. Up to 27 percent of liver resections are affected by complications with bile leakage,¹ and postoperative pancreatic fistula impact up to 41 percent of pancreatic resection patients.² With life-threatening consequences such as infection, abdominal abscesses and sepsis, post-operative bleeding and leakage of aggressive enzymatic fluids into the abdominal cavity result in increased morbidity and mortality, prolonged hospital stays and enhanced costs. There are currently no approved and clinically effective treatment options to reduce fluid leakage after HPB surgery.
 
ACTISEAL, Polyganics’ Liver and Pancreas Sealing Patch, is an easy-to-use and 100 percent synthetic device, made of the company’s bioresorbable and biologically safe polymers. The patch is optimized to significantly reduce fluid leakage during the critical healing period after HPB surgery, as a sealant, withstanding the impact of aggressive bile and pancreatic fluids, and as a hemostat, controlling mild-to-moderate bleeding. The patch is the first product in Polyganics’ General Surgery portfolio. It is being developed in close association with the surgical department of the University Medical Center Hamburg-Eppendorf (UKE). To support clinical validation of the device, Polyganics earlier this year was awarded 1.2 million euros from the European Fund for Regional Development (EFRO) through the Northern Netherlands Alliance (SNN) and the city and province of Groningen.

References
¹ Spetzler VN, Schepers M, Pinnschmidt HO, Fischer L, Nashan B, Li J. The incidence and severity of post-hepatectomy bile leaks is affected by surgical indications, preoperative chemotherapy, and surgical procedures. Hepatobiliary Surg Nutr. 2019 Apr;8(2):101-110
² Bassi C, Marchegiani G, Dervenis C, Sarr M, Abu Hilal M, Adham M, Allen P,Andersson R, Asbun HJ, Besselink MG, Conlon K, Del Chiaro M, Falconi M, Fernandez-Cruz L, Fernandez-Del Castillo C, Fingerhut A, Friess H, Gouma DJ, Hackert T, Izbicki J, Lillemoe KD, Neoptolemos JP, Olah A, Schulick R, Shrikhande, SV, Takada T, Takaori K, Traverso W, Vollmer CR, Wolfgang CL, Yeo CJ, Salvia R, Buchler M; International Study Group on Pancreatic Surgery (ISGPS). The 2016 update of the International Study Group (ISGPS) definition and grading of postoperative pancreatic fistula: 11 Years After. Surgery. 2017 Mar;161(3):584-591