Polyganics, a medical technology company developing, manufacturing and commercializing bioresorbable medical devices, has received 1.2 million euros in funding from the European Fund for Regional Development (EFRO) through the Northern Netherlands Alliance (SNN) and the city and province of Groningen, to support clinical validation of its Liver and Pancreas Sealant Patch. The grant will support a safety and performance study, which is scheduled to take place later this year in multiple renowned clinical centres across Europe.
 
Polyganics’ easy-to-use device is made of the company’s synthetic and safe bioresorbable polymers and optimized to effectively adhere to and seal-off the surgically treated tissue throughout the critical healing period after hepato-pancreato-biliary (HPB) surgery. The patch functions both as a sealant, withstanding the impact of aggressive bile and pancreatic fluids, and as a hemostat, controlling mild-to-moderate bleeding. It is being developed in close association with the surgical department of the University Medical Center Hamburg-Eppendorf (UKE), Germany, and with MercachemSyncom, a contract research organization located in Groningen.

Polyganics’ Liver and Pancreas Sealing Patch is a 100 percent synthetic device. It 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, reducing bleeding. The patch is the first product in Polyganics’ General Surgery portfolio and was designated as a Breakthrough Device by the U.S. Food and Drug Administration (FDA) in 2018. It is currently under pre-clinical development, in close association with the surgical department of the University Medical Center Hamburg-Eppendorf (UKE).
 
IJzebrand Rijzebol, member of the Provincial Executive of Groningen, commented: “We are proud to be able to support innovative companies that provide and inspire future investment in our region. Polyganics is an exemplary candidate for this grant, having enjoyed continued success in R&D, manufacturing and commercialization of medical devices, and provided attractive employment opportunities in Groningen for over 20 years. We congratulate the team and wish them luck with the upcoming study.”

EFRO aims to strengthen the regional economy by supporting local businesses to improve their competitive position, economic growth, and sustainable development, as well as by increasing employment opportunities. As the first product in Polyganics’ General Surgery portfolio, the innovative Liver and Pancreas Sealant Patch is integral to the company’s growth strategy. It will pave the way for additional future applications in the field, increasing the strength and breadth of the company’s offering.
 
Rudy Mareel, CEO of Polyganics, commented: “We are grateful to the EU, SNN and city and province of Groningen for their support towards progressing our Liver and Pancreas Sealant Patch into the next phase of development, particularly in the current unprecedented climate resulting from COVID-19. The grant is testament both to the quality of the preclinical data for this product, and to Polyganics’ strong growth outlook. As demand for products throughout our existing commercial portfolio continues to increase, we are pleased to be expanding into the challenging area of General Surgery, as we strive to provide unique bioresorbable medical devices to address unmet clinical needs.
 
Fluid leakage is a common complication of hepato-pancreato-biliary (HPB) procedures and represents a significant healthcare burden. Bile leaks are one of the most common complications after liver resection with incidence rates up to 27 percent.¹ Postoperative pancreatic fistula (POPF) remains the major cause of morbidity after pancreatic resection, affecting up to 41 percent of cases.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.

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