08 March 2018
FDA Grants Breakthrough Device Designation to Polyganics’ Liver and Pancreas Sealant Patch
Groningen, The Netherlands, 8 March 2018 – Polyganics, a privately held medical technology company that develops, manufactures and commercializes bioresorbable medical devices, today announced that the US Food and Drug Administration (FDA) has granted Polyganics’ request for Breakthrough Device designation to its Liver and Pancreas Sealant Patch. The Liver and Pancreas Sealant patch is considered a unique breakthrough in the prevention of fluid leakage after hepato-pancreato-biliary (HPB) procedures, for which currently no approved or cleared alternatives exist.
The Liver and Pancreas Sealant Patch is made of Polyganics’ proprietary bioresorbable and biologically safe polymers, designed to seal-off the surgically treated tissue during the critical healing period. The polymer formulation of the Liver and Pancreas Sealant has been optimized specifically for HPB surgery, withstanding the interference of aggressive bile and pancreatic fluids. It aims to prevent post-operative leakage of fluids from the site of surgery into the abdominal cavity after HPB surgery, and as an adjunctive hemostatic device to control minimal to moderate bleeding.
A ‘Breakthrough Device’ is a device that may prevent or treat a life-threatening or irreversibly debilitating disease or condition. Under the Breakthrough Devices program, the FDA will provide its support to advance the Liver and Pancreas Sealant Patch from development to marketing decision. As part of this, the FDA is committed to be closely involved in the design of efficient and flexible clinical trials, as well as the collection of pre- and post-market data. It is anticipated that this support, combined with priority review, will enable a reduced regulatory timeline.
Prof.Dr.Med.Dr.Jakob Izbicki, Chairman of the Department of General, Visceral and Thoracic Surgery, Surgeon-in-chief, University Medical Center Hamburg-Eppendorf (UKE), Polyganics’ development partner for the Liver and Pancreas Sealant Patch, commented: “There is a clear need for a device that can effectively control the leakage of fluids in HPB surgery, that can be applied easily and can seal and withstand the enzymatic action and acid substances such as bile and pancreatic fluids. If an effective closure of the surgically treated tissues can be achieved, post-operative morbidities such as infection, abdominal abscesses and sepsis, often leading to a prolonged hospital stay, will be significantly reduced, positively affecting patients’ post-operative quality of life.”
Rudy Mareel, CEO of Polyganics, commented: “We are excited about the FDA’s decision to grant Breakthrough Device designation to our Liver and Pancreas Sealant Patch. It is a great recognition of the potential clinical benefit this device may offer to patients. We look forward to working with the FDA to progress the device more swiftly to market and thereby drive better outcomes for surgical patients.”
Polyganics is a medical technology company with multiple versatile polymer platforms. The Company develops, manufactures and commercializes innovative bioresorbable medical devices that facilitate tissue repair and regeneration.
Polyganics’ portfolio includes products developed in-house and in collaboration with leading medical technology companies and academic centers of excellence. In the Peripheral Nerve Repair (PNR) and neurosurgery field, the portfolio includes three marketed products: VIVOSORB® for minimizing unwanted tissue adhesions after surgery; NEUROLAC® for supporting PNR following hand surgery; and NEUROCAP® for the management of symptomatic neuromas. Products in development include a sealant for the dura membrane and a liver sealant patch.
In 2014, Polyganics sold its Ear, Nose & Throat (ENT) surgery business unit (the NASOPORE® product family including HEMOPORE®, SINUPORE® and OTOPORE®) to Stryker, one of the world’s leading medical technology companies. NASOPORE®, a reliable, easy-to-use, nasal wound care dressing made of biodegradable foam, has been used in over 3.5m procedures globally. Polyganics continues to manufacture the NASOPORE® product range for Stryker.
Polyganics is profitable and privately held. The Company is based in Groningen, The Netherlands, a center of biomedical engineering excellence, in an ISO 13485-certified manufacturing facility. The Company’s polymer platform technologies are protected by a broad portfolio of patents and its products have received clearance from the US FDA, CE-approval, and approval from CFDA and other international authorities.
For more information, visit: www.polyganics.com
Paul Roos, Chief Financial Officer
Romke Ribbels, Director Marketing & Business Development
Telephone: +31 50 588 65 88
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