Polyganics announced that it is initiating the European launch of its Liqoseal dural sealant patch after it won CE Mark approval. The Groningen, The Netherlands–based company’s Liqoseal dural sealant patch is designed to reduce cerebrospinal fluid (CSF) leakage following elective cranial surgery. Liqoseal’s European approval follows the Encase I clinical trial, which revealed an absence […]
Polyganics
Polyganics liver and pancreas sealant wins FDA breakthrough designation
Polyganics said today it won FDA breakthrough device designation for its Liver and Pancreas Sealant Patch designed to prevent fluid leakage after hepato-pancreato-biliary procedures. The Dutch company’s Liver and Pancreas Sealant Patch is made from a proprietary bioresorbable polymer designed to seal-off the surgically treated tissue during the critical healing period. “There is a clear need […]
Polyganics wins $1m grant for dura sealant patch study
Polyganics said last week it was awarded a $1.4 million (EU €1.2 million) grant from the European Fund for Regional Development to support clinical validation of its dura sealant patch. The Dura patch is a dressing sealant composed of bioresorbable polymers designed to be suitable for the resealing of the dura outer membrane surrounding the brain […]
7 medtech stories we missed: Feb. 17, 2017
Several companies released diabetes study results this week, while companies like BioTime closed on their public offerings and Pixium implanted its first bionic eye. Here are 7 medtech stories we missed this week, but were still worth mentioning. 1. Insulet touts glucose control study Insulet Corp. announced the results from its first feasibility study of its Omnipod […]
Polyganics wins CE Mark approval in the European
Polyganics said today it won CE Mark approval in the European Union for its absorbable, implantable Neurocap device designed to reduce neuroma formation and facilitate tissue repair. Neuromas, also known as pinched nerves or nerve tumors, are benign growths of nerve tissue that can cause pain, burning sensation, tingling or numbness, according to the company. “CE regulatory […]
Polyganics wins FDA 510(k) for Neurocap
Polyganics said today it won FDA 510(k) clearance for its Neurocap device, designed to reduce neuroma formation and facilitate tissue repair. Neuromas, also known as pinched nerves or nerve tumors, are benign growths of nerve tissue that can cause pain, burning sensation, tingling or numbness, according to the company. “Neuroma-induced neuropathic pain and morbidity can […]
Polyganics inks distro deal with MicroAire Surgical Instruments
Polyganics said today it signed an exclusive distribution deal with strategic partner MicroAire Surgical Instruments that will put the company in charge of distributing Polyganics peripheral nerve repair portfolio in the U.S., Canada and Puerto Rico. Polyganics develops, manufactures and sells bioresorbable medical devices used in tissue repair and regenerative procedures, the company said. The […]
