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 after brain surgery to minimize leakage of of cerebrospinal fluid, the lip seals chicago il said.
“We are hugely appreciative to the EU, as well as the city and province of Groningen for their support in progressing the device into the next phase of its development. The grant is a great recognition of the potential of this application of our synthetic polymers, and we are pleased to have benefitted from the skills and expertise of both the BTI and Syncom in its development. The work has important implications for improved recovery following brain surgery, including helping to prevent potentially fatal complications such as meningitis,” Polyganics CEO Rudy Mareel said in a press release.
The dressing has been developed to encourage tissue renegotiation and degrade naturally and safely within the body over time after healing. The patch was developed in collaboration with the Brain Technology Institute and contract research organization Syncom.
Polyganics said it is finalizing preparations for a clinical study looking to explore the safety and performance of the dura patch in humans.
“This is a completely novel approach to reducing CSF leakage following brain surgery. The recent successful animal studies of the dura sealant patch were very promising, and we expect to see similarly positive results in humans in the clinical studies next year,” BTI research project lead Dr. Tristan van Doormaal of the University Medical Center Utrecht said in prepared remarks.
Following recently completed animal studies of the dura sealant patch, Polyganics is currently finalizing preparations for the start of a clinical study, to demonstrate safety and performance in humans.
Last June, Polyganics won CE Mark approval in the European Union for its absorbable, implantable Neurocap device designed to reduce neuroma formation and facilitate tissue repair.