The Dutch medical technology Polyganics BV has been awarded a €1.2m funding by the EU and the province Groningen, where it is based, to complete its research and validation of its dura sealant patch.
The company which develops and supplies bioresorbable medical devices said the device was developed using its proprietary bioresorbable polymers to create a dressing suitable for resealing the outer membrane (‘dura’) surrounding the brain after brain surgery.
This will help minimise the leakage of cerebrospinal fluid (CSF), the company explained. CSF leakages occur in 10 to 15% of all intradural procedures, with currently no clinical proven product to prevent this happening as yet available on the market.
The dressing is also claimed to be engineered to encourage tissue regeneration, and to degrade naturally and safely within the body over time, once the membrane has healed.
Polyganics is developing its dura sealant patch under a collaboration with other Dutch institutes Brain Technology Institute (BTI), based in Utrecht, and Syncom, a contract research organisation located in Groningen.
The company has recently successfully completed the patch on animals and is currently working to start a clinical study to demonstrate safety and performance in humans.
Commenting on the funding, Rudy Mareel, CEO of Polyganics said the grant was “a great recognition of the potential of this application of our synthetic polymers.”
The work, he said, has important implications for improved recovery following brain surgery, including helping to prevent potentially fatal complications such as meningitis.”
Project leader at BTI and neurosurgeon at the University Medical Center Utrecht (UMCU), Tristan van Doormaal, also described the test on animals “very promising”, adding that the team expected to see “similarly positive results in humans in the clinical studies next year.”