The trial will assess the safety and efficacy of LIQOSEAL in minimising intra or post-operative CSF leakage in patients undergoing elective cranial surgery
LIQOSEAL is indicated for use as an adjunct to standard methods of cranial dural repair. (Credit: Raman Oza from Pixabay)
Medical technology company Polyganics has treated first patients in its ENCASE II clinical trial of LIQOSEAL dura sealant patch.
LIQOSEAL is an easy-to-use and synthetic dura sealant patch designed to be used as an adjunct to standard methods of cranial dural repair.
The dura sealant patch will help offer watertight closure of the dura mater and minimise cerebrospinal fluid (CSF) leakage.
In addition, the patch is designed to support the regeneration of the dura mater by serving as a scaffold for new fibrotic layer formation (neodura).
Polyganics’ randomised, two-arm and multicentre trial will assess the safety and efficacy of LIQOSEAL in minimising intra or post-operative CSF leakage in patients undergoing elective cranial surgery.
The company will recruit 228 patients in the clinical trial at up to 20 clinical centres across the US and Europe.
It will randomly treat patients at a 1:1 ratio with either LIQOSEAL or an FDA-approved sealant as a control.
Polyganics CEO Rudy Mareel said: “Despite many Covid-related delays to elective procedures during the past year, we are happy that Polyganics has seen strong interest and uptake of LIQOSEAL throughout Europe and in other countries.
“We are proud to have numerous world-renowned clinical centres participating in our ENCASE II study. They are a testament to the unique, life-altering potential of our dura sealant device.”
At the staring of 2020, Polyganics secured CE mark approval for LIQOSEAL based on positive third-month data from its ENCASE I clinical trial. Following the approval, the company introduced the device in Europe.
The device is also registered for use in other countries such as Turkey, Israel, Jordan and Argentina.
Based in Groningen, the Netherlands, Polyganics develops, manufactures and commercialises bioresorbable medical devices that facilitate tissue repair and regeneration.
The company’s portfolio consists of marketed products in the fields of peripheral nerve repair (PNR) and neurosurgery: VIVOSORB to minimise unwanted tissue adhesions after surgery; NEUROLAC to support PNR following hand surgery; and NEUROCAP for the management of symptomatic neuromas.