Polyganics, a medical technology company developing, manufacturing and commercializing bioresorbable medical devices, today announced that it has initiated enrollment of patients into a first-in-human clinical trial of Liqoseal, a new, self-adhesive dura sealant patch.
The trial, titled ‘ENCASE’, is a single-arm, open-label study, evaluating safety and performance of Liqoseal in reducing cerebrospinal fluid (CSF) leakage following elective cranial surgery. Up to 40 adult patients will be recruited at three sites across the Netherlands and Switzerland, with follow-up spanning a 90-day period.
CSF leakage is a common complication of neurosurgical procedures and can lead to life-threatening infections such as meningitis. Liqoseal developed using Polyganics’ bioresorbable polymers, is designed as an adjunct to closure of the outer protective membrane (‘dura’) surrounding the brain after brain surgery, thereby minimizing leakage of cerebrospinal fluid (CSF). The patch has been engineered to encourage regeneration of the dura and to degrade naturally and safely within the body over time, once the membrane has healed.
Dr. Tristan van Doormaal, a neurosurgeon at the University Medical Center (UMC) in Utrecht, the Netherlands, Principal Investigator of the study and leader of the initial research project at the Brain Technology Institute (BTI), has worked on the Dura Sealant Patch from its conception and is ‘very excited about the device entering the clinic’. “We look forward to evaluating the performance of this novel approach in patients for the first time,” he commented.
Rudy Mareel, CEO of Polyganics, commented: “Liqoseal is our first neurosurgery product to enter the clinic, further diversifying our strong pipeline of bioresorbable tissue repair and regeneration products. Preclinical data reveal an excellent ease-of-use and safety profile for the device as well as a highly promising performance, and we therefore have high expectations for its impact in the clinic.”
Details of the ENCASE study can be found at: https://clinicaltrials.gov/ct2/show/NCT03566602.