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®, its dura sealant patch.
The self-adhesive patch has been developed to reduce cerebrospinal fluid (CSF) leakage following brain surgery.
The trial, titled ‘ENCASE’, is a single-arm, open-label study, evaluating safety and performance of LIQOSEAL® in reducing 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 the 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.
Having worked on the Dura Sealant Patch from its conception, I am very excited about the device entering the clinic.
There is an urgent need to effectively manage CSF leakage following brain surgery, to reduce post-operative complications and the associated impact on patient outcomes and recovery time, as there are currently no sealants on the market that have proven effectiveness in reducing post-operative leakage.
We look forward to evaluating the performance of this novel approach in patients for the first time.”
Dr. Tristan van Doormaal, Principal Investigator
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.
We strongly believe in the device’s potential to reduce the risk of infection and improve patient recovery following cranial surgery, meeting an urgent unmet need for patients and surgeons.
This milestone builds on our success in nerve repair and ear, nose and throat surgery, and our strong progress in other types of surgery – including our Liver and Pancreas Sealant Patch which received a breakthrough device designation from the FDA earlier this year.”
Rudy Mareel, CEO of Polyganics