First Patient Treated in Polyganics’ ENCASE II Trial for Innovative Dura Sealant Patch, LIQOSEAL
Polyganics, a medical technology company developing, manufacturing and commercializing bioresorbable medical devices, today announced treatment of the first patient in its ENCASE II clinical trial for LIQOSEAL.
LIQOSEAL is an easy-to-use, synthetic dura sealant patch indicated for use as an adjunct to standard methods of cranial dural repair, to provide watertight closure of the dura mater and reduce cerebrospinal fluid (CSF) leakage. In addition, LIQOSEAL also supports regeneration of the dura mater by acting as a scaffold for new fibrotic layer formation (‘neodura’).
ENCASE II is randomized, two-arm, multicenter study, evaluating the safety and efficacy of LIQOSEAL® in reducing intra- or post-operative CSF leakage in patients undergoing elective cranial surgery. The trial will involve 228 patients, enrolled and treated at up to 20 clinical centres across the US and Europe. Patients will be randomly treated at a 1:1 ratio with either LIQOSEAL or an FDA-approved sealant as a control.
Polyganics achieved CE mark certification for LIQOSEAL in early 2020, based on positive 3-month data from its ENCASE I clinical trial, and immediately launched the device in Europe. The Company has seen good uptake, and now, just over a year after the initial launch, LIQOSEAL is commercially available throughout Europe via a dedicated network of distribution partners and is registered for use in other countries including Turkey, Israel, Jordan, Argentina. Other registrations are also in progress.
Dr. Andrew Carlson, Neurosurgeon at the University of New Mexico Hospitals in Albuquerque, New Mexico, and Global Coordinating Investigator for the study commented: “Cerebrospinal fluid leakage is one of the most common complications of neurosurgical procedures and a significant burden to patients and healthcare systems. LIQOSEAL is a potentially game-changing device, which may offer a unique opportunity to make a meaningful impact on the lives of patients by reducing these CSF leak rates. I am excited to be part of the ENCASE II study where we are rigorously testing this hypothesis.”
Prof. Dr. Med. Tristan van Doormaal, Neurosurgeon at the University Hospital Zurich and University Medical Center (UMC) in Utrecht, and Coordinating Investigator for the study in Europe said: “Having worked on the LIQOSEAL project since inception, I am proud that the device is now entering this large-scale ENCASE II clinical trial. I was delighted with the follow-up results of ENCASE I, showing that there was no CSF leakage and no clinically significant swelling, while there were no device-related adverse events following the first 40 LIQOSEAL surgeries. I am pleased to continue playing my part to critically study this device, ultimately to maximally reduce CSF leakage in our patients.”
Rudy Mareel, CEO of Polyganics, added: “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.”