Encase free trial
#Encase free trial Patch
Products in development include ACTISEAL ®, a Liver and Pancreas Sealant Patch in the field of General Surgery. The portfolio includes marketed products in the fields of Peripheral Nerve Repair (PNR) and Neurosurgery: VIVOSORB ®, for minimizing unwanted tissue adhesions after surgery NEUROLAC ®, for supporting PNR following hand surgery NEUROCAP ®, for the management of symptomatic neuromas and LIQOSEAL ®, a dura sealant patch for the effective control of cerebrospinal fluid leakage. Polyganics’ portfolio comprises of products developed in-house and in collaboration with leading medical technology companies and academic centers of excellence. The company develops, manufactures and commercializes innovative bioresorbable medical devices that facilitate tissue repair and regeneration. Polyganics is a medical technology company with multiple versatile polymer platforms. They are a testament to the unique, life-altering potential of our dura sealant device." We are proud to have numerous world-renowned clinical centres participating in our ENCASE II study. 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. I am pleased to continue playing my part to critically study this device, ultimately to maximally reduce CSF leakage in our patients." 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. 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 am excited to be part of the ENCASE II study where we are rigorously testing this hypothesis."
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.
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.
Other registrations are also in progress.ĭr. 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. 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. Patients will be randomly treated at a 1:1 ratio with either LIQOSEAL ® or an FDA-approved sealant as a control.
#Encase free trial trial
The trial will involve 228 patients, enrolled and treated at up to 20 clinical centres across the US and Europe. 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.