European Regulators Approve New Dural Sealant Patch

Polyganics, a medical technology company developing, manufacturing and commercializing bioresorbable medical devices, has obtained CE marking for LIQOSEAL, its dural sealant patch, and will launch the device in Europe with immediate effect.
 
Approval of the CE mark is based on data from Polyganics’ ENCASE I clinical trial, evaluating the safety and performance of LIQOSEAL in reducing cerebrospinal fluid (CSF) leakage after elective cranial surgery. Three-month follow-up results showed the absence of CSF leakage, as confirmed by MRI, no clinically significant swelling, and no device-related adverse events following surgery.
 
Initially, Polyganics will commercialize LIQOSEAL in selected European countries with renowned distribution partners which have extensive experience in neurosurgical products. During 2020, the company will then grow its network with the addition of multiple distributors throughout Europe.
 
Polyganics is also preparing to launch LIQOSEAL in selected non-European countries. In addition, arrangements are well underway for the start of ENCASE II, a randomized controlled trial, which will enable the company to submit the patch for pre-market approval to the U.S. Food and Drug Administration.
 
Rudy Mareel, CEO of Polyganics, commented: “CSF leakage remains a devastating complication of neurosurgical procedures and represents a significant patient burden with high associated cost. The CE approval of this product is testament to the strength and quality of the clinical data from ENCASE I, showing that LIQOSEAL® establishes effective and enduring watertight dural closure. This is a key milestone in our journey to deliver our dural sealant patch to surgeons and patients in Europe and ultimately worldwide.”
 
The ENCASE I trial is focused on the evaluation of the safety and performance of LIQOSEAL in reducing cerebrospinal fluid (CSF) leakage following elective cranial surgery. The three-month results of ENCASE I show the absence of CSF leakage as confirmed by MRI, no clinically significant swelling, and no device-related adverse events following surgeries that used LIQOSEAL for dural closure. 
 
LIQOSEAL is a safe, synthetic, easy-to-use dura sealant patch, developed using Polyganics’ proprietary bioresorbable polymer technology, already applied worldwide in multiple clinical areas. The patch is indicated for use as an adjunct to standard methods of cranial dural repair to provide a watertight closure of the dura mater and reduce CSF leakage. In-vivo studies show that LIQOSEAL also supports regeneration of the dura mater during the critical healing period, by acting as a scaffold for new fibrotic layer formation (neodura).