The device will be launched 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 commercialise Lioqseal in selected European countries. 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 underway for the start of Encase II, a randomised controlled trial, which will enable the Company to submit the patch for pre-market approval to the US Food and Drug Administration (FDA).
Rudy Mareel, CEO of Polyganics, said: “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.”
