Randomized controlled trial in the US and Europe will enable LIQOSEAL to be submitted for FDA approval
Groningen, The Netherlands, May 21 2021 – 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.”
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Notes to editors
Polyganics is a medical technology company with multiple versatile polymer platforms. The company develops, manufactures and commercializes innovative bioresorbable medical devices that facilitate tissue repair and regeneration.
Polyganics’ portfolio comprises of products developed in-house and in collaboration with leading medical technology companies and academic centers of excellence. 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. Products in development include ACTISEAL®, a Liver and Pancreas Sealant Patch in the field of General Surgery.
In 2014, Polyganics sold its Ear, Nose & Throat (ENT) surgery business unit (the NASOPORE® product family including HEMOPORE®, SINUPORE® and OTOPORE® and NASOPORE-FD®) to Stryker, one of the world’s leading medical technology companies. Polyganics continues to manufacture the NASOPORE® product range for Stryker.
Polyganics is a privately held company based in Groningen, The Netherlands. The Company is ISO 13485-certified, and its products have received clearance from the US FDA, CE-approval, and approval from the CFDA and other international authorities. Polyganics’ polymer platform technologies are protected by a broad portfolio of patents.
About CSF leakage
Cerebrospinal fluid (CSF) leakage is a widely recognized complication of neurosurgical procedures. It represents a significant patient burden, resulting in increased morbidity, prolonged hospital stays, possible surgical revisions, and enhanced costs.1,2 Incidence rates vary depending on age, indication, location of surgery and underlying pathology, but in total CSF leakage occurs in 4-32% of surgical cases.3,4
LIQOSEAL® is a safe and easy-to-use patch indicated for use as an adjunct to standard methods of cranial dural repair during surgery. By ensuring watertight closure of the dura mater, the patch provides effective control of CSF leakage throughout the critical healing period, as well as supporting regeneration of the dura mater by acting as a scaffold for new fibrotic layer formation (‘neodura’). The patch uses Polyganics’ proven proprietary synthetic bioresorbable polymer technology. It is commercially available throughout Europe and in selected other countries via a network of experienced distributors.
For more information, visit: https://polyganics.com/portfolio/neurosurgery/
- Hutter G, von Felten S, Sailer M, Schulz M, Mariani L. Risk factors for postoperative CSF leakage after elective craniotomy and the efficacy of fleece bound tissue sealing against dural suturing alone: a randomized controlled trial. Neurosurgery. 2014. Sep; 121:724-744
- Grotenhuis J. Costs of postoperative cerebrospinal fluid leakage: 1-year, retrospective analysis of 412 consecutive nontrauma cases. Surg Neurol. 2005, Dec; 64(6)|:490-3
- Kinaci A, Algra A, Heuts S, O’Donnell D, van der Zwan A, van Doormaal T. Effectiveness of Dural Sealants in Prevention of Cerebrospinal Fluid Leakage After Craniotomy: A Systematic Review. World Neurosurg. 2018 Oct;118:368-376
- van Doormaal T, Kinaci A, van Thoor S, Redegeld S, Bergmann W, van der Zwan A.Usefulness of Sealants for Dural Closure: Evaluation in an In Vitro Model. Oper Neurosurg (Hagerstown). 2018 Oct 1;15(4):425-432.