The trial, titled ‘ENCASE’, is a single-arm, open-label study, evaluating safety and performance of LIQOSEAL in reducing CSF leakage following elective cranial surgery. Up to 40 adult patients will be recruited at three sites across the Netherlands and Switzerland, with follow-up spanning a 90-day period.
CSF leakage is a common complication of neurosurgical procedures and can lead to life-threatening infections such as meningitis. LIQOSEAL, developed using Polyganics’ bioresorbable polymers, is designed as an adjunct to closure of the outer protective membrane (‘dura’) surrounding the brain after brain surgery, thereby minimizing leakage of cerebrospinal fluid (CSF). The patch has been engineered to encourage regeneration of the dura and to degrade naturally and safely within the body over time, once the membrane has healed.
Dr. Tristan van Doormaal, a neurosurgeon at the University Medical Center (UMC) in Utrecht, the Netherlands, principal investigator of the study and leader of the initial research project at the Brain Technology Institute (BTI) commented, “Having worked on the Dura Sealant Patch from its conception, I am very excited about the device entering the clinic. There is an urgent need to effectively manage CSF leakage following brain surgery, to reduce post-operative complications and the associated impact on patient outcomes and recovery time, as there are currently no sealants on the market that have proven effectiveness in reducing post-operative leakage. We look forward to evaluating the performance of this novel approach in patients for the first time.”
Rudy Mareel, CEO of Polyganics, commented: “LIQOSEAL is our first neurosurgery product to enter the clinic, further diversifying our pipeline of bioresorbable tissue repair and regeneration products. Preclinical data reveal an excellent ease-of-use and safety profile for the device as well as a highly promising performance, and we therefore have high expectations for its impact in the clinic. We strongly believe in the device’s potential to reduce the risk of infection and improve patient recovery following cranial surgery, meeting an urgent unmet need for patients and surgeons. This milestone builds on our success in nerve repair and ear, nose and throat surgery, and our strong progress in other types of surgery—including our Liver and Pancreas Sealant Patch which received a breakthrough device designation from the FDA earlier this year.”
Cerebrospinal fluid (CSF) leakage is one of the most common neurosurgical procedures, occurring in 4 percent to 32 percent of surgical cases.1 Incidence rates vary depending on age, indication, location of surgery and underlying pathology. CSF leakage leads to a significant patient burden, increased morbidity, prolongation of hospital stay, surgical revision, and enhanced costs as well as possible surgical revisions.2,3
Liqoseal has been developed using Polyganics’ proprietary bioresorbable polymers, and is indicated for use as an adjunct to standard methods of dural closure, such as suturing, to provide a watertight closure of the dura mater to prevent CSF leakage after a dural closure procedure. The sealant patch has been engineered to encourage tissue regeneration, and to degrade naturally and safely within the body over time, once the membrane has healed. Polyganics is developing LIQOSEAL in collaboration with the Brain Technology Institute (BTI), located in Utrecht.
In December 2017, Polyganics was awarded funding from the European Fund for Regional Development (ERDF) by the European Union, to support clinical validation of LIQOSEAL. Together with contributions from the city and province of Groningen, the grant totaled 1.2 million euros.
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 includes products developed in-house and in collaboration with medical technology companies and academic centers of excellence. In the peripheral nerve repair (PNR) field, the portfolio includes three marketed products: VIVOSORB for minimizing unwanted tissue adhesions after surgery; NEUROLAC for supporting PNR following hand surgery; and NEUROCAP for the management of symptomatic neuromas. In the neurosurgery and general surgery field, products in development include a sealant for the dura membrane (LIQOSEAL) and a liver and pancreas sealant patch.
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. To date, Polyganics has produced and delivered more than 4.5 million devices.
Polyganics is profitable and privately held. The company is based in Groningen, The Netherlands, in an ISO 13485-certified manufacturing facility. The company’s polymer platform technologies are protected by a broad portfolio of patents and its products have received clearance from the U.S. Food and Drug Administration, CE-approval, and approval from China Food and Drug Administration and other international authorities.
1. 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
2. Hutter G, von Felten S, Sailer MH, 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. J Neurosurg. 2014 Sep;121(3):735-44
3. Grotenhuis JA. Costs of postoperative cerebrospinal fluid leakage: 1-year, retrospective analysis of 412 consecutive nontrauma cases. Surg Neurol. 2005 Dec;64(6):490-3, discussion 493-4.