Adapting versatile polymers to deliver a pipeline of medical devices serving unmet clinical needs

The first product in our Neurosurgery portfolio is LIQOSEAL^®. LIQOSEAL^®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 cerebrospinal fluid (CSF) leakage.

LIQOSEAL^® is CE approved

Certainty in Watertight Dural Closure for the Reduction of CSF leakage

Cerebrospinal fluid (CSF) leakage is a widely recognized complication after 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

Achieving watertight dural closure to provide effective control of CSF leakage is a challenge. A puncture from a single needle is sufficient to cause leakage, and during prolonged operative procedures, the fragile dura mater shrinks due to dehydration, further complicating closure.

Effective dural sealants should reduce the risk of CSF leakage after cranial surgery by enhancing dural closure. However, a recent review showed that existing commercially available dural sealants have not proven to significantly reduce post-operative CSF leakage compared to suturing alone (8.2% versus 8.4% respectively).³

LIQOSEAL^® Properties

EFFECTIVE – Watertight dural closure provides effective control of CSF leakage after cranial surgery, resulting in reduced patient burden and health care costs
ENDURING – Strong and durable tissue adherence enables LIQOSEAL^® to endure fluctuating physiological CSF pressures throughout the critical 30-day healing period
SUPPORTS HEALING -LIQOSEAL^®supports regeneration of the dura mater by acting as a scaffold of new fibrotic layer formation (‘neodura’)
EASY to USE – The soft and pliable patch is easy to apply and ready to use, requiring no time-consuming preparation or applicators.

SAFE – The smart composition from synthetic, bioresorbable polymers, defines timely resorption and ensures a good safety profile, with no clinically significant post-operative swelling, minimizing the risk of neural compression
DEDICATED DEVELOPMENT – LIQOSEAL^®was developed in close collaboration with neurosurgeons using an evidence-based approach, in direct response to their demands for more effective dural sealants
PROVEN TECHNOLOGY – LIQOSEAL^®uses Polyganics’ proprietary bioresorbable polymer technology, already applied worldwide in multiple clinical areas

Product Information

LIQOSEAL^®, is composed of a mix of our proprietary bioresorbable and biocompatible polymers. The device is engineered to ensure certainty in watertight closure during the critical healing period, encourage regeneration of the dura and, after healing is complete, to degrade naturally and safely from the body.

LIQOSEAL^® 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 cerebrospinal fluid (CSF) leakage. The composing polymer mix provides the optimal strength and resilience to endure the fluctuating intradural fluid pressures and maintain durable adherence to the dura mater.

In the international, multi-centered ENCASE clinical study (Utrecht, The Netherlands, Zurich, Switzerland, Tilburg, The Netherlands), all patients met the primary endpoints: no CSF leakage after a period of 3 months, strongly confirming watertight closure. Additionally, no clinically significant swelling was observed and no device related adverse events were reported. Safety end-points will continue to be collected for a period of 12 months. The protocol of the ENCASE study has been published in Neurosurgery.

Polyganics is preparing for ENCASE II, a randomized controlled trial. Based on the results of the study, the company will submit the patch for pre-market approval to the US Food and Drug Administration.

In December 2017, Polyganics was awarded funding from the European Fund for Regional Development 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.

LIQOSEAL^® is developed in close collaboration with the Brain Technology Institute (BTI), Utrecht, The Netherlands, a consortium of internationally renowned institutes focusing on clinical and research aspects of neurosurgery.

Clinical Information

The safety and performance of LIQOSEAL^® in reducing CSF leakage following elective cranial surgery is being evaluated in a single arm open label study, ENCASE. Up to 40 adult patients have been recruited at three sites across the Netherlands and Switzerland. Details of the ENCASE study can be found here.

Regulatory Information

LIQOSEAL^® is classified as a class III medical device in Europe. LIQOSEAL^® is CE approved.

References

1- 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. J. Neurosurgery. 2014. Sep; 121:724-744

2- 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

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

4- Van Doormaal T, Kinaci A, van Thoor S, Redegeld S, Bergmann W, van der Zwan A. Usefullness of sealants for dural closure: evaluation in an in vitro model.

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