Innovation in bone healing and tissue repair

A membrane surrounding the brain and spine separates the central nervous system from the rest of the body. Inside this membrane, called dura, there is a fluid (cerebrospinal fluid, CSF), which is essential for the healthy functioning of the central nervous system. It serves to physically cushion the brain from impact, protect against infection and provide access to nutrients. The dura acts mainly as a protective barrier bathing the brain and spinal cord in CSF.

During most cranial and some spinal surgeries, the dural membrane is cut or torn and thus the water-tight closure is compromised. The primary complications are risks of infection (meningitis), delayed wound healing and pain, which may then result in safety risks to the patient, increased hospitalizations and associated healthcare costs.

Neuroseal (KUR-023) is a synthetic tissue sealant candidate for the prevention of CSF leakage following cranial or spinal surgery. It is based on two synthetic polymers that cross-link in-situ, at the site of administration, to seal the treated tissue. Neuroseal has been specifically designed to be easily applied as a liquid spray forming a watertight gel immediately upon contact with the dura and thus creating an effective seal.

A 40 patient clinical study designed to test the safety and efficacy has been completed. Neuroseal rapidly sealed the leaking dural membrane after a single application and all the clinical end points were met. No safety issues were no observed.

Kuros submitted an application for CE conformity assessment in December 2016. This regulatory filing seeks CE certification for Neuroseal as a class III medical device. Obtaining CE certification will enable the dural sealant to be marketed and sold within the European Union.

 

Kuros Biosciences AG
Wagistrasse 25, 8952 Schlieren, Switzerland
Tel: +41 44 733 47 47   Fax: +41 44 733 47 40   Email: info@kuros.ch

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    Neuroseal (KUR-023)

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Neuroseal (KUR-023)

A membrane surrounding the brain and spine separates the central nervous system from the rest of the body. Inside this membrane, called dura, there is a fluid (cerebrospinal fluid, CSF), which is essential for the healthy functioning of the central nervous system. It serves to physically cushion the brain from impact, protect against infection and provide access to nutrients. The dura acts mainly as a protective barrier bathing the brain and spinal cord in CSF.

During most cranial and some spinal surgeries, the dural membrane is cut or torn and thus the water-tight closure is compromised. The primary complications are risks of infection (meningitis), delayed wound healing and pain, which may then result in safety risks to the patient, increased hospitalizations and associated healthcare costs.

Neuroseal (KUR-023) is a synthetic tissue sealant candidate for the prevention of CSF leakage following cranial or spinal surgery. It is based on two synthetic polymers that cross-link in-situ, at the site of administration, to seal the treated tissue. Neuroseal has been specifically designed to be easily applied as a liquid spray forming a watertight gel immediately upon contact with the dura and thus creating an effective seal.

A 40 patient clinical study designed to test the safety and efficacy has been completed. Neuroseal rapidly sealed the leaking dural membrane after a single application and all the clinical end points were met. No safety issues were no observed.

Kuros submitted an application for CE conformity assessment in December 2016. This regulatory filing seeks CE certification for Neuroseal as a class III medical device. Obtaining CE certification will enable the dural sealant to be marketed and sold within the European Union.