Innovation in bone healing and tissue repair
21 Dec 16
Kuros submits regulatory filing seeking CE certification for Neuroseal, a novel dural sealant

Schlieren (Zurich), Switzerland, December 21, 2016

Kuros submits regulatory filing seeking CE certification for Neuroseal, a novel dural sealant

Kuros Biosciences AG, announced today that it has submitted its application for CE conformity assessment for Neuroseal (also known as KUR-023). 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.

Neuroseal is a novel sealant designed, as an adjunct to suturing, to seal the dura after cranial surgery. The dura is a membrane surrounding the brain and spine and separates the central nervous system from the rest of the body. The dura acts as a protective barrier and ensures that the brain and spinal cord are bathed in cerebrospinal fluid (CSF), which is essential for the healthy functioning of the central nervous system. Amongst other functions it serves as cushion for the brain and protects against physical impacts and infections. During cranial procedures in which the dura is incised the watertight closure is compromised, potentially leading to postoperative CSF leakage. CSF leakage may lead to clinical symptoms and neurological complications, as well increased risk of infection. This may result in longer or recurrent periods of hospitalizations and associated increase in healthcare costs. Hence, there is a clear medical need to reduce the risk of CSF leakage after cranial surgery in which the dura is compromised.   

 

Neuroseal contains two synthetic polymers that are applied via a hand spray device. The two polymers cross-link at the site of application to form a gel that seals the suture gap. A clinical trial in the European Union supported Neuroseal’s safety and effectiveness. All clinical end-points were met with no safety issues observed.

 

Didier Cowling, Chief Executive Officer of Kuros, commented: “We are very pleased to reach this important milestone for the Company. Neuroseal provides a rapid and reliable adjunct to suturing in order to ensure watertight closure of the dura following surgery.” He continued: “We are now planning for Neuroseal’s commercialization in 2017.”



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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Article
21 Dec 16
Kuros submits regulatory filing seeking CE certification for Neuroseal, a novel dural sealant

Schlieren (Zurich), Switzerland, December 21, 2016

Kuros submits regulatory filing seeking CE certification for Neuroseal, a novel dural sealant

Kuros Biosciences AG, announced today that it has submitted its application for CE conformity assessment for Neuroseal (also known as KUR-023). 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.

Neuroseal is a novel sealant designed, as an adjunct to suturing, to seal the dura after cranial surgery. The dura is a membrane surrounding the brain and spine and separates the central nervous system from the rest of the body. The dura acts as a protective barrier and ensures that the brain and spinal cord are bathed in cerebrospinal fluid (CSF), which is essential for the healthy functioning of the central nervous system. Amongst other functions it serves as cushion for the brain and protects against physical impacts and infections. During cranial procedures in which the dura is incised the watertight closure is compromised, potentially leading to postoperative CSF leakage. CSF leakage may lead to clinical symptoms and neurological complications, as well increased risk of infection. This may result in longer or recurrent periods of hospitalizations and associated increase in healthcare costs. Hence, there is a clear medical need to reduce the risk of CSF leakage after cranial surgery in which the dura is compromised.   

 

Neuroseal contains two synthetic polymers that are applied via a hand spray device. The two polymers cross-link at the site of application to form a gel that seals the suture gap. A clinical trial in the European Union supported Neuroseal’s safety and effectiveness. All clinical end-points were met with no safety issues observed.

 

Didier Cowling, Chief Executive Officer of Kuros, commented: “We are very pleased to reach this important milestone for the Company. Neuroseal provides a rapid and reliable adjunct to suturing in order to ensure watertight closure of the dura following surgery.” He continued: “We are now planning for Neuroseal’s commercialization in 2017.”