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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.
Schlieren (Zurich), Switzerland, December 21, 2016
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.”
About Kuros Biosciences Ltd
Kuros Biosciences is focused on the development of innovative products for tissue repair and regeneration and is located in Schlieren (Zurich), Switzerland. The Company is listed according to the International Financial Reporting Standard on the SIX Swiss Exchange under the symbol KURN. Visit www.kuros.ch for additional information on
Kuros, its science and product pipeline.
Forward Looking Statements
This media release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. You are urged to consider statements that include the words “will” or “expect” or the negative of those words or other similar words to be uncertain and forward-looking. Factors that may cause actual results to differ materially from any future results expressed or implied by any forward-looking statements include scientific, business, economic and financial factors, Against the background of these uncertainties, readers should not rely on forward-looking statements. The Company assumes no responsibility for updating forward-looking statements or adapting them to future events or developments.
For further information, please contact:
Kuros Biosciences Ltd
Chief Executive Officer
Tel: +41 44 733 47 47