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Press Release, 21 June 2017
Kuros receives CE certification for Neuroseal ® , a novel dural sealant
Kuros Biosciences (SIX:KURN) announced today that it has received CE certification for its novel dural sealant, Neuroseal®. The CE certification allows for the commercialization of the product anywhere in the European Economic Area. As part of the supporting evidence, Neuroseal® has been tested clinically and demonstrated effective sealing. Furthermore, Neuroseal® is specifically designed for ease of preparation, use and handling thereby reducing the risk of adverse effects which may result in longer hospitalizations and an increase in healthcare costs. With this approval and together with MagnetOsTM, Kuros has now two products ready to be commercialized in Europe.
Schlieren (Zurich), Switzerland, June 21, 2017
The Conformité Européene (CE) mark allows Kuros to sell Neuroseal®, a Class III medical device, in all 27 member states of the European Union, the three countries of the European Free Trade Association (EFTA) plus Switzerland and Turkey. The CE certification testifies that Neuroseal® has been assessed to meet stringent regulatory requirements. The receipt of the CE approval involved a comprehensive audit of Kuros’ quality system and a thorough conformity assessment of Neuroseal® to assure that the product performs safely and as designed. As a result of the CE certification, Kuros is eligible for receiving a payment of USD 533, 000.
Dr. Ivan Cohen-Tanugi, Chief Executive Officer of Kuros, commented: “Today’s CE approval means that the entire European market is now open for us to commercially distribute Neuroseal®. The CE certification is another significant milestone as we continue to deliver on promises made. With Neuroseal® and MagnetOsTM, our portfolio now consists of two approved and commercial-stage products.” He continued: “Neuroseal®ensures watertight closure of the dura following brain surgery. It reduces the risk of postoperative leakage thereby improving quality of life of patients while also reducing hospitalizations costs. We believe the clinically proven advantages of Neuroseal® could make it the preferred option for physicians, patients, and payers.”
Neuroseal® effectively seals the dura reducing the risk of infections
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, neurological complications, and 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 line. Results from a European clinical trial support Neuroseal®‘s safety and effectiveness. All clinical end-points were met with no safety issues observed.
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
Harry Welten
Chief Financial Officer
Phone +41 79 750 15 64