Kuros Biosciences announced 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.
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.
