Swiss tissue repair and regenerative med focused Kuros Biosciences said today it won CE Mark approval in the European for its Neuroseal novel dural sealant.
The Neuroseal sealant is designed as an adjunct to suturing and is used to seal the dura after cranial surgery and reduce the risk of cerebrospinal fluid leakage, the company said. Kuros added that the sealant was designed to be easy to prepare, use and handle to reduce adverse effect risks.
Kuros Biosciences said that the approval is the 2nd for the company following the approval of its MagnetOs Granules, a novel synthetic bone graft substitute designed to regenerate bone in multiple locations.
“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 MagnetOs, our portfolio now consists of two approved and commercial-stage products. 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,” CEO Dr. Ivan Cohen-Tanugi said in a press release.
Kuros Biosciences said that with the CE Mark certification, it is eligible for a $533,000 milestone payment.