HyperBranch Medical Technology, Inc. announced that it has received a CE Mark for its NuSeal 100 dural sealant product. NuSeal 100 is used in cranial neurosurgical procedures where a water tight seal is required on the dura. NuSeal 100 is intended for direct application on the dural surfaces to provide a positive seal after suturing thereby minimizing risks associated with post-surgical CSF leaks. The CE Mark for NuSeal 100 provides regulatory approval for the company to begin sales in Europe and potentially other countries outside the US.
The unique, single use device is terminally sterilized and sets on contact after a spray application. The synthetic, biocompatible composition is stored at room temperature and is delivered through the custom applicator to meet the specific needs of the procedure. The intended users of NuSeal 100 are Neurosurgeons in a surgical environment.
John Conn President and CEO said: NuSeal 100 is a significant improvement in surgical sealants; it is long lasting, strong, has low swelling and is safely eliminated from the body. NuSeal 100 is our second product and represents a major technology enhancement which will provide a platform for the development of several other indications for use.