HyperBranch Medical Technology, Inc. announced today that it has received a CE Mark for its NuSeal 30 hernia mesh fixation sealant product. NuSeal 30 is used in hernia procedures to adhere the mesh. NuSeal 30 provides for secure mesh placement, minimizes pain caused by other fixation devices and gradually degrades as the body heals. The CE Mark for NuSeal 30 provides regulatory approval for the company to begin the registration process in countries outside the U.S.
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 a custom applicator to meet the specific needs of the procedure. The intended users of NuSeal 30 are General Surgeons in a surgical environment.
John Conn, President and CEO, said, “NuSeal 30 is a follow on product to the platform technology developed at Hyperbranch. NuSeal 30 is a major improvement to mesh fixation eliminating the need for staples and tacks while providing secure fixation, reducing pain and creating an anti-microbial environment. The Company will continue to introduce this technology in other indications.”
The Durham, N.C. medical device company recently announced the CE Mark approval of its NuSeal 100 for dural closure and the licensing of OcuSeal ophthalmic bandage to BD Medical. The company is currently conducting US clinical evaluations for the dural closure product and is in various stages of development for other indications of the platform technology.
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