DURHAM, N.C.--(BUSINESS WIRE)--HyperBranch Medical Technology, Inc. announced today that it has received CE Marking for AdherusTM AutoSpray Dural Sealant. Adherus AutoSpray is a novel delivery system used for the delivery of HyperBranch’s dural sealant which is used in cranial and spine surgeries to prevent cerebrospinal fluid leaks following the dural repair. Prevention of cerebrospinal fluid leaks should benefit the patient in fewer post-surgical complications such as leaks and infection thereby resulting in shorter hospital stays. The CE Mark provides regulatory approval for the company to begin sales in countries outside the U.S.
"Adherus AutoSpray is the first self-contained bioadhesive spray applicator that eliminates cumbersome preparation steps for the scrub nurse and allows the surgeon to effortlessly and precisely start and stop dispensing without concern for clogging. It complements the Company’s other neurosurgery products: AdherusTM Dural Sealant and AdherusTM MIS. All the Company’s products share the same proprietary chemistry that provides controlled performance while degrading slowly during the healing process. It not only provides a watertight seal but acts as an adhesion barrier to limit scarring, a major advantage if subsequent surgery is required,” said John Conn, President and Chief Executive Officer.
The AdherusTM products are synthetic hydrogels which polymerize in a moist field, flow optimally depending on the application, and biodegrade as the tissue heals.
HyperBranch Medical Technology, Inc. has now received CE Marks for five of their products. The Company has completed a U.S. feasibility study and is nearing completion of the Pivotal portion for its cranial product which includes the new AutoSpray device. An FDA IDE for the MIS device has also been approved and will follow the same approval path in the U.S. as the AutoSpray.
HyperBranch Medical Technology is a privately-held company based in Durham, N.C. The company is focused on the development of unique products based on its novel hydrogel technology. Development work on HyperBranch’s surgical sealant platform has led to the recognition of several novel hydrogel properties that suggest significant utility in a variety of clinical applications. For more information, visit www.hyperbranch.com.