Spinal Sealant gets CE mark

HyperBranch Medical Technology, Inc. announced today that it has received a CE Mark for Adherus^TM Spinal Sealant. Adherus^TM Spinal Sealant is used in spinal surgeries where a water tight seal is required to prevent cerebrospinal fluid leakage from the dural repair. Prevention of cerebrospinal fluid leaks should benefit the patient in shorter hospital stays and fewer post-surgical complications such as reduced pain and fewer infections. Adherus Spinal Sealant also acts as an adhesion barrier, thereby simplifying subsequent surgeries should the need arise. The unique, single use device is terminally sterilized and can be applied in both Open and MIS procedures through either a 100mm or 150 mm tip. The CE Mark provides regulatory approval for the company to begin sales in Europe and other countries outside the U.S.

“Adherus^TM Spinal Sealant is an easy to use device that complements HyperBranch’s neurosurgical sealant product line. Adherus^TM Dural Sealant, which was first launched in 2009, is currently marketed outside the U.S. for cranial surgery. Adherus^TM Spinal Sealant has negligible swelling, degrades slowly not only provides a watertight seal but also 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 Adherus^TM products are synthetic hydrogels which polymerize in a moist field, flow optimally depending on the application, and are bio-degradable as the tissue re-establishes itself. The biocompatible composition is stored at room temperature and is delivered through a custom applicator to meet the specific needs of the procedure.HyperBranch Medical Technology, Inc. has now received CE Marks for ocular, cranial, and spinal sealants as well as a hernia mesh fixation product. The Company has completed a U.S. feasibility study and is starting the Pivotal portion of the study this month for the Adherus Dural Sealant. The Spinal product will follow the same approval path in the U.S. The company’s ophthalmic sealant is currently licensed to and marketed by BD Medical.

HyperBranch Medical Technology To Market Surgical Sealants under Adherus Product Name

DURHAM, N.C.--(BUSINESS WIRE)--HyperBranch Medical Technology, Inc. announced today that it will begin to market their surgical sealants under a new product identity – Adherus Surgical Sealants. The Adherus name will soon appear on all Company literature but the total transition in the market place will likely take several months to complete. “The new identity brings continuity to our products and allows the end users - doctors, hospitals and nurses - to refer more effectively to our family of products. This is not an unusual change for companies like HyperBranch as they transition from a development company to an established organization in the market, ” said John Conn, President and CEO. HyperBranch’s Adherus product line is a family of synthetic hydrogels which polymerize in a moist field, set immediately upon application, and bio-degrades as the tissue heals. Adherus Surgical Sealants are CE marked and approved for sale outside the United States for ophthalmic, cranial, spine and hernia applications. The Company has also recently completed enrollment of a US FDA pilot study for its Adherus Dural Sealant in preparation for the expanded pivotal trial of the same product. The Durham, N.C. medical device company has also been developing advanced surgical sealants for cardiovascular, pleural (lung), plastic surgery and other related surgical applications. These products are all at various stages of clinical and pre-clinical development and complement the existing CE Marked products. HyperBranch Medical Technology, a privately-held company based in Durham, N.C., is developing innovative medical devices for the ophthalmology, general, and specialty surgery markets. The company is focused on the development of unique products based on its novel hydrogel technology. For more information visit:www.hyperbranch.com.