HyperBranch Completes Clinical Enrollment
DURHAM, N.C. (September 24, 2012) — (BUSINESS WIRE) — HyperBranch Medical Technology, Inc. announced today that it has completed patient enrollment in the Adherus™ Dural Sealant U.S. pivotal clinical trial, a controlled, randomized trial comparing the Adherus™ Dural Sealant in neurosurgery patients, to the only other approved sealant for these procedures. Over 240 patients were treated in the trial. Patients will be followed for four months to evaluate the safety and effectiveness of Adherus, following which, the data will be submitted to the FDA for review as part of the PMA submission.
In addition to their proprietary sealant, the Company offers a novel delivery technology which offers high levels of effectiveness and efficiency. It is the first self-contained bioadhesive spray applicator that eliminates preparation steps and allows for effortless and precise start and stop dispensing without concern for clogging. Adherus AutoSpray is CE Marked and has been commercially available in test markets internationally since May 2012.
“The completion of patient enrollment in the Adherus™ Dural Sealant U.S. pivotal trial is a major step for HyperBranch in bringing the product to the U.S. market. HyperBranch was created to address the clinical need for better, more specialized surgical sealants. It was obvious to us that new solutions were needed to more effectively address the critical need for watertight closures in several clinical applications. The completion of this trial will mark the first step to demonstrate the superior nature of the Adherus™ Sealants in the U.S. market.” said John Conn, President and CEO.
HyperBranch also announced that the company has received FDA IDE approval to begin a pivotal clinical trial for the Adherus™ Dural Sealant in spinal applications. HyperBranch will be using their proprietary 1.5 ml Minimally Invasive Applicator in this trial, allowing surgeons who perform MIS procedures to have a dedicated device with the same innovative sealant used in the neurosurgery procedures. Open spinal surgeries will have the option of using the current 6 ml AutoSpray applicator. Both of these spine products have been recently made available in select international markets.
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. The Company’s sealants have proven to be strong, long lasting and exhibit anti-microbial and anti-adhesion characteristics. For more information, visit www.hyperbranch.com.