HyperBranch Medical Technology, Inc. has announced completion of patient enrollment in the AdherusTM Dural Sealant U.S. pivotal clinical trial, a controlled, randomised trial comparing the AdherusTM Dural Sealant in neurosurgery patients, to the only other approved sealant for these procedures.
HyperBranch Medical Technology 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 such as dural sealing following neurosurgery. The Company claims its sealants have proven to be strong, long lasting and exhibit anti-microbial and anti-adhesion characteristics.
Over 240 patients were treated in the pivotal 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 what is a logical next step for its technology, Hyperbranch has also received FDA IDE approval to begin a pivotal clinical trial for the AdherusTM Dural Sealant in spinal applications. Hyperbranch will be using its 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.
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, hitherto one of the occupational hazards of liquid sealants. Adherus AutoSpray is CE Marked and has been commercially available in test markets internationally since May 2012.
“The completion of patient enrollment in the AdherusTM 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 specialised 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 AdherusTM Sealants in the U.S. market.” said John Conn, President and CEO.
Source: Hyperbranch Medical Technology, Inc.