Oct 24 2009
Cohera Medical, Inc. announced today that it has received approval to begin human clinical trials of its lead product TissuGlu® in Germany. Receipt of the approval allows Cohera Medical to proceed with patient recruitment and initiation of an investigational study of the company's novel internal surgical adhesive being developed for its first intended use to adhere surgical tissues together in large flap surgeries.
The feasibility study will investigate the safety and preliminary effectiveness of TissuGlu® and its effect on wound drainage and associated complications in abdominoplasty (tummytuck) surgeries. The study will be conducted at three sites near Bonn, Frankfurt, and Freiburg in Germany and will enroll 40 patients. Patient recruitment is expected to begin in November this year.
Currently, patients who undergo abdominoplasty require the insertion of drains to remove fluids that accumulate under the skin at the surgical site. In some cases, drainage is inadequate and excessive fluid accumulation (called seroma formation) often requires an additional procedure to remove it. TissuGlu is designed to adhere the tissue flaps created during the procedure, thereby reducing fluid accumulation and ultimately reduce or eliminate the need for surgical drains and reduce the risk of related complications. Patients are expected to experience a faster and more comfortable recovery with the use of TissuGlu.
"This trial will be our first study of TissuGlu in patients and the trial's approval validates the biocompatibility and pre-clinical profile of TissuGlu," said Chad Coberly, JD, vice president of clinical, regulatory and legal affairs of Cohera. "Initiation of this study will allow the company to move closer to a regulatory approval application in Europe for the CE Mark and application for a larger U.S. based trial.
Patrick Daly, president and chief executive officer of Cohera Medical added, "This approval represents a major milestone for our internal adhesive technology and for Cohera. Our company is focused on progressing TissuGlu to the next stage of development in the commercialization process. This unique product will ultimately help surgeons address a critical need and improve patient care."