Study is to investigate safety of TissuGlu and its effect on wound drainage
Cohera Medical has reported the treatment of the first patient in a study of its lead surgical adhesive product, TissuGlu. Initiation of the study marks a major milestone in the company’s progression of the lead product toward clinical practice, said the company.
The clinical investigation is a prospective, open-label, randomized study to investigate the safety of TissuGlu and its effect on wound drainage and associated complications in abdominoplasty, or ‘tummy tuck,’ surgeries. The study will compare standard wound closure techniques alone, plus the application of TissuGlu along with techniques in 40 patients at three sites near Bonn, Frankfurt and Freiburg, Germany.
TissuGlu adheres the tissue flaps created during the procedure to reduce fluid accumulation, and ultimately, the duration of use of the surgical drains. With the use of TissuGlu, patients may experience a significant reduction of fluid accumulation and a more comfortable recovery, which may lead to a quicker return to normal activity.
Patrick Daly, president and chief executive officer of Cohera Medical, said: “Our transition into the clinical development phase brings us closer to helping plastic surgeons to address a critical unmet need and improve patient care.
“Furthermore, the market opportunity for our company with TissuGlu is significant, ranging between $500m and $750m from 2011 to 2015. If you add the additional applications such as facelift, breast reconstruction and body contouring that we will pursue with TissuGlu, the opportunity increases to between $700m to more than $1 billion over the same five-year period.”
Doros Platika, chairman of Cohera Medical, said: “The progress with the development of TissuGlu represents a significant next step in the value creation for Cohera Medical’s investors. Most importantly, it signifies a potential major advance for surgical patients that may help to decrease complications and improve clinical outcomes.”