Cohera Medical announced that the first patient has been treated in a US prospective multicentre randomised clinical trial of its TissuGlu surgical adhesive.
The TissuGlu surgical adhesive is an internal, lysine-derived urethane adhesive which serves the needs of plastic and aesthetic surgeons who perform abdominoplasty and other procedures that require the creation of large planar flaps of tissue.
The chemical composition of the adhesive is resorbable, non-toxic and it forms a strong bond between tissue layers and allows for natural healing, which could ultimately enable faster recovery.
In the study, the effectiveness of TissuGlu on the reduction of wound drainage and post-surgical complications in abdominoplasty surgeries will be evaluated in 150 patients at six sites in the US.
The surgical adhesive, which helps to eliminate or reduce fluid accumulation and the need for post surgical drains, has been used successfully in over 350 surgical procedures in Germany.
Cohera Medical president and chief executive officer Patrick Daly said: "We are honoured to be working with such a distinguished group of surgeons who share our vision for excellent clinical outcomes. We look forward to working with the FDA to bring this breakthrough technology to patients and clinicians here in the United States."
"Initiation of the US clinical trial is a major milestone for Cohera," Daly added.
In September 2011, the company received the CE mark approval for TissuGlu and began selling the product to hospitals and surgeons in Germany.
The company intends to expand the commercial availability of TissuGlu to additional European markets in 2012.
Cohera Medical develops surgical adhesives that improve patient care and quality of life for all surgical procedures, applications and specialties.
