TissueGlu Takes Steps Towards Approval

Tuesday, December 22, 2009 8:22 AM

A new material intended to improve the recovery time for tummy tuck patients is currently undergoing clinical trials of its safety and effectiveness.

The innovative new product TissuGlu, developed by Cohera Medical, took an important step forward on December 16, when the company announced the treatment of the first patient in clinical investigations related to TissuGlu. The patient was treated at the Universitatsklinikum Bonn under the principal investigator Klaus Walgenbach, M.D. and was the first patient in a clinical investigation that will involve over 40 patients.

TissuGlu is being tested as a surgical adhesive designed to adhere tissue flaps created during abdominoplasty, or tummy tucks. Following a tummy tuck, patients currently require drains to remove fluid buildup under the surgical site. Drainage may not always be adequate and excess fluid called seroma may form and have to be surgically removed. TissuGlu is designed to reduce the accumulation of fluid, minimizing the chances of a seroma and leading to a shorter use of drains and a quicker, less painful recovery time.

According to the president and CEO of Cohera Medical, Patrick Daly, this clinical trial "brings us closer to helping plastic surgeons to address a critical unmet need and improve patient care." The trial will involve a comparison of wound closure techniques on patients; standard techniques will be compared to the use of TissuGlu to evaluate the effectiveness of the new product and to identify safety risks.

The study follows the publication of preclinical data entitled "Lysine-Derived Urethane Surgical Adhesive Prevents Seroma Formation in a Canine Abdominoplasty Model" published in the July 2008 issue of Plastic and Reconstructive Surgery. The preclinical data demonstrated that the use of TissuGlu significantly reduced or prevented seromas from forming, and that canines treated with TissuGlu showed little evidence of fluid accumulation. In addition, the animals did not demonstrate signs of inflation or otherwise adverse reactions to the adhesive that might have occurred with the introduction of the foreign body.

Cohera Medical hopes the results will be as positive during this clinical development phase. As Chad Coberly, Vice President of Clinical Regulatory and Legal Affairs and a JD, stated, "this study will enable us to move closer to the CE mark application in Europe and will provide important data in application for a larger U.S.-based trial in 2010."

The potential success of this trial is important for both the company and the plastic surgery. There is a significant market for this product, ranging from between $500 million and $750 million on tummy tucks alone between the years 2011 and 2015. If use is expanded to include facelift, breast reconstruction or body contouring, the product could generate as much as $700 million to over $1 billion in revenue over this same period. Furthermore, as Doros Platika, MD and company chairman says, "more importantly it signifies a potential major advance for surgical patients that may help to decrease complications and improve clinical outcomes."

Related Topics: TissueGlu | Tummy Tuck | Abdominoplasty | Cohera Medical

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