PITTSBURGH, Dec. 16 Cohera Medical Inc. today announced 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.
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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 to standard wound closure techniques plus the application of TissuGlu in 40 patients at three sites near Bonn, Frankfurt and Freiburg, Germany.
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"We are delighted to have treated the first patient in the TissuGlu study," said Klaus Walgenbach, M.D., Ph.D., of the Universitatsklinikum Bonn and the principal investigator for the study. "We were very pleased with the procedure and look forward to enrolling more patients."
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 the excess fluid accumulation called seroma requires an additional procedure for removal. 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.
"Our transition into the clinical development phase brings us closer to helping plastic surgeons to address a critical unmet need and improve patient care," said Patrick Daly, president and chief executive officer of Cohera Medical. "Furthermore, the market opportunity for our company with TissuGlu is very significant, ranging between $500 million and $750 million 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 $700 million to more than $1 billion over the same five-year period."
Chad Coberly, J.D., vice president of clinical, regulatory and legal affairs of Cohera Medical, added: "Initiation of this study culminates significant preclinical work by our company and investigators and demonstrates the primary safety profile of this product. This study will enable us to move closer to CE Mark application in Europe and will provide important data in application for a larger U.S.-based trial in 2010."
Preclinical data published in the July 2008 issue of Plastic and Reconstructive Surgery show that TissuGlu prevented seroma formation in an animal abdominoplasty model. Summarized in a paper titled "Lysine-Derived Urethane Surgical Adhesive Prevents Seroma Formation in a Canine Abdominoplasty Model," (Plast. Reconstr. Surg. 2008; Vol. 122, Issue 1: 95-102) the results demonstrated that TissuGlu successfully prevented the formation of seroma in a novel large-animal model designed to evaluate seroma formation. While the control side in all seven animals used in the study demonstrated large, clinically significant seromas, the side treated with TissuGlu showed little or no evidence of fluid accumulation. In addition, histologic analysis of tissue samples from the animals showed no signs of inflammation or foreign body reaction associated with the adhesive.
"The progress with the development of TissuGlu represents a significant next step in the value creation for Cohera Medical's investors," said Doros Platika, M.D., the company's chairman. "Most importantly, it signifies a potential major advance for surgical patients that may help to decrease complications and improve clinical outcomes."
About Cohera Medical
Cohera Medical Inc. is a Pittsburgh-based company that is developing a revolutionary line of surgical adhesives. Cohera Medical's products are based on a unique chemical design that is purely synthetic, easy to use, biocompatible and fully resorbable. The company's lead product in development, TissuGlu, is an adhesive for plastic surgery procedures. TissuGlu adheres flaps of tissue after surgical procedures, eliminating the spaces where fluid accumulates and reducing wound drainage. Cohera Medical is also developing surgical adhesives targeting mesh fixation, small bone fixation and other plastic surgery indications that will fill similar market needs in plastic, orthopedics and general surgery. For more information, visit www.coheramed.com. TissuGlu and the other Cohera products are currently indicated for investigational use only and have not yet been approved for medical use by the Food and Drug Administration (FDA) in the U.S. or in any other market.
Certain statements made throughout this news release that are not historical facts contain forward-looking statements regarding the Company's future plans, objectives and expected performance. Any such forward-looking statements are based on assumptions that the Company believes are reasonable, but are subject to a wide range of risks and uncertainties and, therefore, there can be no assurance that actual results may not differ materially from those expressed or implied by such forward-looking statements.
SOURCE Cohera Medical Inc.
