First Patients Treated in No-Drain Clinical Study of Cohera Medical’s TissuGlu® Surgical Adhesive
12 July 2012
Study to Investigate the Safety and Effectiveness of TissuGlu in Abdominoplasty Surgeries Without the Use of Postoperative Drains
PITTSBURGH, Pa., July 12, 2012– Cohera Medical, Inc.®, a leading innovator and developer of absorbable surgical adhesives and sealants, today announced the start of a no-drain clinical trial in 30 patients at two prominent surgery centers in Germany. The study will investigate the safety and effectiveness of TissuGlu® Surgical Adhesive in the reduction of wound drainage, post operative seroma and related complications in abdominoplasty patients without the use of drains.
Currently, most patients who undergo abdominoplasty procedures and other large flap procedures 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 (seroma) requires additional procedures for removal. The drains are often painful for the patient, can lead to infection and can impact the recovery process.
TissuGlu adheres the tissue flap created during the surgical procedure to the underlying tissue, helping to reduce the space where fluids can accumulate thereby eliminating the need to use surgical drains. The ability to perform the procedure without drains would lead to a more comfortable recovery and a quicker return to normal activity for patients.
“We are excited to be part of this study utilizing TissuGlu to eliminate postoperative drains,” said Dirk Richter, MD, of Wesseling, Germany. “We look forward to enrolling more patients and believe that conducting abdominoplasty procedures without the need for drains would represent a significant improvement in patient care and comfort in these procedures. The initial patients enrolled appear to be doing very well, with no seromas or complications reported in the first 48 hours after surgery.”
“Initiation of this ‘no drain’ trial represents a major goal for TissuGlu,” said Patrick Daly, President and Chief Executive Officer of Cohera Medical. “We continue to make positive patient outcomes a priority and believe the elimination of post-surgical drains is an important milestone.”
Drain management and discomfort is the leading patient complaint for plastic surgery procedures according to the top plastic surgery publications. In addition, complication rates from seroma formation range from 15% to 52% following abdominoplasty procedures.
Cohera Medical recently received CE Marking approval for TissuGlu and began selling product to hospitals and surgeons in Germany in September 2011. The Company plans to expand the commercial availability of TissuGlu to additional European markets in 2012. TissuGlu has been used successfully in over 450 surgical procedures in Germany by leading plastic and reconstructive surgeons.
About Cohera Medical
Cohera Medical, Inc.® is a leading innovator and developer of absorbable surgical adhesives and sealants. The Company’s first product, TissuGlu® Surgical Adhesive, is an internal surgical adhesive for large flap surgeries, such as abdominoplasty (tummy tuck), that help eliminate or reduce fluid accumulation and the need for post surgical drains. TissuGlu’s chemical composition is resorbable, non-toxic, forms a strong bond between tissue layers and allows for natural healing, which ultimately may enable faster recovery. TissuGlu has received CE Marking approval to be sold in the European Union (EU). Cohera Medical is also developing a unique and proprietary bowel sealant, and a strong adhesive for mesh fixation. Outside of the EU, TissuGlu and the other Cohera products are currently indicated for investigational use only and have not yet been approved for marketing by the Food and Drug Administration (FDA) in the U.S. or in any other market. For more information, visit www.coheramed.com.
Certain statements made throughout this press 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.
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