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First Patient Treated in U.S. No-Drain Clinical Study of Cohera Medical's TissuGlu? Surgical Adhesive
Publish date: Mar 5, 2013
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PR Newswire PITTSBURGH, March 5, 2013
PITTSBURGH, March 5, 2013 /PRNewswire/ -- Cohera Medical,
Inc.
®
, a leading innovator and developer of absorbable surgical adhesives and sealants, today announced that the first patient
of its U.S. no-drain clinical study has been successfully treated. The full study will include a total of 130 patients and
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. The randomized, controlled, multicenter non-inferiority study will take place at five prominent surgery centers in Washington, DC; Baltimore, MD; Charlotte,
NC; Los Angeles, CA; and Dallas, TX.
"Participating in this breakthrough study to eliminate postoperative drains is exciting, because TissuGlu is so easy to
use and extremely valuable to the abdominoplasty procedure healing process," said Joseph P. Hunstad
MD, FACS, of the The Hunstad-Kortesis Center, Charlotte, N.C.
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
and can lead to infection and impact the recovery process. TissuGlu adheres the tissue flap created during the procedure to the underlying tissue, helping to reduce the
fluid that can accumulate in the space during healing and ultimately reducing the need for postoperative drains to remove
the fluid. 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're thrilled to kick off the first no-drain trial in the U.S., bringing us one step closer to facilitating a more natural
healing process in large flap procedures," said Patrick Daly, President and Chief Executive
Officer of Cohera Medical. "By eliminating post-surgical drains, our product has the ability to significantly impact how millions
of patients recover from surgeries throughout the world." Cohera Medical received CE Marking approval for TissuGlu and began selling product to hospitals and surgeons in Germany
in September 2011. An earlier no-drain study of 30 patients was successfully completed in Germany in July 2012. In the U.S., Cohera recently completed enrollment
of a clinical trial for TissuGlu. TissuGlu has been used successfully in over 600 various surgical procedures by leading surgeons.
About Cohera Medical 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.
Contact: SOURCE Cohera Medical, Inc.
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