Cohera Medical, Inc. Receives Approval To Begin Human Clinical Trials of TissuGlu(R) in Europe

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Fri Oct 23, 2009 6:31am EDT

Cohera Medical, Inc. Receives Approval To Begin Human Clinical Trials of
TissuGlu(R) in Europe



PITTSBURGH, Oct. 23 /PRNewswire/ -- Cohera Medical, Inc. announced today that
it has received approval to begin human clinical trials of its lead product
TissuGlu® in Germany. Receipt of the approval allows Cohera Medical to proceed
with patient recruitment and initiation of an investigational study of the
company's novel internal surgical adhesive being developed for its first
intended use to adhere surgical tissues together in large flap surgeries.


The feasibility study will investigate the safety and preliminary
effectiveness of TissuGlu® and its effect on wound drainage and associated
complications in abdominoplasty (tummytuck) surgeries.  The study will be
conducted at three sites near Bonn, Frankfurt, and Freiburg in Germany and
will enroll 40 patients.  Patient recruitment is expected to begin in November
this year. 


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 excessive fluid accumulation (called seroma
formation) often requires an additional procedure to remove it.  TissuGlu is
designed to adhere the tissue flaps created during the procedure, thereby
reducing fluid accumulation and ultimately reduce or eliminate the need for
surgical drains and reduce the risk of related complications.  Patients are
expected to experience a faster and more comfortable recovery with the use of
TissuGlu.


"This trial will be our first study of TissuGlu in patients and the trial's
approval validates the biocompatibility and pre-clinical profile of TissuGlu,"
said Chad Coberly, JD, vice president of clinical, regulatory and legal
affairs of Cohera.  "Initiation of this study will allow the company to move
closer to a regulatory approval application in Europe for the CE Mark and
application for a larger U.S. based trial.  


Patrick Daly, president and chief executive officer of Cohera Medical added,
"This approval represents a major milestone for our internal adhesive
technology and for Cohera.  Our company is focused on progressing TissuGlu to
the next stage of development in the commercialization process.  This unique
product will ultimately help surgeons address a critical need and improve
patient care."


About Cohera Medical
Cohera Medical, Inc. is a Pittsburgh, PA 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, which will fill similar market needs in both
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 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.




SOURCE  Cohera Medical, Inc.

Media, Robert E. Flamm, Ph.D., Russo Partners, +1-212-845-4226,
Robert.flamm@russopartnersllc.com; or Patrick Daly, Cohera Medical,
+1-412-231-1500, Ext. 101, pdaly@coheramed.com; or For Clinical Trial
Information: Chad Coberly, Cohera Medical, +1-412-246-2563,
ccoberly@coheramed.com
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