Navigation Links
First Patient Treated in U.S. Clinical Study of Cohera Medical's TissuGlu® Surgical Adhesive
Date:5/1/2012

PITTSBURGH, May 1, 2012 /PRNewswire/ -- Cohera Medical, Inc.®, a leading innovator and developer of absorbable surgical adhesives and sealants, today announced the treatment of the first patient in a prospective, multicenter, randomized clinical trial for its lead product, TissuGlu® Surgical Adhesive in the United States.  Initiation of the study marks a significant milestone in the Company's progression of the lead product toward commercialization in the United States.

The study will investigate the effectiveness of TissuGlu on the reduction of wound drainage and post-surgical complications in abdominoplasty surgeries in 150 patients at six sites in the U.S. TissuGlu is a resorbable, high-strength surgical adhesive for large flap surgeries, such as abdominoplasty (tummy tuck), that helps eliminate or reduce fluid accumulation and the need for post surgical drains. Enrollment in the study is expected to proceed quickly and upon favorable conclusion will allow the company to complete a PMA application for TissuGlu with the FDA.

"We are excited to have treated the first patient in the TissuGlu study," said Joseph P. Hunstad MD, FACS, of the The Hunstad-Kortesis Center, Charlotte, N.C.  "We look forward to enrolling more patients and believe that these procedures represent a key step forward in helping patients recover faster and more comfortably following large flap procedures."

"Initiation of the US clinical trial is a major milestone for Cohera," said Patrick Daly, President and Chief Executive Officer of Cohera Medical.  "We are honored to be working with such a distinguished group of surgeons who share our vision for excellent clinical outcomes.  We look forward to working with FDA to bring this breakthrough technology to patients and clinicians here in the United States."

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 350 surgical procedures in Germany by leading plastic and reconstructive surgeons.

Currently, most patients who undergo abdominoplasty procedures and other 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. TissuGlu adheres the tissue flap created during the procedure to the underlying tissue, helping to reduce the fluid that can accumulate in the space and ultimately reducing the time to drain removal. The use of TissuGlu may shorten the length of time that drains need to be in place, leading to a more comfortable recovery and a quicker return to normal activity for patients.

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.


'/>"/>
SOURCE Cohera Medical, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Endo Reports First Quarter Financial Results And Announces Return To Steady Supply Of OPANA® ER And Voltaren® Gel
2. Hospira Reports First-Quarter 2012 Results
3. Rigel Announces First Quarter 2012 Financial Results
4. Jazz Pharmaceuticals Announces First Quarter 2012 Financial Results Conference Call On May 8, 2012
5. Luminex Corporation Reports First Quarter 2012 Results
6. Halozyme to Host First Quarter 2012 Financial Results Conference Call
7. Anthera Announces First Quarter 2012 Financial Report and Conference Call
8. Chindex International, Inc. to Report First Quarter 2012 Financial Results
9. CryoLife Reports Record Quarterly Revenues in First Quarter of 2012
10. Accuray Launches First Study to Compare CyberKnife® SBRT to Surgery and IMRT for Treatment of Early-Stage Prostate Cancer
11. Shire Delivers Strong First Quarter Performance and Reiterates its Expectation of Good Full Year Earnings Growth
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/26/2016)... -- A key trend that will boost ... new treatments. Cardax, a development stage life sciences company, ... is expected to fulfil large unmet medical needs in ... to develop new treatments for osteoarthritis. One such study ... osteoarthritis are being investigated, and early trials of stem-cell ...
(Date:5/26/2016)... May 26, 2016 Since its ... into an essential life science tool for conducting genetic ... BCC Research reveals in its new report that the ... phase, one powered by a range of new applications ...      (Logo: http://photos.prnewswire.com/prnh/20140723/694805 ) , ...
(Date:5/25/2016)... , Deutschland und GERMANTOWN, Maryland ... Zusammenarbeit mit Therawis bedient dringenden ... Brustkrebs   QIAGEN N.V. (NASDAQ: ... heute bekannt, eine Lizenz- und Entwicklungsvereinbarung mit Therawis ... für die Onkologie eingegangen zu sein. Ein erstes ...
Breaking Medicine Technology:
(Date:5/26/2016)... ... ... Despite last week’s media reports hinting at a June rate hike after the Federal ... an interest rate increase, according to Rajeev Dhawan of the Economic Forecasting Center at ... Committee (FOMC) dot charts are of interest to the press for their noise potential,” ...
(Date:5/26/2016)... Missouri (PRWEB) , ... May 26, 2016 , ... ... quality and clinical outcomes, hosted members and suppliers for its inaugural Member Conference ... focus on their mission of elevating the operational health of America’s healthcare providers. ...
(Date:5/26/2016)... ... , ... The Woodlands at John Knox Village , Florida’s first Life ... living and healing, celebrated its grand opening, today. The Woodlands at John Knox Village ... Empowered Staff. , “This is an incredibly fulfilling time for John Knox Village as ...
(Date:5/26/2016)... ... 2016 , ... Catalent Pharma Solutions, the leading global provider ... global clinical supply services, today announced two key appointments and the opening of ... strategic growth plans in the Asia Pacific region. , Howard Kim has joined ...
(Date:5/26/2016)... ... May 26, 2016 , ... Memorial Day Weekend marks the unofficial ... is sharing tips to make sure your family and vehicle are ready to ... Council, there may be 439 deaths and an additional 50,500 serious injuries from motor ...
Breaking Medicine News(10 mins):