Navigation Links
Cohera Medical Receives IDE Approval to Begin Pivotal Clinical Trial for TissuGlu® Surgical Adhesive in the U.S.
Date:1/24/2012

PITTSBURGH, Jan. 24, 2012 /PRNewswire/ -- Cohera Medical, Inc.®, a leading innovator and developer of absorbable surgical adhesives and sealants, announced today that it has received Investigational Device Exemption (IDE) approval from the United States Food and Drug Administration ("FDA") to begin a prospective, multicenter, randomized clinical trial for its lead product, TissuGlu® Surgical Adhesive in the United States.

The study will investigate the effectiveness of TissuGlu and its effect on wound drainage and associated complications in abdominoplasty surgeries.  There are currently no medical devices approved by the FDA, or in pivotal clinical trials, for a synthetic adhesive indicated for approximation of tissues in large flap surgeries.

"We are pleased to have FDA approval to begin this pivotal trial that validates the biocompatibility, pre-clinical testing profile and clinical trial design of TissuGlu," said Chad Coberly, Vice President of Clinical, Regulatory and Legal Affairs of Cohera Medical. "Initiation of this study is planned in the first quarter of 2012 and will be conducted at five clinical sites with 150 patients, and upon favorable conclusion will allow the company to complete a PMA application for TissuGlu with the FDA."

"IDE approval of the TissuGlu study is a significant strategic milestone for Cohera and its investors," said Patrick Daly, President and Chief Executive Officer of Cohera Medical.  "We are encouraged by the initial positive outcomes with TissuGlu in clinical studies and commercial use outside the U.S., and we look forward to working with the FDA to bring this breakthrough technology to clinicians and patients 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 early 2012.

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 eliminates or reduces 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 medical use 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. Cohera Medical Raises Over $25 Million in Series C Round
2. Cohera Medical Commercializes TissuGlu® Surgical Adhesive in Germany
3. Cohera Medical and CEO Receive Pittsburgh Tech 50 Awards
4. Cohera Medical Receives CE Mark Approval for TissuGlu® Surgical Adhesive
5. Frost & Sullivan Recognizes Cohera Medical, Inc.® for Developing TissuGlu®, Its Pioneering Surgical Adhesive That Is Strong, Easy-To-Use, Biocompatible and Resorbable
6. First Patient Treated in Clinical Study of Cohera Medicals TissuGlu(R) Surgical Adhesive
7. Varian Medical Systems Showcases Advanced Radiotherapy Systems for Treating Cancer at 2012 Arab Health Congress and Exhibition
8. Crux Biomedicals IVC Filter Receives CE Mark Approval
9. OFS to Present Paper on Optical Fibers with Polyimide Coatings for Medical Applications
10. HealthTech Capital Leads Series A2 With Over $300,000 Investment in Cadence Biomedical
11. Kaiser Permanente Moves to Green Medical Supplies by Converting to Eco-Friendly IV Equipment
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/4/2016)... 2016 Wegener Polyangiitis - Pipeline Review, ... ,Wegener Polyangiitis - Pipeline Review, H2 2015, provides ... This report provides comprehensive information on the ... analysis at various stages, therapeutics assessment by drug ... (RoA) and molecule type, along with latest updates, ...
(Date:2/4/2016)... 4, 2016 Frontier Pharma: Chronic Obstructive ... Innovation Chronic Obstructive Pulmonary Disease ... inflammation of the airways and lungs. Persistent breathing ... the disease one of the leading causes of ... the world. COPD is linked to cumulative exposure ...
(Date:2/4/2016)... 2016 In response to the opioid abuse epidemic, ... for Medical Products and Tobacco, along with other FDA leaders, ... approach to opioid medications. The plan will focus on policies ... pain access to effective relief. --> ... Re-examine the risk-benefit paradigm for opioids and ensure that the ...
Breaking Medicine Technology:
(Date:2/5/2016)... (PRWEB) , ... February 05, 2016 , ... ... organization devoted exclusively to funding innovative lymphoma research and serving the lymphoma community ... is poised to once again host, Swirl, A Wine Tasting Event at the ...
(Date:2/5/2016)... ... February 05, 2016 , ... In ... across the country gathered at the La Valencia Hotel in San Diego, California ... Chicago was named the year’s most outstanding franchise, walking away with the coveted ...
(Date:2/5/2016)... York, New York (PRWEB) , ... February 05, 2016 , ... ... gym use and find themselves having to wait longer to access the treadmills. It’s ... their New Year’s resolutions to lose weight and get in shape by joining gyms, ...
(Date:2/5/2016)... ... 2016 , ... Boar’s Head Brand®, one of the nation’s leading providers of ... Take the stress out of your party preparation – follow these easy, yet delicious ... of the game. , “The key to hosting a successful game-day party is creating ...
(Date:2/5/2016)... ... February 05, 2016 , ... At its annual meeting held ... as Chairman of the National Board of Directors. Mr. McDermott succeeds former APDA Chairman, ... stated Leslie A. Chambers , APDA President and CEO. “Pat has tirelessly served ...
Breaking Medicine News(10 mins):