, Nov. 19, 2013 /PRNewswire/ -- Cohera Medical, Inc.®
, a leading innovator and developer of absorbable surgical adhesives and sealants, announced today it has submitted its fourth and final module for TissuGlu®
Surgical Adhesive in the Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA).
"We are pleased to have submitted the final module of the PMA application for TissuGlu," said Chad Coberly, JD Vice President of Clinical, Regulatory and Legal affairs of Cohera Medical. "This module culminates substantial work by the Cohera team and our investigational partners."
A modular PMA submission is one in which the contents of a PMA are broken into several clearly defined parts or modules. These modules are submitted separately over time and comprise a complete PMA when all of them have been submitted. FDA reviews each module separately which may allow for a more efficient review when the last components are submitted because much of the review work will have already been completed. Cohera Medical has already successfully submitted the first three modules of the PMA application: biocompatibility, design control and manufacturing.
The fourth and final module submitted is comprised of data from Cohera Medical's 'No Drain' study, confirming that TissuGlu is a clinically superior alternative to closed-suction drains for fluid management in large flap procedures such as abdominoplasty. In the pivotal clinical trial, when TissuGlu was used, patients required fewer post-operative treatments and resumed normal activities, such as going to work, showering and using the stairs, more quickly.
"Submitting the final module to FDA is a critical milestone in making TissuGlu Surgical Adhesive available to surgeons and patients in the U.S.," said Patrick Daly, President and Chief Executive Officer of Cohera Medical. "The successful completion of this module represents a huge effort on the part of the entire company and we look forward to continuing our work with FDA."
Currently, most patients who undergo abdominoplasty procedures or other large flap procedures, such as mastectomy or inguinal lymph node dissection, require the insertion of drains to remove fluid that accumulates under the skin at the surgical site. Drains are often uncomfortable for the patient and can lead to additional complications. TissuGlu forms a strong bond between tissue layers, helping to reduce the fluid that can accumulate during healing.
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.