The US Food and Drug Administration (FDA) has granted approval to Cohera Medical's first module of its premarket approval (PMA) application for an internal surgical adhesive.
The CE marked internal adhesive, TissuGlu, is designed for reducing fluid accumulation and the need for post surgical drains that occur while performing large flap surgeries such as abdominoplasty (tummy tuck).
The first module of application included the pre-clinical testing profile for TissuGlu including extensive biocompatibility and toxicological testing information.
Cohera Medical clinical regulatory and legal affairs JD vice president Chad Coberly said the company is pleased to receive FDA approval for the first module of the PMA in which the biocompatibility and pre-clinical testing profile of TissuGlu is acceptable.
"We appreciate the professional and interactive review by the FDA for this module and look forward to working with the Agency on the review of the future modules," Coberly added.
Cohera Medical president and chief executive officer Patrick Daly said, "The approval for this information confirms the basic safety profile of this important new product and allows the Company to proceed with its modular PMA filings on plan."
In addition to the first module, the company is planning to submit the second module of TissuGlu, containing information related to the characterization and specifications, before the end of the 2012, and the remaining two modules describing the manufacturing, quality system and clinical study information in 2013.
