Cohera Medical, Inc.®, a leading innovator and developer of surgical adhesives and sealants, announced today that the U.S. Food and Drug Administration (FDA) has approved its TissuGlu® Surgical Adhesive. The approval allows the Company to begin commercial distribution of TissuGlu in the United States.
TissuGlu is the first tissue adhesive for internal use approved by the FDA in the United States. TissuGlu is approved to adhere tissue layers and close dead space in abdominoplasty procedures. In clinical trials, surgeons were able to eliminate the need for post-surgical drains by using TissuGlu, reducing the need for invasive treatments for their abdominoplasty patients, and improving the patient recovery process. The PMA supports the safety and effectiveness of TissuGlu as an alternative to the use of closed suction drains.
“The FDA’s approval of the first synthetic adhesive for internal use will help some abdominoplasty patients get back to their daily routine after surgery more quickly than if surgical drains had been inserted,” said William Maisel, M.D., M.P.H., Deputy Director for science at FDA’s Center for Devices and Radiological Health.1
The primary clinical data supporting the FDA approval was from a 130 patient study where half of the participants received drains and the other half received TissuGlu and no drains. The study results showed that 73 percent of participants who received TissuGlu required no postoperative interventions to manage postoperative fluid. Study participants who received TissuGlu without drains were generally able to return to most daily activities such as showering, climbing stairs, and resuming their usual routines sooner than those who had drains.
“FDA approval of TissuGlu is the most significant milestone in the Company’s history,” said Patrick Daly, Cohera Medical President and CEO. “We are excited about the approval and look forward to making TissuGlu available to surgeons and patients in the United States.”
“The PMA approval for TissuGlu culminates years of work by the Company, its clinical partners, and the FDA,” said Chad Coberly, JD, Vice President of Clinical, Regulatory and Legal Affairs for Cohera. “The Company would like to thank the FDA and its review team for all their efforts on the PMA over the years.”
TissuGlu is targeted for use in abdominoplasty procedures in which drains are used to control fluid output and seroma formation. There are approximately 175,000 US-based abdominoplasty procedures per year, growing at an annual rate of 7.7 percent that could utilize TissuGlu. The product has been on the market in the EU since 2011, and currently more than 1,500 procedures have been conducted with TissuGlu, bringing great benefit to patients, surgeons, and caregivers. Commercial launch for TissuGlu in the U.S. is scheduled to begin in the upcoming months.
About Cohera Medical
Cohera Medical, Inc. is a rapidly growing medical device company that is actively developing a line of surgical adhesives and sealants. Cohera Medical’s products are based on a unique chemical design that is resorbable, non-toxic, easy-to-use, and forms a strong bond between tissue layers. The Company’s lead product, TissuGlu® Surgical Adhesive, is currently approved for sale in the United States and the EU for the approximation of tissue layers where subcutaneous dead space exists between the tissue planes in large flap surgical procedures such as abdominoplasty. The Company’s second product, Sylys® Surgical Sealant, the first synthetic sealant designed specifically to help reduce anastomotic leaks, is currently under the CE Mark approval process. TissuGlu and Sylys are the first in a pipeline of technology that includes surgical mesh adhesives, hemostatic foam, bone adhesives, and drug delivery. The other Cohera Medical products are currently indicated for investigational use only and have not yet been approved for sale by the Food and Drug Administration (FDA) in the U.S. or in any other market.
1. For FDA’s Press Release related to the approval, visit http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm432906.htm
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.
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