Pittsburgh Technical Council

Cohera Medical, Inc.® Receives PMA Approvable Letter from U.S. FDA for TissuGlu® Surgical Adhesive

Cohera Medical, Inc.® Receives PMA Approvable Letter from U.S. FDA for TissuGlu® Surgical Adhesive

Article Published: January 6, 2015

Cohera Medical, Inc.®, a leading innovator and developer of absorbable surgical adhesives and sealants, announced today that it has received a letter from the U.S. Food and Drug Administration (FDA) that the pending Premarket Approval Application (PMA) for its TissuGlu® Surgical Adhesive is Approvable.  The receipt of the Approvable Letter means that the FDA has largely approved all parts of the PMA. The Company expects to work with the FDA to reach a final approval on the application within a few weeks.

“The receipt of the PMA Approvable Letter is a truly significant milestone for the Company,” said Patrick Daly, Cohera Medical President and CEO. “We are excited about the pending approval for TissuGlu and are looking forward to making TissuGlu available to surgeons and patients throughout the United States.”

TissuGlu is indicated for the approximation of tissue layers where subcutaneous dead space exists between tissue planes in abdominoplasty.  Upon approval, TissuGlu will be the first internal surgical adhesive of its kind approved in the United States.

Mr. Daly will be presenting on this latest milestone and other significant updates at the J.P. Morgan Healthcare Conference on January 13th at 4:00pm PST.

TissuGlu is designed to meet a surgeon’s need for a strong, biocompatible, and easy-to-use surgical adhesive. The Approvable PMA supports the safety and effectiveness of TissuGlu as an alternative to the use of closed suction drains in abdominoplasty procedures, reducing the number of post-operative invasive treatments and improving the patient recovery process.

“TissuGlu, which has the potential to eliminate wound drainage issues from abdominoplasty procedures, represents a major advance in helping patients recover faster and more comfortably following these procedures,” said Joseph P. Hunstad MD, FACS, of The Hunstad-Kortesis Center, Charlotte, N.C. “When approved, it will bring great benefits to both patients and surgeons.”

“Having the PMA approved, minus a few small labeling changes, signifies the FDA has approved the years of scientific, engineering, manufacturing, quality, and clinical work conducted by the Cohera Medical team,” said Chad Coberly, JD, Vice President of Clinical, Regulatory & Legal Affairs for Cohera.

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.

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