Cohera Medical Closes Series D Funding Round

Cohera Medical Inc., a developer of absorbable surgical adhesives and sealants, has secured an additional $9.3 million to close its Series D financing, raising its total for the round to $26.3 million. The company plans to use the funds for U.S. regulatory approval of its TissuGlu surgical adhesive and CE mark in the European Union for its Sylys surgical sealant designed to reduce anastomotic leakage in gastrointestinal procedures.

Cohera Medical submitted its fourth and final module for TissuGlu in a premarket approval application (PMA) to the U.S. Food and Drug Administration (FDA) at the end of last year.

“Our goal is to improve patient care and recovery time through natural healing and reduced post-operative treatments, so patients can quickly resume normal activities,” said Patrick Daly, president and CEO of Cohera Medical. “The continued support from our investors is a testament to our significant milestones of 2013, which included the completion of our pivotal ‘No-Drain’ study for TissuGlu and our first in human study for Sylys.”

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 often are uncomfortable for the patient and can lead to additional complications. TissuGlu forms a bond between tissue layers, helping to reduce the fluid that can accumulate during healing.

Cohera Medical received CE mark for TissuGlu in 2011 and began selling product to hospitals and surgeons in Germany. TissuGlu has been used successfully in more than 1,000 various surgical procedures by leading surgeons, the company reports. In the United States, Cohera Medical submitted the fourth and final module in a PMA application to the FDA. The submission comprised data from Cohera Medical’s ‘No Drain’ study, which, according to the Pittsburgh, Pa.-based firm, demonstrated 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, Cohera officials reported.

The company claims that the Sylys surgical sealant, has the potential to make an enormous impact on an estimated $1 billion to $4 billion surgical market. On average, anastomotic leaks occur in 3-15 percent of colorectal procedures, and are the cause of one-third of the mortalities following colorectal surgery. Sylys is one of the first synthetic sealants specifically designed to significantly reduce anastomotic leakage in intestinal anastomosis procedures. Used in conjunction with standard anastomotic closure techniques, Sylys protects the suture or staple line, supporting the anastomosis during the first few days of healing, when leaks are most likely to occur.