North Side firm's surgical adhesive OK'd in Europe, headed to FDA
Cohera Medical in a solid state
September 14, 2011 4:00 AM
Patrick Daly, president and CEO of Cohera Medical, Inc., demonstrates how the TissuGlu applicator dispenses three drops of the adhesive at a time.
By Steve Twedt Pittsburgh Post-Gazette
Cohera Medical Inc., developers of a surgical adhesive that may help patients to heal more quickly after a major operation, announced today that it has received the necessary approvals to open up the European market for the growing North Side firm.
Company officials say their product, TissuGlu, will be commercially available for the first time in Germany next week, as Cohera moves one step closer to seeking similar approval for TissuGlu from the U.S. Food and Drug Administration.
"This is a very big milestone," said Patrick Daly, Cohera's president and CEO.
TissuGlu addresses a long-time concern about post-operative care by reducing fluid build-up in spaces left after a patient's surgical wound is stapled or sewn following a major stomach operation.
Quite often, fluid build-up requires the patient to have draining tubes inserted through the skin for days, if not weeks, causing discomfort and a risk for infection.
TissuGlu is similar to industrial-strength glues "without the bad bits," said Mr. Daly. Immediately following surgery, it adheres the skin flap to tissue, reducing or eliminating those spaces where fluid can accumulate and possibly speeding up a patient's recovery.
"We think we'll literally be able to eliminate the need for drains," said Mr. Daly.
The product is simple to use, he said. It doesn't require refrigeration or mixing before use and it produces a strong bond.
Surgeons use a handheld applicator that automatically dispenses a drop of TissuGlu in a grid pattern, three drops at a time, across the open wound. The adhesive then holds the skin flap tightly. The application process takes about two minutes, and fully adheres in 30-45 minutes.
Company officials hope the ease of use will appeal to surgeons and the reduction or elimination of draining tubes is a hit with patients.
University of Pittsburgh chemical engineering professor Eric Beckman, senior scientist and a co-founder of Cohera along with surgeon Michael Buckley, is the primary inventor behind the proprietary technology. The "glue" in TissuGlu contains amino acids that eventually dissolve into the body as carbon dioxide, sugar and water.
Beginning in December 2009, surgeons used TissuGlu on 40 patients in 45 days at three separate German hospitals with no complications, said Mr. Daly. Based on those results, and earlier tests on animals, Cohera applied for its CE, or Conformite Europeene, Marking in April.
The CE Marking means the product can legally marketed in European Union countries, including France, Germany, Italy and the United Kingdom.
The first commercial use of the product, also in Germany, should occur next week.
After that, Cohera's next big step will be applying for FDA approval by year's end with clinical trials in the U.S. planned for the first quarter of 2012.
For a new product, it has been a whirlwind ride going from bench top experiment to commercial product in five years. During that time, the company has raised $40 million from investors and now has 52 patents pending and four already issued.
Mr. Daly, a former executive with Johnson and Johnson, was a staff of one when he started Cohera Medical in January 2006. Cohera now employs 27 people, including five overseas.
He said they're already working on additional derivations for TissuGlu, as well as developing an adhesive for bowel procedures and another to keep hernia mesh material in place.