Coeli Carr, Contributor
“Fluid build-up is enemy number one because, when the tissues gets separated by fluids, you don’t know how it will react,” says Dirk F. Richter, a plastic surgeon and chairman of the plastic surgery department at Dreifaltigkeits Hospital, in Wesseling, Germany. When strong tissue adhesion is missing – and fluids start accumulating – drainage tubes are the only recourse. The challenge is even greater with large-flap surgeries: think stomachs undergoing tummy tucks.
However, a new technology which became commercially available in Europe two months ago, may change all that.
Over the last two months, Richter has been using TissuGlu Surgical Adhesive, a product that may be the biggest breakthrough in plastic surgery in years. “It’s what we’ve been waiting for,” he says. “Surgery, which is always a trauma, produces swelling. And the swelling produces fluid in the tissue vacuum. Fluids are the best environment for germs to produce infection.”
TissuGlu holds the layers of tissue in place and prevents fluid accumulation, thereby reducing the need for drainage.
An adhesive developed for plastic surgery procedures, TissuGlu consists of biocompatible material – a lysine-derived urethane polymer adhesive that performs ideally in a moist environment – that can be broken down and assimilated back into the body. TissuGlu’s magic lies in the strength of its adhesive bond, which research has demonstrated to be five times stronger than any commercially available products used in soft-tissue surgical procedures.
“The faster an adhesive can seal the wound – so that tissues can’t be pulled apart – is what controls the accumulation of fluid,” says Richter. In surgeries where he used TissuGlu – the product is delivered in a grid pattern, three drops at a time onto the open wound, through a handheld applicator that automatically releases the product – “fluid accumulation was dramatically reduced.”
Up to this point, there has been no synthetic non-toxic adhesive on the market able to seal layers of internal tissue strongly enough to each other to keep fluid from accumulating, says Patrick Daly, 47, founder and CEO of medical product developer Cohera Medical Inc., which created TissuGlu.
For the past 100 years, Daly explained, the medical establishment has relied on rubber drainage tubes to remove accumulating post-operative fluids. “The tubes stayed in the patient for as long as fluid came out of them, which could be as long as 10 days,” he says. “Tending the tubes are inconvenient and painful to the patient.” Even worse, he adds, between fifteen and 52 percent of patients have medical complications – the drainage tubes may become infected, clogged or leak.
Even after physicians remove the drainage tubes and the patient is sent home, seroma – fluid build-up in dead space after the drain has been removed – may still occur, which results in the wound area “becoming as puffy as a water bed,” says Daly. Then, it’s back to the doctor’s office for fluid removal and perhaps a reinsertion of the drainage tubes.
The genesis of TissuGlu was technology created by Eric Beckman, a chemical engineer, and Michael Buckley, a maxillofacial surgeon. In 2004, the duo had filed paperwork to start a company based on their surgical adhesive technology. The following year, they met Daly, then regional director of Ethicon Endo-Surgery, a subsidiary of Johnson & Johnson. Seeing promise in Beckman’s and Buckley’s work, Daly quit his job and, in January 2006, officially launched Cohera Biomedical Adhesives.
Investors were similarly enthused.
In July 2006 Cohera Medical (the company changed its name in spring of that year) netted $7.86 million from private investors in its first round of financing. Its second round, in October 2008, drew $16.1 million. The third round closes next month and should generate more than $25 million. “Some individuals have invested in all three series,” says Daly, whose company now employs 27 people.
At end of December 2009, Cohera took its TissuGlu Surgical Adhesive – the final version of the product, after several years of research, development and addressing customer feedback – to Germany, where it underwent successful human clinical trials. This July the technology received the European CE Mark, allowing the product to be sold in all member countries of the EU. Already sales have been “robust,” says Daly, who’ll be expanding his sales teams in England, France, Italy, Spain and the Netherlands, and projects sales revenues in the “lower seven figures” for 2012.
With the CE Mark in hand, Daly will pursue FDA approval for TissuGlu and projects the first clinical trials to begin in the U.S. in 2012. He anticipates selling the product in the U.S. by the third quarter of 2014.
In addition to TissuGlu’s cutting down on post-operative risks of infection caused by drainage tubes, the technology saves time. Richter notes that suturing wound tissue that measures between 12 to 16 inches (approximately 30 to 40 centimeters) might take at least a half hour, compared to between three and four minutes using TissuGlu. The product also provides a cost benefit by cutting down time spent in the operating room.
In addition to preparing for TissuGlu’s FDA clinical trials, Cohera is planning to bring its second product, a surgical bowel sealant, to market.
Bonding with end users – a goal for many companies – rings especially true for the company behind TissuGlu. Cohera has found that creating an exceptionally strong bond is incredibly good for business.