|The TissuGlu technology--Courtesy of Cohera Medical|
Cohera Medical got a narrower label from the FDA than it had first targeted after enduring an approvable letter and a tough panel review. The label allows for use of the urethane-based adhesive TissuGlu during abdominoplasty surgery; the company had originally sought an approval similar to its CE mark that would be broadly for large flap surgical procedures.
These include not only abdominoplasty, but also mastectomy, inguinal lymph node dissection, transverse rectus myocutaneous flap reconstruction, latissimus dorsi flap reconstruction and potentially post-bariatric body contouring operations. Much of the panel discussion was focused on to what extent the product should be used in these procedures beyond abdominoplasty.
TissuGlu allows for the elimination of external drains after surgery, which are cumbersome for patients and physicians. TissuGlu received a CE mark in 2011; about 1,500 surgical procedures have used the product.
"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," Dr. William Maisel, deputy director for science at FDA's Center for Devices and Radiological Health, said in a statement.
In a 130 person study, 73% of patients receiving TissuGlue did not require postoperative intervention. But for those who did need surgical intervention, they were more likely to need another operation to insert surgical drains. Patients with TissuGlu generally were able to return to their usual routines faster than those with drains, but there was no difference in reported pain or discomfort due to the surgery.
TissuGlu is an adhesive consisting of a polyurethane pre-polymer generated by reacting trimethylolpropane with lysine diisocyanate ethyl ester. It polymerizes at the surgical site upon contact with moisture and is delivered via a handheld applicator that contains 5 milliliters of the adhesive.
Cohera investors are likely primed for an exit now that it has an FDA approval in hand. The startup is backed by Bradford Capital Partners and Kern Whelan Capital. Founded in 2006, it has raised more than $78 million including $4 million in SBIR grants. The company's most recent venture financing was a $26.3 million Series D round in January 2014.
Already, the startup has also submitted another product candidate, Sylys Surgical Sealant, a synthetic sealant to help reduce anastomotic leaks, for CE mark review. Sylys received Priority Review status from the FDA for Sylys in December. Anastomotic leaks occur at a rate of as high as 23% in gastrointestinal surgical patients, and can lead to severe consequences; it is considered one of the most common causes of post-surgical deaths after colorectal surgery.
- here is the FDA release