Fecal incontinence is a common, devastating condition that often goes untreated. Eyeing the potential multibillion-dollar opportunity, medtech start-ups are developing approaches that range from small and disposable to surgical and permanent.

With health care becoming increasingly data driven, third-party payors are requiring a higher level of evidence before making a positive coverage determination for a new technology or procedure. This has made the road to reimbursement much longer and tougher for device companies in general, and manufacturers of transoral devices for GERD are a prime example.

Founded in 2001, EndoGastric Solutions Inc., a mature medical device company with $140 million in venture backing, hasn’t been able to secure a reliable source of reimbursement dollars for its EsophyX endoscopic treatment for GERD. Under new management, EGS is recommitting itself to collecting necessary clinical data and operating as a lean start-up as it makes its case for coverage and reimbursement with insurers.

Two distinct and effective radiofrequency medical devices to treat two prevalent digestive system disorders have been resurrected in an improved configuration, after the bankruptcy of their original manufacturer. Stretta for gastroesophageal reflux disease and Secca for bowel incontinence were first launched by Curon Medical, which went out of business in 2006. Mederi Therapeutics Inc. acquired the assets and is once again offering these two clinically proven therapies using a new RF generator and redesigned disposables.