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.

Driven by a vast and underserved market in dire need of safer, less-invasive, more effective solutions, manufacturers are developing several next-generation devices for the minimally invasive treatment of obesity. Many of these emerging devices not only mimic the restriction and malabsorption mechanisms involved in bariatric surgery, but are also designed to influence the metabolic responses that are key to losing weight, improving outcomes, and impacting chronic disease. Indeed the obesity intervention paradigm is rapidly changing as ongoing research provides new insights into the underlying mechanisms behind obesity and bariatric surgery, heralding a new era where the primary treatment target for bariatric surgery is becoming disease specific, rather than targeted at obesity alone.