Smart Seal Ostomy Appliance (5R44RR16122-03)

Eden Medical has been awarded a $812 K Phase II National Institutes of Health(NIH) Small Business Innovative Research(SBIR) grant by the National Center for Resource Resources(NCRR) to develop a wearable ostomy appliance device that incorporates innovative technology to provide greater patient confidence and satisfaction, and reduce potential for skin breakdown.The need to provide a reliable and effective skin barrier is becoming increasingly important for colostomy, ileostomy, and urostomy patients. An aging population, higher health care costs, recurrence of peristomal skin problems, cyclic skin breakdown, and poor eyesight are all significant factors adversely affecting ostomy care.  The Phase II project focused on the development a  smart ostomy wafer that will offer patients the following benefits: provide patient "aware" wear time, identify undermining effects, and reduce potential for skin breakdown, provide better patient comfort,  well-being by eliminating cycle of misery due to seal integrity and skin breakdown. Fourteen patients have been tested to date as part of two clinical studies completed in 2009.