SBIR Phase II: Active Device for Reliable Cleaning of Feeding Tubes

This award is funded under the American Recovery and Reinvestment Act of 2009 (Public Law 111-5). This Small Business Innovation Research Phase II project will continue development of the Tube-Clear(TM) device to clear clogged and sluggish feeding tubes, satisfying a critical medical need and reaching a viable commercial market. When compromised patients are unable to swallow food or medication, feeding tubes are used to administer medication and nutrition. A clog leaves the patient without medication or nutrition for hours, or even days, and is extremely frustrating to both patient and caregiver. Approximately 410,000 PEG (long-term) tubes and 5 million NG (short-term) tubes are placed each year in the U.S. Each type of tube presents specific challenges for feeding, clogging and cleaning. The Tube-Clear(TM) PEG prototype cleaned a clog of food and ground medication, in less than one minute, that could not be easily removed using any other available approach. Demonstration of the PEG alpha-prototype at four focus groups, for over 20 nurses from a variety of clinical settings, produced an overwhelmingly positive response toward the device. Phase II (following on Phase IB) will further develop both the PEG tube and NG tube cleaners to beta-prototypes, take the devices through clinical trials, and establish manufacturing protocols, all under a Food and Drug Administration compliant quality system. The Tube-Clear will ease the burden on nursing staff and patients dealing with the frustration of clogged and sluggish feeding tubes. A structured financial and technical plan has been put in place using a combination of funds from SBIR (Phase I, IB, II and IIB), the State of Pennsylvania, Commercial Partners, and equity investment to reach specific milestones over a 2.5 year period. The NSF Phase I project kicked off this development effort with a highly successfully Alpha prototype for PEG tubes, which was tested in a series of nursing focus groups, resulting in extremely positive reviews. The Tube-Clear for PEG cleaning has an anticipated market launch date in 2010, followed by a NG tube cleaning device market launch in 2011. By 2013, Piezo Resonance Innovations (PRII) anticipates revenue for the Tube-Clear (TM) of $25-50 Million. Three commercial partners, with presence in the enteral feeding market, have indicated strong interest in the device and would provide access to their paths to market, marketing staff, and device development expertise. They have also expressed willingness to contribute financially, potentially as Phase IIB partners. PRII staff will also teach guest lectures on medical device design in the Penn State School of Nursing.