SmartPill Begins Clinical Trials Of Its GI Monitoring System

SmartPill Diagnostics, Inc., developer of the SmartPill Capsule, a non-invasive, ingestible medical device that captures biomedical data from within the patient's GI tract, today announced that 510(k) clinical trials of its SmartPill ACT-I Capsule and GI Monitoring System are now underway at Massachusetts General Hospital (Boston, MA).

A total of 130 subjects and five clinical trial sites are expected to participate in 510(k) clinical trials of the SmartPill ACT-I Capsule and SmartPill GI Monitoring System. Of the 130 subjects, 70 are control (healthy) and 60 are gastroparetic. Gastroparesis is one of the primary GI motility disorders in which the SmartPill ACT-I Capsule will aid diagnosis and management. Temple University Hospital (Philadelphia, PA) will begin clinical trials on March 7, 2005, and three other sites will begin clinical trials shortly thereafter.

David Barthel, president and CEO of SmartPill Diagnostics, said, "This is a very significant milestone for our young Company. In addition to clearing the technical hurdles that were implicit to taking this critical step, we continue to hit our marks with respect to building out the business infrastructure needed to bring the SmartPill GI Monitoring System to market later this year. Overall, I am very pleased with our progress and position."

The 510(k) clinical trials will be completed in May 2005 and will lead to 510(k) submission in June 2005. SmartPill Diagnostics successfully completed physiological trials of the SmartPill ACT-I Capsule and GI Monitoring System in June 2004.