SmartPill Completes Clinical Trial of Its GI Monitoring System; Company Focused Now on the FDA 510 Submission and Preparing to Launch the System in Major International Markets

Business Wire, Nov 8, 2005

BUFFALO, N.Y. -- The SmartPill Corporation (www.smartpillcorp.com), developer of the SmartPill pH.p Capsule, a non-invasive medical device that captures biomedical data from within a patient's GI tract, today announced that the clinical trial of its SmartPill pH.p Capsule and GI Monitoring System, which began in March 2005, were successfully completed.

The primary objective of the study was to demonstrate the correlation of gastric residence times measured by the SmartPill pH.p Capsule and gastric emptying scintigraphy. The study encompassed seven of the leading motility centers in the US (Massachusetts General Hospital, Temple University Hospital, Wake Forest University Baptist Medical Center, the University at Buffalo, the University of Louisville, the University of Kansas Medical Center, and the University of Michigan Health System), and a total of more than 130 subjects.

With the study now complete, the Company is now focused on preparing the Pre-market Notification 510(k) submission to the U.S. Food and Drug Administration (FDA), seeking approval to use the system in the diagnosis and characterization of gastroparesis.

"Completing this study represents a significant milestone for our Company," said David L. Barthel, president and chief executive officer of The SmartPill Corporation. "We are extremely pleased with the data obtained from the trial. We believe SmartPill demonstrates a strong correlation to the existing radiological method and will be able to provide physicians with a non-invasive, patient-friendly method to accurately measure gastric emptying time and total GI transit time in patients with suspected gastroparesis. We anticipate that physicians will recognize the advantages of this procedure and adopt its use accordingly."

The Company anticipates non-US launch of the system in major markets (except the United States and Japan) throughout the world in the March/April 2006 timeframe. Following FDA approval, the Company will introduce the system in the United States.

About The SmartPill Corporation

The SmartPill Corporation is the developer of the SmartPill pH.p Capsule and SmartPill GI Monitoring System that is expected to aid in the diagnosis and characterization of gastroparesis and other GI motility disorders; present a more patient-friendly alternative to invasive GI diagnostic procedures; and reduce the cost of exploratory GI examinations. Learn more at www.SmartPillCorp.com or call The SmartPill Corporation at 800.644.4162.