SmartPill Completes Clinical Trial of Its GI Monitoring System; Company Focused Now on the FDA 510(k) Submission and Preparing to Launch the System in Major International Markets.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 scintigraphy /scin·tig·ra·phy/ (sin-tig´rah-fe) the production of two-dimensional images of the distribution of radioactivity in tissues after the internal administration of a radiopharmaceutical imaging agent, the images being obtained . The study encompassed seven of the leading motility motility /mo·til·i·ty/ (mo-til´ite) the ability to move spontaneously.mo´tile Motility Motility is spontaneous movement. centers in the US (Massachusetts General Hospital Massachusetts General Hospital Health care The major teaching hospital for Harvard Medical School, widely regarded as one of the best health care centers in the world , Temple University Hospital, Wake Forest University Baptist Medical Center This article or section needs sources or references that appear in reliable, third-party publications. Alone, primary sources and sources affiliated with the subject of this article are not sufficient for an accurate encyclopedia article. , the University at Buffalo, the University of Louisville See also
1. ^ [1] 2. ^ [2] URL accessed on June 8 2006 3. , the University of Kansas The University of Kansas (often referred to as KU or just Kansas) is an institution of higher learning in Lawrence, Kansas. The main campus resides atop Mount Oread. Medical Center, and the University of Michigan Health System The medical center also includes the Michigan Health Corporation, through which UMHS partners with other medical centers and hospital to provide specialized care throughout Michigan. ), 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 FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ), 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. |
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