SmartPill Corp. (Buffalo, New York), developer of the SmartPill pH.p Capsule, a non-invasive medical device that captures biomedical data from within a patient's gastrointestinal (GI) tract, reported that the clinical trial of its SmartPill pH.p Capsule and GI Monitoring System, has been completed successfully.

The SmartPill product, which measures GI tract pressure, transit time and pH through sensors on the ingestible pill, was studied for the diagnosis of gastroparesis, which is a motility disorder in which food does not pass out of the stomach and through the system normally. The trial was launched in March.

"We're very excited about the results of the clinical trial," SmartPill President and CEO David Barthel told Diag-nostics & Imaging Week, noting that the SmartPill pH.p Capsule is "actually the first device of its kind that allows you to measure the entire GI tract."

Barthel said of the trial, "First of all, it's a significant milestone for the company."

He said it was the "largest gastric emptying trial ever conducted in the U.S."

"We ran 78 healthy and 57 gastroparetic [subjects]," he said. "That in itself is an accomplishment, [because] it's not easy to do. And thirdly, the data is stronger than we had anticipated ...there's a strong correlation for our intended use."

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 company said.

Scintigraphy is the current method of diagnosing gastroparesis, a method that is "very invasive, very uncomfortable," he said.

The study encompassed seven of the leading motility centers in the U.S., the company said, including Massachu-setts General Hospital (Boston), Temple University Hospital (Philadelphia), Wake Forest University Baptist Medical Center (Winston-Salem, North Carolina), the University at Buffalo, the University of Louisville, the University of Kansas Medical Center (Kansas City, Kansas), and the University of Michigan Health System (Ann Arbor).

With the study now complete, the company said it is now focused on preparing the 510(k) submission to the FDA, seeking approval to use the system in the diagnosis and characterization of gastroparesis.

"We will be submitting our 510(k) submission to the FDA this month, the month of November," Barthel told D&IW.

In a prepared statement, Barthel said, "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 global launch of the system in major markets (except the U.S. and Japan) throughout the world in the March-April 2006 time-frame. Following FDA approval, the company will introduce the system in the U.S.

In the U.S., Barthel said, SmartPill will have a direct sales force to market the product of a minimum of 5 people and maximum of 10 as the submission progresses and the launch in the U.S. approaches. The company already has hired two people for the direct sales effort.

"We're going to be doing heavy marketing, heavy advertising ... we're going to have a national campaign," Barthel said.

While SmartPill often is mentioned along with Given Imaging's (Yokneam, Israel) ingestible camera pill product, Barthel said that the two products are "totally different" in that Given's product is a camera and takes pictures, while the SmartPill product takes measurements using a sensor.

"We're actually measuring throughout the entire GI tract – we're not limited to certain sections of the GI tract," Barthel said.

He said the company would be doing additional trials both in the U.S. and in Royal London Hospital beginning Dec. 1 for colonic transit, or the amount of time it takes for food to travel through the colon.

Currently, SmartPill has sufficient funds, having closed a "very large round" in June.

"We'll be looking for additional capital expansion financing in the spring of next year after we begin [generating] revenue," Barthel said.

Given Imaging has PillCam products on the market in the U.S. and abroad for small bowel (PillCam SB) and esophageal (PillCam ESO) applications and is working on other versions of the system for the colon and stomach. Given CEO Gavriel Meron has said that each of those applications "represents multi-billion-dollar revenue products in the U.S. market alone."