By Eileen Buckley
Buffalo, NY – A Buffalo company is seeking FDA approval for a non-invasive way to determine gastrointestinal disorders and diseases. Clinical trials are now under way for for the Smart Pill.
The Smart Pill is the size and shape a large vitamin capsule. It's made in Buffalo. If the FDA approves it, the Smart Pill would be used to examine a patient's GI tract, specifically for those with gastroparetic symptoms, a condition that often affects diabetics, and gastroparesis -- the inability for a stomach to empty.
Smart Pill Diagnostics President and CEO David Barthel says the FDA will be looking for safety and effectiveness following five clinical trials.
"We have indicated three claims that the product will do. Not only will it aid as a diagnostics tool for gastroparesis, but it will perform three necessary procedures for the diagnoses. The FDA will look to see if the data supports those intended claims," Barthel said. "For example, we claim the Smart Pill will perform gastric emptying, which is a very invasive procedure that would normally require a patient to be hospitalized."
The company passed one federal hurdle last year with some initial, phase one, clinical trials. But now, major testing of 130 subjects is underway. Barthel says the first clinical trial started a week ago at Massachusetts General Hospital in Boston. A second began Monday at Temple University Hospital in Philadelphia. And at the end of this month, more clinical trials are planned.
"At the end of March, we begin a clinical trial at Wake Forest University. It is a significant step because what will happen now is 130 patients will be run at five sites," Barthel said. "The other two sites are at the University of Michigan and here in Buffalo at the VA Hospital. They should begin in April."
Barthel says this is a very significant milestone for the young, local company. He says it could take three to six months for FDA approval.
Barthel says he is very confident that the Smart Pill will win approval. However, if rejected, the company would still have a chance to review the FDA's reasons and rework the product.