U.S. regulators have cleared a bite-size camera to help screen the large intestine of patients who have trouble with colonoscopies.
The ingestible pill camera from Given Imaging (NASDAQ: GIVN) is designed to help doctors spot polyps and other early signs of colon cancer. The U.S. Food and Drug Administration cleared the device for patients who have had trouble with the cringe-inducing procedure, which involves probing the colon using a tiny camera on a four-foot long, flexible tube.
The pill camera was previously approved in 80 other countries, including those in Japan, Europe and Latin America.
The Israeli company's technology, developed from missile defence systems, uses a battery-powered camera to take high-speed photos as it slowly winds its way through the intestinal tract over eight hours. The images are transmitted to a recording device worn around the patient's waist and later reviewed by a doctor.
While Given's wireless, image-beaming system may sound like science fiction, it's actually more than a decade old. In 2001, the company received FDA approval for a similar device used to get a close-up view of the small intestine.
At that time, analysts expected Given's approach to grow into a direct competitor with traditional colonoscopy. But company studies found that the images taken by the mini-camera were not quite as clear as those from the in-office procedure. As a result, the company has pursued a more limited market for its PillCam: patients who have trouble undergoing standard colonoscopies.
The FDA approved the company's PillCam Colon for patients who have experienced an incomplete colonoscopy. The company estimates 750,000 U.S. patients are not able to complete the procedure each year, due to anatomy issues, previous surgery or various colon diseases.
Even with this limited indication, analysts estimate the new pillcam could grow to sales of over $60 million in North America by 2019, with room for expansion as the technology improves.
Given Imaging’s U.S. shares opened trading Tuesday morning at $29.99, up four cents from Monday’s close, within a 52-week range from $13.01 U.S to $30.18 U.S.
