Given Imaging's PillCam Colon capsule wins Japanese approval

PillCam Colon--Courtesy of Given Imaging

Given Imaging now has Japan's regulatory sign-off for its new endoscopic pill camera, creating a new avenue for revenue growth in the world's second-largest healthcare market.

Japan's Pharmaceuticals & Medical Devices Agency approval allows physicians to use the Israeli company's ($GIVN) PillCam Colon device when patients are either unwilling or unable to submit to a colonoscopy for potential colon-related diseases or problems. The hope is that the pill capsule will help boost early detection of colon cancer in Japan, and that it can counter low compliance rates for fecal blood tests and colonoscopies.

Beyond improving care, Given also sees enormous potential for expansion. Company President and CEO Homi Shamir said in a statement that the approval should spark a growth in its potential customer base in Japan from 1,000 patients to 10,000, with a goal of boosting patient adherence to screening for more than one million potential patients. The PillCam Colon is also billed as a cheaper option in an era where healthcare costs are more closely scrutinized--about $500 per capsule (similar to the long-selling PillCam SB), compared to $800 to $1200 for a typical colonoscopy.

PillCam Colon is small--11 mm x 31 mm--and has two tiny color video cameras on each end, with a battery and LED light source supplying power and function. Patients swallow the device and then it transmits as many as 35 frames per second over 10 hours.

Given may have finely gotten PillCam Colon into Japan, but its approval in the U.S.--the world's largest healthcare market, has been more challenging. An FDA submission has remained pending since late November. But Shamir said in May that he expects U.S. approval by the end of this year, made possible, in part, by promising new data generated by several European studies. PillCam Colon already has a CE mark. The company confirmed to FierceMedicalDevices that the U.S. timeline is still in place.

- read the release
- here's Reuters' take

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