Targeting Prostate Cancer: Morrisville Firm Wins FDA Approval for Implantable Radiation Sensor
Posted June 21, 2006
MORRISVILLE, N.C. — Physicians treating men with prostate cancer have a new tool to use in locating and then measuring the actual dose of radiation delivered to the tumor after each treatment.
The Food and Drug Administration has approved the use of implantable radiation sensors and accompanying wireless readers for use with prostate cancer victims,
Sicel won FDA approval two months ago for use of its Dose Verification System (DVS) in measuring radiation administered to breast cancer patients.
More than 230,000 men will be diagnosed with prostate cancer and more than 30,000 will die of the disease in the United States this year, according to the Prostate Cancer Foundation.
Of the men receiving prostate cancer treatment, 33 percent of them will have external beam radiation, according to the National Prostate Cancer Coalition's annual men's health survey.
The DVS is much smaller than a dime.
Sicel augments the DVS system with patented technology called SmartMarker to enable physicians to also determine the precise location of the tumor.
The Morrisville-based firm, which developed the DVS based on technology developed at North Carolina State University, also wants to use the system for patients undergoing lung, liver and colorectal cancer treatment.
FDA approval for use with prostate cancer treatment was granted after a clinical study to determine the safety and efficacy of the DVS system.
"We filed the prostate data with the FDA on April 14 and are delighted to have received clearance to market the product for this additional indication in such a short timeframe," said Michael Riddle, chief executive officer of Sicel Technologies. "The Company now has clearance to market DVS for use in an estimated 450,000 breast and prostate cancer patients in the US with the potential for its use in an additional 500,000 European patients."
Sicel describes DVS as the "first permanently implantable, wireless, telemetric, radiation sensor for human use" in the United States.