FDA Clears Radiation Sensor for Treatment of Prostate CancerJune 21, 2006
Government approves expanded use of Sicel Technologies' wireless, implantable Dose Verification System.
RALEIGH N.C. /BUSINESS WIRE/ -- Sicel Technologies, Inc., announced that the company has received Food and Drug Administration (FDA) clearance to market DVS (Dose Verification System), its wireless, implantable radiation sensor and reader for a second indication. The product's clearance for use in prostate cancer comes two months after the FDA cleared the product for use in breast cancer and follows the completion of a multicenter clinical study evaluating safety and efficacy. Using the handheld reader, physicians were able to determine the actual dose of radiation being delivered to the tumor after each treatment.
DVS is the first permanently implantable, wireless, telemetric radiation sensor for human use to be commercially available in the U.S. "We filed the prostate data with the FDA on April 14th and are delighted to have received clearance to market the product for this additional indication in such a short timeframe" said Michael Riddle, president and CEO of Sicel Technologies, Inc. He added, "The company now has clearance to market DVS for use in an estimated 450,000 breast and prostate cancer patients in the U.S. with the potential for its use in an additional 500,000 European patients." The company is currently building inventory and preparing to officially launch the product at next month's meeting of The American Association of Physicists in Medicine in Orlando.
Today's highly conformal radiation therapy treatment options rely on knowing the exact location of the tumor to be treated. While there are several methods available to facilitate tumor localization, none provide actual dose information. Deviations in dose to the tumor or radiation accidentally administered to normal tissue can have a profound impact on long-term survival rates and quality of life for patients treated with radiation therapy. Using its patented telemetric technology, Sicel's miniature DVS sensor (20 mm by 2 mm) provides healthcare professionals with the unique capability to use the device both for tumor localization and to verify radiation dose actually delivered to the tumor and normal tissue. The company has coined the term SmartMarker to describe DVS' differentiating technology. Almost every cancer center has the equipment required to visualize the DVS sensor without the need to purchase additional capital equipment. After reviewing the product's performance in breast and prostate tissue, there has been strong interest in the clinical community to use DVS for other malignancies, such as lung, liver, and colorectal. The company intends to seek clearance for use of DVS in these areas in the near future.
Sicel Technologies, Inc., is a privately owned company with 29 employees headquartered in Raleigh, N.C. The company was established in 1999 to develop a miniaturized, implantable device using multiple sensors in a closed-loop telemetry system. The company's efforts have been focused on the oncology market segment to develop products that can continuously monitor the changes within tumors of patients undergoing radiation and chemotherapy. The implantable Dose Verification System, or DVS, was developed using technology licensed from North Carolina State University.
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