Wireless Implantable Radiation Sensor To Be Used to Treat CancerApril 13, 2006
Sicel Technologies' Dose Verification System receives FDA clearance based on completion of a multi-center clinical study of breast cancer patients.
RALEIGH, N.C. /BUSINESS WIRE/ -- Sicel Technologies, Inc., announced that the Dose Verification System (DVS), its wireless, implantable radiation sensor and reader, has received 510(k) clearance from the FDA. The clearance was based on successful completion of a multi-center clinical study of breast cancer patients, most of whom were implanted with two DVS sensors prior to receiving radiation therapy. Using the handheld reader, physicians were able to determine the actual dose of radiation being delivered to the tumor after each course of therapy. Implantation of the DVS sensor did not lead to any adverse events in the clinical trial.
Sicel claims that the DVS is the first permanently implantable, wireless, telemetric radiation sensor for human use to be commercially available in the U.S. "We believe DVS represents breakthrough technology that provides significant benefit both to the patient as well as to the oncologist treating the patient," said Michael Riddle, President & CEO of Sicel Technologies, Inc. He added, "The company is in the process of completing manufacturing up fit for the device and anticipates beginning to take orders and ship product in the third quarter."
Dr. Charles Scarantino, principal investigator for the DVS clinical trial, commented, "Implantation of the DVS sensor is straightforward and safe. I believe that over time this important new technology may demonstrate its value by helping physicians not only confirm the exact location of the tumor but also confirm that the prescribed dose of radiation has been accurately delivered." Using proprietary telemetric technology, Sicel's miniature DVS sensor (20 mm by 2 mm) can not only pinpoint the target during a patient's treatment cycle but also measure the amount of radiation received by the tumor. Almost every cancer center has the equipment required to visualize the DVS sensor without purchasing additional capital equipment. Today's highly conformal radiation therapy options rely on knowing the exact location of the tumor. Although there are several methods available to facilitate tumor localization, none provide actual dose information. Deviations in the dose received by the tumor, or accidentally administered to normal tissue, can have a serious impact on long-term survival rates and quality of life for the more than 650,000 patients treated annually with radiation therapy. The company anticipates expanding the indications for DVS to allow its use in the treatment of other cancers. To that end, Sicel has completed a study of patients being treated for prostate cancer and anticipates filing this data with the FDA in the near future. Breast and prostate cancer are the second leading causes of cancer related deaths in the U.S., afflicting over 400,000 people a year.
Sicel Technologies, Inc., is a privately owned company with 28 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 oncology and the development of products that can continuously monitor changes in tumors of patients undergoing radiation and chemotherapy. The implantable DVS was developed using technology licensed from North Carolina State University.
Most Read Articles