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Sicel Technologies Receives 510(K) Clearance for DVS(R), the First Implantable Radiation Sensor For Use in Treating Cancer

Posted on: Wednesday, 12 April 2006, 09:01 CDT

Sicel Technologies, Inc., announced today that DVS(R) (Dose Verification System), its wireless, implantable radiation sensor and reader has received 510(k) clearance from the U.S. FDA. FDA clearance was based upon successful completion of a multi-center clinical study of breast cancer patients most of who were implanted with two DVS(R) sensors prior to receiving radiation therapy. Using the hand held 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(R) sensor did not lead to any adverse events in the clinical trial.

DVS(R) is the first permanently implantable, wireless, telemetric, radiation sensor for human use to be commercially available in the United States. "We believe DVS(R) 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(R) clinical trial, commented, "Implantation of the DVS(R) 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(R) sensor (20mm x 2mm) provides the unique capability not only to pinpoint the target during a patient's treatment cycle but also to measure the amount of radiation received by the tumor. Almost every cancer center has the equipment required to visualize the DVS(R) sensor without the need to purchase additional capital equipment. 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 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 four hundred thousand people a year.

Sicel Technologies Inc. is a privately owned company with 28 employees headquartered in Raleigh, North Carolina. The Company was established in 1999 to develop a miniaturized, implantable device utilizing multiple sensors in a closed loop telemetry system. The Company's efforts have been focused in the oncology market segment to develop products that can continuously monitor the changes within tumors of patients undergoing radiation and chemo-therapy. The implantable Dose Verification System or DVS(R) was developed utilizing technology, licensed from North Carolina State University.

Forward-Looking Statements

Statements contained in this release, which are not historical facts, may be considered "forward-looking statements" under the Private Securities Litigation Reform Act of 1995. Forward-looking statements are based on current expectations and the current economic environment.

We caution the reader that such forward-looking statements are not guarantees of future performance. Unknown risk, uncertainties as well as other uncontrollable or unknown factors could cause actual results to materially differ from the results, performance or expectations expressed or implied by such forward-looking statements.

NOTE TO EDITORS: In the product name above denoted as DVS(R), the "(R)" is typically represented as an exponent. Exponents may not appear properly in some systems.

Source: Business Wire

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