| Raleigh NC (April
12, 2006) Sicel Technologies, Inc., announced that DVS®
(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 multicenter clinical study
of breast cancer patients most of who were implanted with two DVS®
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® sensor did not lead to any adverse events in the clinical
trial.
DVS® is
the first permanently implantable, wireless, telemetric, radiation
sensor for human use to be commercially available in the United
States. 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.
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