Sicel Receives FDA Clearance for DVS-HFT

MORRISVILLE, NC /BUSINESS WIRE/ -- Sicel Technologies Inc. announced it has received clearance from the U.S. Food and Drug Administration to begin marketing DVS-HFT, the next-generation of the company's original Dose Verification System (DVS) wireless implantable dosimeter, which remains the "only device to measure actual radiation dose at the tumor site for use in treating breast and prostate cancer patients undergoing external beam radiation therapy."

The medical device expands Sicel Technologies' portfolio because the DVS-HFT dosimeter is specifically calibrated for use with radiation therapy protocols that give patients higher single doses of radiation over a shorter period of time, compared with conventional radiation therapy. Also known as hypo-fractionated therapy, treatment with higher radiation doses over fewer treatments has been highly effective in treating some tumors and is becoming more popular. However, it is critical that physicians confirm that the actual intended dose reaches the target tumor to maximize the therapeutic benefit, as well as to avoid damaging healthy tissue.

"The DVS-HFT is an important advance in hypo-fractionated therapy because physicians can now confidently determine the prescribed dose has been accurately delivered throughout the course of treatment, which is a key determinant in the long-term successful treatment of a tumor," said Arnold Malcolm, MD, Associate Professor Vanderbilt Center for Radiation Oncology. "This device may actually accelerate the use of hypo-fractionated protocols, like those being adopted for treatment of prostate cancer, which may offer benefits across the healthcare spectrum."

Recent changes by the Centers for Medicaid & Medicare Services in the 2009 Hospital Outpatient reimbursement policy for Medicare patients will make DVS accessible to more patients undergoing radiation therapy treatment in hospital outpatient facilities. The change, effective January 1, significantly increases reimbursement to facilities implanting the sensors.

"We are very pleased that CMS has acknowledged the importance of breakthrough technologies such as DVS in cancer treatment, and we continue to work with professional organizations such as ASTRO, AAPM, and the AUA to ensure that all patients have access to innovative treatment options," said Michael Riddle, President and CEO, Sicel Technologies, Inc.

For more information about DVS-HFT or Sicel Technologies Inc., please call 1-888-DVS-6697 or visit the company's Web site.

About Sicel
Founded in 1999 and headquartered in Morrisville, NC, Sicel Technologies Inc. is a privately held specialty-device company, focused on the development of revolutionary therapies that significantly impact the treatment of cancer, a leading cause of death in the U.S., second only to heart disease.

Sicel developed the Dose Verification System, the "first U.S. Food and Drug Administration approved wireless implantable sensors designed to assist clinicians in determining the actual dose of radiation being delivered to the tumor." The company also makes and markets OneDose, patient dosimetry verification systems designed for radiation oncology therapy.

In 2008, Sicel was named "Company of The Year" in the Life Science, Biotech, Medtech category by the North Carolina Technology Association.

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