Sicel Technologies, Inc., Participates in Landmark FDA Public Meeting Addressing Quality Assurance and Device Improvements for Radiation Therapy Treatment Systems

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The only way to know the radiation dose delivered during treatment is to measure the dose received at the tumor site. In Vivo and In Situ dosimetry allows physicians to verify the dose delivered to cancer patients during radiation therapy.

Sicel Technologies, Inc., maker of the Dose Verification System (DVS), the world’s first and only wireless implantable dosimeter cleared for breast and prostate cancer treatment, today announced that two company experts will deliver presentations during an unprecedented public forum hosted by the U.S. Food & Drug Administration (FDA) and the Department of Health and Human Services. The meeting will address issues of patient safety and device improvement during therapeutic radiation therapy—specifically, to reduce the number of under-doses, over-doses, and misaligned exposures.

Sicel Technologies, Inc., oral presentations will include:

  •     The Only Way to Know Dose is To Measure It

Suzanne Schwaller, Regulatory Affairs, Sicel Technologies, Inc.

  •     Quality Assurance of the Radiation Therapy Process…The Missing Link

Jan Pursley, Medical Physicist, Sicel Technologies, Inc.

It is well established that deviations in dose delivered 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. However, radiation therapy for the treatment of cancer patients is the only industry using radiation that does not have a system of exposure validation.

“We are grateful to the FDA for allowing us a forum to present our technology. There simply is no way around the fact that you cannot correct what you do not measure,” said Dr. Charles Scarantino, Medical Director and co-founder of Sicel Technologies. “The DVS smart marker was designed to provide added levels of assurance and accuracy to radiation technicians. We firmly believe that DVS technology is the missing link relative to current treatment practices and safeguards meant to help protect patients during radiation therapy.”

For more information, please visit http://www.dvssmartmarker.com or contact Pamela Burr, Marketing Manager, Sicel Technologies at 919.465.2236 ext 252.

About the Dose Verification System
Sicel Technologies, Inc.’s, in vivo and in situ Dose Verification System® is first and only wireless, implantable dosimeter cleared by the U.S. FDA for the treatment of breast and prostate cancer that measures the amount of radiation that is delivered to the tumor tissue, tumor bed (where the tumor was) and/or healthy tissue. Wireless technology transmits the information to a hand-held monitor and radiation absorption rates are read during daily treatments, enabling healthcare professionals to verify that the patient is receiving the exact prescribed dose.

Traditional radiation therapies rely on knowing the exact location of the tumor, but provide no guidance on quantifying the actual radiation dose being delivered to the tumor. DVS offers the unique capability to use the device both for tumor localization and to verify the actual radiation dose delivered to the tumor and normal tissue for an unprecedented level of precision and added reassurance.

About Sicel Technologies, Inc.
Founded in 1999, and headquartered in Morrisville, North Carolina, 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 Technologies, Inc., developed the Dose Verification System®, the first U.S. Food & Drug Administration-cleared 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 specifically designed for radiation oncology therapy.

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Pamela Burr
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