• E-mail
• Print
• Comment
• Font Size
• Digg
• del.icio.us
• Discuss article

Sicel Technologies Receives FDA 510(K) Clearance to Expand Use of Its DVS(R) Implantable Radiation Sensor in the Treatment of Prostate Cancer

Posted on: Wednesday, 21 June 2006, 09:00 CDT

Sicel Technologies, Inc., announced today that the Company has received FDA clearance to market DVS(R) (Dose Verification System), its wireless, implantable radiation sensor and reader for a second indication. The product's clearance for use in prostate cancer comes two months after the FDA cleared the product for use in breast cancer and follows the completion of a multi-center clinical study evaluating safety and efficacy. Using the hand-held reader, physicians were able to determine the actual dose of radiation being delivered to the tumor after each treatment.

DVS(R) is the first permanently implantable, wireless, telemetric, radiation sensor for human use to be commercially available in the United States. "We filed the prostate data with the FDA on April 14th and are delighted to have received clearance to market the product for this additional indication in such a short timeframe" said Michael Riddle, President & CEO of Sicel Technologies, Inc. He added, "The Company now has clearance to market DVS for use in an estimated 450,000 breast and prostate cancer patients in the US with the potential for its use in an additional 500,000 European patients." The Company is currently building inventory and preparing to officially launch the product at next month's meeting of The American Association of Physicists in Medicine in Orlando.

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 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. Using its patented telemetric technology, Sicel's miniature DVS(R) sensor (20mm x 2mm) provides healthcare professionals with the unique capability to use the device both for tumor localization and to verify radiation dose actually delivered to the tumor and normal tissue. The Company has coined the term SmartMarker(TM) to describe DVS' differentiating technology. Almost every cancer center has the equipment required to visualize the DVS(R) sensor without the need to purchase additional capital equipment. After reviewing the product's performance in breast and prostate tissue, there has been strong interest in the clinical community to use DVS for other malignancies such as lung, liver and colorectal. The Company intends to seek clearance for use of DVS in these areas in the near future.

Sicel Technologies Inc. is a privately owned company with 29 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.

Source: Business Wire

More News in this Category