Healthcare Industry News: linear accelerator
News Release - July 24, 2006
North American Scientific Receives FDA 510(k) Clearance to Market nomosSTAT(TM)Serial Tomotherapy Advanced Treatment
CHATSWORTH, Calif.--(HSMN NewsFeed)--July 24, 2006--North American Scientific, Inc. (Nasdaq:NASI ) announced today that its NOMOS® Radiation Oncology division has received 510(k) clearance from the United States Food and Drug Administration (FDA) to market nomosSTAT(TM), its new serial tomotherapy automated treatment solution which was introduced at the 47th Annual Meeting of the American Society for Therapeutic Radiology and Oncology (ASTRO) in October 2005.
"FDA clearance of nomosSTAT marks another milestone for the Company as we execute our strategy to develop advanced yet affordable technologies that enhance the radiation therapy community's ability to treat cancer more aggressively," said L. Michael Cutrer, president and CEO of North American Scientific. "This approval further expands our ability to provide leading-edge cancer treatment technologies for individuals battling cancer and address an important market opportunity. We expect to record the first revenue from sales of nomosSTAT in the fourth quarter of our current fiscal year ending October 31, 2006."
nomosSTAT integrates the Company's core serial tomotherapy delivery products, nomosSTAT MLC and AutoCrane(TM), with a single user interface. This new interface, with network connection to the CORVUS® IMRT inverse planning system, streamlines the delivery process, improving efficiency and increasing patient throughput. As the only after-market, add-on serial tomotherapy delivery package offered as an upgrade to an existing linear accelerator, it provides an affordable, turnkey solution for facilities wanting to implement IMRT as part of their cancer treatment arsenal without the need to purchase a costly, IMRT-enabled linear accelerator.
nomosSTAT's serial tomotherapy delivery shapes and modulates the radiation beam while the gantry is rotating, providing up to 40 individual intensity-modulated beams per every 5 degrees of rotation. These beams can be fired from virtually any radial angle around the patient and can vary in intensity in 10% steps. Compared to step-and-shoot techniques that deliver multiple overlapping segments to modulate beam intensity at a limited number of angle positions, tomotherapy provides more degrees of freedom to deposit dose to the target while avoiding critical structures.
About North American Scientific
North American Scientific is a leader in radiation therapy products and services in the fight against cancer. Its innovative products provide physicians with tools for the treatment of various types of cancers. They include radioisotope-based brachytherapy seeds, needles and strands used primarily in the treatment of prostate cancer and marketed under the trade names Prospera®, and SurTRAK(TM), external beam radiation therapy products for Serial Tomotherapy Intensity Modulated Radiation Therapy (IMRT) and Image-Guided Radiation Therapy (IGRT). Serial tomotherapy IMRT allows an escalated radiation dose to be delivered to a tumor while limiting exposure and damage to nearby healthy tissue. These products are marketed under the trade names nomosSTAT(TM)and CORVUS® (our proprietary treatment planning software). The Company's IGRT products, BAT®, BATCAM(TM) and nTRAK(TM), provide fast and accurate targeting and localization of a treatment volume on a daily basis. More than 500 hospitals and research sites worldwide are equipped with the Company's clinically proven serial tomotherapy, inverse treatment planning, image-guidance and ancillary treatment solutions. Please visit www.nasmedical.com for more information.
Statements included in this release that are not historical facts may be considered forward-looking statements that are subject to a variety of risks and uncertainties. There are a number of important factors that could cause actual results to differ materially from those expressed in any forward-looking statements made by the Company including, but not limited to, the impact of competitive products and pricing, technological changes, changes in relationships with strategic partners and dependence upon strategic partners for the performance of critical activities under collaborative agreements, the ability of the Company to successfully directly market and sell its products, uncertainties relating to patent protection and regulatory approval, the stable supply of appropriate isotopes, research and development estimates, market opportunities, risks associated with strategic opportunities or acquisitions the Company may pursue and the risk factors included in the Company's filings with the Securities and Exchange Commission. Any forward-looking statements contained in this news release speak only as of the date of this release, and the Company undertakes no obligation to revise or update any forward-looking statements, whether as a result of new information, future results or otherwise.
Source: North American Scientific
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