Healthcare Industry News: image-guided
News Release - February 21, 2006
North American Scientific Receives Chinese State Food and Drug Administration Approval of BAT(R) SXiBAT(R) SXi image-guided Radiation Therapy Equipment Approved for Sale in China
CHATSWORTH, Calif.--(HSMN NewsFeed)--Feb. 21, 2006--North American Scientific, Inc. (Nasdaq:NASI ) today announced that its NOMOS® Radiation Oncology Division (NOMOS) has received regulatory approval from the People's Republic of China State Food and Drug Administration (SFDA) to sell its BAT SXi, an ultrasound-based localization system used to view cancerous tumors prior to the delivery of radiation therapy. The image-guided radiation therapy (IGRT) system is designed to be compatible with all linear accelerators and most treatment planning systems. The SFDA approval clears the way for North American Scientific to immediately begin selling BAT SXi in China.
"We have continued to make progress on our strategy to bring our full range of products to China and the SFDA's approval of BAT SXi is an important indicator of our success," said L. Michael Cutrer, President and Chief Executive Officer of North American Scientific, Inc. "Our BAT SXi system provides proven ultrasound technology to view and target tumors prior to radiation therapy treatments making it an affordable and highly effective tool to deliver comprehensive patient care.
"We received approval for our PEACOCK® intensity-modulated radiation therapy (IMRT) product in September 2005 and announced our first significant sale in January 2006," continued Mr. Cutrer. "We believe that our products and services can meet the existing and unmet needs of healthcare providers focusing on cancer treatment. We also believe that China provides a substantial opportunity for us to expand our international presence. These approvals are two important milestones for our expansion strategy and we remain hopeful that we will have our full range of products available in China during fiscal 2006."
North American Scientific is also in the process of registering in China its Prospera® I-125 brachytherapy seeds for the treatment of prostate cancer.
NOMOS's launch of BAT in 1998 introduced physicians and clinicians in radiation therapy departments and clinics throughout the world to a revolutionary ancillary treatment device. BAT (B-mode Acquisition and Targeting) is an image-guided radiation therapy (IGRT) targeting system that provides fast ultrasound localization of a treatment target on a daily basis. BAT combines ultrasound and a 3D tracking system with a touchscreen-based treatment room interface to non-invasively pinpoint tumor targets rapidly and accurately at the time of a radiation therapy treatment. It dramatically reduces the need for large target margins which have traditionally been used to compensate for errors in localization.
BAT is compatible with all treatment planning systems, from conventional 3D to precision IMRT, and is currently used in conjunction with IMRT and conventional therapies to treat prostate, breast, pancreas and liver cancers.
Today, BAT is in its fourth generation of hardware - BAT Classic, BAT SXi with articulated arm, BAT SXi with optical camera, and today's BATCAM(TM) - and five generations of software that include breakthrough ImageSync(TM).
PEACOCK is the principal IMRT product of the Company's NOMOS division, consisting of the Company's proprietary CORVUS® treatment planning software and its MIMiC® multi-leaf collimator.
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 a set of tools for the treatment of various types of cancers. They include radioisotope-based brachytherapy seeds, used primarily in the treatment of prostate cancer, marketed under the trade name Prospera®; Intensity Modulated Radiation Therapy (IMRT); and Image Guided Radiation Therapy (IGRT). IMRT allows an escalated radiation dose to be delivered to a tumor while limiting exposure and damage to nearby healthy tissue. The Company's principal IMRT products are marketed under the trade names PEACOCK® and CORVUS. 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. Over 500 hospitals and research sites worldwide are equipped with the Company's clinically proven PEACOCK, CORVUS (our proprietary treatment planning software), BAT, BATCAM, 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, the impact of competitive products and pricing, 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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