Healthcare Industry News:  breast brachytherapy 

Devices Oncology FDA

 News Release - November 14, 2006

North American Scientific Announces FDA Clearance of its ClearPath(TM) HDR Breast Brachytherapy System

CHATSWORTH, Calif.--(HSMN NewsFeed)--North American Scientific, Inc. (Nasdaq:NASI ), a leading manufacturer of brachytherapy sources, announced today that the Company has received 510(k) clearance from the United States Food and Drug Administration (FDA) to market the high-dose rate radiation treatment design of ClearPath(TM), its breast brachytherapy product introduced this month at the 48th Annual Meeting of the American Society of Therapeutic Radiology and Oncology (ASTRO). The Company received 510(k) clearance from the FDA to market the low-dose rate system, ClearPath(TM) CR, in April, 2006. The product is designed to enhance current accelerated partial breast irradiation (APBI) treatment options, an estimated $500 million U.S. market.

"This approval marks a significant milestone in the Company's breast brachytherapy program, announced earlier this year," said L. Michael Cutrer, President & Chief Executive Officer of North American Scientific. "We believe that ClearPath's(TM) unique design will offer a new treatment alternative to women electing APBI as part of their Breast Conserving Therapy (BCT). The Company's unique multi-channel catheter system, which is inserted through a single incision, is designed to allow for either low-dose therapy, using the Company's existing Prospera® I-125 seeds, or high-dose rate treatments. Both of the ClearPath(TM) systems are designed to offer physicians greater flexibility in treatment planning and dose optimization to the target region while minimizing exposure to nearby healthy tissue."

"The ClearPath(TM) design really offers the best of both worlds when it comes to APBI treatment," said Dr. Rakesh Patel, Professor of Radiation Oncology at the University of Wisconsin, who presented on the ClearPath(TM) device at ASTRO earlier this month along with Dr. David Schreiber of Littleton Radiation Oncology Center. "We have enjoyed collaborating with the team at North American Scientific and I look forward to treating patients with ClearPath(TM) since it offers an attractive alternative for physicians and patients seeking flexibility in breast cancer treatment."

Brachytherapy, or internal radiation therapy, makes use of radioactive sources or seeds and has emerged as one of the most common treatments of prostate cancer. More recently, brachytherapy has been applied to the treatment of breast cancer through APBI, with two approaches showing good local disease control. The first approach involves the placement of 15-20 needle/catheters through the breast followed by high-dose rate therapy. The second approach utilizes a single catheter device within a balloon followed by high-dose rate therapy. The ClearPath(TM) systems are designed to overcome some of the shortcomings of the two methods such as dose optimization and ease of use.

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 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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