Healthcare Industry News: partial breast irradiation
News Release - November 8, 2006
North American Scientific Introduces ClearPath(TM) at ASTRONew Breast Brachytherapy Device Well Received at Seminar Attended by over 100 Physicians and Clinical Specialists
CHATSWORTH, Calif.--(HSMN NewsFeed)--North American Scientific, Inc. (Nasdaq:NASI ) announced today that it introduced ClearPath, its unique multicatheter breast brachytherapy device, at the American Society for Therapeutic Radiology and Oncology (ASTRO) Annual Meeting in Philadelphia.
ClearPath which is placed through a single incision, is designed to conform to the resection cavity following lumpectomy, allowing for more conformal radiation dose distribution during treatment, and to accommodate either high-dose or low-dose rate treatments. The Company received 510k approval from the United States Food and Drug Administration (FDA) for a low-dose rate, or continuous release treatment utilizing the Company's Prospera® brachytherapy seeds in April 2006. A 510k application to market the high-dose rate version of ClearPath(TM) is pending.
"ClearPath(TM)'s ability to conform radiation delivery offers physicians and patients greater flexibility in treatment options," said L. Michael Cutrer, president and chief executive officer of North American Scientific. "Accelerated partial breast irradiation (APBI) following breast-conserving surgery has shown good results when compared to a six to eight week course of whole breast irradiation. In a period of only four or five days, ClearPath(TM) is intended to provide multiple catheters for easy dose optimization and is designed to allow for reduced radiation to the skin and other critical structures when compared to other treatment modalities. ClearPath(TM) will also be the first multicatheter brachytherapy device designed to provide for both high dose and continuous release treatments. It will provide physicians and patients with options that minimize the radiation exposure to surrounding tissue and reduce the number of visits the patient must make over the week long treatment."
Mr. Cutrer added, "ClearPath(TM) offers a short, convenient treatment regimen. Both continuous release and high-dose treatment options can be delivered over four to five days, compared with a six to eight week whole breast irradiation treatment. The high dose rate treatment will be delivered in twice daily sessions. The continuous release treatment uses SurTRAK strand technology implanted in the device. The continuous release option allows the patient to go home and return five days later, thus avoiding twice-a-day treatments. These patients can go home with a specially designed bra that is fully shielded, light and comfortable. Additionally, ClearPath has broad patient criteria, with few limiting requirements for skin thickness, chest wall position and breast size."
In addition to demonstrating ClearPath's(TM) features to numerous attendees at ASTRO, the Company also hosted a seminar which was attended by over one hundred physicians and clinical specialists. Dr. Rakesh Patel from the Department of Human Oncology at the University of Wisconsin, and Dr. David Schreiber, Director of Littleton Radiation Oncology Cancer Center in Littleton, Colorado each presented on the design benefits of ClearPath versus the other two brachytherapy methodologies for the treatment of breast cancer.
"We were very excited to introduce ClearPath(TM) and believe the strong attendance at our introductory seminar at ASTRO is indicative of the interest in our device and its treatment capabilities," continued Mr. Cutrer. "With our impending entry into the breast brachytherapy market, we have positioned ourselves to enter a market estimated at approximately $500 million. ClearPath(TM) represents our continued focus on expanding our portfolio of cancer therapies and strengthen our position as a leading innovator in the continuum of cancer care."
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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