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North American Scientific Receives FDA 510(K) Clearance to Market New nTRAK(TM) Patient Positioning System for Radiation Therapy

Posted on: Thursday, 7 July 2005, 15:01 CDT

North American Scientific, Inc. (Nasdaq:NASI) announced today that its NOMOS(R) Radiation Oncology division has received 510(k) clearance from the United States Food and Drug Administration (FDA) to market nTRAK, its new stereotactic image guidance system used to position and monitor patients during radiation therapy treatments for head and neck cancers. The new nTRAK system utilizes an optical camera and fiducial markers attached to a customized bite block to provide assurance that a patient is positioned reproducibly within required tolerances throughout a course of radiation therapy treatments. The Company expects sales of nTRAK to begin in the fourth quarter of fiscal 2005.

The new nTRAK system consists of a newly designed mouth bite and trackers, a new Radiotherapy Table Adapter (RTA), ceiling-mounted optical camera and treatment room console. nTRAK monitors, detects out-of-tolerance parameters, and allows for the review and modification of radiation therapy treatments. The patient is positioned using reflective trackers attached to a customized mouth bite apparatus which is tracked by the optical camera system. Once set-up is complete, the system is able to identify the tracker in 'real time' by using a high resolution optical camera and reference its position to the treatment machine's isocenter. Positioning information is displayed in real time, is reflected in six degrees of freedom, and corrected with the RTA that accommodates for tilt and rotation. During treatment, visual and audible patient motion detection alerts the clinician to any change in position. nTRAK also incorporates a study review feature that allows the physician to review the treatment session to determine if modifications to the treatment fields or immobilization system are warranted.

L. Michael Cutrer, President and Chief Executive Officer of North American Scientific, said, "The approval of nTRAK furthers our commitment to developing advanced technologies that enhance the clinical community's ability to treat cancer more aggressively. With the introduction of image-guided radiation therapy (IGRT) and the subsequent release of BAT(R) Classic, BAT SXi and now BATCAM(TM), we continue to innovate new technologies that are transforming the treatment of cancer. With nTRAK, we continue our product development strategy to provide targeted, accurate and effective treatment for patients fighting cancer."

The nVISION(TM) Series of IGRT products introduces a set of patient positioning tools to increase treatment accuracy and user confidence in the delivery of today's requisite serial tomotherapy and IMRT treatment protocols. First in this series was BATCAM, the latest release of the Company's BAT (B-mode acquisition and targeting) technology. BATCAM provides fast, ultrasound localization of a treatment target prior to treatment. It utilizes an optical camera in conjunction with a multi-directional ultrasound probe to image soft tissue structures and their interface with other internal structures and serves as the launch for future multi-probe capability. nTRAK expands the Series to include a head and neck positioning tool to provide more accurate patient positioning for radiation therapy treatments.

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(R); 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(R) and CORVUS(R). The Company's IGRT product, BAT, provides 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 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, uncertainties relating to drug discovery and clinical development processes, the impact of competitive products and 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 brachytherapy 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: Business Wire

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