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North American Scientific Presents Low Dose Rate Breast Brachytherapy Treatment and Proposed Patient Shielding Solutions to Nuclear Regulatory Commission Advisory Committee

Posted on: Monday, 8 May 2006, 09:10 CDT

Unanimous Advisory Committee Informs Company of No Material Concerns of Radiation Risk to Patient or General Public

North American Scientific, Inc. (Nasdaq:NASI) announced today that the Advisory Committee on the Medical Uses of Isotopes (ACMUI) to the U.S. Nuclear Regulatory Commission reviewed the Company's low dose rate radiation breast brachytherapy treatment and unanimously agreed that it did not have a material concern about radiation exposure provided established patient release criteria are followed by physicians. North American Scientific is completing design of its unique multichannel catheter device that can be easily placed by the physician following a lumpectomy procedure and prior to radiation treatment. The new catheter device is intended to accommodate either high dose rate or low dose rate treatments.

"We felt that it was important to allow the Commission to raise any questions or concerns regarding our low dose rate design and the light shielding that is incorporated into surgical garments which will allow patients to go home during their radiation therapy treatment," said L. Michael Cutrer, President & Chief Executive Officer of North American Scientific. He continued, "While we did not anticipate there being a concern about radiation exposure, the ACMUI's determination confirmed our opinion and represents an important step forward in our breast brachytherapy program and the planned introduction this November." Mr. Cutrer concluded, "The ACMUI determination follows the recent FDA 510k Clearance for the low dose rate design and should provide physicians with greater comfort regarding potential regulatory concerns associated with patient release."

The low dose radiation is delivered through a multichannel catheter device that will be placed through a single incision but will offer the unique ability to better conform to the resection cavity allowing for more conformal dose distributions during treatment. The low dose rate option may be preferred by physicians and patients who wish to minimize the dose to surrounding tissue and critical structures. Today, accelerated partial breast irradiation is delivered either through multiple catheters placed in the breast or through a balloon catheter with a single lumen. While both procedures have paved the way for this more convenient treatment option both have drawbacks. Neither is being used for low dose rate treatment. The North American Scientific device is being designed to offer flexibility, reliability, dose optimization and convenience to both the patient and the physician. The Company continues to expect to file a 510k application with the FDA this summer to market a similar device for the high dose rate procedure.

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. The Company's IGRT products, BAT(R), 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.

About the Advisory Committee on the Medical Uses of Isotopes

The Advisory Committee on the Medical Uses of Isotopes (ACMUI) advises the U.S. Nuclear Regulatory Commission (NRC) on policy and technical issues that arise in the regulation of the medical uses of radioactive material in diagnosis and therapy. The ACMUI membership includes health care professionals from various disciplines who comment on changes to NRC regulations and guidance; evaluate certain non-routine uses of radioactive material; provide technical assistance in licensing, inspection, and enforcement cases; and bring key issues to the attention of the Commission for appropriate action.

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: Business Wire

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