North American Scientific Inc. Receives FDA Clearance to
Market Palladium-103 Brachytherapy Treatment for
Prostate Cancer
Business Wire - July 06, 1998 14:33
NORTH HOLLYWOOD, Calif.--(BUSINESS WIRE)--July 6, 1998--North American Scientific Inc. (Nasdaq:NASI) Monday announced receipt of marketing authorization from the U.S. Food and Drug Administration for its Palladium-103 (Pd-103) brachytherapy source intended for the
treatment of prostate cancer and other malignancies.
NASI is now the only commercial supplier authorized to produce and market both Iodine-125 and Pd-103 brachytherapy seeds. Brachytherapy treatment for early-stage prostate cancer with both types of dionuclides has continued to gain favor in the clinical community. A number of clinical studies, including several presented at the recent American Urological Association meeting, confirmed that brachytherapy,
using modern techniques of seed placement shows significantly lower incidence of side effects such as impotence and incontinence when compared to older techniques of surgical radical prostatectomy. While many urologic surgeons continue to see a role for radical surgery, the low complication rates for brachytherapy combined with comparable clinical results at seven to eight years of followup have led to significant growth in the demand for brachytherapy sources.
L. Michael Cutrer, president and CEO, stated "NASI is now the only supplier authorized by the FDA to produce and distribute both I-125 and Pd-103 brachytherapy sources, giving it a significant marketing advantage. Our distributor of IoGold I-125 brachytherapy sources, Mentor Corporation, is rapidly increasing its sales and marketing efforts to meet the needs of our customers. Our manufacturing capacity for I-125 sources has grown according to stated plans and the company
expects to develop capacity to meet similar levels of demand for Pd-103 sources in 1999. Mentor and NASI believe that the demand for brachytherapy sources is growing strongly and are aggressively working to position themselves as a major provider of brachytherapy sources and supporting products."
Cutrer continued, "While we have noted that many urologic surgeons continue to support radical surgery for some patients, objective evaluation of comparative clinical outcome data since modern
brachytherapy techniques have been available demonstrate comparable outcome for surgery and brachytherapy treatment, with cost and complication rates clearly reduced with brachytherapy compared to surgery."
Cutrer concluded, "As clinical outcome data, such as that presented at the recent AUA meeting, continues to show comparable outcomes for radical prostatectomy and brachytherapy, and as the supply of brachytherapy sources increases, we expect many practitioners who now are undecided to become confident of timely delivery of sources and to recommend brachytherapy more often to their patients. Moreover, recent data by Meigs, et al, in the American Journal of Medicine, have show
that 50% of American men aged 50 to 59, and more than 30% of those aged 60 to 69 years, have never received a PSA test. As the population of Baby Boomers enters that age group and as recommendations for PSA testing are more widely adopted, the need for brachytherapy sources for the treatment of prostate cancer should continue to increase."
Irwin Gruverman, North American Scientific's chairman, added, "With our strong cash position and positive cash flow, NASI intends to continue to diversify aggressively into markets which are at least
as large as prostate brachytherapy, and which are within our mission of applying radionuclide technology to detection, management and treatment of cell-proliferative disease, including cancer and restenosis. To this end, " he said, "we are evaluating several exciting investment and partnering opportunities in these areas and expect to make public additional details in the near future."
Statements included here 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 the risk factors appearing in the company's annual report or Form 10-KSB for the fiscal year ended Oct. 31, 1997, the availability of adequate supplies of Pd-103, whether produced by the company or purchased from third party vendors, or other factors identified from time to time in the company's filings with the Securities and Exchange Commission.
North American Scientific manufactures and markets low-level radioactive sources for therapeutic, environmental, industrial and research applications.
CONTACT: North American Scientific Inc., North Hollywood
Alan Edrick, 818/503-9201
or
Paul Gropman, 818/591-6743
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