Healthcare Industry News:  partial breast irradiation 

Devices Oncology

 News Release - September 28, 2007

North American Scientific Announces First ClearPath(TM)-HDR Clinical Experience

Dr. Rakesh Patel Treats First ClearPath-HDR Patient at the University of Wisconsin

CHATSWORTH, Calif.--(HSMN NewsFeed)--North American Scientific, Inc. (Nasdaq:NASI ) today announced that its ClearPath-HDR device has been used in a patient for the first time.

For use in Accelerated partial breast irradiation (APBI) treatment plans, ClearPath-HDR combines the ease-of-use benefits of balloon brachytherapy products with the customized dose planning benefits of the multi-catheter brachytherapy procedure into one device. This innovative combination also allows doctors to take advantage of a shorter five-day APBI treatment plan, compared with the six to eight weeks required for external beam treatment plans. In addition, ClearPath is implanted through a single incision and is designed to minimize radiation exposure of nearby healthy tissue, two key patient benefits, which distinguish this product from others on the market.

"ClearPath-HDR offers targeted, effective radiation treatment as well as convenience and comfort to the patient," said Dr. Rakesh Patel, University of Wisconsin. "The six to eight weeks required for external beam radiation therapy is highly disruptive to the lives of patients and a five-day APBI treatment plan is an attractive alternative. Historically APBI has relied on the complicated placement of multiple catheters in the breast tissue to deliver the necessary radiotherapy. I believe ClearPath-HDR will deliver the same positive results associated with the treatment flexibility and dose optimization characteristics of the multiple-catheter approach, and significantly reduce the patient discomfort typically associated with this method. I am pleased with the initial outcome of this first case, as I was able, for the first time, to deliver optimized radiation dosing to the targeted area in a minimally invasive procedure."

"This first human clinical experience with ClearPath-HDR is a significant milestone," said John B. Rush, President and Chief Executive Officer of North American Scientific. "We believe our ClearPath technology is favorably distinguished from other products on the market, including balloon brachytherapy, interstitial catheters and external beam radiation due to its important benefits to the patient and physician. ClearPath can make APBI a possibility for more patients that were previously not considered good candidates for treatment with balloon brachytherapy products due to breast size and/or tumor location. With its ease-of-use, functionality and few treatment limiting requirements we believe ClearPath has the potential to encourage the use of APBI, a less invasive, more focused treatment option for many afflicted with breast cancer."

The ClearPath systems are placed in the patient through a single incision and are designed to adapt to the resection cavity, allowing for more conformal therapeutic radiation dose distribution following lumpectomy compared to other methods of APBI. ClearPath is designed to accommodate either high-dose, ClearPath-HDR, or low-dose rate, ClearPath-CR, treatment methods. The Company has received 510k approval from the United States FDA for both ClearPath-HDR and ClearPath-CR. North American Scientific estimates that the ClearPath systems will serve an addressable market of more than $500 million.

About North American Scientific

North American Scientific is a leader in radiation therapy in the fight against cancer. Its innovative products provide physicians with tools for the treatment of various types of cancers. They include ProsperaŽ brachytherapy seeds and SurTRAK(TM) needles and strands used primarily in the treatment of prostate cancer. In addition the Company plans to commercialize its ClearPath(TM) multi-channel catheter breast brachytherapy devices in 2007, which are the only devices approved for both high dose and continuous release, or low dose, radiation treatments. The devices are designed to provide flexible, precise dose conformance and an innovative delivery system that is intended to offer the more advanced form of brachytherapy for the treatment of breast cancer. 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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