Healthcare Industry News:  brachytherapy 

Devices Oncology

 News Release - November 8, 2007

North American Scientific Showcases ClearPath-HDR(R) at ASTRO

Highlighted Study Concludes ClearPath-HDR Achieves Superior Dose Conformity

CHATSWORTH, Calif.--(HSMN NewsFeed)--North American Scientific, Inc. (Nasdaq:NASI ) announced today that its ClearPath-HDR device was highlighted at a Company-hosted seminar during the 49th Annual Meeting of the American Society for Therapeutic Radiology and Oncology (ASTRO). The Company also announced that a study presented by Adam Dickler, M.D., Rush University Medical Center (Chicago) concluded that ClearPath-HDR delivers less radiation to healthy tissue than balloon brachytherapy.

Seminar Highlights

On October 28, 2007, Dr. Rakesh Patel, University of Wisconsin, and Dr. Peter Beitsch, Dallas Surgical Group, presented the results of the first human ClearPath HDR cases at a well-attended information session hosted by North American Scientific. Dr. Patel’s presentation, entitled “50 Ways to Irradiate the Breast,” offered a review of the various APBI devices available. He noted that he preferred ClearPath due to its flexibility and ability to provide optimal dosing. Dr. Beitsch’s presentation demonstrated the ease of placing ClearPath in the breast. He noted it is important for the breast surgeon and radiation oncologist to work closely together to ensure successful APBI procedures.

Study Highlights:

ClearPath-HDR Delivers Less Radiation to Healthy Tissue vs. Balloon brachytherapy

Dr. Dickler presented a comparison of ClearPath-HDR with balloon brachytherapy entitled “A Dosimetric Comparison of MammoSite™ and ClearPath HDR Breast brachytherapy Devices.” The abstract for the study was published in a November 2007 supplement of the International Journal of Radiation Oncology. The study concluded that while both methods offer comparable target volume coverage during the accelerated partial breast irradiation treatment process (APBI), ClearPath-HDR delivers less radiation to normal tissue.

“Drs. Patel and Beitsch discussed the clinical benefits that ClearPath-HDR offers to patients and physicians,” said John B. Rush, president and CEO of North American Scientific. “Our ClearPath-HDR has the ability to limit the radiation exposure to healthy tissue, which is a significant advantage over existing treatments. We believe that this will make APBI an option for patients that were previously not considered good candidates for treatment with balloon brachytherapy products due to concerns about radiation exposure to vital structures. The study presented by Dr. Dickler further supports these findings. We were very pleased with the positive feedback that we received from physicians that attended the conference, and based upon these insights and others, we have expanded our controlled rollout of ClearPath-HDR to a total of five clinical sites. We look forward to a full commercial launch in 2008.”

About ClearPath

ClearPath-HDR, which is designed for use in Accelerated Partial Breast Irradiation (APBI) treatment plans, 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. Treatments can be delivered over a 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.

The ClearPath systems 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 Prospera® brachytherapy seeds and SurTRAK™ needles and strands used primarily in the treatment of prostate cancer. In addition the Company plans to commercialize its ClearPath™ 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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