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IsoRay Medical, Inc. To Expand Production of Cesium-131 Isotope for Prostate Cancer Treatment Through Leased New Facility

Posted on: Thursday, 17 February 2005, 09:00 CST

Interim Facility Sets Stage for Multi-State Review of Permanent Sites

IsoRay Medical, Inc., a developer, manufacturer and marketer of medical isotopes, has signed an agreement establishing interim production facilities through Pacific EcoSolutions, Inc. in Richland, Washington.

The leased facility will allow IsoRay Medical to expand production capabilities, eventually manufacturing seeds on enhanced production lines for up to 600 patient procedures per month.

In 2004, Richland-based IsoRay Medical Inc. launched production and commercialization of Cesium-131 brachytherapy seeds for the treatment of prostate cancer. The breakthrough was the first significant advancement in prostate cancer treatment technology in more than 18 years.

"The establishment of this interim facility gives us additional time and flexibility as we conduct a multi-state due diligence review of permanent production site options," said IsoRay Medical CEO and Chairman Roger Girard. IsoRay will be making a decision on the permanent facility location later this year.

"It appears at this time that Idaho and Washington are the frontrunners for our new facility," said Girard.

Girard expressed appreciation for efforts by Bob Ferguson, Chairman and CEO of Nuvotec, Inc., and Dave Dalton, President and COO of Pacific EcoSolutions, Inc., in meeting IsoRay's terms and technical needs.

Production of Cesium-131 seeds by IsoRay staff at Pacific EcoSolutions is expected to begin in late second quarter of 2005. Depending on meeting demand, production will be gradually phased out at facilities contracted through the Pacific Northwest National Laboratory (PNNL) and the Department of Energy in Richland, where the seeds are currently manufactured.

IsoRay Medical currently employs nineteen personnel nationwide, and Girard said the company projects hiring 3-10 people per month as production ramps up at the intermediate facility.

"IsoRay Medical will lease the facilities on a short-term basis from Pacific EcoSolutions, which offers the combination of technical facilities along with the required licenses and permits," said Girard.

The treatment of prostate cancer is an obvious first application for IsoRay Medical's Cesium-131 technology. Seed implant therapy is a proven and common treatment for this form of cancer, with 50,000 to 60,000 procedures conducted each year.

Seed implant therapy has a proven high cure rate in prostate cancer patients. It is particularly effective as a brachytherapy treatment option in early stages, and in tandem with external beam therapy in more advanced tumors. The short half-life and high-energy characteristics of Cesium-131 provide significant clinical advantages over current isotopes commonly used in cancer treatment today. IsoRay Medical expects its Cesium-131 brachytherapy seed to become a leading worldwide treatment therapy for prostate cancer and other malignancies.

IsoRay Medical is investigating new isotope delivery systems that could be used in addition to the titanium capsule of its current seed. IsoRay Medical yesterday signed a contract with PNNL to increase the purity of yttrium-90, which already has FDA approval to market for cancer treatment.

The market introduction of the Cesium-131 seed is the culmination of two generations of vision and work and millions of dollars in investment. IsoRay was founded in Richland, Washington, in 1998 to develop, manufacture and commercialize isotopes for use in the medical treatment of various malignant diseases. In March 2003, IsoRay Medical received FDA approval to market its Cesium-131 seed for the treatment of prostate, breast, brain, liver, head and neck cancers, and other malignant diseases. Research and development is currently underway at IsoRay in these areas.

Medicare and Medicaid have established a specific reimbursement code for Cesium-131, and most insurance companies also cover low-dose (LDR) seed brachytherapy.

"As we continue the introduction of Cesium-131 and other isotopes to the medical community, we expect new applications and treatment combinations to unfold for our products -- benefiting cancer patients worldwide," said Girard.

For more information, please visit www.isoray.com.

Safe Harbor Statement

Statements in this news release about IsoRay Medical, Inc.'s future expectations, including the advantages of our Cesium-131 seed and all other statements in this release, other than historical facts, are forward-looking statements. It is important to note that actual results and ultimate corporate actions could differ materially from those in such forward-looking statements based on such factors as physician acceptance and use of our products, our ability to successfully manufacture, market and sell our products, our ability to manufacture our products in sufficient quantities to meet demand within required delivery time periods while meeting our quality control standards, and our ability to enforce our intellectual property rights, among other factors.

Source: Business Wire

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