A Medical Device Daily

IsoRay (Richland, Washington), a manufacturer of brachytherapy seeds for the treatment of prostate cancer and other solid tumors, has become a 30% owner in a new Russian isotope company, UralDial (Yekaterinburg, Russia).

Roger Girard, CEO and chairman of IsoRay, said the creation of the new medical isotope company should “significantly reduce” manufacturing costs in the U.S. as well as Russia, which should improve his company’s gross margins, assure a steady exclusive supply of isotopes from multiple Russian sources, and open new international markets for its Proxcelan Cesium-131 brachytherapy seeds.

Girard said, “This is an important and exciting time as we continue to hit strategic milestones at IsoRay, and I believe that this opportunity, along with other initiatives that are currently under way, will allow IsoRay to become a much larger player in the cancer therapy field, both domestically and internationally. This is truly a pivotal turning point for the company.”

Under the terms of the UralDial charter, IsoRay will own a 30% share in the new company through its IsoRay International subsidiary.

Unona Holdings, a private holding company set up to drive medical initiatives in concert with the Russian government, will have a 40% ownership, and 30% ownership will be held by Russian engineers and scientists involved in the new operations.

IsoRay said all capital investments for the new manufacturing plant and the development of centers of excellence is expected to be provided by Unona Holdings, using funds from the British Petroleum/RENO Joint Venture and the Russian Central Railroad in support of the Russian government’s new men’s health initiatives.

Girard said, “We have been laying the groundwork for the formation of this new operation for the past three years. It supports our strategy in a number of ways, including using enriched barium, lowering manufacturing costs and increasing through-put efficiency. It essentially marks the opening of entirely new markets for seed brachytherapy. The Russian government understands the benefits of brachytherapy using Cesium-131 as an effective treatment option for prostate cancer, and understands the great potential of this new venture.”

Cesium-131 is the newest isotope used in brachytherapy seed treatment for prostate cancer, and is considered the first breakthrough in more than 20 years, according to IsoRay. “It is a powerful, aggressive new medical isotope offering patients faster dose delivery, better quality of life and improved tumor penetration,” the company said.

Alexander Petrov, president of Unona, said, “The new Russian manufacturing facility — which will be similar to IsoRay’s recently opened new facility in Richland — is expected to take nine months to complete. Its planned design will have all the support functions of the Richland plant, including assay and pre-loading departments.”

Initial seed manufacturing capacity at the Russian facility is expected to support treating up to 2,500 patients per month with Cesium-131 (Cs-131) brachytherapy seeds and an additional 2,500 with Iodine-125 (I-125) seeds. Other medical isotopes may be manufactured at the plant in the future.

Petrov said, “Until the new plant is completed we expect that patients will be treated with shipments from IsoRay’s Richland facility as soon as all of the required certifications are met to import Cesium-131 seeds.”

Igor Lenontiev, MD, PhD, the Russian deputy minister of health and one of Russia’s leading urologists, said, “Initially patients will be treated from Yekaterinburg and the surrounding Sverdlovskaya region through centers of excellence developed by UralDial and the Russian Health Ministry. We plan to expand from Yekaterinburg to market to all of Russia, along with its neighboring countries.”

Lenontiev added: “It is estimated that 2 million to 5 million men in Russia may have prostate cancer currently, according to the government’s report of recent autopsies. Up to this point there has been no regular testing or screening for prostate cancer, but now as part of our new men’s health initiative all men over 50 years old must be screened to receive government health benefits.”

Two more Merci Retrievers approved

Concentric Medical (Mountain View, California) reported receiving European regulatory clearance for its Merci L4 and Merci L6 Retrievers. These new Retrievers, released in the U.S. last year, join the existing Merci Retrievers already on the market in Europe, providing physicians with additional choices in their efforts to restore blood flow in ischemic stroke patients, the company said.

The Merci Retriever, a shaped wire constructed of nitinol that allows delivery of the Retriever in linear form, using standard catheterization techniques, is designed to restore blood flow by engaging, capturing and removing blood clots.

A small puncture in the groin is used to introduce the Merci Retriever into an artery leading to the brain. Upon reaching the targeted area, the Merci Retriever is deployed and returns to its original helical shape.

The Merci L4 and L6 join Concentric’s L family of Retriever products, which incorporate filaments into the retrieval helix. The company said these filaments “provide an additional mechanism for securing blood clots during retrieval from the brain.”

The Merci L6 Retriever has a 2.7 mm cylindrical helix and is designed for use in larger vessels than the Merci Retrievers currently on the European market. The Merci L4 Retriever has a 2.0 mm cylindrical helix and is designed for use in smaller vessels.

Cogenics in accord with UK research center

The Cogenics division of Clinical Data (Newton, Massachusetts) reported the signing of a multi-year agreement with the John Innes Centre (JIC; Norwich, UK) for Cogenics to provide the JIC with gene expression and other genomics services in a solutions-oriented approach that will help the center enhance its plant science and microbiology research.

JIC and Cogenics revealed the first result of their collaboration – a custom Brassica gene expression microarray – at the Plant and Animal Genome Conference in San Diego in mid-January.

Ian Bancroft, project leader in the JIC Crop Genetics department and head of the JIC Genome Laboratory, said, “Our partnership with Cogenics provides us with exciting opportunities to bring more advanced genomics technologies for plant and microbial research into the reach of the wider plant and microbial science community.”