Advanced Medical Isotope (AMIC; Kennewick, Washington) reported this week that it has started producing Fluorine-18, the first in a series of isotopes that it plans to manufacture at its Kennewick production facility, after receiving its radioactive materials license from the state of Washington on May 14.

CEO Bill Stokes told Medical Device Daily that the company has installed a compact proton linear accelerator at Kennewick and plans to use it to produce radioisotopes for use in PET imaging.

But because the company needed permission from the state to make radioactive materials, the license was a "big milestone" for AMIC, Stokes said.

"Our initial product line is diagnostic, enhanced imaging and we understand from our medical colleagues that a good 40% of the procedures are directly affected by what they see on the PET scans ... so the PET imaging is extremely important to the diagnostic process," Stokes said.

The license allows AMIC to proceed with start-up operations of its production center, which Stokes said is built around the nation's first compact proton linear accelerator used for isotope production. The permit was issued, he said, after an "in-depth review" by state officials of the company's personnel, operations controls and physical security. Without the license, AMIC would not be able to produce, possess or distribute radioisotopes.

"The state regulators appeared to be very impressed with our attention to safety and the quality of our staff and facilities," said Dr. Fu-Min Su, AMIC's radiochemistry manager and radiation safety officer.

"Our device is relatively unique in that we have basically no shielding in the walls, the shielding is contained on the machine itself," Stokes said.

He also noted that the machine is unique because it is considered compact at 16 feet in length.

The company said it began hot functional testing the linear accelerator "immediately" after getting the license, and produced its first batch of radioactive materials just two days later.

"Now that we've accomplished this important milestone, our team is aggressively moving forward to complete the balance of systems testing and startup," said James Katzaroff, AMIC's president and chairman. "AMIC is on target for a mid-June delivery of our first AMIC-manufactured, pharmaceutical-grade product for human use."

The license was issued just a week after the company reported signing a letter of intent to buy all the assets of the Center of Molecular Research (CMR; Moscow), which makes and sells stable and radioactive isotopes to clients worldwide.

The acquisition by AMIC includes CMR technologies of separation processes, and analytical works from multiple production and scientific partners, as well as several proprietary contracts, the company noted.

Stokes told MDD that AMIC has been in a contractual relationship with CMR for "some time" and that the acquisition gives the company "direct access to what probably is right now the leading supplier of isotopes."

CMR has nine manufacturing partners throughout Russia, and has a global sales presence including government research centers and commercial ventures.

"Today, CMR is in a leadership position between the sales of isotopes in and from the Russian Federation throughout the world," said Dimitry Dirinko, general director for CMR. "I expect that the new combination will greatly accelerate our presence in the growing revenue stream of commercial and research isotopes."

According to AMIC, the outlook for the medical isotope industry for diagnostic isotopes is expected to grow from roughly $1.7 billion to $3.5 billion and sales of therapeutic isotopes from $900 million to $1.9 billion by 2012.

"The Center of Molecular Research and its unique history, combined with AMIC, is expected to create a seamless activity level of increased revenue and delivery standards," Katzaroff said. "Our purchase of CMR is expected to change the strategic landscape and assist in furthering our competitive position. The dynamics of further penetrating the marketplace will now accelerate, as CMR will operate as a wholly owned subsidiary with expanded organizational capabilities."