Jeremy L. Dillon
RW Monitor
10/31/2014
Perma-Fix Environmental Services is attempting to pivot its design for the production of molybdenum-99 into a larger-scale version of its technology, Perma-Fix CEO Lou Centofanti said this week. The company announced earlier this year the successful demonstration of its technology to produce the medical isotopes used in millions of procedure annually, and Perma-Fix has been trying to raise funding to move its design through the regulatory process in Europe and the United States. Centofanti indicated, however, that the company felt a larger production design is needed to fully take advantage of the market. “We changed priorities a little bit,” Centofanti told RW Monitor this week. “What we’ve done is step back and look at designing a larger design, because what we saw in the market was a need for something just a little bigger than what we had designed. We are presently in the process of putting together a larger generator and building a prototype of that.”
While a larger design would better fit the larger markets, the time needed to re-configure the design will push back Perma-Fix’s ability to begin production. Originally, the company had anticipated filing for Food and Drug Administration approval by the end of the year, but according to Centofanti, the regulatory submittals are more likely to happen sometime next year. “It’s going to take three or four months before we finalize the final design, so that puts it right after the first of the year,” he said. “Then we will focus on that design and look at moving forward more on the regulatory front. I would be real surprised if we submit anything before the first quarter. It will probably be in the middle of next year for the larger design.”
However, such schedule delays could cost Perma-Fix market share in the long-run. With Canada set to stop government spending in 2016 on the National Research Universal (NRU) reactor, one of the world’s largest suppliers of moly-99 and technetium-99m, the medical isotope industry is expecting a shortage in the market in the coming years. This shortage had led to a slew of startups —eight –to-nine companies have already sent the Nuclear Regulatory Commission letters of intent to submit construction authorization licenses for a potential Moly-99 production facility— looking to fill the lucrative void. Most, if not all, of these companies have a timeline for the end of 2016/beginning of 2017 to reaching production capabilities, and with many saying they could produce up to 50 percent of the industry demand, it appears there will not be room for all these companies.
Centofanti said, though, that Perma-Fix’s original design still has applications in smaller, diverse markets, but a larger design is needed for the large markets. “With the smaller unit, we are continuing to develop that technology, because it has applications in the smaller markets, especially in the developing markets, but in the European and American market, there’s a need for a larger unit, which would be the ideal unit. We’ve gone back, and there is four or five ways we can take what we got and scale it up, so we are going through those tests right now to determine the best final design for a larger unit,” he said.
Polish Investment Firm Increases Shares in Perma-Fix Medical
Meanwhile, Astoria Capital SA, a Polish investment firm, has increased its shares in Perma-Fix Medical, a subsidiary of Perma-Fix, by approximately seven percent, Reuters reported this week. The increase in stocks would raise the investment firm’s share in the company to 10 percent, an indication of its belief in Perma-Fix’s ability to leverage its moly-99 technology. Following the company’s capital increase, Perma-Fix has its votes in the subsidiary reduced to 64 percent from 80 percent, Reuters reported.