National Editor

Clearant Inc.'s technology to inactivate pathogens in therapeutic proteins and blood products bagged an $18 million Series B financing round, mostly from new institutional investors impressed by what the company called a growing demand for the process in tissue implants.

The tissue application, on which the company has been focused for the past 18 months, will be the primary area in which the new cash will be used, said Alain Delongchamp, chief operating officer of Los Angeles-based Clearant.

"The tissue implant industry is not currently regulated by the FDA, specifically," he told BioWorld Today. "Under the Public Health Act, [tissue handlers] should be doing everything to prevent contamination, but there is no direct FDA oversight."

Each year, more than 800,000 tissue allograft implants are distributed in the U.S., and the Centers for Disease Control and Prevention in Atlanta has found a series of serious infectious transmissions through transplanted tissue.

"But I don't think we should be blaming the industry," Delongchamp said. "The lack of available technologies is another factor."

That is, it was a factor until now. The Clearant Process is the first method to allow for validated sterilization of tissue implants in their final packaging. Three tissue processors have licensed the method from Clearant, which was founded in 1999 and employs 75 people.

"With the first [processor], we have nearly completed the transfer," Delongchamp said, and implants treated with the process will be released in September. "With the other two, we're in the process of beginning the same situation."

Combining patented and trade-secret technology based on gamma irradiation, the one-step process is said to reduce enveloped and nonenveloped viruses, as well as the vegetative, spore or cyst stages of bacteria, fungi and protozoa. It has shown preliminary evidence of reducing prion infectivity, too.

"We built all the know-how in-house," Delongchamp said. "We find conditions - temperature, degree of moisture and other similar conditions - that allow for the implant to be sterilized in its final packaging" after it has been treated with gamma radiation, he explained. Under ordinary conditions, he noted, "gamma radiation applied to any biological material would simply destroy it."

Cash from the financing came from "some [venture capital funds] and some private equity investors" who asked to remain undisclosed, Delongchamp said. After the tissue application in the U.S., proceeds will be used to advance the process for the same application in Europe.

"It also will allow us to transfer the Clearant Process to the other two key market segments: plasma protein, recombinant proteins," he said.