On Monday, FDA awarded 18 research grants totaling more than $19 million to promote the development of products to fight rare diseases.
Only one of the 18 went to a device research project. A FDA spokeswoman clarified that typically more drug applications come through the agency's doors resulting in a higher proportion of grants being made to drug projects.
This year, the device firm that won one of the grants is Innovative BioTherapies, based in Ann Arbor, Michigan. The company will receive about $1.6 million over four years to study its Selective Cytopheretic Device for the treatment of pediatric patients with acute kidney injury.
Innovative BioTherapies was founded in 2003 by Dr. H. David Humes, professor of medicine at the University of Michigan to commercialize intellectual property developed at the university. The company is funded by federal grants and contracts that focus on developing bioartificial organ based devices utilizing adult progenitor cells, biomaterials and MEMs technology, according to the company's website.
The Selective Cytopheretic Device is intended to treat acute inflammatory conditions that can be life-threatening. The SCD sequesters and deactivates those cells associated with the inflammation, and reduces their inflammatory activity.
"The FDA is in a unique position to help those who suffer from rare diseases by offering important incentives to promote the development of products, one of which is our grants program,” said Gayatri R. Rao, M.D., J.D., director of the FDA’s Office of Orphan Product Development, in the news release. “The grants awarded this year support much-needed research in 17 different rare diseases, many of which have little, or no, available treatment options.”
The Orphan Products Grants Program was created in 1983 and since then has provided more than $350 million to fund more than 570 new clinical studies and supported the marketing approval of more than 50 products.
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