ARTICLE | Company News

Cytori, U.S. Department of Health and Human Services gene/cell therapy, other news

September 26, 2016 7:00 AM UTC

HHS’s Biomedical Advanced Research and Development Authority (BARDA) amended for a second time an option it exercised in August 2014 under Cytori’s September 2012 contract to develop a cell therapy to treat thermal burns from radiation injury. The amendment increases the amount Cytori may receive to $16.6 million from $14.1 million. Last year, BARDA increased the option amount to $14.1 million from $12.1 million. The option -- the first exercised under the deal -- will fund R&D required to support an investigational device exemption (IDE) from FDA for a pilot trial. Upon IDE approval, Cytori expects BARDA to provide an additional $8.3 million to fund the pilot trial, bringing the total value of the option extension to $24.9 million (see BioCentury, Sept. 15, 2014). ...