Cytori Therapeutics Inc (NASDAQ: CYTX) shares surged on Nasdaq as the US FDA approved an Investigational Device Exemption (IDE) for a pilot clinical trial to assess its Cytori cell therapy in patients with thermal burn injury.
This trial, named the RELIEF trial, will assess safety and feasibility of intravenous delivery of the firm's therapy in patients with thermal burn injuries covering between 20% and 50% of their body.
It is expected to enroll up to 30 patients in up to 10 US sites.
Dr Marc Hedrick, president and chief executive, said it was another 'milestone' for the firm.
"Approval of RELIEF is a major step towards the ultimate goal of making this technology available to our citizens as a national countermeasure against burn injuries potentially including those complicated by radiation exposure," he said.
The biotech added that the current healthcare system was ill-prepared for large numbers of patients requiring simultaneous treatment for thermal burns, particularly those complicated by radiation exposure.
"Current standard of care consists of dressings, skin grafts and skin substitutes. Despite these treatments, patients with severe burns commonly suffer from prolonged pain, aggressive scarring, skin contracture and reduced range of motion.
"Cellular therapeutics such as those offered by Cytori may have the potential not only to improve the quality and rate of wound healing and reduce scarring but also to be deployable in a cost effective manner, even in mass casualty situations."
Shares in the company shot up over 35% to stand at $1.85 each.