Cytori Therapeutics Inc (NASDAQ:CYTX) has announced that its Investigational Device Exemption (IDE) has been approved by the U.S. Food and Drug Administration (FDA). The IDE is used in a pilot clinical study to examine Cytori Cell Therapy™ in thermal burn injury patients. The study, dubbed the RELIEF trial is an extension of the company’s current research and development agendas a contract with Biomedical Advanced Research and Development Authority (BARDA) which is a subsidiary of U.S. Department of Health and Human Services.
The RELIEF trial will have access to feasibility and safety of intravenous delivery of the therapy as an addition to use conventional care among thermal burn injury patients with 20% to 50% of the body affected. The study has been approved to admit 30 in up 10 sites in the U.S. The initiation of RELIEF will depend on how the contract with BARDA is executed so as offer the required funding.
Cytori President and Chief Executive Officer Dr. Marc Hedrick said the announcement is a major breakthrough achieved by both his company and BARDA as both companies steer the technology through the development stage after the clinical and preclinical implementation. He adds that the approval is a big step towards the final goal of unveiling the technology for use by those who are in need.
The healthcare system is currently not well prepared to deal will large influx of patients in need of treatment for burns especially patients with radiation complications. The currently care standards include skin grafts, dressings and skin substitutes. Patients with complicated burns always experience a lot of pain, skin contracture, aggressive scarring and reduction in motion. Cellular treatment like that offered by Cytori have the ability to improve the rate of healing as well as reduce scarring. They are also used in a mass treatment situation at cost effective means.
Going by data from the American Burn Association there were around 450,000 injuries resulting from burn in 2013 that needed medical attention in the U.S with 40,000 of these in need of hospitalization. A report by the Government Accountability Office indicate that nearly 10,000 patients may require thermal burn care in the case of mass casualty. Due to the few number of specialist surgeons available in the U.S, there is a public deficit for wound treatment that can be applied by medical personnel who are not specialists.