Cytori Therapeutics (CYTX) IDE Approved by FDA for Pilot Clinical Trial to Evaluate Cytori Cell Therapy

April 10, 2017 7:02 AM EDT
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Cytori Therapeutics, Inc. (NASDAQ: CYTX) today announced that the U.S. Food and Drug Administration (FDA) has approved an Investigational Device Exemption (IDE) for a pilot clinical trial to evaluate Cytori Cell Therapy™ in patients with thermal burn injury. This trial, named the RELIEF trial, is a continuation of Cytori’s ongoing research and development efforts under its contract with the Biomedical Advanced Research and Development Authority (BARDA), a division of the U.S. Department of Health and Human Services.

The RELIEF trial will assess safety and feasibility of intravenous delivery of Cytori Cell Therapy™ as an adjunct to usual care in patients with thermal burn injuries covering between 20% and 50% of their body surface area. The trial is approved to enroll up to 30 patients in up to 10 U.S. sites. Initiation of RELIEF is dependent upon execution of a contract option by BARDA to provide the necessary funds.

“This announcement is yet another milestone achieved as BARDA and Cytori continue to move this technology forward through the development process, from preclinical to clinical implementation,” said Dr. Marc Hedrick, President and Chief Executive Officer of Cytori. “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.”

The current healthcare system is 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.

According to the American Burn Association, there were approximately 450,000 burn injuries in 2013 that required medical treatment in the United States, with approximately 40,000 requiring hospitalization. According to a report from the Government Accountability Office, as many as 10,000 patients could require thermal burn care in a mass casualty event. The limited number of specialist surgeons and burn centers in the U.S. creates a public health need for a burn wound therapy that can be quickly and broadly applied by non-specialist medical personnel following such an event.

The RELIEF Trial is designed as a prospective, open-label, parallel group, usual care controlled, multi-center randomized (2:1, active: usual care alone) safety and feasibility study targeting thermal burns. Subjects will have at least one deep partial or full thickness burn wound that is to be autografted with a meshed split thickness skin graft (STSG). Subjects randomized to Cytori Cell Therapy will undergo small volume fat harvest (100 to 150 mL) during scheduled burn surgery followed by intravenous delivery of Cytori Cell Therapy. Subjects randomized to usual care will not undergo a fat harvesting procedure.

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