CYTORI THERAPEUTICS INC Cytori Therapeutics, Inc. (NASDAQ:CYTX) will present data from two preclinical studies describing safety and efficacy of ADRCs for treatment of thermal burn injuries at the Annual Meeting of the American Burn Association (ABA) in Chicago on April 21-24, 2015. This research, funded by the contract with the Biomedical Advanced Research and Development Authority (BARDA) of the Department of Health and Human Services, was part of the package of data submitted to the US Government as part of the In-Process Review meeting that led to the execution of the current contract option valued at $14.1 million, and part of Cytori’s $106 million BARDA contract framework.
The first presentation will describe the use of Cytori Cell Therapy in combination with a widely used skin substitute in a full thickness burn injury model. Data to be presented show increased wound vascularity and maturation in wounds treated with Cytori Cell Therapy. The second presentation will describe a novel model of full thickness thermal burn injury with concomitant radiation exposure. Data to be presented demonstrate that delivery of Cytori Cell Therapy accelerates wound re-epithelialization in this context. These data will form the basis of an Investigational Device Exemption (IDE) package to be submitted to FDA for a proposed clinical trial using Cytori Cell Therapy in thermal burn injury.
“These are encouraging data that support the advancement of Cytori Cell Therapy to accelerate wound healing in severe burn patients,” said Dr. Tenenhaus, a plastic surgeon from UCSD Burn Center who specializes in reconstructive surgery for burns and other traumatic injuries. Dr. Marc Hedrick, President and CEO of Cytori commented: “We remain focused on continuing execution of key deliverables under our BARDA contract and believe that, when coupled with ongoing research and development activities, the data to be presented at ABA will support an FDA IDE approval and unlocking of the next BARDA milestone, which includes $8.3 million in clinical trial funding. We look forward to their full publication in the scientific literature in the near future.”
The treatment of thermal burns remains a critical underserved medical need. Despite standard of care primarily consisting of dressings, skin grafts and skin substitutes, patients frequently suffer from pain, scarring, skin contracture and reduced range of motion. Autologous cell therapies such as those offered by Cytori have the potential to improve the quality and rate of wound healing and reduce scarring.
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. In a mass casualty event, the Government Accountability Office reports that as many as 10,000 patients could require thermal burn care. 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.
About Cytori Therapeutics, Inc.
Cytori Therapeutics is a late stage cell therapy company developing laboratory equipment and autologous cell therapies from adipose tissue to treat a variety of medical conditions. Data from preclinical studies and clinical trials suggest that Cytori Cell Therapy™ acts principally by improving blood flow, modulating the immune system, and facilitating wound repair. As a result, Cytori Cell Therapy™ may provide benefits across multiple disease states and can be made available to the physician and patient at the point-of-care through Cytori’s proprietary technologies and products. For more information, please visit www.cytori.com.
Cautionary Statement Regarding Forward-Looking Statements
This press release includes forward-looking statements that involve known and unknown risks and uncertainties. All statements, other than historical facts, including statements regarding our expectation that the research and development activities, and the data to be presented at ABA will lead to FDA IDE approval and unlocking of the next BARDA contract milestone are forward looking statements. Such statements are subject to risks and uncertainties that could cause our actual results and financial position to differ materially. Some of these risks include clinical, pre-clinical and regulatory uncertainties, risks in the collection and results of data, uncertainty associated with any future approvals by the FDA, dependence on third party performance, the right of the Federal Government to cut or terminate further support of the thermal burn injury program in its sole discretion, and other risks and uncertainties described under the "Risk Factors" in Cytori's Securities and Exchange Commission Filings, included in our annual and quarterly reports.
