Cytori Publication On Cytori Cell Therapy For Combined Radiation And Thermal Injury

SAN DIEGO--(BUSINESS WIRE)--Cytori Therapeutics, Inc. (NASDAQ: CYTX) announced today the publication of preclinical safety and efficacy study data using Cytori Cell Therapy™ for combined radiation and thermal injury. This preliminary study was performed with support from the Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services.

“We are leveraging this data in a forthcoming U.S. FDA investigational device exemption (IDE) application for the RELIEF Phase I clinical trial to assess the safety and feasibility of the intravenously administered Cytori Cell Therapy as a novel thermal burn countermeasure.”

The paper, entitled “Development of a Combined Radiation and Full Thickness Burn Injury Minipig Model to Study the Effects of Uncultured Adipose-Derived Regenerative Cell Therapy in Wound Healing,” was published in the International Journal of Radiation Biology and is now available online.

The paper reports that injection of Cytori Cell Therapy by either local or intravenous administration led to improvement of healing of full thickness burns that were compromised by concomitant exposure to sub-lethal, marrow-damaging total body irradiation. Treated wounds exhibited 3.5-fold greater re-epithelialization at two weeks post-treatment (relative to control), increase in blood vessel density by an average of 67%, and an increase in matrix (collagen) deposition of 30%. Similar results were observed when the Therapy was injected directly into the wound or by intravenous administration. Local and intravenous Therapy delivery were well tolerated and no serious side effects related to body weight, loss of appetite, infection, activity, or complete blood counts was observed over the course of the study.

“These preclinical data support the clinical rationale for the investigational use of topical or intravenous administration of Cytori Cell Therapy in burn patients,” said Dr. John Fraser, Cytori’s Chief Scientist. “We are leveraging this data in a forthcoming U.S. FDA investigational device exemption (IDE) application for the RELIEF Phase I clinical trial to assess the safety and feasibility of the intravenously administered Cytori Cell Therapy as a novel thermal burn countermeasure.”

The current healthcare system is ill-prepared for large numbers of patients requiring simultaneous treatment. 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. Autologous Cell Therapies such as those offered by Cytori have the potential to improve the quality and rate of wound healing and reduce scarring and also can be deployed in a cost-effective manner, even in mass casualty situations.

In a mass casualty event, the Government Accountability Office estimates 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. Therefore, the Cytori Cell Therapy approach represents a novel potential medical countermeasure not only to address these challenges but also to promote wound healing and tissue repair and help improve casualty care.

About Cytori Therapeutics, Inc.

Cytori Therapeutics is a late stage cell therapy company developing 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, visit www.cytori.com.

Cautionary Statement Regarding Forward-Looking Statements

This press release includes forward-looking statements regarding events, trends, and/or business prospects, which may affect our future operating results and financial position. Such statements, including statements regarding potential benefits of use of topical or intravenous administration of Cytori Cell Therapy in burn patients (including for wound healing and reduction of scarring), use of preliminary study data in a planned forthcoming U.S. FDA investigational device exemption and RELIEF clinical trial to assess the safety and feasibility of Cytori Cell Therapy as a novel thermal burn countermeasure, and the ability to deploy cellular therapeutics such as Cytori’s in a cost-effective manner in mass casualty situations, are subject to risks and uncertainties that could cause our actual results and financial position to differ materially. These risks and uncertainties include preclinical, clinical and regulatory uncertainties, such as those associated with the BARDA preclinical studies, including risks in the collection and results of preclinical data, risks that the anticipated U.S. FDA IDE and/or anticipated RELIEF clinical trial are not approved or funded, risks that BARDA may lose the ability to keep funding Cytori’s clinical studies, or may elect to discontinue its funding of Cytori’s work, unfavorable results of any clinical studies or trials using Cytori Cell Therapy, final clinical outcomes, 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. There may be events in the future that we are unable to predict, or over which we have no control, and our business, financial condition, results of operations and prospects may change in the future. We assume no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless we have an obligation under U.S. Federal securities laws to do so.