Cytori Therapeutics, Inc.’ Preclinical Data For The Treatment Of Thermal Injury Published In The Journal Burns

SAN DIEGO--(BUSINESS WIRE)--Cytori Therapeutics, Inc. (NASDAQ: CYTX) announced today that preclinical and mechanistic data from its thermal injury study, performed with support from the Biomedical Advanced Research and Development Authority (BARDA), was published in the journal Burns, the official journal of the American Burn Association. The paper, entitled “Uncultured adipose-derived regenerative cells seeded in collagen scaffold improves dermal regeneration, enhancing early vascularization and structural organization following thermal burns” (Foubert P and coll. Published online: June 7, 2015 | DOI: 10.1016/j.burns.2015.05.004), is now available online [http://www.burnsjournal.com/article/S0305-4179(15)00132-1/abstract] and expands upon data presented earlier this year at the American Burn Association meeting.

“This ability to enhance healing supports a paradigm in which Cytori Cell Therapy is used to improve the quality and rate of wound healing and to reduce scarring when used in combination with a range of temporary and permanent skin substitutes thereby providing a means of improving burn care.”

This paper reports that seeding Cytori Cell Therapy™ onto a widely used dermal substitute led to improvement in a number of parameters of healing of full thickness burns. Specifically, histopathological assessment demonstrated that the average depth of tissue within the wound was increased by approximately 2-fold in animals treated with Cytori Cell Therapy. This was associated with an increase in collagen deposition (1.7-fold), blood vessel density (1.5-fold), and mean vessel area (1.8-fold). Immunohistochemical analysis revealed an increase in the number of vessels expressing a-SMA (a marker for mature blood vessels) in animals treated with Cytori’s Cell Therapy. Taken together, these results demonstrate that seeding Cytori Cell Therapy onto this scaffold promotes blood vessel maturation. Finally, the findings showed increased vascularity (1.5-fold) and cellularity (1.45-fold) of the dermal substitute itself.

Use of skin substitutes provides an important option for care of patients with larger burns who cannot undergo definitive wound coverage in a single procedure. Such options will be particularly important following a mass casualty event that could overwhelm the capacity of specialist burn care centers. In this context a considerable portion of burn care will likely have to be provided by medical personnel without specialist burn surgery experience.

“The data in this paper present a picture of accelerated maturation and organization of the tissue both within the wound and within the skin substitute,” stated John Fraser, Cytori’s Chief Scientist. “This ability to enhance healing supports a paradigm in which Cytori Cell Therapy is used to improve the quality and rate of wound healing and to reduce scarring when used in combination with a range of temporary and permanent skin substitutes thereby providing a means of improving burn care.”

This research, funded by a contract from the Biomedical Advanced Research and Development Authority (BARDA) of the Department of Health and Human Services, will be included in an Investigational Device Exemption (IDE) package to be submitted to FDA for a proposed clinical trial using Cytori Cell Therapy in thermal burn injury.

While there has been tremendous improvement in survival following severe thermal burn injury, hospitalization time, the development of scarring with pain and restricted range of motion, and other problems at both the injury and skin graft donor site remain significant issues. Autologous cell therapies such as those offered by Cytori have the potential to improve the quality and rate of wound healing and reduce scarring. In addition, during a mass casualty event, availability of specialized burn centers for burn injuries may be limited and alternative therapeutic approaches will likely be required. Therefore, autologous Cytori’s Cell Therapy represents a novel medical countermeasure not only to address these challenges but also to promote wound healing and tissue repair and 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 solutions.

Cautionary Statement Regarding Forward-Looking Statements

This press release includes forward-looking statements that involve known and unknown risks and uncertainties. Some of these risks 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 and 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.

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