Topical Administration Of Cytori Therapeutics, Inc. Cell Therapy Effective In Thermal Burn Approach

SAN DIEGO--(BUSINESS WIRE)--Cytori Therapeutics, Inc. (NASDAQ: CYTX) announced today the publication of preclinical data demonstrating that Cytori Cell Therapy can promote burn wound healing via topical spray delivery, achieving similar effects to local injection. The option for spray delivery expands the potential utility and offers greater ease of use for Cytori Cell Therapy in the burn setting. The study was performed with support from the Biomedical Advanced Research and Development Authority (BARDA), and is described in a paper entitled “Adipose-Derived Regenerative Cell Therapy for Burn Wound Healing: A Comparison of Two Delivery Methods” (Foubert P. et al. DOI: 10.1089/wound.2015.0672) now available online (http://online.liebertpub.com/doi/abs/10.1089/wound.2015.0672).

“These data clearly show that topical spray delivery represents an effective solution to administer Cytori Cell Therapy and potentially optimize standard of care in fragile burn patients”

“These data clearly show that topical spray delivery represents an effective solution to administer Cytori Cell Therapy and potentially optimize standard of care in fragile burn patients,” said Dr. Mayer Tenenhaus, a plastic surgeon from UCSD Burn Center.

The purpose of this study was to compare the effects of topical spray delivery and local injection of Cytori Cell Therapy in a porcine model of thermal burn. Importantly, the data demonstrated that administration by topical spray led to statistically significant improvement over control in epithelialization, blood vessel density, and inflammatory cell infiltration. Results with topical spray were equivalent to those with local injection suggesting that delivery via a spraying mechanism is a viable and favorable alternative to other, more cumbersome delivery routes.

This research, performed as part of a development collaboration with BARDA, is planned for inclusion 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.

Results showed that delivery of Cytori Cell Therapy by topical spray or local injection of Cytori Cell Therapy increased wound epithelialization by about 21% over control at day 12 post-treatment (p<0.05). In addition, at day 7 post-treatment, digital analysis showed that microvessel density was significantly greater in wounds receiving either topical spray or local injection of Cytori Cell Therapy compared to control treatment (1.5-fold. p<0.05). Finally, blinded histopathology and immunohistochemistry analyses showed that topical spray or local injections of Cytori Cell Therapy reduced neutrophil infiltration in burn wounds at day 7 post-treatment (p=0.05). The data are consistent with the cell therapy promoting angiogenesis, modulating inflammation and promoting wound repair.

The current standard of care of full-thickness burns requires early wound excision and application of autologous split-thickness skin grafts (STSG). For large injuries, STSG must be often widely meshed due to limited donor sites and are often associated with scarring and functional and cosmetic complications. Cytori Cell Therapy is potentially an attractive option to optimize skin graft healing and functional outcome. The results presented herein suggest that topical spray delivery or local injection of Cytori Cell Therapy may improve skin graft reepithelialization and healing outcome and support the use of Cytori Cell Therapy as an adjunct therapy to skin grafting in severe burn patients.

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, proposed BARDA-sponsored IDE trials involving Cytori Cell Therapy clinical outcomes (including benefits of Cytori Cell Therapy for burn), benefits of our Cytori Cell Therapy, 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.