Cytori Reports Preclinical and Mechanistic Data Supporting Use of Cytori Cell Therapy in Wounds Combining Thermal Burn and Radiation Exposure

Cytori Therapeutics, Inc. (NASDAQ: CYTX) presented data from two preclinical studies funded through its contract with the United States Biomedical Advanced Research and Development Authority (BARDA) at the 2015 American Burn Association Meeting this week in Chicago. The findings provide greater detail as to how Cytori's cellular therapeutic improves healing following thermal burn injury even in subjects with substantial radiation exposure.

"Our data show that Cytori Cell Therapy acts at the cellular and molecular level to modulate different phases of wound healing thereby accelerating wound closure in clinically relevant large animal models. Treatment led to increased angiogenesis, blood vessel maturation, and deposition of collagen matrix which, along with accelerated epithelialization led to faster repair," said Dr. John Fraser, Chief Scientist of Cytori Therapeutics. “These data are consistent with our prior studies with cells derived from adipose tissue in situations involving ischemia, inflammation and fibrosis.”

The first presentation titled “Autologous Adipose-Derived Regenerative Cells (ADRCs) Enhance Wound Healing in a Minipig Model of Concomitant Radiation and Thermal Burn Injury” establishes in a preclinical model that Cytori Cell Therapy may be a safe and effective means for improving burn wound healing in the context of concomitant radiation exposure. This model comprises radiation exposure sufficient to damage the bone marrow combined with full thickness burn injury. This is the first reported large animal model reflecting the clinical situation of patients exposed to both thermal and radiation injury following detonation of an improvised nuclear device.

Results demonstrate that delivery of Cytori Cell Therapy accelerated wound healing with an average 67% increase in blood vessel density, 30% increase in matrix (collagen) deposition, and a 3.5-fold increase in epithelialization two weeks after treatment (compared with control wounds). In addition, molecular analysis demonstrated a 4-fold increase in E-cadherin expression (a marker of epithelialization) in cell-treated wounds. Importantly, similar results were observed when the product was injected directly into the wound or, using a modified formulation, by intravenous administration. Dr. Dunstana Melo, Director of the Center for Countermeasures Against Radiation at Lovelace Respiratory Research Institute (LRRI) noted that, “The knowledge obtained with the referred model will accelerate the assessment of new medical countermeasures to be deployed following a mass-casualty event involving detonation of an Improvised Nuclear Device”.

The second poster presentation titled, “Autologous Adipose-Derived Regenerative Cells (ADRCs) Seeded in Collagen Scaffold Improves Dermal Regeneration, Enhancing Early Vascularization and Structural Organization Following Thermal Burn Injury," shows that seeding the Cytori cell therapy product onto a widely used dermal substitute after full thickness burn injury increases depth of wound tissue, collagen deposition, and wound tissue maturation. Specifically, histological analysis revealed that blood vessel density was increased by 50% in wounds receiving cell therapy compared to control. Similarly, the number of aSMA-positive vessels increased by 60% compared with control. This quantitative and qualitative improvement in vascularity was associated with 2-fold increase in tissue thickness and 1.7-fold increase in collagen I deposition within the wound bed. In addition to these improvements in wound healing parameters, addition of the cell therapy product to the scaffold did not impair the ability of the scaffold to resist wound contraction. Wound contraction is a precursor to the development of burn scar. One of the functions of the collagen scaffold is to resist contraction. The data showed no relevant difference in wound contraction between treated and untreated wounds, which can be considered supportive of the safety of the cell product. These data demonstrate that the delivery of the cell therapy product along with skin substitutes creates the potential for earlier application of autologous skin grafts thereby reducing patient hospitalization, recovery time, and outcome following severe thermal burn. “These are important findings providing new insights for combination of Cytori Cell Technology with engineered biomaterials for wound healing in severe burn patients,” said Dr. Mayer Tenenhaus, plastic surgeon at UCSD Burn Center, specializing in surgery for burns and other traumatic injuries.

Presentations Details:
Abstract #268
Title: Autologous Adipose-Derived Regenerative Cells (ADRCs) Seeded in Collagen Scaffold Improves Dermal Regeneration, Enhancing Early Vascularization and Structural Organization Following Thermal Burn Injury
Presenter: Philippe Foubert
Poster: P17. Wounds – Translational Science I
Link: http://www.abstractsonline.com/Plan/ViewAbstract.aspx?sKey=e752e0e6-8276-4926-aa40-0cc3a2b5e0c9&cKey=ca9c9a72-946f-4fb7-81a1-7e178df8f16a&mKey=%7b71D9A9F0-A27E-4F56-8DF3-AB7E39E05F96%7d

Abstract #273
Title: Autologous Adipose-Derived Regenerative Cells (ADRCs) Enhance Wound Healing in a Minipig Model of Concomitant Radiation and Thermal Burn Injury
Presenter: Philippe Foubert
Poster: P17. Wounds – Translational Science I
Link: http://www.abstractsonline.com/Plan/ViewAbstract.aspx?sKey=e752e0e6-8276-4926-aa40-0cc3a2b5e0c9&cKey=a7df1c71-1600-494e-9581-a6e84f9af6c7&mKey=%7b71D9A9F0-A27E-4F56-8DF3-AB7E39E05F96%7d

Abstracts are currently available on the American Burn Association website at http://www.ameriburn.org/47thAnnualMeeting.php

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.