8/19/2014 8:58:20 AM
BARDA Executes Contract Option with Cytori for Continued Development of Thermal Burn Injury Counter Measure
Option Valued at $12.1 Million plus $8.3 Million for FDA Approved IDE Trial
SAN DIEGO--(BUSINESS WIRE)--Cytori Therapeutics (NASDAQ: CYTX) and Biomedical Advanced Research and Development Authority (BARDA), a division of the U.S. Department of Health and Human Services announced the execution of a contract option to fund the continued investigation and development of Cytori Cell Therapy for use in thermal burn injuries. The current extension is valued at approximately $12.1 million. Upon IDE approval by the FDA, BARDA anticipates funding to cover costs associated with execution of the clinical trial, currently estimated at approximately $8.3 million, bringing the combined value to up to $20.4 million.
The execution of this option funds the remaining research and development activities required to enable a pilot clinical trial of Cytori Cell Therapy in thermal burn. It also funds approximately two years of preclinical studies in other burn-related areas that could lead to broadening of the utility of Cytori technology to burn centers and in wound healing more generally. The immediate focus of contract activities is directed at preclinical, clinical and regulatory activities leading to FDA Investigational Device Exemption (IDE) approval for the trial. The contract retains two additional options in the original contract to fund a pivotal clinical trial and additional work in thermal burn complicated by radiation exposure valued at up to $45 million and $23 million respectively.
“We are honored to be the first technology in the area of thermal burn to have a contract option executed by BARDA,” said Dr. Marc Hedrick, President and Chief Executive Officer of Cytori. “As part of the review and negotiation process, we submitted to BARDA a comprehensive package of preclinical and clinical safety data from our research under this contract as well as data from our U.S. clinical trials. The preclinical data from the initial phase of the project has been very positive and consistent with what we have observed in patients with chronic wounds treated with ADRCs and we anticipate submitting the data for publication later this year. Execution of this contract option allows us to keep national preparedness a top corporate priority and represents a key partner funded pathway to market in parallel with ongoing Cytori-funded activities.”
In September 2012 Cytori was awarded a contract with BARDA for the development of Cytori Cell Therapy for thermal burns combined with radiation injury. The initial base period of the contract covered three contract milestones which were achieved to the government’s satisfaction. These milestones included:
* Preclinical studies demonstrating improved healing parameters using Cytori Cell Therapy in a thermal burn model
* Preliminary design and development of Cytori’s next generation Celution® System, and
* Demonstration of feasibility of obtaining viable, functional regenerative cells from adipose tissue samples from burn patients.
By exercising this option of the contract, originally awarded to Cytori in September 2012, this investment funds research and development activities as to whether ADRCs™ could serve as a valuable medical countermeasure for thermal burns when combined with radiation injury as part of the U.S. government’s national preparedness initiative. This contract is part of BARDA’s national preparedness initiative to prepare for a possible mass casualty event by developing technologies that may address unmet medical needs in the area of bio-defense. In the event of a radiological or nuclear emergency, people are likely to have combined injuries involving trauma, radiation, and thermal burns. In a mass casualty event, healthcare providers will need a variety of effective ways to diagnose and treat the wide range of illnesses and injuries. Cytori’s technology could be effectively pre-deployed at hospitals throughout the U.S., creating a wide network that could be utilized by non-specialist personnel, which would allow for an efficient response to such an event.
The treatment of thermal burns remains a critical unmet medical need. Despite standard of care treatment 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 Cytori Cell Therapy have the potential to improve the quality and rate of wound healing and to reduce scarring. According to the American Burn Association, there were approximately 450,000 burn injuries that required medical treatment in the United States in 2013, 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.
Cytori Therapeutics is developing cell therapies based on autologous adipose-derived regenerative cells (ADRCs) to treat cardiovascular disease and other medical conditions. Our scientific data suggest ADRCs improve blood flow, moderate the inflammatory response and rescue tissue at risk of dying. As a result, we believe these cells can be applied across multiple “ischemic” conditions. These therapies are made available to the physician and patient at the point-of-care by Cytori’s proprietary technologies and products, including the Celution® System product family. www.cytori.com
Cautionary Statement Regarding Forward-Looking Statements
This communication includes forward-looking statements regarding events, trends and business prospects, which may affect our future operating results and financial position. Such statements, including, but not limited to, those regarding an FDA Investigational Device Exemption (IDE) approval for a pilot clinical trial of Cytori Cell Therapy in thermal burn, and anticipated BARDA funding of approximately $8.3 million to cover the costs of the pilot clinical trial for thermal burn, further extensions, option exercises or additional contract work that may be sponsored by BARDA, are subject to risks and uncertainties that could cause our actual results and financial position to differ materially. Some of these risks and uncertainties include future Government funding and procurement priorities, the Government’s sole discretion in determining funding timing and amounts, the Government’s ability to reduce, modify or terminate the contract if it determines it is in the Government’s best interests to do so, regulatory uncertainties, dependence on third party performance, and other risks and uncertainties described under the "Risk Factors" section in Cytori's Securities and Exchange Commission Filings on Form 10-K and Form 10-Q. Cytori assumes no responsibility to update or revise any forward-looking statements contained in this press release to reflect events, trends or circumstances after the date of this communication.
Megan McCormick, +1 858-875-5279
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