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U.S. Patent on Cytori’s Celution® System Technology Issued
Tuesday, June 24, 2008
Celution® System Commercialization not Impacted by Recent 6,777,231 Patent Inventorship Decision
San Diego, CA -- U.S. Patent No. 7,390,484 ("the ‘484 patent") covering Cytori’s (Nasdaq: CYTX) Celution® System technology was issued today by the United States Patent and Trademark Office. The ‘484 patent provides Cytori critical market protection for its commercialization of the Celution System in the United States, where the Company is seeking regulatory approval. The ‘484 patent also protects Cytori’s rights to manufacture the Celution Systems in the United States for commercialization into all markets, including Europe and Asia-Pacific, where the device is currently being sold. Other related patent filings are in progress around the globe.
The ‘484 patent specifically protects Cytori's device technology that processes adipose tissue to obtain a diverse and mixed population of cells. Key claims are directed to a closed processing system for tissue collection, filtration, concentration and a provision for aseptic removal. The ‘484 patent describes a system for bringing to the patient’s bedside, a mixed population of cells including, but not limited to fibroblasts, red blood cells, white blood cells, smooth muscle cells, smooth muscle progenitor cells, endothelial cells, endothelial progenitor cells, lymphatic cells, lymphatic progenitor cells, as well as adult stem cells.
On June 12, 2008, the United States District Court in the Central District of California made public its June 9, 2008 ruling regarding inventorship of U.S. Patent 6,777,231. The Court’s decision does not impact Cytori’s primary ongoing business activities or product development pipeline because Cytori’s products do not practice the ‘231 patent. Cytori’s Celution® System yields an output comprising a diverse mixture of cells found in adipose tissue whereas the ‘231 patent covers a narrowly defined population of adipose derived adult stem cells in an environment substantially free of other cellular materials found in adipose tissue. The output that is covered by the ‘231 patent requires different isolation or processing techniques, which are unnecessary for therapeutic efficacy, and which the Celution System, by design, does not perform.
Cytori believes the recent decision on the ‘231 patent is in error and that work completed at the University of California was critical to obtaining this patent. Cytori recognizes that ‘231 may have value in the long term in areas unrelated to the Company’s existing product pipeline, and consequently Cytori and the UC Regents are reviewing their legal alternatives to this ruling, including that of appealing this decision to the Federal Circuit. It is Cytori’s intention to aggressively protect its business, its intellectual property and its investors.
Cytori’s (Nasdaq: CYTX) goal is to be the global leader in regenerative medicine. The company is dedicated to providing patients with new options for reconstructive surgery, developing treatments for cardiovascular disease, and banking patients' adult stem and regenerative cells. The Celution® 800 System is being introduced in Europe into the reconstructive surgery market while the Celution® 900 System will be launched in Japan for cryopreserving a patient's own stem and regenerative cells. Clinical trials are ongoing in cardiovascular disease and planned for spinal disc degeneration, gastrointestinal disorders, and other unmet medical needs. www.cytoritx.com.
Cautionary Statement Regarding Forward-Looking Statements
This press release includes forward-looking statements regarding events, trends and business prospects, which may affect our future operating results and financial position. Such statements 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 our history of operating losses, the need for further financing, regulatory uncertainties regarding the collection and results of, clinical data, dependence on third party performance, and other risks and uncertainties described under the "Risk Factors" in Cytori’s Securities and Exchange Commission Filings. We assume no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made.
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