Cytori Therapeutics, Inc. Obtains Celution(R) Approval in Russia; to Launch Product Line for Plastic Surgery and Select Soft Tissue Therapies
Published: May 30, 2012
SAN DIEGO, CA--(Marketwire - May 30, 2012) - Cytori Therapeutics (NASDAQ: CYTX) has obtained approval to sell the Celution® 800 System in Russia for various medical uses. These clinical uses are based on those in the current European CE Mark, and include the use of the Celution® system and its output of adipose-derived stem and regenerative cells (ADRCs) for plastic surgery and select soft tissue therapies.
The Celution® system and related products will be sold into Russia for these indications exclusively through Cytori's distribution partner Human Stem Cells Institute of Moscow (HSCI). HSCI develops and commercializes a diverse portfolio of cell and gene-based treatments. With Cytori, they intend to initially target physicians and clinics seeking to perform a full range of soft tissue procedures such as injections, autologous fat grafting and tissue repair procedures.
"This regulatory achievement and the distribution partnership with HSCI gives us immediate access to the Russian market through an established and scientifically driven organization with a sales and marketing team already trained and knowledgeable in cell therapy," said Clyde W. Shores, Executive Vice-President of Marketing & Sales. "We anticipate beginning to see the incremental impact from Russian sales starting in the second half of 2012. This approval is an important achievement and helps fulfill our stated 2012 goal to obtain additional market approvals for our technology."
Russia is now the 11th largest medical market in the world and is experiencing double digit growth. The plastic and reconstructive surgery market, which is predominately private pay, represents a part of this growth. Specifically, more than 25,000 anatomical soft tissue augmentations and an additional estimated 12,000 fat grafting procedures are performed each year in Russia.
About Human Stem Cells Institute
Human Stem Cells Institute (eng.hsci.ru) is Russia's first public biotech company and was founded in 2003. The main focus of HSCI is research and development as well as commercialization and marketing of innovative proprietary products and services in the areas of cell-based and gene and post-genomic technologies. Additionally, HSCI owns the largest family cord blood stem cells bank in Russia -- Gemabank®.
Cytori Therapeutics, Inc. is developing cell therapies based on autologous adipose-derived regenerative cells (ADRCs) to treat cardiovascular disease and repair soft tissue defects. Our scientific data suggest ADRCs improve blood flow, moderate the immune response and keep tissue at risk of dying alive. 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 our ability to successfully develop the market for Celution® in Russia, 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 the challenges inherent in convincing physicians and patients to adopt the new technology, creating and implementing a successful marketing and sales strategy, as well as our history of operating losses, regulatory uncertainties, dependence on third party performance, and other risks and uncertainties described under the "Risk Factors" in Cytori's Securities and Exchange Commission Filings, including its annual report on Form 10-K for the year ended December 31, 2011. 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 press release.