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HSCI Receives Authorization for Innovative Technology Using Fat Tissue in Reconstructive Surgery

Moscow, 1 June 2012 – On May 24 the Federal Service for Supervision of Healthcare and Social Development of the Russian Federation (Roszdravnadzor) issued the Human Stem Cells Institute marketing authorization (Registration Certificate No. FSZ 2012/12193) for a device called Celution 800 System, a closed system which processes human adipose (fat) tissue. The apparatus is manufactured by the US-based Cytori Therapeutiсs. The beginning of sales planned for the third quarter of 2012.

The revolutionary technology employed by Celution allows for lipofilling – a procedure used to correct cosmetic defects as well as to create of new contours via injection of a patient’s own adipose-derived regenerative cells (ADRCs). This technology allows for breast correction and enhancement (including following a partial mastectomy) through a natural method, thus avoiding the use of such materials as silicone implants. One of the key advantages of this technology is that the liposuction procedure can be conducted, ADRCs isolated and injected into the fat graft, and the grafting procedure completed all within one and a half hours in the operating room. This allows for better graft survival and also reduces the recovery period and risks of complications associated with standard lipofilling procedures.

At present the Celution system is used in approximately 250 clinics around the world. This technology has been used on more than 5000 patients in Europe and Japan. Since 2010 Celution has been available in the Ukraine. In 2011 the Human Stem Cells Institute signed an agreement with Cytori Therapeutiсs for the exclusive distribution rights to this technology in Russia.

Clyde Shores, Executive Vice President of Marketing & Sales at Cytori Therapeutiсs, commented on the news: “Our partnership with the Human Stem Cells Institute makes is possible to introduce in a very short time frame the unique Celution technology to the Russian market. This approval by Russian regulatory bodies is an important achievement for our company and one which to a large degree was made possible thanks to the high level of professionalism of HSCI’s management”.

On May 28 at the V Annual International Symposium “Topical issues of gene and cellular technologies” in Moscow, Dr. Marc Hedrick, President of Cytori Therapeutiсs, spoke about the latest developments in clinical applications for adipose-derived stem cells. He also announced that “at present Cytori is holding clinical trials on the use of adipose-derived stem cells for the treatment of cardiovascular diseases, stress urinary incontinence, gastrointestinal disorders, spinal disc degeneration and also wound healing.”

According to Arthur Isaev, General Director of HSCI, “marketing authorization of this technology in Russia is not only an achievement for the Human Stem Cells Institute but also for Russian healthcare in general. The Celution system represents a new development in regenerative medicine and incorporates several innovative ideas, which make this technology effective and convenient for both doctors and patients. All of the laboratory tasks and cell processing are carried out by this device, which allows for standardization of the procedure. This is the safest cell-technology format providing the use of the patient’s own cells with minimal impact and manipulations. It is important to note that we are not lagging behind our foreign colleagues and this technology is coming to the Russian market just three years following its creation.”

01 June 2012