Regenerative medicine - a new catch word in health care, is an emerging field that involves engineering of living cells, tissues and organs to repair or restore lost or damaged tissue function due to the effects of injury, disease, and aging. Though still in infancy, it is one of the hottest areas of research in contemporary science.
Cytori Therapeutics Inc. (CYTX) is a company that is focused on developing medical technologies, which harness the potential of adult stem and regenerative cells from adipose tissues.
The company's lead product is a system known as Celution, which helps to extract stem cells from the fat (adipose tissue) withdrawn from a patient in a simple liposuction procedure. Since adipose tissue contains abundant stem cells, there is no need for cell culture. The stem cells extracted can then be administered to the same patient where tissue repair or regeneration is needed. According to Cytori, since the patients' own stem cells are utilized, the need to use embryonic stem cells or cells from donors doesn't arise.
According to Cytori, its other pipeline products include PureGraft, which allows the operator to prepare a fat graft in about 20 minutes; Harvest Instrument Set - a collection of instruments necessary for tissue collection that has been optimized for use with Cytori's tissue processing technology; and Delivery Instrument Set.
The Celution family of products include Celution 800/CRS, Celution 900/MB and Celution 700 System.
Celution 800/CRS System was introduced during 2008 into the European cosmetic and reconstructive surgery market through a network of medical distributors. The company expects to begin commercializing the Celution 800/CRS System for use for breast reconstruction for partial mastectomy defects as early as 2010 pending supporting clinical data and expanded CE certification. A 70-patient, multi-center study dubbed RESTORE II, was initiated in Europe in 2008 and interim results from the trial are expected in December.
A five-patient pilot study in Japan, the results of which were reported Thursday, has found that use of stem and regenerative cells from a patient's own fat tissue to treat stress urinary incontinence is safe and feasible. The cells in the study were processed using Cytori's Celution 800 System during the operative procedure. Stress urinary incontinence, or SUI, results in the loss of one's ability to control urinary flow. About 16 million patients are diagnosed with SUI each year in the U.S. alone.
The Celution 900/MB is marketed in Japan through Cytori's commercialization partner, Green Hospital Supply, Inc. as part of the comprehensive StemSource Cell Bank, which prepares cells for cryopreservation ( preserving living tissues at sub-zero temperature) for future use. The company is also preparing a medical device application to file with the Ministry of Health in Japan.
In the U.S., the company is planning to seek regulatory and marketing approval of Celution 700 System in aesthetic body contouring and/or filling of soft tissue voids. In July, the FDA agreed to regulate Celution 700 system as a medical device under the Federal Food, Drug, and Cosmetic Act. The regulation clears the way for Cytori to compile and submit a marketing application to the FDA for the Celution 700 System for use as a medical device in aesthetic body contouring and/or filling of soft tissue voids.
The company is preparing for the next steps in the process of working with the FDA and if everything turns out the way as expected, Celution 700 System could be approved as early as 2010.
Early this year, Cytori formed a partnership with GE Healthcare, a unit of General Electric Co. (GE), to commercialize Celution in select European countries. In May, Cytori expanded its existing agreement under which, GE Healthcare will commercialize Cytori's StemSource technology in the North American stem cell banking and research markets.
According to the company, its Celution System family of products is also being investigated for gastrointestinal disorders, vascular disease, pelvic health conditions, and orthopedic and spinal applications.
During a recent conference call, the company revealed that two of its cardiovascular disease studies in Europe evaluating Celution System have met their primary safety and feasibility objectives by an independent steering committee. Clinical data from both trials are being accumulated and results are expected in the first half of 2010.
In 2005, Cytori formed a joint venture with Japan-based Olympus Corp. (OCPNY.PK) to develop a next generation tissue processing device to extract and concentrate adipose-derived stem and regenerative cells in less time and with larger tissue processing volume ranges as compared to Cytori's current devices.
On February 23, 2006, Cytori granted Olympus an exclusive right to negotiate a commercialization collaboration for the use of adipose stem and regenerative cells for a specific therapeutic area outside of cardiovascular disease and received a payment of $1.5 million from Olympus. The exclusive right expired on December 31, 2008.
In addition to making progress in clinical trials, Cytori has also improved its financial metrics. For the second-quarter ended June 30, 2009 net loss narrowed to $0.8 million or $0.02 per share from $8.4 million or $0.33 per share in the year-ago quarter. The company credited the improvement in bottomline mostly to increased development revenue and the significant reduction in research and development and general and administrative expenses during the second quarter of 2009.
The company's total revenue for the quarter surged to $8.5 million from $1.4 million in the comparable quarter last year. Due to the completion of enrollment in the cardiovascular disease clinical safety and feasibility studies, Cytori recognized $7.3 million in development revenue in the second-quarter of 2009, as part of its Olympus partnership.
Cytori had total cash of $13.9 million and total debt of $6.54 million at the end of the second-quarter of 2009.
Cytori shares once traded as high as $11 during late 2000. The stock, which has thus far hit a low of $1.42 and high of $5.14 in the last twelve months, closed Thursday's trading at $3.74.
Will the improving financials and progressing clinical trials be able to regenerate the stock price of Cytori, which is working its way to become the global leader in regenerative medicine? Stay tuned...
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