Cytori Patents Method of Treating Renal Diseases Using Adipose-Derived Regenerative Cells
<0> Cytori Therapeutics Inc.Media:Megan McCormick, +1-858-875-5279orInvestors:Tom Baker, +1-858-875-5258 </0>
(NASDAQ: CYTX) received US Patent No. 8,404,229 (the ‘229 patent) for methods of treating renal diseases using adipose-derived regenerative cells (ADRCs). The ‘229 patent covers treatment of a broad range of renal disorders, including acute kidney disease (AKD) and chronic kidney disease (CKD). The ‘229 patent also covers multiple means of delivering the ADRCs, including to the kidney directly, to the renal vasculature or to the renal parenchyma.
The ‘229 patent complements Cytori’s previously issued European Patent No. 1 778 834 (the ‘834 patent) directed to the treatment of renal disorders. Similar to the ‘229 US patent, the ‘834 European patent covers treatment of a broad range of renal disorders, including AKD and CKD. The ‘834 patent is effective in the United Kingdom, Germany, France, Netherlands, Spain, Belgium, Sweden, and select other European countries. Cytori now has 60 issued patents and more than 75 active patent applications worldwide.
“The renal patents are an important addition to our growing portfolio of ADRC patents,” said Chris Calhoun, Chief Executive Officer of Cytori. “CKD is an important co-morbidity of cardiovascular disease, Cytori’s core focus. Our platform technology and recent European approval of Intravase® for intravascular delivery allows us to explore related indications without compromising our focus on the core indications. Potentially, we would partner this indication to expedite bringing this therapy to market.”
Cytori’s renal patents reflect the Company’s previously showing that ADRCs improve renal function and reduce mortality in acute kidney injury (AKI). AKI represents a major clinical problem with high mortality and limited causal treatments. In the study, animals received either ADRCs or control after a renal injury was induced. Specific markers for kidney function and survival were assessed daily for seven days. Survival in the ADRC treated group was 100% and a statistically significant outcome compared to only 57% survival in the control group (p<0.005). Statistically significant functional and histologic improvements were also shown in serum creatinine (p<0.0001), blood urea nitrogen (p<0.0001) and renal cell necrosis (p<0.0001). This study provides substantial evidence of the potential of ADRC therapy for treating acute kidney injury.
The estimates that more than 10% of Americans, or 20 million people, suffer from chronic kidney disease (CKD). In addition, rates of acute kidney disease (AKD) are on the rise in the United States. According to a published in December 2012, on average, the incidence of AKD increased by 10% per year for the past decade. In 2010, the US renal market was estimated to be worth $21.7 billion, based a 2011 report from GBI Research.
Adipose tissue is the richest source of stem and regenerative cells in the body. This mixed population of cells, collectively referred to as ADRCs, is accessible at the point-of-care through the Celution® System for use in the same patient, creating new treatment opportunities for currently unmet medical needs. ADRCs collectively contribute to the healing process via cell-to-cell signaling, supporting improved blood flow and regulation of the inflammatory response.
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 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.
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 the possibility of gaining a partner to expedite bringing a renal therapy to market, 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, 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" 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 press release.