Cytori Therapeutics, Inc. has identified a number of therapeutic areas that we think may benefit from the use of our Tissue Processing System. It is already approved, or CE marked, for certain uses in Europe. In order to be a commercially available option for physicians and patients for some additional therapeutic areas we have identified, the System must go through clinical evaluation that ultimately ends with each country’s regulatory authority reviewing data from clinical trials. Each country will determine if the clinical trial data shows that using the product provides a clinical benefit to patients and is safe. In addition, Cytori is working with the U.S. Food and Drug Administration on an ongoing basis to begin conducting studies in the United States.
Cytori’s initial clinical trials focus on two therapeutic areas: heart disease and reconstructive surgery.
In the area of heart disease, Cytori is sponsoring two European clinical trials that evaluate the use of adipose-derived stem and regenerative cells (ADRCs) to treat acute myocardial infarction (heart attack) and chronic myocardial ischemia (a severe form of coronary artery disease).
In the area of reconstructive surgery, Cytori is sponsoring a European clinical study for patients requiring breast reconstruction after lumpectomy for breast cancer.