IntelliCell BioSciences Announces That Its Cellular Tissue Laboratory was inspected by FDA
, /PRNewswire/ -- IntelliCell BioSciences, Inc. ("Company") (OTC Pink: SVFC) announced today that on through , its cellular laboratory facility underwent a thorough inspection by the FDA. The observations from the FDA inspection were provided to the company in the Form 483. The Company will respond to those observations in a timely manner. IntelliCell will take the necessary actions to address the relevant FDA observations.
IntelliCell's Chairman and CEO, Dr. Steven Victor, stated, "Our Company is very pleased that the FDA has inspected our new flagship cellular laboratory. While there are many companies and physicians' practices in the cellular/regenerative medicine space that may attempt to avoid contact with the FDA, IntelliCell has adopted a more transparent approach. We will continue to work hard with the FDA to meet all cGTP requirements for the manufacturing of Human Cells, Tissues, and Cellular and Tissue-Base Products (HCT/P's)."
About IntelliCell BioSciences
IntelliCell BioSciences is a Regenerative Medicine company developing novel technologies that address the regenerative, curative and preventative conditions of disease states with high unmet clinical needs. The Company has several patent-pending applications and one published patent for an industry unique method of obtaining autologous stromal vascular fraction (SVF) cells from the vasculature surrounding adipose tissue containing adult stem cells and a robust population of regenerative healing cells. The Company is also pioneering the development of autologous and allogeneic cells from living and non-living tissue donors for research purposes. IntelliCell is planning a series of in-human clinical studies with top tier universities for the treatment of osteoarthritis, multiple sclerosis, lower limb ischemic wounds, and gum regeneration in the oral cavity as well as medical aesthetics. The Company has developed a first in class cGTP cellular processing facility in New York City, purpose built and designed to be fully integrated into an ambulatory surgery center.
Certain statements set forth in this press release constitute "forward-looking statements." Forward-looking statements include, without limitation, any statement that may predict, forecast, indicate, or imply future results, performance or achievements, and may contain the words "estimate," "project," "intend," "forecast," "anticipate," "plan," "planning," "expect," "believe," "will likely," "will reach," "will change," "will soon," "should," "could," "would," "may," "can" or words or expressions of similar meaning. Such statements are not guarantees of future performance and are subject to risks and uncertainties that could cause the company's actual results and financial position to differ materially from those included within the forward-looking statements. Forward-looking statements involve risks and uncertainties, including those relating to the Company's ability to grow its business. Actual results may differ materially from the results predicted and reported results should not be considered as an indication of future performance. The potential risks and uncertainties include, among others, the Company's limited operating history, the limited financial resources, domestic or global economic conditions, activities of competitors and the presence of new or additional competition, and changes in Federal or State laws. More information about the potential factors that could affect the Company's business and financial results is included in the Company's filings, available via the United States Securities and Exchange Commission.
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