NEW YORK, July 08, 2013 (eTeligis via ACCESSWIRE) -- IntelliCell BioSciences, Inc. (SVFC), a developer of novel, patented technology used to isolate stromal vascular fraction cells (stem cells) from adipose (fat) tissue. These cells are used to address the regenerative, curative and preventative conditions of disease, announced New York based Maxim Group has issued a research opinion on stem cell sector, and our position within the industry.
Jason Kolbert, the research analyst at Maxim Group commented in his report, “IntelliCell’s position on the legal/regulatory status of SVFC (stromal vascular fraction cells) is that the product is a human cell, tissue, and cellular and tissue-based product (“HCT/Ps”) and is regulated under the regulations created under 21 C.F.R. § 1271. The Company maintains that the SVFC product falls within the exemption from FDA regulation found under 21 C.F.R. § 1271.15(b). This is because the HCT/Ps are removed from and reintroduced into the same patient during the same surgical procedure as that term is used in the practice of medicine. The cells that are reintroduced are exactly the same cells (i.e., “such cells”) as the cells removed from the autologous patient. Thus, the SVFC product falls under an exemption to FDA regulation.”
”Alternatively, even if the SVFC product is not exempt under 21 C.F.R. 1271.15(b), the company maintains that it meets the requirements in 21 C.F.R. § 1271.10(a) for regulation solely under PHS Act § 361 and Part 1271 as a “361 HCT/P” and not as a drug, device, and/or biologic requiring an approved application. Under that section of the regulation, HCT/Ps that are from an autologous source, minimal manipulation, and for homologous use, and do not include added components (with some minor exceptions) are exempt from FDA pre-approval as a drug.”
”Under these guidelines IntelliCell Biosciences is empowering clinicians to treat patients today for everything from orthopedic injuries to multiple sclerosis. The company has treated over 300 patients and in some cases with dramatic results. We went so far as to review patients stories and case histories, publications and even met with the company’s attorneys (ex-FDA reviewers) to understand the definitions of minimally manipulated and the legal guidelines by which the company’s process allows physicians to treat patients. We left believing that this is the only company, at the moment that qualifies with a process that meets current guidelines.”
To download the full report from Maxim group please visit www.filesanywhere user: Victor07 Password: Anna249249
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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 patented technology for the use of ultrasonic cavitation for separating stromal vascular fraction with stem cells from adipose tissue and several patent-pending. 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 cardiac disease, 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 class cGTP cellular processing facility in New York City, purpose built and designed to be fully integrated into an ambulatory surgery center and hospitals. www.intellicellbiosciences.com
This news release contains forward-looking statements regarding IntelliCell BioSciences, Inc., and its future business plans, which statements involve known and unknown risks and uncertainties that may cause actual results and future achievements of IntelliCell BioSciences to be materially different from those implied by these forward-looking statements. IntelliCell BioSciences has and undertakes no obligation to provide public updates and revisions to these forward-looking statements to reflect any changes in its expectations of future events.
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- Health Care Industry
- stem cells