Intellicell Biosciences Inc (fka SVFC)

[Sal70]

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.”

http://finance.yahoo.com/news/maxim-group-issues-stem-cell-170100035.html