US Stem Cell Inc (USRM)

[Gsdubb]

Autologous stem cells proliferated in a lab (expanded) have typically been considered more than minimally manipulated and therefore products derived from the cells would be subject to regulation under section 351 of the PHS Act. As explained above, products regulated under section 351 of the PHS Act require pre-market approval. References for the categorization of stem cell-based products derived from expanded cells as being more than minimally manipulated are available here:

The approval process for stem cell-based products follows the same basic path as other biologics. Overviews of those regulatory pathways can be found at the following link: