M GROUP EQUITY RESEARCH INDUSTRY REPORT Regenerative Cell Therapy Osiris Grafix: Trick or Treat? Grafix Goes Through the Front Door Companies mentioned include.• Athersys, Inc. (ATHX) — $1.75 — Buy Baxter (BAX)- $65.25 - NR Capricor (private) Cytori Therapeutics (CY7X)- $2.24 - Buy Dendreon (DNDN) - $2.40- Sell Biosciences (SVFC) - $0.007 - NR Mesoblast (MBLTY) - $29.25 - Buy Osiris (OSIR) — $14.51 — NR Pfizer (PFE) — $30.40 — NR Pluristem (PSTI) — $3.63 — Buy RTI Biologics (RTIX)— $3.43 — NR Teva Pluarmaceuticals (TEVA) — $40.21 — Buy. *Closing prices (10/21/2013) anon Kolbert October 12 2013 > Last month, Osiris Therapeutics demonstrated the utility of Grafix—the company's allogeneic product for diabetic foot ulcers (DFU), long a graveyard of failed therapies. Grafix is a 3D cellular matrix comprising endogenous mesenchymal stem cells (MSCs) and growth factors. It has been sold in the U.S. to treat chronic wounds, under FDA regulatory pathway 21 C.F.R. Part 1271. We examined this regulatory pathway (in ow 8/16/2013 report), trying to make sense of its implications in the cell therapy space. Yesterday, Osiris clarified the regulatory status. > The company announced that it has reached an agreement with the FDA regarding the regulatory pathway for its biosurgery products, Grafix and Ovation: o After discussions with the FDA, the regulatory status of Grafix is confirmed, and the product will remain on the market as a wound cover for the treatment of acute and chronic wounds. For certain expanded indications for Grafix, Osiris has committed to submit a Biologics License Application (BLA). o Osiris will leverage existing clinical data in the preparation of the applications, including data from Protocol 302, its multi- center, randomized controlled trial that demonstrated a 192% relative improvement in closure rates of chronic diabetic foot ulcers as compared to patients receiving conventional therapy (p < 0.0001). > In addi