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Bio Jamie M. Grooms

Bio Jamie M. Grooms. B.S. Biology from Old Dominion University Start-Up Experience Beginning In 1984 Navigated Corporate World through Manufacturing and Product Development First CEO role 1995 UFTB, inc (Became RTIX) Partner of Synogen CEO of AxoGen, (AXGN)

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Bio Jamie M. Grooms

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  1. BioJamie M. Grooms • B.S. Biology from Old Dominion University • Start-Up Experience Beginning In 1984 • Navigated Corporate World through Manufacturing and Product Development • First CEO role 1995 UFTB, inc (Became RTIX) • Partner of Synogen • CEO of AxoGen, (AXGN) • CEO, The Florida Institute for the Commercialization of Public Research

  2. Avance® Increases Graft Length Neubauer et al, 2007, Experimental Neurology – 207, 163-170 • Enhanced axon regeneration • Axons through entire 4 cm graftand were myelinated vs. sparse axons in controls • Tight organized bundles with multiple axons • Achieved functional recovery • 8 of 9 had positive pinch test response vs. none in controls 40mm Ch treated vs. Vehicle treated acellular grafts in rat sciatic nerve model [n=9), 12 weeks recovery] Distal host; tibial n. 3mm distal to distal coaptation; data (+/- SE) of 9 nerves for each

  3. What We KnowSciatic Rat Model • Wow Factor: 4cm Bridge with Recovery • Restored Sensory Sensation • Axons Grew through the full length of the Graft • Axons were Myelinated • Axons leveraged the 3-D Architecture • ChABC grafts performed better than Controls

  4. What We Need to KnowSciatic Rat Model • The complete process: Including Recovery Protocol, The implant needs to be de-cellularized to commercial viability • Process Parameters: Minimum and Maximum for exposure times and concentration • Bio-Activity of ChABC • Alternate Vendors • ChABC implants vs. Gold Standard • Will Motor Function be Restored • Characterization of Final Product

  5. How to Proceed • Sub-Contract • Pros • Control Costs • Quicker Start • Cons • Technology Transfer Risk • Lose of Project Control Failure Law Suite Time • Build Infrastructure • Pros • Control of Development • Delay Start • Cons • Greater Facility Cost • Greater Employee Cost

  6. Avance® Technology Compares Favorably with Autograft Muir et al, 2007, ASSH Annual Meeting; Manuscript in Process Studied functional assessments measured in a composite index (sensory and motor) Shows promise as a better than autograft alternative “Decellularized, chondroitinase-treated, sterile nerve grafts provide superior results to live isografts and may represent a major breakthrough for clinical nerve repair.” Processed Allograft Isograft 33% Improvement 10mm AxoGen processed grafts (n=6) vs. Isograft (n=6) in rat sciatic nerve graft model; 24 weeks recovery

  7. What Do We KnowSciatic Rat Model • The complete process • Process Parameters • Bio-Activity of ChABC • Alternate Vendors • ChABC implants vs. Gold Standard • Characterization of Final Product for Rats and the Pre-Clinical Studies

  8. What Does More Data Mean

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