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Regenerative Medicine: The Next Frontier. SpineSmith Partners, LP. Company Overview. SpineSmith’s mission is develop innovative technologies created through the collaborative relationship between engineer and spine surgeon with a focus on regenerative medicine

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Presentation Transcript
company overview
Company Overview
  • SpineSmith’s mission is develop innovative technologies created through the collaborative relationship between engineer and spine surgeon with a focus on regenerative medicine
  • Celling Technologies mission is the research and development of regenerative medicine and the clinical use of adult stem cells to facilitate the bodies capacity to heal itself
hardware portfolio
Hardware Portfolio
  • Cimplicity
    • Cervical Peek Cage, Small & Large Footprints
  • Cequence
    • Cervical Plate System, Multi-Level, Semi-constrained and Constrained Systems
  • Cynch-TLIF
    • Peek, Banana Cage, Suture Guided
  • Cynch-T-PLIF
    • Peek, Straight Cage, Large Graft Volume
    • Focus Group Launch May 2010
    • Full Launch July 2010
  • Visualif
    • 2-piece inter-body, Open anteriorly, 0° Profile
    • Focus Group Launch May 2010
    • Full Launch July 2010
biologics product portfolio
Biologics Product Portfolio
  • Aspiration Kit & Graft Delivery System
    • Bone Marrow Aspirate Preparation System
    • Bone Marrow Concentrate Delivery System
  • MXP
    • Bone Marrow Concentration System
    • Automated, Closed System
    • Data Tracking
    • > 90% Recovery of MNC’s
  • ResQ
    • Bone Marrow Concentration System
    • Automated Closed System
    • Electromechanical Separation
    • Fluid Dynamic Capturing Funnel
    • > 85% Recovery of MNC’s
cell therapy clinical development basics
Cell Therapy Clinical & Development Basics

Safe, Predictable, Consistent, Reliable…

and less expensive than InFuse

  • What are the characteristics of an efficacious therapeutic cell concentrate
  • How is the cell concentrate delivered to achieve optimal performance
  • How Much of a therapeutic cell concentrate is required to achieve optimal performance
  • How Much does it cost
spinesmith clinical study objectives
SpineSmith Clinical Study Objectives
  • Evidence - based outcomes studies
    • Efficacy
    • Benefit to patient & physician
    • Product development
    • Economics
  • Marketing & competitive positioning studies
    • Develop advocates
    • Promote cell-based therapies
    • Drive adoption
    • Grow sales
spinesmith bmac spinal fusion studies
SpineSmith BMAC Spinal Fusion Studies
  • BMAC v. autograft in PLF (R. Johnson, MD)*
  • BMAC v. InFuse in ALIF (R. Dryer, MD)*
  • BMAC in ACDF (C. Chaput, MD)
  • Local bone + BMAC in PLF/TLIF
  • Optimized cell “concentration” in PLF/PLIF
  • Optimized cell “concentration” in ACDF
  • Optimized cell “presentation” – alternative scaffold development

* Performed with Harvest BMAC

future product initiatives
Future Product Initiatives
  • Hardware
    • Cynch SuperCage
  • Biologics
    • Synthetic Carrier development with GenOsteo
    • NexGen Bone Marrow/Adipose concentration device
  • Major Clinical Studies
    • Evidence based clinical trials in lumbar spine and soft tissue
      • 50-75 patient studies
      • IRB approved, published in major journals
future of biologics hardware
Future of Biologics & Hardware
  • Combining Hardware & Cell-Based Products is a Compeling Strategy
    • Surgeon Interest is High
    • Opportunity for Surgeons to Contribute
    • Development Focus
    • Drives Sales
    • Adds Value
    • Further Strengthens SpineSmith Identity
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