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SpineSmith Partners, LP

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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SpineSmith Partners, LP

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  1. Regenerative Medicine: The Next Frontier SpineSmith Partners, LP

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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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