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Product . SMI has developed the Lumbar Matrix System A unique spinal physiology imaging scan used to diagnose disc, facet and chronic LBP pathology SMI is the only company that offers this technology 10 issued US Patents (1 pending) 5 issued foreign patents (1 pending) FDA approved

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  1. SpineMatrix

  2. Product • SMI has developed the Lumbar Matrix System • A unique spinal physiology imaging scan used to diagnose disc, facet and chronic LBP pathology • SMI is the only company that offers this technology • 10 issued US Patents (1 pending) • 5 issued foreign patents (1 pending) • FDA approved • UL approved • 4 functional CPT reimbursement codes • 10 peer-reviewed published clinical papers SpineMatrix

  3. We manufacture our own arrays • We will begin manufacturing our hardware/software systems in July • Control of vendors and W.I.P., provides as-needed inventory management • Adds significant value to the company SpineMatrix

  4. Stage of Company • Launched the LMS System in February SpineMatrix

  5. Customers • Neuro and orthopaedic spine surgeons • LMS usage cascade of treatment (when and how) SpineMatrix

  6. Creation of Company • Technology Founder - Mark Finneran, MD Wooster, Ohio • Trained neurosurgeon / rehabilitation physician who saw the need • 30-40% of L.B. spine surgeries result in “failed back syndrome” • Clearly points to the need for improved diagnostic and better defined treatment pathways SpineMatrix

  7. Market Demand • Large, strong market demographics • 21 million LBP hospital visits per year • $145 billion spent annually on LBP patients resulting in 1.5 million spinal surgeries • 60-65% success rate SpineMatrix

  8. Entrepreneur/CEO Market Exposure • Twenty-Five Years experience in the ortho/spine marketplace • Theken Spine – President • Wright Medical Spine, Trauma, Biologics, Sr. VP • Medtronic Sofamore Danek, VP SpineMatrix

  9. Financing • Series A ($9.5 MM) • NationWide Insurance (OH) • ABL Group (OH) • Z2 Ventures (OH) • X-Gen (OH) • Ohio Innovation Fund (OH) • Dan Kellogg (OH) • Series B ($8 MM) • Psilos Group (NYC) (lead) • ODOD (OH) • ABL Group (OH) *Follow-on is available SpineMatrix

  10. Original Business Plan • To outsource development and manufacturing • Launch in the rehabilitation/workers’ comp. markets • Utilize Independent distribution network SpineMatrix

  11. Revised Business Plan • In-house manufacturing control • Target neuro/ortho spine surgeons • Utilize published and defined clinical support data • Direct sales organization SpineMatrix

  12. Future • Large Market • Advantage-current cost savings environment for medical procedures • Need for outcome-focused reproducible results • No current competition for LMS System SpineMatrix

  13. Impact Of NE Ohio On Company • Governor Strickland, Lt. Governor Fisher and ODOD – very supportive • Akron Mayor Donald Plusquellic and his staff – very supportive • BioEnterprise Interaction SpineMatrix

  14. Challenges • Recruiting at the Sr. Management level • Medical device vendors and contract Manufacturing base to service small companies • Overall economic trends in the Akron region • Lack of larger (lead) VC firms in Ohio that focus on medical devices and have significant follow-on capacity SpineMatrix

  15. Lessons Learned / Business Plan • Never assume that previous device development and manufacturing data has value • Adoption curve for something brand new • Issues with third-party payers SpineMatrix

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