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4.23.2020 webinar presentation for website

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Whiteboard2Boardroom presents innovations from regional universities, hospitals, research organizations to encourage commercialization.

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4.23.2020 webinar presentation for website

  1. 1. Technology Snapshots MU Coulter Biomedical Accelerator April 23, 2020
  2. 2. MU COULTER BIOMEDICAL ACCELERATOR MIDWEST BIOMEDICAL ACCELERATOR CONSORTIUM “Translating academic biomedical innovations into products that improve patient care and public health” $1M+/year in funding, project management and commercialization support for MU innovators $1M+/year in funding, project management and commercialization support for UM System and KU innovators
  3. 3. Jaya Ghosh, PhD MU Coulter Program Director MBArC Lead Program Manager Phone: (573) 882-0522 Email: ghoshj@missouri.edu
  4. 4. QUESTIONS?
  5. 5. Technology Snapshots Mizzou BioJoint Flex James L. Cook, DVM, PhD, OTSC April 23, 2020
  6. 6. What is the problem? ARTHROFIBROSIS Loss of Motion Pain and Disability Diminished Quality of Life $$$$$
  7. 7. How does BioJoint Flex solve the problem? • An affordable, easy to use knee range of motion device that provides a gentle, prolonged stretch for people experiencing motion loss ARTHROFIBROSIS
  8. 8. What is the market use? 25% of US adults have knee pain (60.5 million people) >1 million major knee surgeries/year >75,000 patients per year with arthrofibrosis following surgery Patient version HCPCS code E1811 – Medicare reimburses $149 Pro version Market price ~$500 10% Entry Market Share over first 3-5 years 7,500 patient units + 1,000 pro units = $1.1M/yr
  9. 9. What competition exists? FEATURES: JAS Brace CPM Physical Therapy Surgery Early Intervention X X X Gentle X Affordable ~$700 $100/wk $75-150/session $6,000-10,000 Clinic Use X X X Home Use X X Prolonged Stretch X Track Record X X X ARTHROFIBROSIS Loss of Motion Pain and Disability Diminished Quality of Life ✓ ✓ $149* ✓ ✓ ✓ ✗
  10. 10. What is the status of the intellectual property? • US nonprovisional patent application pending – Application No. 16/180,783 – Publication No. US 2019/0133864 – “Knee Flexion Device and Associated Method of Use” – Filing Date: November 5, 2018 • Evaluation revealed other devices that promote knee mobility, but nothing with similar specifications Patent/ Application # Patent/Application Title Status Application: 16/180,783 Knee Flexion Device and Associated Method of Use Pending
  11. 11. What is the stage of development? • Prototypes developed and tested in initial prospective randomized clinical trial • Complete data for 29 patients – BioJoint Flex = 16 • 6F, 10M mean age 63 yrs – Control = 13 • 10F, 3M mean age 64 yrs
  12. 12. Does it work? • BETTER Flexion • BETTER Function* • BETTER Pain Relief* • BETTER Patient Satisfaction • Safe, Comfortable, Easy to Use 0 20 40 60 80 100 120 140 PreOP 6w 12w BJF Standard PT Knee Flexion measured with goniometer 0 10 20 30 40 50 60 70 80 90 100 PreOP 6w 12w BJF Standard PT Knee Function based on IKDC PROM * = statistically significant difference (p<0.05) Knee Pain based on VAS PROM 0 1 2 3 4 5 6 7 8 9 10 PreOP 6w 12w BJF Standard PT 0 1 2 3 4 5 6 7 8 9 10 BJF Standard PT Patient Satisfaction $$$$$$$$$$
  13. 13. What is needed for further development? • Experienced Licensee with expertise in orthopaedic device manufacturing, sales and distribution – Invest ~$1M for manufacturing, assembly, and marketing of product for year 1 • Finalize Patient version – $50 → $149 • Finalize Pro version – Features: motorized, sensors, microcontroller, digital display, blue tooth, multi-use – $100 → $500 • Regulatory Pathway – 510K Exempt – Class 1 = safe & effective • READY for commercialization
  14. 14. Jimi Cook, DVM, PhD, OTSC Clinical Research & Development Trent Guess, PhD Engineering & Manufacturing Cory Crecelius, PT Clinical Implementation Kylee Rucinski, MHA Healthcare Financials Sam Bish, PhD Technology Advancement The Mizzou BioJoint Flex Team
  15. 15. QUESTIONS?

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