This webinar aims to attract entrepreneurs and corporations to license two technologies presented: the Mizzou BioJoint Flex knee range of motion device. The webinar will include 10-minute presentations on each technology and a question period. The BioJoint Flex addresses knee arthrofibrosis by providing a gentle, prolonged stretch at home or in a clinic. It has undergone initial clinical trials demonstrating benefits in flexion, function, pain and satisfaction over physical therapy. Further development needs include finding a licensing partner for manufacturing and marketing, finalizing the patient and pro versions, pursuing 510k clearance, and commercialization. The presentation provides details on intellectual property, development stage, clinical results, market opportunity, competition, and the development team.
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Mizzou bio joint flex snapshot
1. W2B Technology Snapshot Webinar Overview
Webinar Objectives
• Attract entrepreneurs to license technologies and start companies
• Attract corporations to license technologies as new product
opportunities
• Solicit input on the commercial viability of the technologies
presented
Agenda
Webinar schedule
Two technology opportunities
8-10 minute presentations
5-10 minute questions as needed
Send technology inquiries to Jim Baxendale at baxendalej@umkc.edu
3. What is the problem?
ARTHROFIBROSIS
Loss of Motion
Pain and Disability
Diminished Quality of Life
$$$$$
4. 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
5. 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
6. 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*
✓
✓
✓
✗
7. 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
8. 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
9. 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
$$$$$$$$$$
10. 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
11. 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