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

1. Technology Snapshots
MU Coulter Biomedical
Accelerator
April 23, 2020

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. Jaya Ghosh, PhD
MU Coulter Program Director
MBArC Lead Program Manager
Phone: (573) 882-0522
Email: ghoshj@missouri.edu

4. QUESTIONS?

5. Technology Snapshots
Mizzou BioJoint Flex
James L. Cook, DVM, PhD, OTSC
April 23, 2020

6. What is the problem?
ARTHROFIBROSIS
Loss of Motion
Pain and Disability
Diminished Quality of Life
$$$$$

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. 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. 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. 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. 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. 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. 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. 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. QUESTIONS?