1. A Temporary Prosthetic for Lower Leg
Injuries
Mike Sanders - CEO
Mark Roberts - CTO
Seth Gonzalez - CMO

4. Strengths:
 Low cost: $20-$75
 Can traverse various terrains
 Most common choice: High Awareness
Weaknesses:
 Movement is slow
 Uncomfortable to use for long periods
 Hard to store
 Requires both hands for use

5. Strengths:
 Faster to move long distances
 Less effort required for use
 Claim reduced muscle atrophy
Weaknesses:
 Extremely bulky
 Hard to store and transport
 Can't traverse the stairs or
tight spaces
 Requires both hands for use
 Expensive: $150-$850

6. • World wide cost of sports injuries: $1 Billion
• 79% of these occur in lower extremities
Monetizable?
• Over 5 Million total lower leg (below knee) injuries
annually
• 3.4 Million of these visit the emergency room each year
• US ambulatory aid market: $220 Million

7. 1. Those with temporary lower leg injuries want a hands-
free mobility device
2. We can inexpensively repurpose prosthetic devices
and apply it to a new market
3. There are no acceptable hands-free devices currently
on the market

8. Consumer/User
Revenue share
Device Hands-free Orthopedic Customer/Users
manufacturer Doctor/Supplier
mobility doctors Patients with
relationship
Podiatrists lower-leg injuries
Doctor/professio Warranties Superior recovery - Recommendation (5m)
nal - prescriptions
mobility
Patient/consumer
marketing
experience Insurred/Uninsurre
Prosthetic manuf. d
- Technology How? Prosthetic
- Relationships tech to the Patients under 50
temp-injured
Motivations:
Product diversity Retail/Rental
Deliver Online/web presence
Patent Medical Supply
Superior mobility inexpensively to Medical Supply
Stores
FDA approval both insured and Stores
solution Doctor offices:
Insurance uninsured Doctor’s offices
- Orthopedic
Patient registration patients through - Podiatrist - Orthopedic
satisfaction (HCPCS) device sale and - Hospital - Podiatrist
rental Medical Supply
R&D Online distributors
Rental
Consumer testing Athletic
Departments
Value proposition: Prefer to pay
Rent, utilities, For both rental
through insurance
High initial FC salaries and sale
customers
Fixed pricing on
Develop economies Product delivery currently pay for
device
for lower material DME out of
VC Device pocket, through
Weekly rental
registration costs insurance or both
Cust. Acquisition rate
(FDA, etc)

9. Results:
Concept
MVP
Surveyed 50+
• More stability needed
respondents • Better traction
• Aesthetics/shape of
leg
• Strapping system

10. Prototype #3
• Natural Mobility:
20-40 degree knee flexion
10-15 degree ankle flexion
• Advanced Leg Performance
Compliant members
Composite materials
• Collapsible for Easy Storage
• Greater Stability

12. Place
“What about FDA approval?”
4th Feedback:
200+ students
“Will insurance cover this?”
50+ adults (age: 30-50)
2th
“Why hasn’t anyone thought of
“What is the actual patient
process inbefore?”selection?”
this device
Top 8
“Did you get out of
“I wish I would have had this ____
“Who will actually pay for it?”
the building?”
months/years ago …”
“Did you actually talk to
1st “This is way better than crutches”
doctors/distributors/insurance
companies?”

13. Consumer/User
Revenue share
Device Hands-free Orthopedic Customer/Users
manufacturer Doctor/Supplier
mobility doctors Patients with
relationship
Podiatrists lower-leg injuries
Doctor/professio Warranties Superior recovery - Recommendation (5m)
nal - prescriptions
mobility
Patient/consumer
marketing
experience Insurred/Uninsurre
Prosthetic manuf. d
- Technology How? Prosthetic
- Relationships tech to the Patients under 50
temp-injured
Motivations:
Product diversity Retail/Rental
Deliver Online/web presence
Patent Medical Supply
Superior mobility inexpensively to Medical Supply
Stores
FDA approval both insured and Stores
solution Doctor offices:
Insurance uninsured Doctor’s offices
- Orthopedic
Patient registration patients through - Podiatrist - Orthopedic
satisfaction (HCPCS) device sale and - Hospital - Podiatrist
rental Medical Supply
R&D Online distributors
Rental
Consumer testing Athletic
Departments
Value proposition: Prefer to pay
Rent, utilities, For both rental
through insurance
High initial FC salaries and sale
customers
Fixed pricing on
Develop economies Product delivery currently pay for
device
for lower material DME out of
VC Device pocket, through
Weekly rental
registration costs insurance or both
Cust. Acquisition rate
(FDA, etc)

14. Materials
Great flexion in lower appendage
Protect against hyperextension
Big toe is important in balance
Design
Longer leg rest
Padding materials (Osgood-Schlatter’s)
Overall
“[We] like this concept! [We] would
recommend it“
“People are looking for other
alternatives to crutches”
“You look like you have done your
homework”
MVP
“You need to show this to Dr. Faux”

15. “This is a great idea … I would recommend
it, definitely worth looking at”
“Shoulders aren’t designed to be weight
bearing joints, knee scooters have been
nice for this reason”
“An especially good for patients and for a
person with a leg injury combined with an
upper extremity injury”
“Cool idea, I like the idea… that’s clever”
MVP
“Protect and pad the peroneal nerve so
you don’t end up with drop-foot”
“You ought to show this to Dr. Faux and
Lance our bracing specialist”

16. Like it/ Cost Prescribe Distribute
Recommen
d
3 Physical Therapists N/A
3 Orthopedic Surgeons
2 Orthopedic Technicians
- Bracing & Cast Specialists N/A
2 Podiatrists
MVP
* With
insurance

17. Mark McGuire – International Orthopedic Care
“Great idea, I have never seen anything like it, that’s
probably because you started with prosthetics”
“More and more people are trying to avoid crutches”
AHM Agent
“For insurance, the patient needs an HCPCS
Code”
MVP Trends: Ordering 0nline
Scooter rental

19. BOM MTL Cost
Knee Pad (Dense) $ 1.50
Sale Price: $200 Crutches: Average: $50$ 1.50
Knee Pad (Soft)
Knee Scooters: Average: $400
V. Leg (Plastic) $ 4.50
Insurance: 70% Velc Straps (3) $ 1.50
HCPCS CODE is E0118 Crutch4.50
H. Leg (Plastic) $
substitute, lower leg platform,
V. Stab Arm (2) $ 2.00
Cost to the patient: $60 with or without wheels $ 3.50
Curv Stab Arm (2)
Support (horiz) Bar $ 2.50
Bracket (Main) $ 3.00
Adjust BTM Arm Center $ 2.50
Rental Price: $30 Crutches: Average: $5*
Adjust BTM Arm Outer (4pcs) $ 4.00
Knee Scooters: Average: $35
Viberglass Foot Pcs $ 9.00
*Insurance: 70%
Heel Pad (Soft) $ 1.00
Heel Pad (Rubber) $ 1.00
Heel Pad (Traction) $ 1.00
Toe Pad (Soft) $ 1.00
Toe Pad (Rubber) $ 1.00
Toe Pad (Traction) $ 1.00
TOTAL $ 46.00

20. Sales Estimates
Emergency Room Visits per year 3.40 Million
Non-emergency Room Visits (Est.) 1.70 Million
Total Below Knee Injuries/year 5.10 Million
Covered by Insurance 74%
Insured injured customers 3.77 Million
% Will require mobility devices 10%
Potential Customers 0.38 Million
Sales Price $200 per unit
Revenue from Sales $75.5 Million

21. RentalEstimates
Sales Estimates
Emergency Room Visits per year
Emergency Room Visits per year 3.40 3.40 Million
Million
Non-emergency Room Visits (Est.)
Non-emergency Room Visits (Est.) 1.70 1.70 Million
Million
Total Below Knee Injuries/year 5.10 Million
Total Below Knee Injuries/year 5.10 Million
Uninsured Insurance
Covered bypatients 26%
Covered by Insurance 74%
Uninsured injured customers 1.33 Million
Insured injured customers
% Will require mobility devices 10% 3.77 Million
% Will require mobility devices 0.13 10%
Potential Customers Million
Potential Customers
Average rental weeks per customer 3 0.38 Million
weeks
Sales Price
Total rental weeks per year $200 per unit
0.40 Million weeks
Rental Price
Revenue from Sales $30 per week
$75.5 Million
Revenue from Sales $12.0 Million
$4.0

22. Consumer/User
Revenue share
Device Doctor/Supplier Hands-free Orthopedic Customer/Users
manufacturer relationship mobility doctors Patients with
Podiatrists lower-leg injuries
Doctor/professio Warranties Superior recovery - Recommendation (5m)
nal - prescriptions
Patient/consumer mobility
marketing experience Insurred/Uninsurre
Prosthetic manuf. d
- Technology How? Prosthetic
- Relationships tech to the Patients under 50
temp-injured
Motivations:
Product diversity Retail/Rental
Deliver Online/web presence
Patent Medical Supply
Superior mobility inexpensively to Medical Supply
Stores
FDA approval both insured and Stores
solution Doctor offices:
Insurance uninsured Doctor’s offices
- Orthopedic
Patient registration patients through - Podiatrist - Orthopedic
satisfaction (HCPCS) device sale and - Hospital - Podiatrist
rental Medical Supply
R&D Online distributors
Rental
Consumer testing Athletic
Departments
Value proposition: Prefer to pay
Rent, utilities, For both rental
through insurance
High initial FC salaries and sale
customers
Fixed pricing on
Develop economies Product delivery currently pay for
device
for lower material DME out of
VC Device pocket, through
Weekly rental
registration costs insurance or both
Cust. Acquisition rate
(FDA, etc)

23. FDA Agent: Geeta Pamidimukkala
FlexLeg is a:
FDA/CDRH/Office of Device Evaluation
• Class I Medical Devise
• • Disclosed our device to understand parallel review
"Substantially Equivalent" to a Crutch
What we found out: is:
Therefore, FlexLeg
• • FlexLeg classifies as an orthosis, limb brace
Exempt from Premarket Approval application process (PMA)
• • Therefore exempt from: 510k, PMA and IDE not required (IDE)
Investigational Device Exemption process
Meaning: Register with the FDA and we can go to market!
Durable Medical Equipment
• Insurance covers 50%-80% for the patient
• Register as a supplier to receive HCPCS Code (E0118)
• Doctor writes a prescription: patient may purchase at
medical supply store, online or pharmacy

25. Consumer/User
Revenue share
Device Doctor/Supplier Hands-free Orthopedic Customer/Users
manufacturer relationship mobility doctors Patients with
Podiatrists lower-leg injuries
Doctor/professio Warranties Superior recovery - Recommendation (5m)
nal - prescriptions
Patient/consumer mobility
marketing experience Insurred/Uninsurre
Prosthetic manuf. d
- Technology How? Prosthetic
- Relationships tech to the Patients under 50
temp-injured
Motivations:
Product diversity Retail/Rental
Deliver Online/web presence
Patent Medical Supply
Superior mobility inexpensively to Medical Supply
Stores
FDA approval both insured and Stores
solution Doctor offices:
Insurance uninsured Doctor’s offices
- Orthopedic
Patient registration patients through - Podiatrist - Orthopedic
satisfaction (HCPCS) device sale and - Hospital - Podiatrist
rental Medical Supply
R&D Online distributors
Rental
Consumer testing Athletic
Departments
Value proposition: Prefer to pay
Rent, utilities, For both rental
through insurance
High initial FC salaries and sale
customers
Fixed pricing on
Develop economies Product delivery currently pay for
device
for lower material DME out of
VC Device pocket, through
Weekly rental
registration costs insurance or both
Cust. Acquisition rate
(FDA, etc)

26. 1. Keep getting out of the building!
• Contact and understand online medical supply retailers
• Talk with Dr. Faux and more professionals
2. Meet with manufacturers: ACT & Otto Bock
3. Finish product website: FlexLeg.com
4. Obtain various registrations (FDA, HCPCS, etc)
1. The end user is not the only customer
2. “Get out of the building” both fun and NECESSARY
3. Validate, validate, validate

27. FlexLeg makes your daily life with
a lower leg injury more like your
daily life without one.

29. Similar product to Prototype #2,
yet it still has limitations that are
remedied by the features and
abilities of FlexLeg:
• Natural Mobility:
20-40 degree knee flexion
10-15 degree ankle flexion
• Advanced Leg Performance
Compliant members
Composite materials
• Collapsible for Easy Storage
• Greater Stability
Sales Price of iWalk-Free: $400