1. AxioMed Spine Corp
Technology
2014
1

2. AxioMed Spine Corp
• AxioMed’s mission is to develop products focused on
spinal function for patients with degenerative spine
disease, thus advancing the standard of care beyond
fusion and first generation total disc replacement.
• Surgeon Development Team
o Edward Benzel, MD
• Chairman, Cleveland Clinic Spine Institute
o Isador Lieberman, MD
• Texas Back Institute (TBI), Plano, Texas
o E. Raymond Ross, MB, ChB, FRCS
• Consultant Spine Surgeon, Hope Hospital, Manchester,
England
2

3. Corporate Overview
• Freedom® Cervical Disc System:
o CE Mark Approved in EU
o Single and multi-level patients with data out past one year
o Undergoing clinical evaluation through a post market study in
the EU to support both an expanded EU market launch and a
FDA IDE Study
• Freedom® Lumbar Disc program:
o Multi-center pilot clinical study completed in the EU in 2008
• Strong evidence of performance with results presented at
international spine meetings and published in a peer reviewed journal
• CE Mark approved in EU
• Over 500 implanted globally with some patients out beyond 8 years
• FDA IDE Study currently has 400 randomized patients enrolled
• Fully validated manufacturing facility with ISO certification
• Intellectual property includes eight US patents and multiple PCT
patents, as well as exclusive rights to the polymer
3

4. DEKRA Certification B.V. Renewal
(ISO & CE) Audit of AxioMed Spine
Corp QMS successfully completed
Jan 2014
4

5. Freedom Cervical Disc (FCD)
Freedom Lumbar Disc (FLD)
FREEDOM® TECHNOLOGY
PLATFORM
5

6. 6
Freedom Technology Philosophy
• An ideal TDR restores healthy function to the
diseased segment, in that the TDR performance:
o Reestablishes the physiologic stiffness in all
loading modes, which provides both physiologic
motion and resistance to excess motions or
loads.
o Restores the index level lordosis and stability
compromised due to the disease process and
alteration of ligament structures during surgical
intervention.

7. Premise: Functional Restoration
Stability Stability + Motion
Function
Motion
Fusion
Natural Disc
↓
Viscoelasticity
↓
Freedom Disc
Ball & Socket Discs
Advantages
Restoration of height
Stabilizes segment
Advantages
Restoration of height
Restoration of lordosis
Restoration of natural motion
Resists excess motion (stability)
No excess stress on surrounding anatomy
Advantages
Restoration of height
Provides motion
Disadvantages
No motion
Excess stress to adjacent levels
Disadvantages
Excess motion (instability)
Excess stress to facet joints
Excess stress to adjacent levels
7

8. Freedom® Technology Platform
• Next Generation TDR platform
featuring:
o Designs which mimic the
function of the human disc
o An exclusive proprietary
polymeric material
o Proprietary manufacturing
o Extensive biomechanical
and biocompatibility
characterizations
o Numerous clinical
assessments which validate
the Freedom Technology
o Reproducible surgical
technique
8

9. Freedom Cervical Disc (FCD)
• Levels C3 to C7
• Unique, asymmetric design
• Multiple sizes with an 8°
wedge angle
o Within the ranges of both
healthy discs and
competitive TDRs
• Enrollment in a multi-center
EU post market study
• FDA IDE study targeted for
2014
• CE Mark approved, primary
indication – degenerative disc
disease
9

10. FCD Single and Multi-level
10

11. % NDI – FCD vs. Other TDRs
51.4
22.5
Mean NDI by Interval
17.6
27.5
22 23
20.7 21.7
17.1 17.5
16.1
53.9
29
55.7
27.1
51.8
20
15 14
67.8
30.9
22.7
47.3
20
80
70
60
50
40
30
20
10
0
PreOp 1.5 Mos 3 Mos 6 Mos
Bryan ProDisc-C Prestige ST Secure-C M6-C Freedom
*Note that the values cited for some TDRs are approximated from data figures in the publication since the actual means were not
described but visually abstracted from charts/figures for the results in the article. Substantial differences exist in the sample size of
each other device’s study reported compared to the number of subjects reported for the FCD Study.
11

12. VAS Neck Pain-FCD vs. Other TDRs
75.4
VAS Neck Pain (mm) vs. Other TDRs
32.7
27.1
32
24.4 25
24.1
65
22
18 19
68
18
15
19
66
20
13
16
68.4
28.2
77
29
90
80
70
60
50
40
30
20
10
*Note that the values cited for some TDRs are approximated from data figures in the publication since the actual means were not
described but visually abstracted from charts/figures for the results in the article. Substantial differences exist in the sample size
of each other device’s study reported compared to the number of subjects reported for the FCD Study.
25
56
23.2 23.4
18
0
Preop 1.5 Mos 3 Mos 6 Mos
Bryan ProDisc-C Prestige ST Secure-C PCM M6-C Freedom
12

13. Month 6 – ROM (11.0°)
Subject 1-01
Pink dot is the center of
rotation (COR)
13

14. Freedom Lumbar Disc (FLD)
• Levels L3/L4 to L5/S1
• Multiple sizes and wedge
angles
o Footprints 26, 28, and 30
mm
o Angles 8° & 12°
• Completed EU multi-center
study with patients out beyond
8 years
• Completed enrollment in FDA
IDE study
• CE Mark approved, primary
indication – degenerative disc
disease
14

15. FLD Single and Multi-Level
Implantations
15

16. Results: EU Clinical Study Outcomes
At 24 months, half of the patients had ODI ≤ 10%, and
half of the patients had VAS low back pain ≤ 1 cm.
46
Oswestry Disability Index (%)
32
25
14 15
10
50
40
30
20
10
0
Pre-Op 6 Weeks 3 Months 6 Months 12 Months 24 Months
Mean Median
7.5
VAS Low Back Pain (cm)
2.4
1.9
1.5
2.1
1.0
8
7
6
5
4
3
2
1
0
Pre-Op 6 Weeks 3 Months 6 Months 12
Months
24
Months
Mean Median
16

17. Health Status Scores
FLD versus TDRs
• Statistically significant difference at 3-6 months, 1 year & 2 years
1.000
0.800
0.600
0.400
0.200
0.000
EQ-5D Health Status Index
SWISSspine Registry TDRs
FLD
p=0.270
Preoperatively 3-6 Months 1 Year 2 Years
Podium Presentation ISASS 2012
peer reviewed paper in draft
p=0.029
p=0.002
p=0.035
17

18. VAS Low Back Pain Scores
FLD versus TDRs
• Statistically significant difference at each interval
100.0
80.0
60.0
40.0
20.0
0.0
Preoperatively 3-6 Months 1 Year 2 Years
Podium Presentation ISASS 2012
peer reviewed paper in draft
Pain Score (mm)
VAS Low Back Pain
SWISSspine Registry TDRs FLD
p=0.025
p=0.004 p<0.001 p=0.015
18

19. VAS Low Back Pain
• Minimum clinically relevant (MCR) back pain relief of 18
VAS points achieved in 96.3% of FLD patients vs. 83.3%
of ALIF patients (p=0.091)
– Adjusted multivariate logistic regression showed a
borderline non-significant p-value (p=0.051)
100
80
60
40
20
0
Pre-op 3-6 months 1 year 2 years 3 years
Pain Score (mm)
VAS Low Back Pain
VTDR
Fusion
Podium Presentation ISASS 2013
peer reviewed paper in draft
19

20. VAS Leg Pain
• Minimum clinically relevant (MCR) back pain relief of 18 VAS
points achieved in 88.9% of FLD patients vs. 57.6% of ALIF
patients (p=0.004)
– Adjusted multivariate logistic regression showed a non-significant p-value
(p=0.098)
100
80
60
40
20
0
Pre-op 3-6
months
1 year 2 years 3 years
Pain Score (mm)
VAS Leg Pain
VTDR
Fusion
Podium Presentation ISASS 2013
peer reviewed paper in draft
20

21. 21
Market Expansion
• Available data for additional country regulatory
approval
o CE Mark and PMA clinical data
o Biomechanical testing
o Biocompatibility testing
o Safety data
o Information from both EU CE Mark and FDA PMA
files
o ISO 13485:2012 Certification

22. 22
Future Opportunity
• Clinical correlation on Freedom benefit for facets
• Clinical correlation on Freedom maintenance of sagittal
spine balance
• Clinical experience provides opportunity for expanded
indications in addition to Degenerative Disc Disease
• Freedom Technology complementary to dynamic
stabilization and fusion systems
• Disc oriented for lateral delivery
• Optimized asymmetric Freedom disc for L5-S1:

23. Thank You
23