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AxioMed Spine CorpTechnology

2014

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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 Teamo 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

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Corporate Overview

• Freedom® Cervical Disc System:o CE Mark Approved in EUo Single and multi-level patients with data out past one yearo 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

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

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FREEDOM® TECHNOLOGY PLATFORM

Freedom Cervical Disc (FCD)Freedom Lumbar Disc (FLD)

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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.

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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

Premise: Functional Restoration

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Freedom® Technology Platform

• Next Generation TDR platform featuring:o Designs which mimic the

function of the human disco An exclusive proprietary

polymeric materialo Proprietary manufacturingo Extensive biomechanical

and biocompatibility characterizations

o Numerous clinical assessments which validate the Freedom Technology

o Reproducible surgical technique

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Freedom Cervical Disc (FCD)

• Levels C3 to C7• Unique, asymmetric design• Multiple sizes with an 8°

wedge angleo 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

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FCD Single and Multi-level

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% NDI – FCD vs. Other TDRs

*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.

PreOp 1.5 Mos 3 Mos 6 Mos0

10

20

30

40

50

60

70

80

51.4

22.5

17.6 16.1

53.9

29

22 23

55.7

27.1

20.7 21.7

51.8

20

15 14

67.8

30.927.5

22.7

47.3

2017.1 17.5

Mean NDI by Interval

Bryan ProDisc-C Prestige ST Secure-C M6-C Freedom

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VAS Neck Pain-FCD vs. Other TDRs

*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.

Preop 1.5 Mos 3 Mos 6 Mos0

10

20

30

40

50

60

70

80

90

75.4

32.7

27.124.1

65

2218 19

68

1815

19

66

20

1316

68.4

28.224.4 25

77

2932

25

56

23.2 23.4

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VAS Neck Pain (mm) vs. Other TDRs

Bryan ProDisc-C Prestige ST Secure-C PCM M6-C Freedom

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Month 6 – ROM (11.0°)

Subject 1-01

Pink dot is the center of rotation (COR)

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Freedom Lumbar Disc (FLD)

• Levels L3/L4 to L5/S1 • Multiple sizes and wedge

angleso Footprints 26, 28, and

30 mmo 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

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FLD Single and Multi-Level Implantations

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Results: EU Clinical Study Outcomes

Pre-Op 6 Weeks 3 Months 6 Months 12 Months

24 Months

0

10

20

30

40

50 46

32

25

14 15

10

Oswestry Disability Index (%)

Mean Median

Pre-Op 6 Weeks

3 Months

6 Months

12 Months

24 Months

0

1

2

3

4

5

6

7

8 7.5

2.41.9

1.52.1

1.0

VAS Low Back Pain (cm)

MeanMedian

At 24 months, half of the patients had ODI ≤ 10%, and half of the patients had VAS low back pain ≤ 1 cm.

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Health Status ScoresFLD versus TDRs

• Statistically significant difference at 3-6 months, 1 year & 2 years

Podium Presentation ISASS 2012 peer reviewed paper in draft

Preopera-tively

3-6 Months 1 Year 2 Years0.000

0.200

0.400

0.600

0.800

1.000

EQ-5D Health Status IndexSWISSspine Registry TDRsFLD

p=0.270

p=0.029p=0.002

p=0.035

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VAS Low Back Pain ScoresFLD versus TDRs

• Statistically significant difference at each interval

Podium Presentation ISASS 2012 peer reviewed paper in draft

Preopera-tively

3-6 Months 1 Year 2 Years0.0

20.0

40.0

60.0

80.0

100.0VAS Low Back Pain

SWISSspine Registry TDRs FLD

Pain

Score

(m

m)

p=0.025

p=0.004 p<0.001 p=0.015

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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)o Adjusted multivariate logistic regression showed a

borderline non-significant p-value (p=0.051)

Pre-op 3-6 months

1 year 2 years 3 years0

20

40

60

80

100 VAS Low Back PainVTDR

Fusion

Pain

Score

(m

m)

Podium Presentation ISASS 2013 peer reviewed paper in draft

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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)o Adjusted multivariate logistic regression showed a non-significant

p-value (p=0.098)

Pre-op 3-6 months

1 year 2 years 3 years0

20

40

60

80

100

VAS Leg Pain

VTDRFusion

Pain

Score

(m

m)

Podium Presentation ISASS 2013 peer reviewed paper in draft

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Market Expansion

• Available data for additional country regulatory approvalo CE Mark and PMA clinical datao Biomechanical testingo Biocompatibility testingo Safety datao Information from both EU CE Mark and FDA

PMA files  o ISO 13485:2012 Certification

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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:

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Thank You