Naturally Transformative Bone...

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OSSIOfiber enables intelligent bone regeneration with nothing left behind. Nature works in magical ways and has the amazing ability to heal fractured bone. OSSIOfiberharnesses that power to reinforce and restore healthy bone using a strong, bio-integrative material, leaving the body renewed without permanent hardware. Naturally Transformative Bone Healing INTRODUCTION MATERIAL COMPONENTS STRENGTH BIO-INTEGRATIVE COMPETITIVE COMPARISON PRODUCT INFORMATION SURGICAL TECHNIQUE COMPANY OVERVIEW SUMMARY

Transcript of Naturally Transformative Bone...

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OSSIOfiber™ enables intelligent bone regeneration with nothing left behind. Nature works in magical ways and has the amazing ability to heal fractured bone. OSSIOfiber™ harnesses that power to reinforce and restore healthy bone using a strong, bio-integrative material, leaving the body renewed without permanent hardware.

Naturally Transformative Bone Healing

INTRODUCTION

MATERIAL COMPONENTS

STRENGTH

BIO-INTEGRATIVE

COMPETITIVE COMPARISON

PRODUCT INFORMATION

SURGICAL TECHNIQUE

COMPANY OVERVIEW

SUMMARY

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Vast Surgical Applications

OSSIOfiber™ is a proprietary material platform aimed to provide the first credible replacement to permanent implants. As a first-of-its-kind implant material, OSSIOfiber™ is stronger than cortical bone and leaves nothing permanent behind. It combines the strength required for functional fixation with the ability to fully integrate into the native anatomy—without adverse inflammation.This technology has broad surgical applications through OSSIO’s ability to manufacture endless implant designs that utilize existing reimbursement and do not alter surgical techniques.

Utilizes Existing Reimbursement and Surgical Techniques

Bone In-Growth, Regeneration, and Replacement

Avoids Risks and Costs Associated with Permanent Implants

Strong, Secure Fixations

5 Critical Elements over other implant materials

OSSIOfiber™ Intelligent Bone Regeneration Technology

INTRODUCTION

MATERIAL COMPONENTS

STRENGTH

BIO-INTEGRATIVE

COMPETITIVE COMPARISON

PRODUCT INFORMATION

SURGICAL TECHNIQUE

COMPANY OVERVIEW

SUMMARY

INTRODUCTION

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What makes OSSIOfiber™ unique?Proven materials engineered into a proprietary strong and bio-integrative matrix

50% Natural Mineral Fibers • Composed of silica, magnesium, calcium, and other natural

minerals found in bone• Mineral fibers have been in clinical use for over 30 years,

most commonly as osteoconductive bone void fillers

50% Polymer• Poly-L-D-lactide (PLDLA) binds the fiber matrix together • PLDLA has over 30 years of clinical success and can be gradually

and naturally cleared by the body through hydrolysis

Natural mineral fiber matrix suspended in the polymer

Scanning Electron Microscopy (SEM)of natural mineral fiber

suspended in the polymerSurface texture enables early bone attachment

OSSIOfiber’s reinforced bio-integrative material composition and structural design support both biomechanical performance and bone incorporation.

Balanced, favorable bone regeneration environment

Mineral fibers integrated and replaced by bone

Polymer cleared by hydrolysis (blue arrows)

INTRODUCTION

MATERIAL COMPONENTS

STRENGTH

BIO-INTEGRATIVE

COMPETITIVE COMPARISON

PRODUCT INFORMATION

SURGICAL TECHNIQUE

COMPANY OVERVIEW

SUMMARY

MATERIAL COMPONENTS

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INTRODUCTION

MATERIAL COMPONENTS

STRENGTH

BIO-INTEGRATIVE

COMPETITIVE COMPARISON

PRODUCT INFORMATION

SURGICAL TECHNIQUE

COMPANY OVERVIEW

SUMMARY

MATERIAL COMPONENTS

Proven materials engineered into a proprietary strong and bio-integrative matrix

Natural mineral fiber matrix suspended in the polymer

Scanning Electron Microscopy (SEM)of natural mineral fiber

suspended in the polymerSurface texture enables early bone attachment

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Data on File at OSSIO.

The desired strength for insertion and secure fixationA high-performing matrix of reinforcing mineral fibers

OSSIOfiber™ sustains mechanical performance for bone fixation throughout the healing period of an osteotomy, fusion, or fracture.

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Healing BoneGradual Integration and Load Sharing0

5,000

10,000

15,000

20,000

25,000

2 4 6 8 10 12 104

Stre

ngth

: Ela

stic

Mod

ulus

(MPa

)

Weeks Post Surgery

Strong, Fixation PhaseOSSIOfiber™

0

Conventional BioresorbablesPEEK Pre-injury

0Renewed Healthy BoneHealthy Cortical Bone Strength

RESTORE

Initial, secure fixation at the time of surgery1.5X strength above cortical bone for secure insertion and initial fixationUp to 2X strength compared to PEEKUp to 5X strength compared to conventional polymer bioresorbables

INTRODUCTION

MATERIAL COMPONENTS

STRENGTH

BIO-INTEGRATIVE

COMPETITIVE COMPARISON

PRODUCT INFORMATION

SURGICAL TECHNIQUE

COMPANY OVERVIEW

SUMMARY

STRENGTH

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24

Healing BoneGradual Integration and Load Sharing0

5,000

10,000

15,000

20,000

25,000

2 4 6 8 10 12 104

Stre

ngth

: Ela

stic

Mod

ulus

(MPa

)

Weeks Post Surgery

Strong, Fixation PhaseOSSIOfiber™

0

Conventional BioresorbablesPEEK Pre-injury

0Renewed Healthy BoneHealthy Cortical Bone Strength

Data on File at OSSIO.

The desired strength for insertion and secure fixationA high-performing matrix of reinforcing mineral fibers

REGROW

Healing and rehabilitation phase with sustained fixation strength and gradual bone integrationBetter match than metal to natural bone’s stiffness to aid in prevention of stress risersGradual bone integration within OSSIOfiber™ implants enables load sharing during healing and rehabilitation

OSSIOfiber™ sustains mechanical performance for bone fixation throughout the healing period of an osteotomy, fusion, or fracture.

INTRODUCTION

MATERIAL COMPONENTS

STRENGTH

BIO-INTEGRATIVE

COMPETITIVE COMPARISON

PRODUCT INFORMATION

SURGICAL TECHNIQUE

COMPANY OVERVIEW

SUMMARY

STRENGTH

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Data on File at OSSIO.

The desired strength for insertion and secure fixationA high-performing matrix of reinforcing mineral fibers

24

Healing BoneGradual Integration and Load Sharing0

5,000

10,000

15,000

20,000

25,000

2 4 6 8 10 12 104

Stre

ngth

: Ela

stic

Mod

ulus

(MPa

)

Weeks Post Surgery

Strong, Fixation PhaseOSSIOfiber™

0

Conventional BioresorbablesPEEK Pre-injury

0Renewed Healthy BoneHealthy Cortical Bone Strength

RENEW

Only nature remainsPatient is healed with no permanent hardware left behind

OSSIOfiber™ sustains mechanical performance for bone fixation throughout the healing period of an osteotomy, fusion, or fracture.

INTRODUCTION

MATERIAL COMPONENTS

STRENGTH

BIO-INTEGRATIVE

COMPETITIVE COMPARISON

PRODUCT INFORMATION

SURGICAL TECHNIQUE

COMPANY OVERVIEW

SUMMARY

STRENGTH

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INTRODUCTION

MATERIAL COMPONENTS

STRENGTH

BIO-INTEGRATIVE

COMPETITIVE COMPARISON

PRODUCT INFORMATION

SURGICAL TECHNIQUE

COMPANY OVERVIEW

SUMMARY

STRENGTH OSSIOfiber™ sustains mechanical performance for bone fixation throughout the healing period of an osteotomy, fusion, or fracture.

24

Healing BoneGradual Integration and Load Sharing0

5,000

10,000

15,000

20,000

25,000

2 4 6 8 10 12 104

Stre

ngth

: Ela

stic

Mod

ulus

(MPa

)

Weeks Post Surgery

Strong, Fixation PhaseOSSIOfiber™

0

Conventional BioresorbablesPEEK Pre-injury

0Renewed Healthy BoneHealthy Cortical Bone Strength

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OSSIOfiber™ Gradual and intelligent incorporation Polymer is virtually eliminated by 78 weeks

OSSIOfiber™

Early bone attachment and in-growth Gradual integration with surrounding anatomy with no adverse inflammation observed

OSSIOfiber™ fully integrated within 78-104 weeks

! No observed integration within 52 weeks! Fibrotic encapsulation and cracks in material observed! Severe, abrupt decline of polymer content from

78-104 weeks suggests local adverse inflammation due to burst effect, commonly observed within conventional polymer bioresorbables1-4

Pre-clinical Animal Study

vs Conventional Bioresorbable

In-bone implantation in rabbit femurs (weeks)

Polymer Incorporation Profile5

% o

f pol

ymer

rem

aini

ng

0%

25%

50%

75%

100%

0 10412 26 52 78

Conventional Bioresorbable

80%polymer

remaining

10-15%polymer remaining

Virtuallyeliminated

OSSIOfiber™

OSSIOfiber™

Fully integrated into surrounding bone within 78-104 weeks

ControlSevere, abrupt decline in polymer

content suggests burst effect

!

Incorporation Timeline

+

INTRODUCTION

MATERIAL COMPONENTS

STRENGTH

BIO-INTEGRATIVE

COMPETITIVE COMPARISON

PRODUCT INFORMATION

SURGICAL TECHNIQUE

COMPANY OVERVIEW

SUMMARY

BIO-INTEGRATIVE

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INTRODUCTION

MATERIAL COMPONENTS

STRENGTH

BIO-INTEGRATIVE

COMPETITIVE COMPARISON

PRODUCT INFORMATION

SURGICAL TECHNIQUE

COMPANY OVERVIEW

SUMMARY

BIO-INTEGRATIVE

In-bone implantation in rabbit femurs (weeks)

Polymer Incorporation Profile5

% o

f pol

ymer

rem

aini

ng

0%

25%

50%

75%

100%

0 10412 26 52 78

Conventional Bioresorbable

80%polymer

remaining

10-15%polymer remaining

Virtuallyeliminated

OSSIOfiber™

OSSIOfiber™

Fully integrated into surrounding bone within 78-104 weeks

ControlSevere, abrupt decline in polymer

content suggests burst effect

!

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Bone in-growth, regeneration, and complete replacement Pre-clinical animal study5: OSSIOfiber™ Implant vs Conventional Bioresorbable Polymer Implant (Control) Proven in pre-clinical studies, OSSIOfiber™ integrates into the native anatomy without adverse inflammation, local osteolysis, cyst formation, or fibrotic encapsulation. Only nature remains in the bone.

OSSIOfiber™ Control (PLDLA)

0-13 WEEKS

2 weeks New trabecular bone forming and attaching

6 weeks Bone-forming cells penetrating implant surface and surrounding mineral fibers

13 weeks Bone and tissue in-growth continues with <75% polymer remaining

Cortical Bone

EARLY BONE ATTACHMENT AND IN-GROWTH NO OBSERVED INTEGRATION

Implant

Cortical Bone

13 weeks

Polymer Profile

+

INTRODUCTION

MATERIAL COMPONENTS

STRENGTH

BIO-INTEGRATIVE

COMPETITIVE COMPARISON

PRODUCT INFORMATION

SURGICAL TECHNIQUE

COMPANY OVERVIEW

SUMMARY

BIO-INTEGRATIVE

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INTRODUCTION

MATERIAL COMPONENTS

STRENGTH

BIO-INTEGRATIVE

COMPETITIVE COMPARISON

PRODUCT INFORMATION

SURGICAL TECHNIQUE

COMPANY OVERVIEW

SUMMARY

Pre-clinical animal study5: OSSIOfiber™ Implant vs Conventional Bioresorbable Polymer Implant (Control)

OSSIOfiber™ Control (PLDLA)

0-13 WEEKS

EARLY BONE ATTACHMENT AND IN-GROWTH NO OBSERVED INTEGRATION

2 weeks New trabecular bone forming and attaching

6 weeks Bone-forming cells penetrating implant surface and surrounding mineral fibers

13 weeks Bone and tissue in-growth continues with <75% polymer remaining

Cortical Bone

Implant

Cortical Bone

13 weeks

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Pronounced new bone and tissue in-growth within implant

Implant

Implant remainsFibrotic encapsulation of implant

Medullary Fat

Medullary Fat

Bone in-growth, regeneration, and complete replacement Pre-clinical animal study5: OSSIOfiber™ Implant vs Conventional Bioresorbable Polymer Implant (Control) Proven in pre-clinical studies, OSSIOfiber™ integrates into the native anatomy without adverse inflammation, local osteolysis, cyst formation, or fibrotic encapsulation. Only nature remains in the bone.

GRADUAL BONE INTEGRATION NO BONE IN-GROWTH

OSSIOfiber™ Control (PLDLA)

26-52 WEEKS

Polymer Profile

+

INTRODUCTION

MATERIAL COMPONENTS

STRENGTH

BIO-INTEGRATIVE

COMPETITIVE COMPARISON

PRODUCT INFORMATION

SURGICAL TECHNIQUE

COMPANY OVERVIEW

SUMMARY

BIO-INTEGRATIVE

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INTRODUCTION

MATERIAL COMPONENTS

STRENGTH

BIO-INTEGRATIVE

COMPETITIVE COMPARISON

PRODUCT INFORMATION

SURGICAL TECHNIQUE

COMPANY OVERVIEW

SUMMARY

BIO-INTEGRATIVE

Pre-clinical animal study5: OSSIOfiber™ Implant vs Conventional Bioresorbable Polymer Implant (Control)

OSSIOfiber™ Control (PLDLA)

26-52 WEEKS

GRADUAL BONE INTEGRATION NO BONE IN-GROWTH

Pronounced new bone and tissue in-growth within implant

Implant

Implant remainsFibrotic encapsulation of implant

Medullary Fat

Medullary Fat

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Bone in-growth, regeneration, and complete replacement Pre-clinical animal study5: OSSIOfiber™ Implant vs Conventional Bioresorbable Polymer Implant (Control) Proven in pre-clinical studies, OSSIOfiber™ integrates into the native anatomy without adverse inflammation, local osteolysis, cyst formation, or fibrotic encapsulation. Only nature remains in the bone.

ONLY NATURE REMAINS DELAYED BURST EFFECT

OSSIOfiber™ fully integrated into surrounding anatomy within 78-104 weeks

104 weeks Polymer eliminated and mineral fibers remodeled into bone

78 weeksHealthy cortical bone remodeled at implant site

104 weeks Presence of lymphocytes and macrophagesSevere, abrupt degradation in polymer content suggests local adverse inflammation due to burst effect

78 weeksCracks propagating throughout the implant>80% polymer remains

OSSIOfiber™ Control (PLDLA)

78-104 WEEKS

Polymer Profile

+

INTRODUCTION

MATERIAL COMPONENTS

STRENGTH

BIO-INTEGRATIVE

COMPETITIVE COMPARISON

PRODUCT INFORMATION

SURGICAL TECHNIQUE

COMPANY OVERVIEW

SUMMARY

BIO-INTEGRATIVE

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INTRODUCTION

MATERIAL COMPONENTS

STRENGTH

BIO-INTEGRATIVE

COMPETITIVE COMPARISON

PRODUCT INFORMATION

SURGICAL TECHNIQUE

COMPANY OVERVIEW

SUMMARY

BIO-INTEGRATIVE

Pre-clinical animal study5: OSSIOfiber™ Implant vs Conventional Bioresorbable Polymer Implant (Control)

OSSIOfiber™ Control (PLDLA)

78-104 WEEKS

ONLY NATURE REMAINS DELAYED BURST EFFECT

104 weeks Presence of lymphocytes and macrophagesSevere, abrupt degradation in polymer content suggests local adverse inflammation due to burst effect

78 weeksCracks propagating throughout the implant>80% polymer remains

OSSIOfiber™ fully integrated into surrounding anatomy within 78-104 weeks

104 weeks Polymer eliminated and mineral fibers remodeled into bone

78 weeksHealthy cortical bone remodeled at implant site

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Stro

ng

Mec

hani

cal p

erfo

rman

ce fo

r bon

e fix

atio

n

Natural Bone Regeneration Ability to fully integrate into native bone without adverse inflammation

PEEK

Bioresorbables

Bio-composites

New Category:Bio-Integrative Fixation

Metal

OSSIOfiber™

OSSIOfiber™: A breakthrough fixation material platform

The generations of trade-offs for

orthopedic fixation between strength and

bone regeneration have been solved.

Material Characteristics

INTRODUCTION

MATERIAL COMPONENTS

STRENGTH

BIO-INTEGRATIVE

COMPETITIVE COMPARISON

PRODUCT INFORMATION

SURGICAL TECHNIQUE

COMPANY OVERVIEW

SUMMARY

COMPETITIVE COMPARISON

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INTRODUCTION

MATERIAL COMPONENTS

STRENGTH

BIO-INTEGRATIVE

COMPETITIVE COMPARISON

PRODUCT INFORMATION

SURGICAL TECHNIQUE

COMPANY OVERVIEW

SUMMARY

COMPETITIVE COMPARISON St

rong

M

echa

nica

l per

form

ance

for b

one

fixat

ion

Natural Bone Regeneration Ability to fully integrate into native bone without adverse inflammation

PEEK

Bioresorbables

Bio-composites

New Category:Bio-Integrative Fixation

Metal

OSSIOfiber™

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Data on File at OSSIO.

StrongDesired strength for insertion and secure fixation

Bio-IntegrativeRapid bone regrowth, incorporation, and complete replacement without adverse complications

See how the characteristics of strong and bio-integrative OSSIOfiber™ compare to metal, PEEK, and bioresorbable materials.

Finally, an evolution for fixation materials that are strong and bio-integrative

Metal PEEK Bioresorbable Bio-Integrative

Eliminate risk of permanent hardware removal

Ability to incorporate into native bone in <2 years

Early bone attachment and in-growth

Strong fixation for load-bearing implants

Strength during insertion

Stiffness matched for cortical bone

Ability to drill through implant for

easier revision surgeries

Artifact-free CT and X-ray imaging, MRI safe

Non-permanent fixation

Platform Strengths

INTRODUCTION

MATERIAL COMPONENTS

STRENGTH

BIO-INTEGRATIVE

COMPETITIVE COMPARISON

PRODUCT INFORMATION

SURGICAL TECHNIQUE

COMPANY OVERVIEW

SUMMARY

COMPETITIVE COMPARISON

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OSSIOfiber™ Hammertoe Fixation System

Kit Ordering Information

Tactile feedback upon insertion with stopper

Opposing barbs to prevent pull-out and rotation

Data on File at OSSIO.

Convenient Disposable KitThe Strong and Bio-Integrative Implant

• Disposable K-Wire, Drill Bit, and Inserter provided

• Implants packaged with disposable instruments and as stand-alone forcost savings

• No additional handling requirements or freezer storage required

Comprised of OSSIOfiber™ Intelligent Bone Regeneration Technology

• Strong, secure fixation for PIP fusions

• Fully integrates into native anatomy without adverse inflammation, as proven in pre-clinical studies

• Visible yet artifact-free on CT and X-ray, MRI safe

Three sizes (2.5 mm, 2.9 mm, and 3.2 mm)Two orientations (0º and 10º) Implant

pre-loaded on Inserter

CT and X-Ray Imaging

INTRODUCTION

MATERIAL COMPONENTS

STRENGTH

BIO-INTEGRATIVE

COMPETITIVE COMPARISON

PRODUCT INFORMATION

SURGICAL TECHNIQUE

COMPANY OVERVIEW

SUMMARY

PRODUCT INFORMATION

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Data on File at OSSIO. Not available for sale outside the US.

Kit ordering information

Hammertoe Fixation Implant

*Implants are packaged pre-loaded on an inserter.†Instrument kits include a Drill Bit and K-Wire.

Disposable kits (implant + instrumentation) and stand-alone implants are available in 3 sizes (small, medium, and large) and in 2 orientations (straight and angled).

Size Description Product Code

Small

OSSIOfiber™ Hammertoe Fixation Implant 2.5 x 16 mm, 0° Straight*

OF10025160

OSSIOfiber™ Hammertoe Fixation System 2.5 x 16 mm, 0° Straight Implant and Instrument Kit† OF20025160

OSSIOfiber™ Hammertoe Fixation Implant 2.5 x 16 mm, 10° Angled*

OF10025161

OSSIOfiber™ Hammertoe Fixation System 2.5 x 16 mm, 10° Angled Implant and Instrument Kit† OF20025161

Medium

OSSIOfiber™ Hammertoe Fixation Implant 2.9 x 19 mm, 0° Straight*

OF10029190

OSSIOfiber™ Hammertoe Fixation System 2.9 x 19 mm, 0° Straight Implant and Instrument Kit†

OF20029190

OSSIOfiber™ Hammertoe Fixation Implant 2.9 x 19 mm, 10° Angled*

OF10029191

OSSIOfiber™ Hammertoe Fixation System 2.9 x 19 mm, 10° Angled Implant and Instrument Kit† OF20029191

Large

OSSIOfiber™ Hammertoe Fixation Implant 3.2 x 21 mm, 0° Straight*

OF10032210

OSSIOfiber™ Hammertoe Fixation System 3.2 x 21 mm, 0° Straight Implant and Instrument Kit† OF20032210

OSSIOfiber™ Hammertoe Fixation Implant 3.2 x 21 mm, 10° Angled*

OF10032211

OSSIOfiber™ Hammertoe Fixation System 3.2 x 21 mm, 10° Angled Implant and Instrument Kit† OF20032211

INTRODUCTION

MATERIAL COMPONENTS

STRENGTH

BIO-INTEGRATIVE

COMPETITIVE COMPARISON

PRODUCT INFORMATION

SURGICAL TECHNIQUE

COMPANY OVERVIEW

SUMMARY

PRODUCT INFORMATION

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Artifact-free CT and X-Ray Imaging OSSIOfiber™ Intelligent Bone Regeneration Technology has similar radiodensity to cortical bone for artifact-free CT and X-Ray, MR safe imaging. The images below show a 2nd toe proximal interphalangeal (PIP) joint fusion with the Medium, Straight OSSIOfiberTM Hammertoe Implant.

Patient x-rays are representative of a selection of patients of similar demographics who underwent identical surgical approaches and have reached the indicated follow up time points. Results are not predictive of results in other cases. Results may vary.

Post-operative X-Ray

Post-operative CT Scan

6-week CT Scan

Post-Operative X-Ray

INTRODUCTION

MATERIAL COMPONENTS

STRENGTH

BIO-INTEGRATIVE

COMPETITIVE COMPARISON

PRODUCT INFORMATION

SURGICAL TECHNIQUE

COMPANY OVERVIEW

SUMMARY

PRODUCT INFORMATION

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Artifact-free CT and X-Ray Imaging OSSIOfiber™ Intelligent Bone Regeneration Technology has similar radiodensity to cortical bone for artifact-free CT and X-Ray, MR safe imaging. The images below show a 2nd toe proximal interphalangeal (PIP) joint fusion with the Medium, Straight OSSIOfiberTM Hammertoe Implant.

Patient x-rays are representative of a selection of patients of similar demographics who underwent identical surgical approaches and have reached the indicated follow up time points. Results are not predictive of results in other cases. Results may vary.

12-Week CT Scan

INTRODUCTION

MATERIAL COMPONENTS

STRENGTH

BIO-INTEGRATIVE

COMPETITIVE COMPARISON

PRODUCT INFORMATION

SURGICAL TECHNIQUE

COMPANY OVERVIEW

SUMMARY

PRODUCT INFORMATION

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Artifact-free CT and X-Ray Imaging OSSIOfiber™ Intelligent Bone Regeneration Technology has similar radiodensity to cortical bone for artifact-free CT and X-Ray, MR safe imaging. The images below show a 2nd toe proximal interphalangeal (PIP) joint fusion with the Medium, Straight OSSIOfiberTM Hammertoe Implant.

Patient x-rays are representative of a selection of patients of similar demographics who underwent identical surgical approaches and have reached the indicated follow up time points. Results are not predictive of results in other cases. Results may vary.

12-Week X-Ray

INTRODUCTION

MATERIAL COMPONENTS

STRENGTH

BIO-INTEGRATIVE

COMPETITIVE COMPARISON

PRODUCT INFORMATION

SURGICAL TECHNIQUE

COMPANY OVERVIEW

SUMMARY

PRODUCT INFORMATION

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Artifact-free CT and X-Ray Imaging OSSIOfiber™ Intelligent Bone Regeneration Technology has similar radiodensity to cortical bone for artifact-free CT and X-Ray, MR safe imaging. The images below show a 2nd toe proximal interphalangeal (PIP) joint fusion with the Medium, Straight OSSIOfiberTM Hammertoe Implant.

Patient x-rays are representative of a selection of patients of similar demographics who underwent identical surgical approaches and have reached the indicated follow up time points. Results are not predictive of results in other cases. Results may vary.

6 Month Post-Operative X-Rays

INTRODUCTION

MATERIAL COMPONENTS

STRENGTH

BIO-INTEGRATIVE

COMPETITIVE COMPARISON

PRODUCT INFORMATION

SURGICAL TECHNIQUE

COMPANY OVERVIEW

SUMMARY

PRODUCT INFORMATION

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Artifact-free CT and X-Ray Imaging OSSIOfiber™ Intelligent Bone Regeneration Technology has similar radiodensity to cortical bone for artifact-free CT and X-Ray, MR safe imaging. The images below show a 2nd toe proximal interphalangeal (PIP) joint fusion with the Medium, Straight OSSIOfiberTM Hammertoe Implant.

Patient x-rays are representative of a selection of patients of similar demographics who underwent identical surgical approaches and have reached the indicated follow up time points. Results are not predictive of results in other cases. Results may vary.

6 Month Post-Operative X-Rays

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PIP arthrodesis surgical techniqueUsing the OSSIOfiber™ Hammertoe Fixation Implant The OSSIOfiber™ Hammertoe Fixation Implant provides the necessary strength for proximal interphalangeal (PIP) fusion procedures with a bio-integrative intermedullary implant made from OSSIOfiber™ Intelligent Bone Regeneration Technology. This proprietary material technology is comprised of natural mineral fibers engineered into a high-performing matrix suspended within a Poly-L-D-lactide (PLDLA) polymer. OSSIOfiber™ material gradually incorporates into the surrounding anatomy, leaving nothing permanent behind.

Surgical Technique Guide

Prepare JointResect both sides of the joint, perpendicular to the dorsal cortex, with an oscillating saw or rongeur. Drill the provided K-wire into the medullary canal of the proximal and middle phalanx. Note: Ensure K-wire is parallel to the dorsal cortex during drilling for optimal tunnel placement.

1

Refer to the product Instructions for Use for warnings, precautions, indications, contraindications, and technique. Medical professionals must use their professional judgment for patient selection and appropriate technique. Data on File at OSSIO. Not available for sale outside the US.

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INTRODUCTION

MATERIAL COMPONENTS

STRENGTH

BIO-INTEGRATIVE

COMPETITIVE COMPARISON

PRODUCT INFORMATION

SURGICAL TECHNIQUE

COMPANY OVERVIEW

SUMMARY

SURGICAL TECHNIQUE

Surgical Technique Guide

Prepare JointResect both sides of the joint, perpendicular to the dorsal cortex, with an oscillating saw or rongeur. Drill the provided K-wire into the medullary canal of the proximal and middle phalanx. Note: Ensure K-wire is parallel to the dorsal cortex during drilling for optimal tunnel placement.

1

Refer to the product Instructions for Use for warnings, precautions, indications, contraindications, and technique. Medical professionals must use their professional judgment for patient selection and appropriate technique. Data on File at OSSIO. Not available for sale outside the US.

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Prepare Proximal PhalanxUsing the pilot hole created by the K-wire, drill a tunnel in the proximal phalanx referencing the proximal laser mark on the drill bit for the recommended tunnel length.

Surgical Technique Guide

2

Refer to the product Instructions for Use for warnings, precautions, indications, contraindications, and technique. Medical professionals must use their professional judgment for patient selection and appropriate technique. Data on File at OSSIO. Not available for sale outside the US.

PIP arthrodesis surgical techniqueUsing the OSSIOfiber™ Hammertoe Fixation Implant The OSSIOfiber™ Hammertoe Fixation Implant provides the necessary strength for proximal interphalangeal (PIP) fusion procedures with a bio-integrative intermedullary implant made from OSSIOfiber™ Intelligent Bone Regeneration Technology. This proprietary material technology is comprised of natural mineral fibers engineered into a high-performing matrix suspended within a Poly-L-D-lactide (PLDLA) polymer. OSSIOfiber™ material gradually incorporates into the surrounding anatomy, leaving nothing permanent behind.

INTRODUCTION

MATERIAL COMPONENTS

STRENGTH

BIO-INTEGRATIVE

COMPETITIVE COMPARISON

PRODUCT INFORMATION

SURGICAL TECHNIQUE

COMPANY OVERVIEW

SUMMARY

SURGICAL TECHNIQUE

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INTRODUCTION

MATERIAL COMPONENTS

STRENGTH

BIO-INTEGRATIVE

COMPETITIVE COMPARISON

PRODUCT INFORMATION

SURGICAL TECHNIQUE

COMPANY OVERVIEW

SUMMARY

SURGICAL TECHNIQUE

Surgical Technique Guide

Prepare Proximal PhalanxUsing the pilot hole created by the K-wire, drill a tunnel in the proximal phalanx referencing the proximal laser mark on the drill bit for the recommended tunnel length.

2

Refer to the product Instructions for Use for warnings, precautions, indications, contraindications, and technique. Medical professionals must use their professional judgment for patient selection and appropriate technique. Data on File at OSSIO. Not available for sale outside the US.

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Prepare Middle PhalanxCreate a second tunnel in the middle phalanx referencing the distal laser line on the drill bit for the recommended tunnel length.

Surgical Technique Guide

3

Refer to the product Instructions for Use for warnings, precautions, indications, contraindications, and technique. Medical professionals must use their professional judgment for patient selection and appropriate technique. Data on File at OSSIO. Not available for sale outside the US.

+

PIP arthrodesis surgical techniqueUsing the OSSIOfiber™ Hammertoe Fixation Implant The OSSIOfiber™ Hammertoe Fixation Implant provides the necessary strength for proximal interphalangeal (PIP) fusion procedures with a bio-integrative intermedullary implant made from OSSIOfiber™ Intelligent Bone Regeneration Technology. This proprietary material technology is comprised of natural mineral fibers engineered into a high-performing matrix suspended within a Poly-L-D-lactide (PLDLA) polymer. OSSIOfiber™ material gradually incorporates into the surrounding anatomy, leaving nothing permanent behind.

INTRODUCTION

MATERIAL COMPONENTS

STRENGTH

BIO-INTEGRATIVE

COMPETITIVE COMPARISON

PRODUCT INFORMATION

SURGICAL TECHNIQUE

COMPANY OVERVIEW

SUMMARY

SURGICAL TECHNIQUE

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INTRODUCTION

MATERIAL COMPONENTS

STRENGTH

BIO-INTEGRATIVE

COMPETITIVE COMPARISON

PRODUCT INFORMATION

SURGICAL TECHNIQUE

COMPANY OVERVIEW

SUMMARY

SURGICAL TECHNIQUE

Surgical Technique Guide

Prepare Middle PhalanxCreate a second tunnel in the middle phalanx referencing the distal laser line on the drill bit for the recommended tunnel length.

3

Refer to the product Instructions for Use for warnings, precautions, indications, contraindications, and technique. Medical professionals must use their professional judgment for patient selection and appropriate technique. Data on File at OSSIO. Not available for sale outside the US.

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Fixate Implant Insert the proximal end of the OSSIOfiber™ Hammertoe Fixation Implant into the proximal phalanx until the stopper is reached, using the implant holder.

Surgical Technique Guide

4

Refer to the product Instructions for Use for warnings, precautions, indications, contraindications, and technique. Medical professionals must use their professional judgment for patient selection and appropriate technique. Data on File at OSSIO. Not available for sale outside the US.

+

PIP arthrodesis surgical techniqueUsing the OSSIOfiber™ Hammertoe Fixation Implant The OSSIOfiber™ Hammertoe Fixation Implant provides the necessary strength for proximal interphalangeal (PIP) fusion procedures with a bio-integrative intermedullary implant made from OSSIOfiber™ Intelligent Bone Regeneration Technology. This proprietary material technology is comprised of natural mineral fibers engineered into a high-performing matrix suspended within a Poly-L-D-lactide (PLDLA) polymer. OSSIOfiber™ material gradually incorporates into the surrounding anatomy, leaving nothing permanent behind.

INTRODUCTION

MATERIAL COMPONENTS

STRENGTH

BIO-INTEGRATIVE

COMPETITIVE COMPARISON

PRODUCT INFORMATION

SURGICAL TECHNIQUE

COMPANY OVERVIEW

SUMMARY

SURGICAL TECHNIQUE

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INTRODUCTION

MATERIAL COMPONENTS

STRENGTH

BIO-INTEGRATIVE

COMPETITIVE COMPARISON

PRODUCT INFORMATION

SURGICAL TECHNIQUE

COMPANY OVERVIEW

SUMMARY

SURGICAL TECHNIQUE

Surgical Technique Guide

Fixate Implant Insert the proximal end of the OSSIOfiber™ Hammertoe Fixation Implant into the proximal phalanx until the stopper is reached, using the implant holder.

4

Refer to the product Instructions for Use for warnings, precautions, indications, contraindications, and technique. Medical professionals must use their professional judgment for patient selection and appropriate technique. Data on File at OSSIO. Not available for sale outside the US.

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Align and ReduceManually reduce the middle phalanx over the distal end of the OSSIOfiber™ Hammertoe Fixation Implant, applying slow, steady pressure until bone-to-bone contact is achieved. Complete the procedure by routine closure using preferred technique.

Surgical Technique Guide

5

Refer to the product Instructions for Use for warnings, precautions, indications, contraindications, and technique. Medical professionals must use their professional judgment for patient selection and appropriate technique. Data on File at OSSIO. Not available for sale outside the US.

+

PIP arthrodesis surgical techniqueUsing the OSSIOfiber™ Hammertoe Fixation Implant The OSSIOfiber™ Hammertoe Fixation Implant provides the necessary strength for proximal interphalangeal (PIP) fusion procedures with a bio-integrative intermedullary implant made from OSSIOfiber™ Intelligent Bone Regeneration Technology. This proprietary material technology is comprised of natural mineral fibers engineered into a high-performing matrix suspended within a Poly-L-D-lactide (PLDLA) polymer. OSSIOfiber™ material gradually incorporates into the surrounding anatomy, leaving nothing permanent behind.

INTRODUCTION

MATERIAL COMPONENTS

STRENGTH

BIO-INTEGRATIVE

COMPETITIVE COMPARISON

PRODUCT INFORMATION

SURGICAL TECHNIQUE

COMPANY OVERVIEW

SUMMARY

SURGICAL TECHNIQUE

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INTRODUCTION

MATERIAL COMPONENTS

STRENGTH

BIO-INTEGRATIVE

COMPETITIVE COMPARISON

PRODUCT INFORMATION

SURGICAL TECHNIQUE

COMPANY OVERVIEW

SUMMARY

SURGICAL TECHNIQUE

Surgical Technique Guide

Align and ReduceManually reduce the middle phalanx over the distal end of the OSSIOfiber™ Hammertoe Fixation Implant, applying slow, steady pressure until bone-to-bone contact is achieved. Complete the procedure by routine closure using preferred technique.

5

Refer to the product Instructions for Use for warnings, precautions, indications, contraindications, and technique. Medical professionals must use their professional judgment for patient selection and appropriate technique. Data on File at OSSIO. Not available for sale outside the US.

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Refer to the product Instructions for Use for warnings, precautions, indications, contraindications, and technique. Medical professionals must use their professional judgment for patient selection and appropriate technique. Data on File at OSSIO. Not available for sale outside the US.

+

PIP arthrodesis surgical techniqueUsing the OSSIOfiber™ Hammertoe Fixation Implant The OSSIOfiber™ Hammertoe Fixation Implant provides the necessary strength for proximal interphalangeal (PIP) fusion procedures with a bio-integrative intermedullary implant made from OSSIOfiber™ Intelligent Bone Regeneration Technology. This proprietary material technology is comprised of natural mineral fibers engineered into a high-performing matrix suspended within a Poly-L-D-lactide (PLDLA) polymer. OSSIOfiber™ material gradually incorporates into the surrounding anatomy, leaving nothing permanent behind.

INTRODUCTION

MATERIAL COMPONENTS

STRENGTH

BIO-INTEGRATIVE

COMPETITIVE COMPARISON

PRODUCT INFORMATION

SURGICAL TECHNIQUE

COMPANY OVERVIEW

SUMMARY

SURGICAL TECHNIQUE

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Who we are

OSSIO Israel HQ

Dedicated to pioneering a breakthrough category of non-permanent fixationOSSIO is an orthopedic fixation company committed to transforming the orthopedic experience for patients, physicians, and payers. Our vision is to provide the first credible replacement to metal implants in the $10B+ orthopedic fixation market (screws, pins, and plates) with an Intelligent Bone Regeneration Technology. OSSIOfiber™ represents a breakthrough material platform for orthopedic and podiatric surgeons who seek a more biologically friendly way to restore patient stability and mobility with nothing permanent left behind. The development headquarters of OSSIO are in Caesarea, Israel, and its commercial headquarters are in Boston, Massachusetts.

Developing the right balance of strength and bio-friendlinessIn 2014, OSSIO began as the culmination of years of biomechanical research and a vision for the possibility of better bone healing. The technological basis of OSSIOfiber™ was developed and laid the groundwork for a breakthrough category of non-permanent fixation: bio-integrative hardware that has both the desired strength AND bio-friendliness. Hardware that has the mechanical strength for easy insertion and secure fixation while enabling the body to regrow bone to incorporate and replace the implant has remained elusive to the industry until now. Adverse inflammation and weakness are often seen in bioresorbables and other bio-composites.

Manufacturing area

OSSIO strives to become THE gold standard in orthopedic fixation by encouraging natural bone healing that will ultimately eliminate hardware removal procedures, minimize implant-related complications, alleviate pain, and dramatically improve the healthcare economics of orthopedics.

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COMPANY OVERVIEW

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Naturally Transformative Bone HealingOSSIOfiber™ enables intelligent bone regeneration with nothing left behind.

For more on OSSIO and OSSIOfiber™, please visit ossio.io, call 833-781-7373 or email [email protected]

Additional Information

Vast Surgical Applications

Utilizes Existing Reimbursement and Surgical Techniques

Bone In-Growth, Regeneration, and Replacement

Avoids Risks and Costs Associated with Permanent Implants

Strong, Secure Fixations

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DOC000341 Rev 02 08/2019DOC000342 Rev 01 12/2018 DOC000343 Rev 03 08/2019 DOC000345 Rev 01 08/2019 DOC000346 Rev 02 08/2019DOC000688 Rev 01 07/2019

References: 1. Ambrose CG, Clanton TO. Bioabsorbable implants: review of clinical experience in orthopedic surgery. Ann Biomed Eng. 2004;32(1):171–177. 2. Kontakis GM, Pagkalos JE, Tosounidis TI, Melissas J, Katonis P. Bioabsorbable materials in orthopaedics. Acta Orthop Belg. 2007;73(2):159–169. 3. Cox CL, Spindler KP, Leonard JP, Morris BJ, Dunn WR, Reinke EK. Do newer-generation bioabsorbable screws become incorporated into bone at two years

after ACL reconstruction with patellar tendon graft?: a cohort study. J Bone Joint Surg Am. 2014;96(3):244–250. 4. Konan S, Haddad FS. A clinical review of bioabsorbable interference screws and their adverse effects in anterior cruciate ligament reconstruction surgery.

Knee. 2009;16(1):6–13. 5. Pre-clinical animal studies (in-bone implantation of OSSIOfiber™ and PLDLA control in rabbit femurs). Data on File at OSSIO.

Not available for sale outside the US.

OSSIO and OSSIOfiber are trademarks of OSSIO Ltd.OSSIO Inc, 300 Tradecenter Drive, Suite 3690, Woburn, MA 01801www.ossio.io | email: [email protected] | phone number: 833-781-7373

Summary

INTRODUCTION

MATERIAL COMPONENTS

STRENGTH

BIO-INTEGRATIVE

COMPETITIVE COMPARISON

PRODUCT INFORMATION

SURGICAL TECHNIQUE

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SUMMARYSUMMARY