ElastiGraftTM  Composite  Biomaterial

“Versatility Implanted”

Clemson BIOE – Innoventure Connect Symposium

22APR14

J. MERCURI, PhDjmercur@clemson.edu

The Laboratory of Orthopaedic Tissue Regeneration & Orthobiologics

O RTHO X

™

“To improve clinical outcomes for patients suffering from orthopaedic conditions through the development and application of biomaterials and stem cell technologies in collaboration with clinicians and industry leaders.”

Who We Are / Our Mission:

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The Laboratory of Orthopaedic Tissue Regeneration &

Orthobiologics

Our Technology

ElastiGraftTM

A Versatile and Novel Shape-Memory Sponge Biomaterial

We are seeking partners for development or licensing for this

emerging technology as well as other under development in our lab!

Original Inventors:Jeremy Mercuri, PhD (Assistant Professor of Bioengineering)Dan Simionescu, PhD (Associate Professor of Bioengineering)

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The Laboratory of Orthopaedic Tissue Regeneration &

Orthobiologics

Background

• The Intervertebral Disc (IVD)– Functions to absorb and distribute load

and allows flexibility

– Consists of two distinct regions

• Annulus Fibrosus (AF): Concentric sheets of collagen surrounding the NP

• Nucleus Pulposus (NP): Centrally located, resilient hydrogel core

• Initial location of degeneration

• Degenerating IVDs can result in pain and spinal instability

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The Laboratory of Orthopaedic Tissue Regeneration &

Orthobiologics

One Opportunity – NP Replacement•

• Worldwide spine device market in 2011: $6.5B*

• NPR accounted for ~5% of total market ($325M)

• Gap in treatment options for spinal disc degeneration

Adapted from: Adams et al. The Biomechanics of Back Pain, Elsevier.2006.

(Early Degeneration)

(Fibrous NP)

(Inward bulging of AF)

(Severe Degeneration)

•

• NP replacement is an emerging advanced treatment for mild to moderate IVD degeneration

*Global Information Market Reports (2012)

Future of Spine Surgery

Severity of Treatment

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The Laboratory of Orthopaedic Tissue Regeneration &

Orthobiologics

The Competition

• Several replacement devices and materials in development

• Injectable Synthetic Gels– Gentis, J&J (Synthes), Spine Wave

• Biopolymer Based Hydrogel– Cryolife (For herniated discs)

• Preformed Devices– Raymedica, Pioneer medical, Replication

Medical, Biomet, Trans S1, Nuvasive

Images adapted from: Wilke et al. 2006, Halloran et al. 2008, and Yue et al. 2008.

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The Laboratory of Orthopaedic Tissue Regeneration &

Orthobiologics

The Problem

• Current options offer NP replacement without regeneration

Opportunity for novel solutions to replace degenerating Nucleus Pulposus and regenerate functional tissue:

1. Mimic native NP in form and function to alleviate pain

2. True Solution- Support autologous cell viability and tissue regeneration

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The Laboratory of Orthopaedic Tissue Regeneration &

Orthobiologics

The InventionShape-memory preformed material for replacing and

regenerating NP in situ

Requirements Features

Matching compressive stiffness

Highly resilient (shape memory)

Porous

Moldable to patient NP anatomy

Supports viable cells

Remodeled as NP tissue develops

Minimally invasive implantation

Resistant to enzymatic degradation

Consistent, scalable process

For use w or w/o autologous cells

Composition:Composite

biopolymer with proprietary crosslinking

materials and methods

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The Laboratory of Orthopaedic Tissue Regeneration &

Orthobiologics

The Science

Demonstrated To Date:Hydrogel formation and fabrication

Repeatable process Can be molded into complex shapes

Biochemical and mechanical characterization Robust mechanical properties Resistance to accelerated enzymatic degradation /

biodegradability.

In vitro studies Viability of human adipose stem cells and nucleus pulposus

cells

In vivo animal studies (subdermal implantation) Biocompatibility

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The Laboratory of Orthopaedic Tissue Regeneration &

Orthobiologics

The ScienceMimic NP Form and Function• Deformable and resilient

• Designed to mimic natural NP

• Expels fluid during deformation and re-absorbs it as load decreases

• Supports functional tissue development

Biocompatible and promotes cell viability: • Viable human adipose derived stem cells within the

hydrogel after 14 days of in vitro culture• Supported by in vivo studies

Green = live cells on ElastiGraftTM

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The Laboratory of Orthopaedic Tissue Regeneration &

Orthobiologics

Summary of Benefits – Thank you!

• Invention aims to be offer new benefits versus current technologies– Next generation product potential – Replacement & Regeneration

• Attractive market• Worldwide spine device market in 2011: $6.5B*

• NPR accounted for ~5% of total market ($325M)

• Intellectual property– Proprietary materials and methods

• Other applications exist– Soft tissue repair / reconstructive surgery– Cartilage defect repair– General broad-based biomaterial

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The Laboratory of Orthopaedic Tissue Regeneration &

Orthobiologics

*Global Information Market Reports (2012)