O RTHO X

ElastiGraftTM Composite Biomaterial

The Laboratory of Orthopaedic Tissue Regeneration & Orthobiologics

Versatility Implanted
Clemson BIOE Innoventure Connect Symposium

22APR14

jmercur@clemson.edu

J. MERCURI, PhD

Who We Are / Our Mission:

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.
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The Laboratory of Orthopaedic Tissue Regeneration & Orthobiologics

Our Technology
ElastiGraftTM A Versatile and Novel ShapeMemory Sponge Biomaterial

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)

Future of Spine Surgery

Gap in treatment options for spinal disc degeneration

(Early Degeneration)

(Fibrous NP)

Severity of Treatment

(Inward bulging of AF) (Severe Degeneration)

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

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

*Global Information Market Reports (2012)

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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 Invention
Shape-memory preformed material for replacing and regenerating NP in situ

Requirements
Matching compressive stiffness Highly resilient (shape memory) Porous Resistant to enzymatic degradation

Features

Supports viable cells

Remodeled as NP tissue develops For use w or w/o autologous cells Moldable to patient NP anatomy Minimally invasive implantation Consistent, scalable process The Laboratory of Orthopaedic Tissue Regeneration & 4/22/2014 Orthobiologics

Composition: Composite biopolymer with proprietary crosslinking materials and methods

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 Science
Mimic 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 4/22/2014

The Laboratory of Orthopaedic Tissue Regeneration & Orthobiologics

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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
*Global Information Market Reports (2012)

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