Eric Hauck – CEO & President

Dr. Tom Hedman – Founder, CSO & Associate Professor

Intralink-Spine,

Inc.Introducing a Chemically-Made

Class III Medical Device

for the treatment of

Degenerative Disc Disease

An unmet clinical need…Low Back Pain, Degenerative Disc Disease, Spinal Instability• 3rd most common reason for surgery

• 9.4% of US population (diabetes 5.9%, heart disease 8.1%, cancer 0.5%)

• Most costly ailment for working age adults

• >15 million/year in US receiving treatment

• For every surgical patient there is >20 back pain sufferers receiving treatment for back pain

• Majority of back pain cases (~90%),

termed “Mechanical Back Pain”,

involve muscle strains and

inflammation, resolve in weeks

• Due largely to mechanical

insufficiency (instability) of the

passive joint tissues (the disc)

• Reoccurring episodes (chronic

pain) is the norm (60-70% within

next year)

Clinical Targets:

Nonsurgical solution that’s better than surgery

Surgical Market:

$3.3Billion, growing 16%/year

Improved conservative care solution,

not just temporary relief of pain, but

repairing the core mechanical

insufficiency

• Tissue revitalization for

avascular, nutritionally deficient

tissues

• ILS’s product: NEXTNonsurgical EXogenous Crosslink Therapy

• Chemical reagent that augments

crosslinking of native collagen matrix

NEXTTM

Crosslinking Collagen Chains in the Native

Tissue

A Revolutionary Approach:

Injectable Collagen Crosslinking

•Better than

surgery

•Cost

effective

•4-fold reduction of joint instability – Better than surgical fusion

•30% reduction in disc bulge under compressive load – Pain reduction

•Doubled nutritional flow to center of disc – Long term viability

•50% increase in tear resistance – Prevent disc herniation

•93% restabilization post-discectomy – Ideal adjunct to discectomy

•2-3 fold improvement in fatigue resistance – Durability

•2-fold increase in tensile strength - Strength

•25% reduction in intradiscal pressure, 50% less depressurization during loading – Pain

•3-8 fold reduction in annular tensile stress – Elimination of tensile failure

•No inflammatory or adverse biological response – In vivo validation

•Prevented/counteracted mechanical degradation in animal model

•No concerns after in vitro and subcutaneous in vivo biocompatibility studies

•Formulations optimized for reaction kineticsHedman 2003, 2006, Elliott 2005, Iatridis 2007, Hedman 2009, Hedman 2007, Cochrane 1997, Hunter 2005, Hedman 2007, Hedman 2003, Hedman

2006, Hedman 2009, Hedman 2008, Slusarewicz 2010a, 2010b, Hedman 2010

11 yrs of In Vitro & In Vivo Testing with human,

large animal, and small animal models

Research Grants

Grants Received

Granting Agency Amount

Granted (USD)

Date of

Grant

Purpose of the Grant

NIH $70k 8/10/2007 SBIR Phase I for formulation

optimization

NIH $100k 10/24/2001 STTR Phase I for in vitro human

cadaveric efficacy testing

NIH $768k 2/01/2010 2-year SBIR Phase II for additional in

vitro and in vivo studies

Grants Anticipated

Granting Agency Amount (USD) Date

Anticipated

Purpose of the Grant

DOD $2.2M 10/01/2010 2.5 year translational study funding

requested from Department of Defense

NIH $400k 1/01/2011 Follow on SBIR applications of NEXT in

scoliosis, knee meniscus, discectomy

NEXT™ – Competitive AdvantageSurgical Treatment

Fusions (PLIFs, ALIFs)

Posterior Dynamic Stabilization (AccuFlex Rod, Dynesys)

Interspinous Devices (X-Stop, Coflex, DIAM, Wallis)

Total Disc Replacements (Charite, ProDisc, Acroflex, Maverick, Flexicore)

Nucleus Replacements (PDN, Newcleus, Dascor, Biodisc, Nucor, Nubac)

Decompression Surgeries (Laminectomy, Laminotomy, Discectomy)

Minimally Invasive (IDET, RF, Chemonucleolysis)

NEXT Advantages

No surgical morbidity

Dramatic reduction of cost

No destabilization, No pseudoarthrosis

Restoration of normal stable motion, No loss of motion, No non-physiologic motions and associated tissue stresses

Suggests elimination of adjacent segmentdisorders

No destruction of functional tissue

No device failure, expulsion, or displacement

Effective, Follows natural pathway, Burns no bridges

7

NEXT™ – Competitive Advantage

Nonsurgical Treatment

Pharmaceutical (NSAIDS, Muscle relaxants, Opioids)

Injections (Corticosteroid epidurals, Prolotherapy)

Manual Therapies (Chiropractic, Massage)

Acupuncture, Supplements, Transcutaneous Electrical Stimulation

Cell-Based Therapies (Emerging: Conventional tissue engineering, Stem cells, Growth factors, Gene therapy)

Watchful Waiting

NEXT Advantages

Not just temporary pain relief

Treats core mechanical deficiency

Resists ongoing degradation

Effective – immediately

Reduces number and severity of reoccurring episodes

Dramatic reduction of lifetime treatment costs

Immediate Repair

• Improves tissue strength, tear resistance, durability, joint stability, reduces disc bulge

• Improves nutritional flow

• Better than surgery in restoring normal biomechanics

Long-Term Repair

• Not just temporary pain relief

• Remedies underlying mechanical insufficiency

• Tissue Durability + Joint Stability + Improved Nutrition = End of DDD

Patient Friendly

• NONSURGICAL

• Low Cost

• Avoids risks of surgery

• Final Solution

• Follows natural pathway

• Burns no bridges

Disruptive Technology:

Management Team• 25 years in Spine, led 1st North American artificial disc design and development team

• Graduate of MIT, & Ph.D. in Bioengineering from Strathclyde University

• Currently Associate Professor at Texas A&M, BME Dept. & College of Med., Department of Surgery

Dr. Thomas Hedman

CSO, Founder

Biomechanical Engineering

• 20+ years experience as CEO leading several disruptive technologies to market with Somfy International a fortune 50 European company, Damart International

• Worldwide manufacturing experience, ISO and CM compliance, 6 sigma certified facilities with worldwide distribution centers, extensive merger and acquisition experience in consumer electronics

Eric Hauck

CEO/President

• 20 successful years in medical device regulatory , clinical, and quality functions

• Successful in bringing other crosslinking technology through FDA

• Worked at Baxter, Cordis J&J, CryoLife (Dir), Percutaneous Valve Technologies (Sr. Dir. –Head RA/CA), and AtriCure (VP) with successful FDA approval track record

• Maintains her RAPS Regulatory Affairs Certification

Elsa Abruzzo

VP Reg./Clinical Affairs

Ind.& Manuf. Engineering

• 25 years as a CPA -Price Waterhouse, Somfy International, Waste Management

• Led financial teams with small start up’s and fortune 500 companies

• Currently working for publicly traded company-Waste Management Inc. (WMI)

Rick Schackel CFO

Certified Public Accountant

Advisory Board and Mentors

US Clinical Trails Champion

Dr. Hansen Yuan M.D.

• Prof. Orthopedic and Neurological Surgery

State University of New York Upstate Medical University

• Past President of Spinal Arthroplasty Society and North American Spine Society

CMS Reimbursement Consultant

Katharine Barry MPH,MSN,RN

• 25 years in FDA reimbursement issues with CMS

Regulatory & Clinical Consultant

Lori Adels PhD

• 20 years experience in Medical

Device regulation

• Past VP of Guidant Corporation

• VP RA/CA, HVT at Edward

Lifesciences

CRO Consultant and

Coordinator

Intellectual PropertyIssued Patents

Patent Number Issue Date Issue Title

10/230,671 8/16/08 Condition of

Allowance

USC Use of crosslinking agents to reduce mechanical degradation

of intervertebral disc

7,435,722 8/14/08 USC Crosslinking agents to increase disc permeability

2002335683

Australia

1/26/09 USC Use of crosslinking agents to reduce mechanical degradation

of intervertebral disc

2004268620

Australia

10/16/09 USC Crosslinking reagents for treating intervertebral disc disorders

Selected Patents PendingFile Number Date Filed Owner Title

11/712,684 2/28/07 Orthopeutics Direct Application Of Non-Toxic Crosslinking Reagents To

Resist Progressive Spinal Degeneration

11/726,790 3/22/07 Orthopeutics Direct application of non-toxic crosslinking reagents to

restabilize surgically destabilized intervertebral joints

12/192,746 8/15/08 Orthopeutics Improved formulations for nonsurgical exogenous crosslink

therapy

NEXT will follow a Medical Device Regulatory Path- US & OUS

Similar Crosslinking or Polymerizing Devices:

• BioGlue Surgical Adhesive (CryoLife, Inc.) is comprised of Bovine Serum

Albumin (protein) and Glutaraldehyde (GLUT), a crosslinking agent,

packaged in a syringe with a mixing tip.

• BioGlue’s primary mode of operation is to chemically crosslink the BSA to

the patient’s own vascular tissue to approximate and reinforce weak tissues.

• BioGlue was approved as medical device in the US and OUS.

• TruFill Liquid Embolic (Cordis JNJ) is comprised of n-Butyl Cyanoacrylate

(n-BCA) which is mixed with tantalum powder and a commercially available

contrast agent, Ethoiodol (for radiopacification).

• TrueFill polymerizes (crosslinks) into a cast when it comes in contact with

the blood.

• TruFill is intended to occlude (embolize) brain AVMS (presurgically).

• TruFill was approved as a medical device in the US and OUS.

20142013201220112010

FIM Trials

Dr. Singh

Malaysia

Pilot Trials

Dr. Lee & Dr. Shim

Korea

Korea/Asia

Sales

CE Marking Trials

CE Mark Approval

Europe SalesPilot Trials

Dr. Yuan

ChinaIDE/PMA Application

FDA

Dr. Yuan (US Champion) Multi Site Trials

SFDA Approval

Hong Kong/ChinaChina Sales

Clinical Trial

Regulatory ApprovalMalaysia

Malaysia

Sales

Pre IDE Meeting

FDA

US Sales

Regulatory Approval Plan (funding dependent)

Implementation

of Quality

System

Development of GMP Facility and Product

“It is companies like Intralink

Spine that will provide solutions

to the current financial crisis our

healthcare system is

experiencing without sacrificing

the highest standards of care

Americans deserve and expect.”

– Congressman John Carter

“And the best way for us to do that is to

reduce health care costs. That's not just my

opinion. That's the opinion of almost every

single person who has looked at our long-

term fiscal situation.” President Obama, national press conference

March 24th 2009

Non-surgical modification

of spinal discs

Non-surgical prevention

of knee meniscus degradation

Regenerative therapy including immediate

stabilization & nutritional support

Non-surgical solution

for spinal deformity

Non-surgical modification

of spinal discs for the treatment of Degenerative Disc Disease

Degenerative Disc Disease

Low back pain

• 2nd most common reason for seeing a physician

• 3rd most common reason for surgery

4.7% to 9.4% of US population

>15 million/year in US

~1 in 20 back pain sufferers elect surgery

It is reasonable to expect that a non-surgical solution would become the first line of therapy for disc disease.

Adjunct Treatment• Fusions, TDR, discectomy

• Adjacent Level Syndrome

• >1 million spine surgeries annually

• worldwide market > $17 billion, growing 16%/year

+

Primary Treatment

DDD Degenerative PathwayNormal Aging,

Disc Degeneration /Dehydration

Annulus Overload / Nutritional Deficiency

Bulges / Fissures / Cracks /

Mechanical Insufficiency

Disc Collapse / Herniations

Nerve Root Compression /

Facet Joint Pain

Primary Treatment

Scoliosis

• 2.5% - 6%

• External braces

• Noncompliance

• Surgery intensive

vs.

Spondylolisthesis

• “Slipped” discs

• Grade I&II

• 6%

Adjunct Treatment

Post-surgical deformity

• Ever-present concern to spine surgeons

– “Falling off” (kyphotic deformity) – above

– Flat-back syndrome –below

Can Cell-Based Treatments Work in the Intervertebral Disc?

1. Harsh, nutritionally deficient environment of the disc

led to DDD in the first place – Buckwalter 1995

a. Cell environmental conditions limit cell/cytokine viability &

prevent cells from producing matrix proteins

i. Waste accumulation pH productivity

b. “Degenerative discs may not be able to support the added

nutrient demands resulting from an increase in cellular

activity or cell number… the treatment will fail [growth factors,

gene therapy, tissue engineered constructs, stem cells] ” –

Urban 2006

c. Increasing nutritional demand without improving nutritional

conditions of nutritionally deficient tissues doesn’t make

sense!

2. Biological treatments offer no near-term effect! Not

appropriate as a stand-alone treatment.

Regenerative Therapy & Tissue Modification Hybrids

NEXT + Cell-Based Therapies

Makes Sense !

• NEXT provides near term stabilization

• NEXT provides long term nutritional

support

• Retention of GAGs Swelling Pressure ,

Hydration , Diurnal Flow , Waste Products &

Nutritional Exchange

• Hydraulic & Macromolecular Permeability

Diurnal Flow , Waste Products & Nutritional

Exchange Vertebral Body

(well vascularized)

Intervertebral Disc

(largely avascular)

Primary Treatment – Meniscal Repair

High-prevalence, parallel application: knee meniscus

Meniscus damage is the most common knee injury

• 850,000 surgeries/year in US

• Most tears cannot be repaired

Meniscal degeneration leads to knee osteoarthritis.

In Summary Immediate Repair

• Improves joint stability, tissue strength, tear resistance, durability, reduces disc bulge

• Improves nutritional flow

• Better than surgery in restoring normal biomechanics

Long-Term Repair

• Not just temporary pain relief

• Remedies underlying mechanical insufficiency

• Tissue Durability + Joint Stability + Improved Nutrition = End of disc degradation and back pain

Patient Friendly

• NONSURGICAL

• Low Cost

• Avoids risks of surgery

• Final Solution

• Follows natural pathway

• Burns no bridges