Chronic TOTB @ Chronic TOTB @ Orthopeutics Orthopeutics Chronic TOTB @ Chronic TOTB @ Orthopeutics Orthopeutics Tom Hedman, Ph.D. Tom Hedman, Ph.D. A it R hP f Associate Research Professor Department of Neurosurgery and Center for Biomedical Engineering University of Kentucky Founder, General Partner and Chief Scientific Officer, Orthopeutics, LP Founder, Equinext, LLC Founder, Chairman, Intralink Spine, Inc.
Tom Hedman, Ph.D.TomHedman,Ph.D. A i t R hP fAssociateResearchProfessor Department of Neurosurgery and Center for Biomedical Engineering University of Kentucky Founder, General Partner and Chief Scientific Officer, Orthopeutics, LP Founder, Equinext, LLC Founder, Chairman, IntralinkSpine, Inc.
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Tom Hedman, Ph.D.Tom Hedman, Ph.D.A i t R h P fAssociate Research ProfessorDepartment of Neurosurgery and Center for Biomedical EngineeringUniversity of Kentucky
Founder, General Partner and Chief Scientific Officer, Orthopeutics, LPFounder, Equinext, LLCFounder, Chairman, Intralink Spine, Inc.
Clinically Driven InnovationClinically Driven Innovation& k
Clinical Needs• Spinal disc degeneration & LBP
Necessity, who is the mother of invention.l h bl (
DDD & Low Back Pain:•3rd most common reason for surgery
NEXT generation
Plato, The Republic (427 BC –347 BC)•9.4% of US population (diabetes 5.9%, heart disease 8.1%, cancer 0 5%)We are surrounded by engineers' follies: too
t h i l
0.5%)
•Most costly ailment for working age adults, $100B+/yr. in US
many technical solutions still looking for problems to solve
•>15 million/year in US receiving treatment
•For every surgical patient there is
First generationPerformance Enhancement vs. Replacement
for problems to solve.David Tansley>20 back pain sufferers receiving treatment from a clinician
Increasing Crosslinking of Native Tissues Increasing Crosslinking of Native Tissues --Flies in the Face of Conventional Wisdom: Flies in the Face of Conventional Wisdom:
Age-increasing crosslinking “… the major cause of dysfunction of collagenous tissues” – Bailey ‘98
Wh did th ?Why did we go there?1. No data to support strong literature bias – repeated claims of increased
brittleness, loss of fatigue resistance with no biomechanical datag2. Duance3. HC-UHMWPE
Why not inject a biologic agent Why not inject a biologic agent (the ‘mainstream’(the ‘mainstream’ aproachaproach)?)?(the mainstream (the mainstream aproachaproach)?)?
x Harsh, nutritionally deficient environment of the avascular disc Intervertebral Discenvironment of the avascular disc led to degeneration in the first place
x “Degenerative discs are not able to support the added nutrient demands
Intervertebral Disc(largely avascular)
support the added nutrient demands from increase in cellular activity or cell number…”
x Biological treatments offer no nearVertebral Body(well vascularized)x Biological treatments offer no near-
term effect, not appropriate as a stand-alone treatment
x More challenging regulatory path
(well vascularized)
x More challenging regulatory pathx More expensive to produce
stabilization in the extremely non-compliant patient p p(equus ferus caballus)
• Snoring & obstructive sleep apnea
• Spinal elongation in 0g• …
Will All of These Be Successful?Will All of These Be Successful?"I have not failed once. I've just found 10,000 ways that didn't work." --Thomas Edison"The way to succeed is to double yourThe way to succeed is to double your failure rate.“ -- Thomas Watson, Founder of IBM"Failure is only the opportunity to b i i i t lli tl “begin again more intelligently.“ --Henry Ford"We are not retreating -- we are advancing in another direction.“ --gDouglas MacArthur"Never confuse a single defeat with a final defeat.“ -- F. Scott Fitzgerald"Fall seven times stand up eight "Fall seven times, stand up eight. --Japanese Proverb
Sources of Funding
Kentucky SBIR Matching Grant NIH-NIAMS SBIR Grant R44 AR55014-02A1NIH-NIAMS SBIR Grant R43 AR55014-01A1NIH-NIAMS STTR Grant R41 AR47470-01A1University of Kentucky College of EngineeringUniversity of Kentucky College of Medicine University of Southern California (Royalties-TPH)Orthopeutics (Equity ownership-TPH)Equinext (Equity ownership-TPH)
(Financial disclosures)
Thank You!
U S D t t f H lth
Thank You!
U.S. Department of Health and Human Services
Supported By
National Institutes of Health
National Institute of Arthritis and Musculoskeletal and Skin Diseases