Hyperbaric Oxygen Therapy for Acquired Brain Injury:

How To Bring It to the Football World?

Stephen D. Reimers, MS, PEChief Financial Officer, IHMF & IHMA

IHMA & IHMF: Sister Organizations Translating Science into Medical Practice and Public Policy to Create Healthcare Solutions for the 21st Century

Typical Multiplace Hyperbaric Chamber

HBOT is the simple act of breathing pure oxygen at pressures greater than 1 ATA.

It comfortable, painless and has an exceptional safety record.

As with any medical intervention, there are risks (primarily ear barotrauma). However, those risks are well understood and readily managed.

Typical Monoplace Hyperbaric Chamber

What is HBOT?

HBOT is NOT new. “Standard of care” for neurologic decompression sickness in divers for 80+ years and acute CO poisoning for 30+ years . Those are forms of acute brain injury.

What IS new is the spreading understanding that with a different protocol (different Tx pressure, Tx time and no. of Tx), HBOT can also be used effectively in chronic brain injuries, such as blast injury, concussion CTE, chronic CO poisoning, etc.

NOT yet considered “proven” in chronic apps. Our goal it to generate the “evidence” req’d to unlock third-party reimbursement.

What is IHMF Goal?

Retired NFL Player: Age 58Pre-Post HBOT 1.5

4 NFL Players now treated with similar results

Source: MicroCog Assessment-- Independent Evaluation by Amen Clinic.

How Big is the Overall Problem: Public Health Cost of Untreated Brain Insults

• CDC reports 1.7 million new civilian injuries per year with 275,000 hospitalizations and 52,000 deaths. Est. costs of medical costs and lost productivity: $2 billion/week.

• Veterans: 33%+ of all deployed, approx. 600,000 total to date

• Overall, an estimated 30-40 million working age Americans are estimated to be living with an untreated brain injury.

• Lost Productivity: mTBI patients have approx ½ of the life-time income of their non-injured counterparts, matched for education, intelligence, etc.

• Incarceration: 61% County/56% State/45% Fed have some form ofMental illness (usually w/ underlying untreated brain insult)If could halve population, est. savings in 10 years = $30B.Typical symptoms of brain injury = poor executive function, irritability, poor impulse control, headaches.

Education (IDEA Children): 50%+ have brain injury. If 20% were brought to normal, savings would be $18 billion per year.

Welfare: Avg IQ = 85, brain injury effect ??

Homelessness: 67+% overall Vets homeless at 4x rate of non-vets.

Mental Illness: Brain injury known to have risk of psychological sequelae

Trafficked & Battered Women & Children: Brain injury is frequent_______________________________________________________

This effort goes far beyond football.

What football can do here to help its own, will lead to help for many others as well.

How Big is the Overall Problem: Public Health Cost of Untreated Brain Insults

Veteran Casualty Crisis• Military Med Confused: PTSD shares symptoms with Mild-TBI!

– sleep cycle disruption, impulse control, irritability, and difficulty concentrating

• About 600,000 IEF/IOF war veterans blast/concussion casualties– MOST DO NOT RECOGNIZE THEY HAVE A BIOLOGICAL INJURY!

- This is not because they were not “STRONG” enough to take it!- It is not a moral weakness!

• Each Untreated Casualty Costs up to $60,000 per year in safety net, substance abuse & Incarceration Costs

• Each Casualty that Returns to Work– Is a $10,000 minimum Annual Revenue Source to Federal,

State and Local governments– Reduced Need for Services– HBOT (biological repair) Treatment is paid for within 14 months– Each Active Duty Rescued-$2.6 million per veteran over lifetime

NBIRR-01: Principles• 1,000 patient observational multi-center study of Military or Civilian subjects with an Independent diagnosis of mild-moderate TBI/PTSD. (Patients MUST be >6 months post injury in the “chronic” stage, and ages 18-65.)• Bayesian data analysis (Level 1 Evidence)

– IRB-Oversight– Patient is their own control– Methodology of “Coverage with Evidence” at CMS– Multiple objective measures: ANAM, CNS-Vital Signs, Post- Concussion Syndrome

Scale, PTSD Scale, Depression Scale• All Participants get Real Services (No Placebo)

• Third Party Payment is, therefore, made possible (takes some effort, need more result to get administrators to chg their practices. Our aim = provide the necessary results)

• Therefore, cost of “research” is (hopefully) limited to the administrative overhead costs necessary in addition to the treatment costs, about 10% of treatment cost.

• John Eisenberg Treatment Registry – Integrated Software with built-in metrics– Secure & Web Based

• Low Cost Research ($25,000 per patient = $25 million w/ $1.6 million Admin)

HBOT For Brain Injury: Where Are We re Football?

• 4+ Former NFL players with TBI/CTEhave completed NBIRR Protocol. All have received benefit. (Note: NBOT is not a “magic bullet”, but to date everyone with TBI has achieved significant benefit.)

• Several more in various stages of treatment• 120+ evaluated by Amen Clinic-Newport Beach• All above efforts predominantly pro bono. • The task is huge. To move forward with any reasonable

speed, support from within the football community is needed.

HBOT For Brain Injury: Possible Pathways for Football?

• Acute brain injuries are difficult to study. Many variables, consensus on a protocol will take some time.

• Chronic brain injuries (> 6 months since injury) are remarkably stable, therefore study design is simpler, easier & less costly.

• NBIRR-01 study is underway & inclusion criteria include football-related injuries. Tx can start quickly----limited only by funds.

HBOT for Football Brain Injury: A Workable Plan for Action

• Goal is to treat ~50 players already screened by Amen Clinic-Newport who live close (transit time < 1 hour) to NBIRR sites

• Approx Cost is $25,000 each ($20,000 HBOT, $5,000 diagnostics & study costs)

• All req’d resources are in place except the funds

• Each person completes ~5 months after funding

HBOT for Football Brain Injury: A Workable Plan for Action

• Overall, need is $1,250,000• However, 1st patient can start as soon as first

$25K is on hand, and so on.• Pace of study determined by pace of funds. • Could complete all 50 by end of 2011 if funds

available.• Funds from sources outside football

community unlikely. Too many competing needs.

HBOT for Football Brain Injury: How to Raise the Funds????

• Individual contributions?– Facebook pages for players w/visible names– Facebook pages by friends of players– Reach out to “football moms”, universities, etc.

• Fund raisers (celebrities, etc.)?• Grants?• NFL and NFLPA?• Insurance plan payments?• Support from other sports orgs?

Retired NFL Players:How You Can Help

• Best way to get started quickly.• Direct personal contribution, if able• Solicit help from others• Set up Facebook pages

ImportantThis is an ongoing study under IRB supervision.

ALL public “advertisements” for participants MUST be in a form approved by the IHMF and the study IRB.

HBOT for Football Brain Injury: Donation Pathways

• www.nbirrfund.org (Easiest way. Click the “Add a Designation” box and then enter “NFL Vets” in the window that opens)

• Direct contribution to IHMF www.hyperbaricmedicalfoundation.org (“Friends Donor” page, select button for Support Research to Help Veterans & Others with TBI or PTSD)

• Individual FaceBook Pages (requires some IT skill, IHMF will help)

IHMF Stands Ready to Help

• Our Team Leaders have decades of experience with Hyperbaric Medicine

• Our Team Leaders have over 20 years of experience treating Brain Injury with this protocol

• The NBIRR-01 Study is IRB-approved• The Study is Listed at www.ClinicalTrials.gov• The National Call Center Number is: (800) 288-9328• Numerous participating clinics throughout the nation• We Are Helping to Solve the Real Problems of Brain

Injured Persons with Biological Repair for their Injury

Sponsor: International Hyperbaric Medical FoundationLocations for N-BIRR HBOT 1.5 Study N=1,000

Sites with Confirmed InvestigatorsSites Being Planned

Investigators with Capacity for 2,000 Treatments per DayAnticipate 1,000 veterans or service personnel being able to return to full duty status every 150 days. 90 total sites have sufficient equipment, training and skill to join the effort and treat these casualties. 1,000 could be brought on line.NBIRR Study Sponsored by Int’l Hyperbaric Medical Foundation

Sites Being Planned as MobileUnits Under an Investigator

HBOT for Football-Related Brain Injury.

It can start here.

Thank you.