VAR-AIR SHOE Comfort & Safety for the Diabetic’s Foot

Kathleen Brennan EMBA 2016Medicine for Managers 15.132 May 5, 2016

AGENDA

1. Market Opportunity 2. Preventing Amputations 3. VAR-AIR Design 4. Medicare 5. Competitive Landscape 6. Trials 7. FDA 8. Corporate Structure / Implementation

MKT OPPTY = $ 67.4 B WW BY 2020* NIH

275 Million Diabetes WW …… 350M by 2030 Most new entrants …. Age 40-60 today / shifts to age 65-75 by

2030 1/3 in US Market…. Major increases in India and China’s population

REDUCE THE RISK OF AMPUTATION

LACK OF SENSATION…. LEADS TO INJURY

ROAD TO VAR- AIR SHOE SOLUTION IDENTIFY PATIENT WITH NARAPATHY AND/OR UNCONTROLLED

DIABETES OR ANYONE WITH CHRONIC FOOT PROBLEM ie flat feet, fallen arches or anyone who stands for extended periods of time.

REFERRALS FROM MD / CASE MANAGER / PODIATRIST / PHYSICAL or OCCUPATIONAL THERAPISTS

For Diabetes…. Examine feet and redistribute the pressure by adjust air pressure chambers therefore avoiding further irritation / injury

For other patient categories… take data from gait analysis and create customized shoe to support walking and safety

USE AIR PRESSURE TO REPOSITION FOOT AND REDUCE STRESS ON PAINFUL AREA Physical Therapist creates initial shoe ‘air pressure load’ based

on gait analysis and fitting consultation. Patient taught how to adjust air chambers using mini pump / w detailed diagrams and phone/online support.

pro-active design for caretaker or patient to adjust shoe with mini pump to address any irritations noted by redness on foot. Monthly checks by physical therapist if fine-tuning required.

Additional sensors would drive need for clinical trials / FDA regulation ; today the intervention is adjustable non-invasive air chambers.

INTERCHANGABLE SUPPORTS

ADJUSTABLE AIR CHAMBERS TO REDUCE FRICTION AND INJURY

Air Chambers can surround the foot

Modify with ‘mini-pump’

Medicare Shoe Bill Medicare Therapeutic Shoe Bill. What Is Your Diabetic Shoe Benefit?

If you have diabetes, Medicare has specific coverage guidelines regarding what shoes it will cover and for what conditions. In general, under Medicare Part B, has diabetes, Medicare will cover one pair of therapeutic shoes per calendar year

One pair of depth-inlay shoes and 3 pairs of inserts; orOne pair of custom-molded shoes (including inserts) if a beneficiary can't wear depth-inlay shoes because of a foot deformity plus 2 additional pairs of inserts. In order for Medicare to pay for a beneficiary's therapeutic shoes, the doctor treating his/her diabetes must certify

A podiatrist or other qualified doctor prescribes the shoes, & qualified individual fits and provides the shoes. Has at least one of the following conditions in one or both feet:Partial or complete foot amputationPast foot ulcersCalluses that could lead to foot ulcersdamage caused by diabetes with evidence of callus formationPoor circulationDeformed foot (feet)Is being treated under a comprehensive diabetes care plan and needs therapeutic shoes and/or inserts because of diabetes.

COMPETITION – ORTHOTIC MARKET $3.5B BY 2020 CAGR 5.8%Expensive custom designed orthotics (post- damage)

Heavily padded shoes / foot inserts for diabetic segment largest followed by rheumatoid arthritis market. *

Source http://www.medgadget.com/2015/08/foot-orthotic-insoles-market-analysis-2020-industryarc-report.html

Bayer Healthcare AGHenge Prosthetic and OrthoticsBauerfiend AGSuperfeet Worlwide INCOttoback Top 5 in marketplace

IS FDA APPROVAL REQUIRED? For Air Chamber shoe…..NO however as you add mobile

applications to synch to device and any additional sensors then it may be required.

Title 21 CFR FDA Chapter 1 Subchapter H part 890 Physical Medical Devices

890-1615 Miniature Pressure transducer measures pressure between device and soft tissue890-3025 Prosthetic and orthotic accessory (incld splints/cast shoe) ** FDA approval significantly increases costs and requires controlled clinical trials http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/

cfrsearch.cfm?cfrpart=890&showfr=1

INITIAL BUDGET TO INCLUDE

R&D Design and Prototype / Trials with Prototype / Market Acceptance

Patent protectionProduction prototypes a ) US market / Expansion to children’s market where orthotics are quickly obsolete.

b) adapt product to market demand in China and India

FDA approval if you enhance with monitoring sensors etc.

Subcontract with current shoe mfg. / ie DANSKO , REEBOK , NIKE

GRACIOUS THANKS TO CONTRIBUTORS Hany Beshara Physical Therapist

Anthony Coston Biomedical Engineer PhD PMP

Wayne Lipson MD Cardio Thoracic Surgeon

Sahar Hashmi MD PhD Candidate MIT