Flex leg intl bmc final without video

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  • #3. there are no ACCEPTABLE hands-free…(because there is iwalk-free)
  • Proto 1 was a quick mock up to get insight fast and prove validity of the idea. Proto 2 was our first attempt and it included the idea that we could fold the leg down (this is evidenced by the semi-circle pattern of holes in the picture).
  • It is hard to see the product in this picture because of the black background. We may have a better picture or maybe we change the background to non-black.
  • Not sure what should be here, nothing shows up on my computer.
  • Should the second box say not covered by insurance?
  • Months instead of years … I mean month … (singular)Regulation 890.3150 – no 510k and no PMAAccess Data websiteMeet definition Limb or ptosisRegister firm and list device you attend to marketWe can go to market after listingBut for definitions to use in marketingGeetaMake estab registrationMake listing for deviceIn listing register for product – should be instantaneous – public info is 1 per month
  • Similar product to proto 2, but it doesn’t come from the approach of prosthetics which causes it to miss the mark in functionality; it’s not a bio-mimic device, it’s a stick with straps. Talking about iwalk-free will be helpful to some groups and not to others, we should talk about what case this is for the BMC.

Transcript

  • 1. A Temporary Prosthetic for Lower Leg Injuries Mike Sanders - CEO Mark Roberts - CTO Seth Gonzalez - CMO
  • 2. Strengths:  Low cost: $20-$75  Can traverse various terrains  Most common choice: High AwarenessWeaknesses:  Movement is slow  Uncomfortable to use for long periods  Hard to store  Requires both hands for use
  • 3. Strengths:  Faster to move long distances  Less effort required for use  Claim reduced muscle atrophyWeaknesses:  Extremely bulky  Hard to store and transport  Cant traverse the stairs or tight spaces  Requires both hands for use  Expensive: $150-$850
  • 4. • World wide cost of sports injuries: $1 Billion • 79% of these occur in lower extremities Monetizable?• Over 5 Million total lower leg (below knee) injuries annually• 3.4 Million of these visit the emergency room each year• US ambulatory aid market: $220 Million
  • 5. 1. Those with temporary lower leg injuries want a hands- free mobility device2. We can inexpensively repurpose prosthetic devices and apply it to a new market3. There are no acceptable hands-free devices currently on the market
  • 6. Consumer/User Revenue shareDevice Hands-free Orthopedic Customer/Usersmanufacturer Doctor/Supplier mobility doctors Patients with relationship Podiatrists lower-leg injuriesDoctor/professio Warranties Superior recovery - Recommendation (5m)nal - prescriptions mobility Patient/consumer marketing experience Insurred/UninsurreProsthetic manuf. d- Technology How? Prosthetic- Relationships tech to the Patients under 50 temp-injuredMotivations:Product diversity Retail/Rental Deliver Online/web presence Patent Medical SupplySuperior mobility inexpensively to Medical Supply Stores FDA approval both insured and Storessolution Doctor offices: Insurance uninsured Doctor’s offices - OrthopedicPatient registration patients through - Podiatrist - Orthopedicsatisfaction (HCPCS) device sale and - Hospital - Podiatrist rental Medical Supply R&D Online distributors Rental Consumer testing Athletic Departments Value proposition: Prefer to pay Rent, utilities, For both rental through insurance High initial FC salaries and sale customers Fixed pricing on Develop economies Product delivery currently pay for device for lower material DME out of VC Device pocket, through Weekly rental registration costs insurance or both Cust. Acquisition rate (FDA, etc)
  • 7. Results: Concept MVPSurveyed 50+ • More stability needed respondents • Better traction • Aesthetics/shape of leg • Strapping system
  • 8. Prototype #3• Natural Mobility: 20-40 degree knee flexion 10-15 degree ankle flexion• Advanced Leg Performance Compliant members Composite materials• Collapsible for Easy Storage• Greater Stability
  • 9. Place “What about FDA approval?” 4th Feedback: 200+ students “Will insurance cover this?” 50+ adults (age: 30-50) 2th “Why hasn’t anyone thought of “What is the actual patient process inbefore?”selection?” this deviceTop 8 “Did you get out of “I wish I would have had this ____ “Who will actually pay for it?” the building?” months/years ago …” “Did you actually talk to 1st “This is way better than crutches” doctors/distributors/insurance companies?”
  • 10. Consumer/User Revenue shareDevice Hands-free Orthopedic Customer/Usersmanufacturer Doctor/Supplier mobility doctors Patients with relationship Podiatrists lower-leg injuriesDoctor/professio Warranties Superior recovery - Recommendation (5m)nal - prescriptions mobility Patient/consumer marketing experience Insurred/UninsurreProsthetic manuf. d- Technology How? Prosthetic- Relationships tech to the Patients under 50 temp-injuredMotivations:Product diversity Retail/Rental Deliver Online/web presence Patent Medical SupplySuperior mobility inexpensively to Medical Supply Stores FDA approval both insured and Storessolution Doctor offices: Insurance uninsured Doctor’s offices - OrthopedicPatient registration patients through - Podiatrist - Orthopedicsatisfaction (HCPCS) device sale and - Hospital - Podiatrist rental Medical Supply R&D Online distributors Rental Consumer testing Athletic Departments Value proposition: Prefer to pay Rent, utilities, For both rental through insurance High initial FC salaries and sale customers Fixed pricing on Develop economies Product delivery currently pay for device for lower material DME out of VC Device pocket, through Weekly rental registration costs insurance or both Cust. Acquisition rate (FDA, etc)
  • 11. Materials Great flexion in lower appendage Protect against hyperextension Big toe is important in balanceDesign Longer leg rest Padding materials (Osgood-Schlatter’s)Overall “[We] like this concept! [We] would recommend it“ “People are looking for other alternatives to crutches” “You look like you have done your homework” MVP “You need to show this to Dr. Faux”
  • 12. “This is a great idea … I would recommend it, definitely worth looking at” “Shoulders aren’t designed to be weight bearing joints, knee scooters have been nice for this reason” “An especially good for patients and for a person with a leg injury combined with an upper extremity injury” “Cool idea, I like the idea… that’s clever”MVP “Protect and pad the peroneal nerve so you don’t end up with drop-foot” “You ought to show this to Dr. Faux and Lance our bracing specialist”
  • 13. Like it/ Cost Prescribe Distribute Recommen d 3 Physical Therapists N/A 3 Orthopedic Surgeons 2 Orthopedic Technicians - Bracing & Cast Specialists N/A 2 PodiatristsMVP * With insurance
  • 14. Mark McGuire – International Orthopedic Care “Great idea, I have never seen anything like it, that’s probably because you started with prosthetics” “More and more people are trying to avoid crutches” AHM Agent “For insurance, the patient needs an HCPCS Code”MVP Trends: Ordering 0nline Scooter rental
  • 15. BOM MTL Cost Knee Pad (Dense) $ 1.50 Sale Price: $200 Crutches: Average: $50$ 1.50 Knee Pad (Soft) Knee Scooters: Average: $400 V. Leg (Plastic) $ 4.50 Insurance: 70% Velc Straps (3) $ 1.50 HCPCS CODE is E0118 Crutch4.50 H. Leg (Plastic) $ substitute, lower leg platform, V. Stab Arm (2) $ 2.00Cost to the patient: $60 with or without wheels $ 3.50 Curv Stab Arm (2) Support (horiz) Bar $ 2.50 Bracket (Main) $ 3.00 Adjust BTM Arm Center $ 2.50 Rental Price: $30 Crutches: Average: $5* Adjust BTM Arm Outer (4pcs) $ 4.00 Knee Scooters: Average: $35 Viberglass Foot Pcs $ 9.00 *Insurance: 70% Heel Pad (Soft) $ 1.00 Heel Pad (Rubber) $ 1.00 Heel Pad (Traction) $ 1.00 Toe Pad (Soft) $ 1.00 Toe Pad (Rubber) $ 1.00 Toe Pad (Traction) $ 1.00 TOTAL $ 46.00
  • 16. Sales EstimatesEmergency Room Visits per year 3.40 MillionNon-emergency Room Visits (Est.) 1.70 MillionTotal Below Knee Injuries/year 5.10 MillionCovered by Insurance 74%Insured injured customers 3.77 Million% Will require mobility devices 10%Potential Customers 0.38 MillionSales Price $200 per unitRevenue from Sales $75.5 Million
  • 17. RentalEstimatesSales EstimatesEmergency Room Visits per yearEmergency Room Visits per year 3.40 3.40 Million MillionNon-emergency Room Visits (Est.)Non-emergency Room Visits (Est.) 1.70 1.70 Million MillionTotal Below Knee Injuries/year 5.10 MillionTotal Below Knee Injuries/year 5.10 MillionUninsured InsuranceCovered bypatients 26%Covered by Insurance 74%Uninsured injured customers 1.33 MillionInsured injured customers% Will require mobility devices 10% 3.77 Million% Will require mobility devices 0.13 10%Potential Customers MillionPotential CustomersAverage rental weeks per customer 3 0.38 Million weeksSales PriceTotal rental weeks per year $200 per unit 0.40 Million weeksRental PriceRevenue from Sales $30 per week $75.5 MillionRevenue from Sales $12.0 Million $4.0
  • 18. Consumer/User Revenue shareDevice Doctor/Supplier Hands-free Orthopedic Customer/Usersmanufacturer relationship mobility doctors Patients with Podiatrists lower-leg injuriesDoctor/professio Warranties Superior recovery - Recommendation (5m)nal - prescriptions Patient/consumer mobility marketing experience Insurred/UninsurreProsthetic manuf. d- Technology How? Prosthetic- Relationships tech to the Patients under 50 temp-injuredMotivations:Product diversity Retail/Rental Deliver Online/web presence Patent Medical SupplySuperior mobility inexpensively to Medical Supply Stores FDA approval both insured and Storessolution Doctor offices: Insurance uninsured Doctor’s offices - OrthopedicPatient registration patients through - Podiatrist - Orthopedicsatisfaction (HCPCS) device sale and - Hospital - Podiatrist rental Medical Supply R&D Online distributors Rental Consumer testing Athletic Departments Value proposition: Prefer to pay Rent, utilities, For both rental through insurance High initial FC salaries and sale customers Fixed pricing on Develop economies Product delivery currently pay for device for lower material DME out of VC Device pocket, through Weekly rental registration costs insurance or both Cust. Acquisition rate (FDA, etc)
  • 19. FDA Agent: Geeta Pamidimukkala FlexLeg is a: FDA/CDRH/Office of Device Evaluation • Class I Medical Devise • • Disclosed our device to understand parallel review "Substantially Equivalent" to a Crutch What we found out: is: Therefore, FlexLeg • • FlexLeg classifies as an orthosis, limb brace Exempt from Premarket Approval application process (PMA) • • Therefore exempt from: 510k, PMA and IDE not required (IDE) Investigational Device Exemption processMeaning: Register with the FDA and we can go to market! Durable Medical Equipment • Insurance covers 50%-80% for the patient • Register as a supplier to receive HCPCS Code (E0118) • Doctor writes a prescription: patient may purchase at medical supply store, online or pharmacy
  • 20. Consumer/User Revenue shareDevice Doctor/Supplier Hands-free Orthopedic Customer/Usersmanufacturer relationship mobility doctors Patients with Podiatrists lower-leg injuriesDoctor/professio Warranties Superior recovery - Recommendation (5m)nal - prescriptions Patient/consumer mobility marketing experience Insurred/UninsurreProsthetic manuf. d- Technology How? Prosthetic- Relationships tech to the Patients under 50 temp-injuredMotivations:Product diversity Retail/Rental Deliver Online/web presence Patent Medical SupplySuperior mobility inexpensively to Medical Supply Stores FDA approval both insured and Storessolution Doctor offices: Insurance uninsured Doctor’s offices - OrthopedicPatient registration patients through - Podiatrist - Orthopedicsatisfaction (HCPCS) device sale and - Hospital - Podiatrist rental Medical Supply R&D Online distributors Rental Consumer testing Athletic Departments Value proposition: Prefer to pay Rent, utilities, For both rental through insurance High initial FC salaries and sale customers Fixed pricing on Develop economies Product delivery currently pay for device for lower material DME out of VC Device pocket, through Weekly rental registration costs insurance or both Cust. Acquisition rate (FDA, etc)
  • 21. 1. Keep getting out of the building! • Contact and understand online medical supply retailers • Talk with Dr. Faux and more professionals2. Meet with manufacturers: ACT & Otto Bock3. Finish product website: FlexLeg.com4. Obtain various registrations (FDA, HCPCS, etc)1. The end user is not the only customer2. “Get out of the building” both fun and NECESSARY3. Validate, validate, validate
  • 22. FlexLeg makes your daily life with a lower leg injury more like your daily life without one.
  • 23. Similar product to Prototype #2,yet it still has limitations that areremedied by the features andabilities of FlexLeg: • Natural Mobility: 20-40 degree knee flexion 10-15 degree ankle flexion • Advanced Leg Performance Compliant members Composite materials • Collapsible for Easy Storage • Greater StabilitySales Price of iWalk-Free: $400