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PUUMA Systems, Inc

PUUMA Systems, Inc. Innovations in torso support. Existing solutions: Limit passable terrain Create more work for the user to locomote or require massive amounts of power State of the art: Computer controls designed for gait replication Decrease work through reduced weight (titanium)

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PUUMA Systems, Inc

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  1. PUUMA Systems, Inc Innovations in torso support

  2. Existing solutions: Limit passable terrain Create more work for the user to locomote or require massive amounts of power State of the art: Computer controls designed for gait replication Decrease work through reduced weight (titanium) Several thousand dollars (but largely covered by insurance) Today’s Torso Support Dilemma 2

  3. Sources of Need • Weakness • Atrophy • Paralysis (total, or partial) • Amputation (with prosthetic in place) 3

  4. Existing Solutions and Shortcomings • Knee braces • Locking: bad swing phases; Bad on sloped terrain • Non-locking: little to no torso support • ((T|)H|)KAFOs • Substantial weight; Expensive; Customization; Only SotA has acceptable swing phase • Wheel-chair/cart • Expensive; No stairs*; Special accomodations • Walker/arm-brace cane • Stigma; Slow locomotion; Reduced use of hands 4

  5. Best Practice (Auto-locking knee joint) • SCOKJ (Horton technology) • Free walk (Otto Boch) 5

  6. On the Horizon (Active locking) • Smart-knee (Horton technology) • Replaces mechanical clutch actuator with sensor triggered solonoids • Sensor walk (Otto Boch) • Computer controlled clutch actuation based on assorted sensors 6

  7. PUUMA Solutions • Energy conservation: • More than compensates for the extra work • Leads to a more natural gate • More natural feel • Energy dissipation: spring loading and clutch slipping reduce pressure of a locked knee joint allowing for: • Faster locomotion • Less painful emergency locking 7

  8. Market Opportunity • 100-150k with Post Polio Syndrome over next 10-20 years • ~400k MS/MG/HSP/GBS/MD patients • 4m Stroke, 5k ALS, 50k Parkinson’s patients annually • 7m >65 with chronic disability • 10m morbidly obese • (TBD) debilitating injury and acute disability (e.g.: partial paralysis; post cast removal) 8

  9. Market Opportunity:Existing met demand • Sold each year: • TBD KAFO’s • TBD carts for the obese/weak • TBD walker’s 9

  10. Reasonably Addressable Market • TBD. Likely a large portion of the market for the SCOKJ and FreeWalk plus more people with traditional KAFOs who could see more benefit for their increased cost, plus those who can get by without braces but might choose them if the weight/ unnatural gait were less problematic, particularly the morbidly obese and more post-polio sufferers 10

  11. PUUMA Architecture • A locking spring-loaded hinge with computer controls • A frame to attach the hinge to • Sensors 11

  12. Just the hinge (for orthotists to build a KAFO with) Just the knee (hinge in a knee brace, not a KAFO) Full KAFO Full double HKAFO – a backpack mount PUMAX variation PUUMA Family 12

  13. PUUMA Applications • Anywhere existing quads are insufficient: • Atrophied muscle • General weakness • Excess load (obesity, body armor, etc.) • Frequent spasm or other regular sudden loss of quad strength 13

  14. Customer Benefits • A KAFO that carries it’s own weight and then some 14

  15. Development Milestones • Sufficient for testing parts: spring, clutch • Sufficient for demo software (i.e. only inputs are a strain guage and a heel switch) • Testable protoype • Lifetime cycle test • Clinical trial ready prototype • Road show prototype 15

  16. Cash Flow - First Product • TBD – do we have a sense yet of the production cost of just the hinge? Do we have an estimate of time and costs for the aforementioned prototypes and tests? Do we have a sense of regulatory costs and delays (no—it’s time to consult a pro)? 16

  17. The PUUMA Systems Vision • We are going to bridge the gap from KAFO’s being a “only if you can’t walk without them” product to a life aid people, who could do without, may choose to use, be it those who can’t carry the weight of a kafo, or those who wish to carry more weight 17

  18. Risks • Potential FDA complications • Unforseen patent infringement • Orthotist bias against non-orthotists • Orthotist minimums to begin offering • Failure to secure insurability comparable to competitor products • Personal injury liability • Severe sensitivity to staff losses • Possibly unrealistic quality control demands 18

  19. Backup • If we reduce our development to a focus on just the hinge we have 19

  20. Competing Solutions • Existing competitors: SCOJK/SmartKnee and FreeWalk/Sensor walk • Potential competitors: • Durfee/Rivard Pneumatic Stored-Energy, Hybrid Orthosis • Gharooni/Heller/Tokhi Hybrid Spring Brake Orthosis • Agrawal/Banala Active Leg Orthisis • Hal • Bleex • Yobotics 20

  21. Key Differentiators • Strong basis in energy conservation principals not well grasped by others (if the existing research is any guide) • Strong team of engineers • Greater applicability to non-medical uses 21

  22. Potential Customers • Orthotists • Direct to the afflicted • Rehab centers • Military • “human mule” operations (brain-fart: could also be used on pack animals to increase their load capacity) 22

  23. Financials (much TBD) • We need to forecast our operations cost, estimate our prototyping costs, and guestimate our cost to produce 10 units • We need to identify our regulatory compliance cost • We need to get clear separation between company vs. Carvey assets 23

  24. Financial Assumptions • FDA costs will be low • Little to no additional IP costs • No expensive ingredients • At least a year of burn 24

  25. Cash Flow • Income is >1 year away • Profitability is significantly beyond that • Salaries • R&D • COGS 25

  26. Engineering • <others> 26

  27. Operations Phase one • Planning/FDA compliance Phase two • Final prototyping • Testing • Funding seeking Phase three • Money grubbing • Marketing/road show (orthotics conferences) • Finalizing shipping product and planning production 27

  28. Marketing and Sales Phase One • Market Size Study • Early Customer Identification • Strategic relationships • Sales and distribution planning • Feature Release planning Phase Two • Shows, white papers, press releases • Marketing Rollout, Sales Kit • Strategic relationships/partnerships 28

  29. General and Administration Phase one • Planning • Settling Incorporation Phase two • Finance • Contracts • Legal/regulatory • Human Resources • Management/roles/responsibilities 29

  30. PUUMA SW Architecture • <others> 30

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