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PUUMA Systems, Inc

PUUMA Systems, Inc. Innovations in torso support. Existing solutions: Severely 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

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PUUMA Systems, Inc

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  1. PUUMA Systems, Inc Innovations in torso support

  2. Existing solutions: Severely 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) • Desire for more carrying capacity • 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 accommodations • 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. 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 11

  12. 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 12

  13. Customer Benefits • A KAFO with a more natural gait (TBD) • A KAFO that carries it’s own weight • and then some… 13

  14. PUUMA Architecture • Three main components: • Joint (knee, hinge, drum) consisting of: • Outer Clutch • Spring • Inner Clutch • Control (microprocessor and interface) • Frame (human physical interface) • consisting of • Thigh frame • Shank frame • (optional?) Ankle/heel/foot frame • Potential for using existing infrastructure (Orthotists) 14

  15. 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(s) *(not necessarily “orthotic”) PUUMA Family 15

  16. 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 16

  17. 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 17

  18. 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) 18

  19. 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 19

  20. Backup Note: don’t go into the wilderness over this – a basic plan for the minimum means of cashing in on our work to date • Reduce our development to a focus on just the hinge • Market the hinge alone to Orthotists • License to Horton and/or Otto Bock 20

  21. Engineering • <others> 21

  22. Development Milestones • Knee Development • Control Development • Frame • Alpha prototype • Clinical trial ready prototype • Road show prototype 22

  23. Drum Development Milestones • M1 - Single spring 100k cycle test • (M1a – 4 spring 100k cycle test) • M2 - Inner clutch/single spring 100K • M3 – Outer clutch 100k cycle test • M4 – Inner clutch/spring/outer spring 100K • M5 – Software Testbed 23

  24. Milestone OneSingle spring 100k cycle test -Cam Lifts Weight to apex, weight falls, applies torque to spring. -Monitor drum angle over 100K cycles -Make sure spring does not fracture or fatigue 24

  25. Milestone TwoInner clutch/single spring 100K -Inner clutch engaged, weight drops -Spring compresses, inner clutch latches -Inner clutch released, weight goes up -Monitor drum angle, clutch engagement angle 1 2 3 4 25

  26. Milestone ThreeOuter clutch 100k cycle test -Outer Clutch engaged, weight drops -Outer clutch catches, released, then weight lifts -Small spring lifts lever for next cycle -Monitor clutch engagement angle, test for controlled slippage 1 1 2 3 3 4 26

  27. Milestone FourInner clutch/spring/outer spring 100K -Outer and Inner clutch engaged, weight drops, spring compresses -Inner clutch catches at max compression -Inner clutch releases, spring helps to lift weight, outer clutch rotates -Outer clutch released, retaining spring pulls outer clutch in correct position -Monitor drum angle, inner clutch engagement angle, etc 1 2 3 4 27

  28. Milestone FiveSoftware Testbed -Ankle can slide to simulate a step -Best representation of actual walking -Used to develop software, not to specifically test components 28

  29. PUUMA SW Architecture • <others> 29

  30. Financial Assumptions • FDA costs will be low • Little to no additional IP costs • No expensive ingredients • At least a year of burn 30

  31. Cash Flow • Income is >1 year away • Profitability is significantly beyond that • Salaries • R&D • COGS 31

  32. 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…)? 32

  33. 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 33

  34. Operations Phase one • Planning/FDA compliance Phase two • Final prototyping • Testing • Funding exploration Phase three • Marketing/road show (orthotics conferences) • Finalizing shipping product and planning production 34

  35. 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 35

  36. General and Administration Phase one (Next 10 days) • Management/roles/responsibilities • Near term deliverables • Settling Incorporation/Stock • Separation between company vs. Carvey assets • Ownership behind us: • Cannot kick down the road, but maintain flexibility to resolve inequitabilities • Default position we can agree on now, 6 month moratorium • Minutia: Bank accounts, filings, identity (website, contact points, logo, etc.) 36

  37. General and Administration Phase two (next 30 days) • Planning • Operations: budget, contracts, legal/regulatory • Engineering: frame, control, knee milestones reviewed, resource list Phase three • “Hello world”, marketing, conference circuit • Seeking investment or choosing not to 37

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