PUUMA Systems, Inc

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PUUMA Systems, Inc

• Innovations in torso support

2
Todays Torso Support Dilemma

• 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)

3
Sources of Need

• Weakness
• Atrophy
• Paralysis (total, or partial)
• Desire for more carrying capacity
• Amputation (with prosthetic in place)

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

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Best Practice (Auto-locking knee joint)

• SCOKJ (Horton technology)

• Free walk (Otto Boch)

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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

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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

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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 Parkinsons patients
  annually
• 7m gt65 with chronic disability
• 10m morbidly obese
• (TBD) debilitating injury and acute disability
  (e.g. partial paralysis post cast removal)

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Market OpportunityExisting met demand

• Sold each year
• TBD KAFOs
• TBD carts for the obese/weak
• TBD walkers

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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

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The PUUMA Systems Vision

• We are going to bridge the gap from KAFOs being
  a only if you cant walk without them product
  to a life aid people, who could do without, may
  choose to use, be it those who cant carry the
  weight of a kafo, or those who wish to carry more
  weight

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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

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Customer Benefits

• A KAFO with a more natural gait (TBD)
• A KAFO that carries its own weight
• and then some

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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)

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PUUMA Family

• 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)

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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

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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

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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)

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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

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Backup

• Note dont 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

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Engineering

• ltothersgt

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Development Milestones

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

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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

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Milestone One Single 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
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Milestone Two Inner 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
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Milestone Three Outer 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
2
1
3
4
3
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Milestone Four Inner 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
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Milestone Five Software Testbed
-Ankle can slide to simulate a step -Best
representation of actual walking -Used to develop
software, not to specifically test components
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PUUMA SW Architecture

• ltothersgt

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Financial Assumptions

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

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Cash Flow

• Income is gt1 year away
• Profitability is significantly beyond that
• Salaries
• RD
• COGS

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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
  (noits time to consult a pro)?

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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

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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

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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

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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.)

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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