Post on 17-Dec-2015
PUUMA Systems, Inc
Innovations in torso support
28 March 2001 2
Today’s Torso Support Dilemma
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)
28 March 2001 3
Sources of Need Weakness Atrophy Paralysis (total, or partial) Amputation (with prosthetic in
place)
28 March 2001 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
28 March 2001 5
Best Practice (Auto-locking knee joint)
SCOKJ (Horton technology)
Free walk (Otto Boch)
28 March 2001 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
28 March 2001 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
28 March 2001 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)
28 March 2001 9
Market Opportunity:Existing met demand
Sold each year: TBD KAFO’s TBD carts for the obese/weak TBD walker’s
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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
28 March 2001 11
PUUMA Architecture A locking spring-loaded hinge with
computer controls A frame to attach the hinge to Sensors
28 March 2001 12
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
28 March 2001 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
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Customer Benefits A KAFO that carries it’s own
weight and then some
28 March 2001 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
28 March 2001 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)?
28 March 2001 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
28 March 2001 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
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Backup If we reduce our development to a
focus on just the hinge we have
28 March 2001 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
28 March 2001 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
28 March 2001 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)
28 March 2001 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
28 March 2001 24
Financial Assumptions FDA costs will be low Little to no additional IP costs No expensive ingredients At least a year of burn
28 March 2001 25
Cash Flow Income is >1 year away Profitability is significantly beyond
that Salaries R&D COGS
28 March 2001 26
Engineering <others>
28 March 2001 27
OperationsPhase one Planning/FDA compliancePhase two Final prototyping Testing Funding seekingPhase three Money grubbing Marketing/road show (orthotics conferences) Finalizing shipping product and planning production
28 March 2001 28
Marketing and SalesPhase One Market Size Study Early Customer Identification Strategic relationships Sales and distribution planning Feature Release planningPhase Two Shows, white papers, press releases Marketing Rollout, Sales Kit Strategic relationships/partnerships
28 March 2001 29
General and Administration
Phase one Planning Settling IncorporationPhase two Finance Contracts Legal/regulatory Human Resources Management/roles/responsibilities
28 March 2001 30
PUUMA SW Architecture <others>