PUUMA Systems, Inc

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

28 March 2001 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

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

28 March 2001 14

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

28 March 2001 19

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>