PUUMA Systems, Inc

Innovations in torso support

28 March 2001 2

Today’s 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)

28 March 2001 3

Sources of Need Weakness Atrophy Paralysis (total, or partial) Desire for more carrying capacity 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 accommodations 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

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 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

28 March 2001 13

Customer Benefits A KAFO with a more natural

gait (TBD) A KAFO that carries it’s own

weight and then some…

28 March 2001 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)

28 March 2001 15

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”)

28 March 2001 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

28 March 2001 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

28 March 2001 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)

28 March 2001 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

28 March 2001 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

28 March 2001 21

Engineering <others>

28 March 2001 22

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

28 March 2001 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

28 March 2001 24

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

28 March 2001 25

Milestone Two

Inner clutch/single spring 100K 1 2

3 4

-Inner clutch engaged, weight

drops

-Spring compresses, inner clutch latches

-Inner clutch released, weight

goes up

-Monitor drum angle, clutch

engagement angle

28 March 2001 26

Milestone Three

Outer clutch 100k cycle test

1 2

3 4

1

3

-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

28 March 2001 27

Milestone Four

Inner clutch/spring/outer spring 100K

1 2

3 4

-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

28 March 2001 28

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

28 March 2001 29

PUUMA SW Architecture <others>

28 March 2001 30

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 31

Cash Flow Income is >1 year away Profitability is significantly beyond

that Salaries R&D COGS

28 March 2001 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…)?

28 March 2001 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

28 March 2001 34

OperationsPhase one Planning/FDA compliancePhase two Final prototyping Testing Funding explorationPhase three Marketing/road show (orthotics conferences) Finalizing shipping product and planning production

28 March 2001 35

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 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.)

28 March 2001 37

General and AdministrationPhase two (next 30 days) Planning Operations: budget, contracts,

legal/regulatory Engineering: frame, control, knee

milestones reviewed, resource listPhase three “Hello world”, marketing, conference

circuit Seeking investment or choosing not to