Title: PUUMA Systems, Inc
1PUUMA Systems, Inc
- Innovations in torso support
2Todays 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)
3Sources of Need
- Weakness
- Atrophy
- Paralysis (total, or partial)
- Desire for more carrying capacity
- Amputation (with prosthetic in place)
4Existing 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
5Best Practice (Auto-locking knee joint)
- SCOKJ (Horton technology)
6On 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
7PUUMA 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
8Market 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)
9Market OpportunityExisting met demand
- Sold each year
- TBD KAFOs
- TBD carts for the obese/weak
- TBD walkers
10Reasonably 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
11The 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
12PUUMA 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
13Customer Benefits
- A KAFO with a more natural gait (TBD)
- A KAFO that carries its own weight
- and then some
14PUUMA 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)
15PUUMA 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)
16Competing 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
17Key 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
18Potential 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)
19Risks
- 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
20Backup
- 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
21Engineering
22Development Milestones
- Knee Development
- Control Development
- Frame
- Alpha prototype
- Clinical trial ready prototype
- Road show prototype
23Drum 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
24Milestone 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
25Milestone 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
26Milestone 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
27Milestone 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
28Milestone Five Software Testbed
-Ankle can slide to simulate a step -Best
representation of actual walking -Used to develop
software, not to specifically test components
29PUUMA SW Architecture
30Financial Assumptions
- FDA costs will be low
- Little to no additional IP costs
- No expensive ingredients
- At least a year of burn
31Cash Flow
- Income is gt1 year away
- Profitability is significantly beyond that
- Salaries
- RD
- COGS
32Cash 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)?
33Financials (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
34Operations
- 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
35Marketing 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
36General 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.)
37General 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