Transcript document

Listing 690
Overview of Developer
 Founded in 1999
 Technology Portfolio
 Sensor Technologies – materials and chemistry
 Software to monitor & predict pH shifts
 Intellectual Property Portfolio
 Patents filed worldwide
 Copyrights and Trademarks
 Market Applications
 Healthcare, Food Safety, Biomedical, Biohazards,
Water Safety, Viticulture/Agriculture
Technology Overview
 Proprietary Sensor
 Predictive Sensors
 predict pH shifts
 Proprietary Indicator System
 Preventive Indicators
 prevent unhealthy conditions caused by pH
shifts
 System senses & displays danger points in-
advance creating opportunity for intervention
and prevention
The Market Opportunity
 U.S. Adult Institutional markets
 Skilled nursing and extended care
facilities
 Briefs and pads
 New Premium Brand & Positioning
 Higher value proposition product
 Advanced & new technology provides
market leadership position
 Promotes additional products,
technology, or services bundling and
revenue generation
Institutional Market Assumptions
 Total U.S. Skilled Nursing Facilities
 #1,500,000,000 units/year
 $1,500,000,000+/year
 New Brand @ 15% penetration
 #225,000,000 units/year
 Premium value of +$0.40/unit @$1.40*
 * Without CMS remuneration
 Estimated net new revenue
$90,000,000/year
Market Analysts
 “Lister technology provides the first
measurable, scientific method of diaper
changing. It should be attractive to all major
manufacturers”
 Alan Perlman, Marketing Opinion Letter, formerly of Arthur D.
Little
 “The user benefits provided by the predictive
indicators make powerful claims for both adult
and infant markets.”
 John Starr, John R. Starr Inc.
The pH Problem with Diapers
 Exposure to elevated pH is the underlying
cause of skin degradation and infections in
diapered area
 Diapered skin pH cannot be controlled by
the diaper manufacturer
 skin degradation & proclivity to infections
are idiosyncratic & idiopathological
 pH in diapered area rises variably
according to the individual wearer
 pH increases at an accelerating rate
Dynamics of pH in Diapers
 Known: pH will rise as long as diaper is
worn.
 Known: pH will become increasingly
deleterious to wearer.
 Unknown: what is pH at any given
time, and how fast is it rising, and when
will it reach the problem stage?
Usage Problem with Diapers
 Caregivers don’t know when to change because
they have no way to know pH status =
ineffective & inefficient care
 Changing too frequently
 Wastes time & money
 Changing too infrequently
 promotes costly skin degradation / infections /
malodors / discomfort
This Technology Solves the Problem
 Predictive pH indicators provide advance
warning when the diaper/pad will need to be
changed to prevent and reduce skin damage
and infections
 Time to change:
 Not too soon …..
 Not too late …..
 Just in time!
 Optimizes usage, costs and prevention
pH Sensors
for Absorbent
Articles
Bruce G. Pound, Ph.D.
Exponent, Inc.
May 2005
SF26810.000 A0T0
1101 BP13
What is pH?
 Measure of acidity or alkalinity of a liquid
 pH = - log (activity of hydrogen ions)
 Activity ~ concentration
 pH range usually taken as 0 to 14
Acidic
0
Neutral
7
Alkaline
14
Wetness Enables Smart Sensors?
 pH is measurable if liquid is present
 Conductivity is measurable if liquid is
present
 Certain compounds change color with a
change in hydration due to liquid
Wetness sensors vs. pH sensors
 Wetness sensors are binary
 Detect only wet/dry state
 Not necessarily chemical changes
 Not multiple changes
 “Smart” pH sensors monitor chemical changes
that affect skin health
 Follow change in pH with time
Predict remaining safe life of
absorbent article
Types of pH sensors
 Chemical sensors
 Color of dye changes with pH
 No intrinsic electrical signal
 Electrochemical sensors
 Electrochemical potential changes with pH
 Voltage output gives predictive capability
Electrode Requirements for
Diaper Use
 Comfort
 Flexible, low profile= thin wire or foil
 Safety
 Unbreakable components
 Non toxic, non-irritant chemicals
 Cost/Disposability
 Low-cost materials and manufacture
 Environmentally acceptable materials
Electrochemical pH Sensors
 Two components
 pH electrode
 Reference electrode
Foil Strip Electrodes
Copper reference electrode
Untreated ends
Aluminum pH electrode
pH Kinetic in Diapers (Typical)
11
10
9
pH
8
7
6
1
2
3
4
5
6
7
Hours
8
9
10
11
12
13
pH Kinetic in Diapers
(Extended Range)
11
10
9
pH
8
7
6
1
2
3
4
5
6
7
Hours
8
9
10
11
12
13
pH Kinetic in Diapers (Short
Range)
11
10
9
pH
8
7
6
1
2
3
4
5
6
7
Hours
8
9
10
11
12
13
Ph Change in Diapers
120 minutes
7.0
pH
5.5
Time
Response of pH Wire Sensor
 Potassium
-0.7
Potential Difference of pH Sensor (Volts)
chloride solution
 Stepwise addition
of potassium
hydroxide
 Time for voltage
to stabilize
decreases as pH
increases
 Stable after a few
minutes at higher
pH
First addition of KOH
-1.1
pHE-7/RE-1
pHE-8/RE-2
-1.5
-1.9
0
2000
4000
Time (seconds)
6000
8000
Locations with different pH
 Different pH levels simultaneously present at
different locations in a diaper
 Strips of filter paper on 10-inch foil sensor
electrodes
pH 7 solution at
location 1
pH 10 solution at
location 2
Sensor Response with
Different pH
14.0
Dry
Wet
— pH 7 solution deposited at first location
-0.4
Potential Difference (V)
Potential Difference (V)
10.0
6.0
pH 10 solution deposited at second location
-0.8
-1.2
pH 7 solution deposited at first location
-1.6
0
200
2.0
400
600
800
Time (s)
pH 10 solution deposited at second location
}
-2.0
0
200
400
Time (s)
600
800
Implications of Sensor Response
 Onset of wetness was immediately detected
through pH measurement
 pH monitored was the most alkaline (highest)
value along the sensor
 Response of sensor was a novel and critical
result
 for detecting “hot” pH zones
 for predicting when to change a diaper
Lister Intellectual Properties
 U.S. Patent
 Electro-chemical pH sensor for diapers
 International patent filings
 Copyrights, trademarks, provisional patents
and regulatory filings
 U.S. Patent Pending
 Color change chemical pH sensor
Basic Patent 6,617,488
 “Method and Apparatus for Indicating the
Conditions in an Absorbent Article”
 ABSTRACT
 “systems for displaying the pH on the
outside of the article that provide visual
and/or audible warnings that toxic levels
are approaching and that it is time to
remove and replace the article”
 KEY CLAIM
 “A method of predicting the remaining
safe life of a diaper.”
Medical Values of Lister Technology
 Projected Medical Efficacies
 Reduce incidence of Stage 1 skin
degradation.
 Reduce incidence of infections.
 Slow progression of Stage 2, 3, 4 skin
degradation.
 Mitigate infections.
 Reduce skin care costs, including doctors.
 Reduce hospitalizations for above illnesses
 Reduce nosocomial costs.
Lister Dermatology Study Conclusion
 “The goal with diaper pH indicators is to save
money on manpower, as well as improve quality
of life for the aged, with less disruption of sleep
and other activities, as well as effective
prevention of diaper rash. This study
demonstrates such a goal is relevant and
obtainable.”
 Ruby Ghadially MD, UCSF Dermatology, Principal Investigator
on Lister study.
Incontinence Management
Problems
 In Skilled Nursing and Extended Care
facilities incontinence management is:




Inefficient
Medically ineffective
A major profit drain
A client satisfaction and PR dilemma
 Regulatory demand is for prevention of
dermal deterioration
 Lack of standards for incontinence management
makes compliance impossible
 U.S. cost of non-compliance
 I.T.I. est. $3+ billion/year
Solution - SmartChange™ System
SmartChange SystemTM
Systemizes
Incontinence Management
SmartChange™ System
Secured patient unit
Embedded pH sensors
Caregiver receives
instant updates on
“time-to-change”
Caregi
ver
Unit
Bedsid
e
Nursing station exchanges
real time data from multiple
beds/patients/caregivers
Transcei
ver
Bedside transceiver
receives real time data
from pH sensor
Nurse’s
Workstation
SmartChange™ System
Reusable
transmitter fits in
secure pouch
SmartChange™ System
User Friendly information
display – easy to
understand and initiate
action as needed
Bedside
Transceiv
er
Nurse’s
Workstation
SmartChange™ System
Caregiver
Unit
Universal and compatible to
current wireless handheld
systems – easy to read and
create action
SmartChange™ System Benefits
 Skilled Nursing & Extended Care Facilities
 Direct Cost Savings
 Fixed labor cost savings
 Automated status and feedback eliminates
need for manual diaper checks & unnecessary
changes
 Facility wide reduction in labor required for
skin care
 Reduces costly skin care treatment
procedures for damaged or infected skin
 Automated reporting reduces administrative
costs
 Material cost savings
 Optimized diaper changes & reduced
ointment/treatment medicines & medicaments
SmartChange™ System Benefits
 Skilled Nursing & Extended Care Facilities
 Indirect Cost Savings
 Skin degradation lawsuit filings are increasing due
to Medicare requirements (MDS)
 Facility liability insurance is increasing due to
higher awards per claim
 Increased federal and state penalties/fines for
noncompliance
 Lower turnover rates from patient movement and
better client relations
SmartChange™ System Benefits
 Skilled Nursing & Extended Care Facilities
 510(k) medical device (filing in progress)
 Best method available to produce highest quality
patient care
 Decubitus care directives and urgency of the
ulceration problem is driving innovation and new
standards for prevention
 Remuneration potential is established for 510(k)
devices for improved incontinence management
 Qualifies facility to receive remuneration &
to promote themselves as providing higher
quality (QIC) indicators
Hot Zones are Critical Factors
 Predictive + Preventive = Remunerative
SmartChange™ System Benefits
 Benefits to the End User
Maximized comfort and care
Improved health and quality of life
 Change only as needed – optimum timing
 Not an arbitrary schedule
 No unnecessary sleep interruption
 Better relations with caregiver
 Patient dignity
Promotes more effective and efficient
caregiver habits
Defining the Market
 Five constituencies that desire improvement –
all must be satisfied
 Government agencies, clients/patients,
institution owners, facility administrators
and individual caregivers
 Government – Prevention
 Patients – Quality of life
 Owners – Cost containment & efficiency
 Facility manager – Compliance, higher QI ratings,
staff/patient retention and morale
 Caregiver – User friendly technology, improved
patient relations, reduced workload, respect
Benefits to Diaper Manufacturer
 Efficient Marketing/Sales
 Large chains dominate SNF market – few corporate
sales yield large market shares
 Standardization Potential
 State governments and VA regions may mandate use
of the technology, based on 510(k) health benefits
 Bundling Potential
 Incontinence products pull other product lines
 Reputation
 Create image as ‘The Healthy Diaper Company’
Benefits to Diaper Manufacturer
 Remuneration Potential
 Likelihood of securing 510(k) based on
SmartChange health benefits
 FDA and CMS cooperating to foster new
technologies to prevent skin degradation
and infection spread
 CMS mandate to prevent skin ulceration
 CMS can act independently of FDA to
establish remuneration policy
 Conclusion: remuneration likely
Benefits to Diaper Manufacturer
 Protection from Competition
Lister basic patent (6,617,488)
overcomes seminal Kimberly Clark
patent to Everhart
Lister basic patent overcomes
seminal Procter & Gamble patents
to Roe
Lister patent portfolio includes
minefield protections of basic
patent
Benefits to Diaper Manufacturer
 Cost of Goods Efficiencies
 SmartChange™ Diaper
 Foresight of when a diaper will need to be
changed should lead to less costly diapers
 “Modified cost models have been constructed
that show that Lister predictive indicators may
permit cost-saving modifications in the diaper
design….particularly the absorbent core.”
 COGs Analysis, John R. Starr, John Starr,
Inc.
Diaper of the Future Multifunctional
 The Diaper as a Diagnostic Device
 Additional information/data generation
 Incorporating sensors into diapers opens the
path for many useful on-line reports:
 Pulse (predictive)
 Temperature (predictive)
 Patient location
 Other diagnostics
Enhanced Functionality
Colormetric, Predictive pH Indicators
 IP folio includes patent
pending and patent filings on
color-change indicators for a
number of mass market
products.
 Patent coverage for
predicting safe-life of infant
diapers, for predicting the
onset of malodors, and for
predicting the shelf life of
packaged foods.
pH 8.5 - 10+
Act Now!
pH 7.5 - 8.5
Act ASAP
pH 6.5 - 7.5
Act in 1 hour
pH 5.5 - 6.5
Safe-No Action
Color/Smart ™ Technology
 Patent pending
 R&D at Arthur D. Little and Stanford Research
Institute International
 extensive experience in diaper R&D
 extensive experience in colorimetrics
 pH Sensor/Indicators developed:
 display bright distinct range of colors/hues
 employ pH sensitive dyes, leuco dyes, pH
sensitive coatings, chelating compounds and
hybrids of the previous
 Any range of pH change can be measured
and predicted with custom sensors
Markets for Color/Smart ™
Indicators
 Advance warning of skin discomfort/damage:
 Infant Diapers
 Advance warning of odor formation:
 Adult Retail Diapers
 Adult Assisted Living / Home Care diapers
 Catamenial products
 Advance warning of packaged food spoilage:
 Meat / Chicken / Fish / Dairy et. al.
Infant Diaper - Get Ready to Change
Indicators can be
placed where
consumers prefer
Infant Diapers
 What does the customer want?
 70% CONVENIENCE
fewer changes / no leaks
 15% COMFORT / SKIN WELLNESS
 15% LOWEST PRICE
 Reference: John R. Starr
Longevity Problem with Infant
Diapers
 Consumers Demand Convenience
 In 2005, diapers worn twice as long as in
1990.
 Over long-wearing, pH rises continuously faster & faster.
 High diaper pH causing an epidemic of skin
problems:
 66% of infants have diaper rash monthly
 Parent or daycare providers do not know
when to change...
Marketing Claims for Infant Diapers
 The Most Convenient Diaper
 The indicator tells at a glance and in
advance when a change will be needed.
(No need to open, sniff, feel the diaper.)
 The Most Comfortable Diaper
 Timely changing will help prevent skin
irritation/discomfort.
 The Healthiest Diaper
 Timely changing helps keep healthy skin
healthy.
Current Development Activity
 Design for Manufacturing Activity
 High volume sensor manufacturing
 Wireless/IT components manufacturers
 Ongoing clinicals at UCSF
 FDA 510(k) filings
 Ongoing market research
 VA hospitals
Summary and Next Steps
 This technology is unique and protected
 Electrochemical SmartChange™ technology
 Manufacturable unique sensors
 Proprietary software
 Remuneration has value for higher profits
 Color/Smart Color change technology
 Low cost, easy to use, market focused
 Available to Diaper Manufacturers for license.
Follow Up
 Please refer to Tynax listing
number: 690 with regard to
this opportunity.
 Inquiries should be directed
to:
 David Smith
 [email protected]
Thank You