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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
facilitiesBriefs 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 infrequentlypromotes 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!Just in time!
Optimizes usage, costs and prevention
pH Sensorsfor Absorbent
ArticlesBruce 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
0 147
Acidic Neutral Alkaline
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
Aluminum pH electrodeUntreated ends
pH Kinetic in Diapers (Typical)
6
7
8
9
10
11
1 2 3 4 5 6 7 8 9 10 11 12 13
Hours
pH
pH Kinetic in Diapers (Extended Range)
6
7
8
9
10
11
1 2 3 4 5 6 7 8 9 10 11 12 13
Hours
pH
pH Kinetic in Diapers (Short Range)
6
7
8
9
10
11
1 2 3 4 5 6 7 8 9 10 11 12 13
Hours
pH
Time
Ph Change in Diapers
pH
5.5
7.0
120 minutes
Response of pH Wire Sensor
Potassium chloride solution
Stepwise addition of potassium hydroxide
Time for voltage to stabilize decreases as pH increases
Stable after a few minutes at higher pH
-1.9
-1.5
-1.1
-0.7
0 2000 4000 6000 8000
Time (seconds)
Pote
nti
al D
iffere
nce
of
pH
Senso
r (V
olt
s)
First addition of KOH
pHE-8/RE-2
pHE-7/RE-1
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
-2.0
2.0
6.0
10.0
14.0
0 200 400 600 800Time (s)
Pote
nti
al D
iffere
nce (
V)
Wet — pH 7 solution deposited at first location
pH 10 solution deposited at second location
Dry
}
-1.6
-1.2
-0.8
-0.4
0 200 400 600 800
Time (s)
Pote
nti
al D
iffere
nce (
V)
pH 7 solution deposited at first location
pH 10 solution deposited at second location
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$3+ billion/year
Solution - SmartChange™ System
SmartChange SystemTM
SystemizesIncontinence Management
SmartChange™ System
Nursing station exchanges real time data from multiple
beds/patients/caregivers
Nurse’s Workstation
Caregiver receives instant updates on “time-to-change”
Caregiver Unit
Embedded pH sensors
Secured patient unit
Bedside
Transceiver
Bedside transceiver receives real time
data from pH sensor
SmartChange™ System
Reusable transmitter fits
in secure pouch
SmartChange™ System
Bedside
Transceiver
Nurse’s Workstation
User Friendly information display – easy to understand and initiate action as needed
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 UserMaximized 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 caregiversGovernment – PreventionPatients – Quality of lifeOwners – Cost containment & efficiencyFacility manager – Compliance, higher QI ratings,
staff/patient retention and moraleCaregiver – 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 CompetitionLister 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 - 8.5Act ASAP
pH 6.5 - 7.5Act in 1 hour
pH 5.5 - 6.5Safe-No Action
Color/Smart ™ Technology
Patent pending R&D at Arthur D. Little and Stanford Research
Institute Internationalextensive experience in diaper R&Dextensive 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 sensorsProprietary softwareRemuneration has value for higher profits
Color/Smart Color change technologyLow 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
