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Folliculogenesis In Vivo™
FIV™
Fundamental
SELF-HELP MEDICAL DEVICES FOR WOMENFUNDAMENTAL DATA FOR PHYSICIANS
(AND INSURERS)
FROM ADOLESCENCE TO MENOPAUSE
TechnologyFIV is a convergence of:
• Life Science ) Ovulona™• Physical science ) for• Bioprobe microelectronics ) home use
• Software (SaaS) ) Ovulograph™• IT ) for • Web 2.0 ) office use
Prototype of Ovulona™ Tissue Biosensorwith output for the physicians’ Ovulograph™ data
management system
BOTH MOBILE PHONE-COMPATIBLE
What Is Folliculogenesis?The biological foundation of a woman’s well-being.
Brain – ovary interactionsAll the time. Throughout her lifetime.
What Is Folliculogenesis?The biological foundation of women’s well-being.
• Women’s health and lifestyle revolve around it.
• Life itself depends on the F in FIV.
Fertilizable egg produced only
every so often, and only very shortly
• Predisposition to dis-ease• Timing of medications
and medical procedures• Aptitude• Mood & Well-being• PMS/PMDD• Migraines
Viable egg: About every 3 – 6 weeks, for about 12 hours or so.
What Is Folliculogenesis?It is the biological foundation of a woman’s well-being.
1) It is NOTNOT this or that hormone alone.2) Ultrasound sees –belatedly- the result, NOTNOT the process.
This periodic signature process isis the F in FIV.LH and/or estrogen can NOTNOT yield this information.
Your body has the information. We probe Your body has the information. We probe for it.for it.Smart Storage Case™ user-interface via cell phone or TV- for input of symptom data.
Try for a boy
Try fora girl
Try foreither
gender
For birth control,For birth control,avoid insemination avoid insemination during these 3 daysduring these 3 days
WhatWhatFIVFIV ™™
does fordoes forwomenwomenand forand forfamilyfamilyplanninplannin
gg
Fundamental breakthrough
• Unprecedented accuracy • Diagnostic indications in plain English – interprets results• Automatically detects & monitors pregnancy, computes EDD (delivery date)• Automatically screens for cervical cancer, STDs• Requires no chemical work, no graphing, no interpretation of data• Provides FIV data to healthcare system
MOSTLYMOSTLYBOYS BOYS BORNBORN77%77%
MOSTLY MOSTLY GIRLS GIRLS BORNBORN69%69%
Users’ Profile
30%
70%
100%
Three statistics tell the storyPersonalized medicine - diagnostic tools
Context: $232 Billion personalized medicine market to grow 11% annually
says PricewaterhouseCoopers
30% of women/couples cannot conceive
30% of women/couples cannot get pregnant when wanted[Source: Fertility and Sterility 2008; 89:e27–9. ©2008 by American Society for Reproductive Medicine]
70% of women “would switch”
70% of women who “would buy” the Ovulona, would switch from their current birth control to our Ovulona
fertility status monitor [from a survey of 5,000 US women]
100% of women are threatened
100% of women are threatened by cervical cancer, and other gynecological problems, STDs.
Plus: personalized medicine, PMS/PMDD management, sex education, and other needs require FIV.
GoalAddress the 100% population
via the 30% and 70% sub-populations
PlanPlease email [email protected]
Prototype already FDA 510k certified
• Predicts and detects ovulation = conception & birth control aid
• Innocuous cervical cancer screen - better than Pap smear
• Will help to privately pre-select gender of baby
• Detect & monitor early pregnancy, compute delivery date
• Assist management of PMS/PMDD, and of hormone therapy
• Generates fundamental data for use by healthcare providers
PMS = Pre Menstrual Syndrome PMDD = Pre Menstrual Dysphoric Disorder
Photo of mockup model of our core product prototype Ovulona™ with output for the physicians’ Ovulograph™
Absence of the peaks Absence of the peaks anticipates failure to anticipates failure to
ovulate. ovulate. Ovulona anticipates LPD = Luteal Phase Defect, which
often causes failure to conceive – by normal
healthy women
Ovulona’s Ovulona’s diagnostic diagnostic power will power will save save reproductivereproductivemanagement management money. money.
This cannot be matched by ovulation kits or by any other
such product.
Comparative summary of technologies available to women in the self-help
conceptive aidconceptive aid market segment
NoNoNoNoYesMulti-purpose long-term use?
NoNoNoNoYesFolliculogenesis profile for healthcare?
NoNoNoNoYesCan it compute date of delivery?
NoNoNoNoYesCan it do built-in pregnancy check?
NoNoNoNoYesCan be used to preselect baby’s sex?
NoNoNoNoYesCan be used for birth control?
LowLowLowLowHighInformation content
NoYesNoYesYesLow cost
NoYesNoNoYesConvenience of use
NoYesNoYesYesImmediacy of results
LowLowLowLowHighReliability
LowLowLowLowHighAccuracy
Body fluidConductivi
ty
Saliva magnifying
glass
LH kitsurine chemistry
BBTthermometer
s
Ovulona™
Characteristics
The Ovulona provides the most value, the most quality per dollar spent
“Price Is Not An Advertising Point In This Category”,
“Chief Selling Points Are Simplicity And Accuracy” [marketresearch.com]
Women’s Health Technology Companies’ Mergers & Acquisitions
• $281MM FEI Women's Health: 3 years after start-up was acquired in 2006 by Barr Laboratories
• $452MM Adeza Biomedical: acquired by Cytyc Corporation about 3 years
after their 2004 IPO• $427MM
Visicu Inc.: an example from telemedicine, healthcare information technology, acquired in 2008 by Royal Philips Electronics
• $1.6 Billion Digene Corporation: a player in cervical cancer screening, with
sales of $191.1MM (8.4x) and EBITDA of $39.0 MM (41x) agreed in 2007 to a takeover by Qiagen
Our year 4 and year 5 projections - even just in the baseline scenario - are comparable to or better than the Digene
performance numbers
OFFER TO STARTUP INVESTOR
Please email [email protected]
Note:
Seeking investors, not “clever” people who expect
to get paid for a promise.Success fee to a middleman
is the only doable proposition.
FIV throughout a woman’s life
10 20 30 40 50 60 70 80
sex ed birth control cervical cancer screen PMS/PMDD management
hormone therapy
pregnancy detect &monitorcompute EDD/EDCbaby gender planningPMS/PMDD management
conception aid
Ovulographic FIV monitoring ->HRT
Different peak sizes show the different speed of maturation of the
egg in different menstrual cycles(maturation of dominant follicle)
Ovulation is detected as estrogen control switches to
progesterone controlThis is the ovarian “I am ready” signal
These are follicular waves These are follicular waves preparing for the next cycle. preparing for the next cycle. The number of these waves The number of these waves indicates how fast the woman indicates how fast the woman approaches menopause.approaches menopause.
See the See the unprecedenteunprecedented wealth of d wealth of information information inherent in inherent in the FIVthe FIV ™™ signature signature cyclic profilecyclic profile
See the See the unprecedenteunprecedented powerful d powerful diagnostic diagnostic capability capability inherent in inherent in the FIVthe FIV ™™ signature signature cyclic profilecyclic profile
This is the ovarian “I am ready” signal
This is the dominant follicle maturation peak
And here the sensor detects delayed ovulation – in this
case delayed by 2 days.
No other product can do this for women at home
-and for their physicians.
This is an example from real-life –not a baseline data from a laboratory
Two fol l icular waves in this cycle.
Re: Ovarian aging.
Pre-ovulation rise of COPE scores
0
5
10
15
20
25
1 4 7 10
13
16
19
22
25
day of cycle
CO
PE
sco
res a
nd
pro
be
read
ing
s [
uA
]
COPE score
probe reading/10
Post-ovulation rise of COPE scores
0
5
10
15
20
25
1 4 7 10 13 16 19 22 25
day of cycle
CO
PE
sco
res
and
pro
be
read
ing
s [u
A]
COPE score
probe reading/10
Ovulograph™
Differential diagnosis is based on how symptom scores relate to folliculogenesis.folliculogenesis. E.g., PMS/PMDD vs. clinical depression.
COPE = Calendar Of Premenstrual ExperiencesAn example of established measurement of symptoms
Unprecedented ability to correlate with Unprecedented ability to correlate with folliculogenesis the self-reported folliculogenesis the self-reported
symptoms symptoms - and also - and also
other diagnostic data.other diagnostic data.GOOD DIAGNOSIS NEEDS THIS CORRELATION
Why Do It
Will help solve costly medical problems with unplanned pregnancies, sub-fertility, STDs, etc., etc.
• Impact on public health Simple affordable powerful personal health management tools
Sure Bet!FIV™ for reproductive management –
our first launch product, the Ovulona™our first launch product, the Ovulona™will be – inevitably -- preferred over alternatives
SINCE IT IMPROVES QUALITY OF PLEASURE • Happiness – Pursuit of Pleasure
THE FUNDAMENTAL DRIVING FORCE OF THE FUNDAMENTAL DRIVING FORCE OF PEOPLE EVERYWHEREPEOPLE EVERYWHERE
• We humans are pleasure - seeking organisms• Our brain prefers “ancient” sensory pleasures
- including unprotected sex, no contraception• Existing products don’t satisfy the preference• Existing approach to infertility unsatisfactory
Ref.: ANTHROPOLOGY – “The Pursuit of Pleasure” by Lionel Tiger, 1992