1. Folliculogenesis In Vivo™
FIV™
Fundamental
SELF-HELP MEDICAL DEVICES FOR WOMEN
FUNDAMENTAL DATA FOR PHYSICIANS
(AND INSURERS)
FROM ADOLESCENCE TO MENOPAUSE

2. Technology FIV is a convergence of:
Life Science ) Ovulona™
Physical science ) for
Bioprobe microelectronics ) home use
Software (SaaS) ) Ovulograph™
IT ) for
Web ) office use
BOTH MOBILE PHONE-COMPATIBLE
Prototype of Ovulona™ Tissue Biosensor
with output for the physicians’ Ovulograph™ data management system

3. What Is Folliculogenesis?
The biological foundation of a woman’s well-being.
Brain – ovary interactions
All the time. Throughout her lifetime.

4. Life itself depends on the F in FIV.
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.
Predisposition to dis-ease
Timing of medications and medical procedures
Aptitude
Mood & Well-being
PMS/PMDD
Migraines
Fertilizable egg produced only
every so often, and only very shortly
Viable egg: About every 3 – 6 weeks, for about 12 hours or so.

5. What Is Folliculogenesis?
It is the biological foundation of a woman’s well-being.
1) It is NOT this or that hormone alone.
2) Ultrasound sees –belatedly- the result, NOT the process.
This periodic signature process is the F in FIV.
LH and/or estrogen can NOT yield this information.
The cervix has the information. We probe for it.
Smart Storage Case™ user-interface via cell phone or TV
- for input of symptom data.

6. What FIV™ does for women and for family planning For birth control,
avoid insemination
during these 3 days
What
FIV™
does for
women
and for
family
planning
Try for
either gender
Try for
a boy
Try for
a girl
The multitude of repeatable measurable features of the cyclic pattern makes it possible to determine the boundaries of the fertile window for every individual cycle (rather than having to rely on some assumption of unchanged timing of these events from cycle to cycle in the manner of the methods of prior art).
Nota bene, note well:
This is why our technology can be used for birth control whereas the prior art technologies cannot.
(The older techniques do NOT have a multitude of measurable features in their cyclic profiles, and CANNOT therefore determine the boundaries of the fertile window.)

7. Fundamental breakthrough
MOSTLY
BOYS BORN
77%
MOSTLY GIRLS BORN
69%
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

8. says PricewaterhouseCoopers
Users’ Profile
30%
70%
100%
Three statistics tell the story
Personalized medicine - diagnostic tools
Context: $232 Billion personalized medicine market to grow 11% annually
says PricewaterhouseCoopers

9. 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]

10. 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]

11. 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.

12. Prototype already FDA 510k certified
Goal
Address the 100% population
via the 30% and 70% sub-populations
Plan
Generate early revenues within the 30% market segment
= Highly motivated, eager, impatient. Price not a factor.
Prototype already FDA 510k certified
Introduce birth control product in year 3. Next new products in year 4.
Self-financed from profits.

13. Innocuous cervical cancer screen - better than Pap smear
Photo of mockup model of our core product prototype
Ovulona™ with output for the physicians’ Ovulograph™
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
Knowledgebase covered currently by 10 Patent Cases, a few issued, most pending. (The ones, without which the competition could not make any me-too clones, we’ll want to keep as trade secrets… = avoiding publication.)
The photograph is of a product as planned for the market introduction (product is not quite ready for launch; funding is required).

14. Absence of the peaks anticipates failure to ovulate.
Ovulona anticipates LPD = Luteal Phase Defect, which often causes failure to conceive – by normal healthy women
Ovulona’s diagnostic power will save reproductive
management money.
This
cannot be matched
by ovulation kits
or by any other
such product.

15. Comparative summary of technologies available to women in the self-help conceptive aid market segment
Characteristics
Ovulona™
BBT
thermometers
LH kits
urine chemistry
Saliva
magnifying glass
Body fluid
Conductivity
Accuracy
High
Low
Reliability
Immediacy of results
Yes No
Convenience of use
Low cost
Information content
Can be used for birth control?
Can be used to preselect baby’s sex?
Can it do built-in pregnancy check?
Can it compute date of delivery?
Folliculogenesis profile for healthcare?
Multi-purpose long-term use?
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]

16. Women’s Health Technology Companies’ Mergers & Acquisitions
$281MM
FEI Women's Health: 3 years after start-up was acquired in 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

17. bioZhena Start-up Timeline
TASKS VS. MONTHS AFTER FUNDING 01 02 03 04 05 06 07 08 09 10 11 12
OvulonaTM Repackage & Pilot Run
FDA 510(k) re-certification
Ovulona manufacturable and marketable, 10 units tested
Manufacture and test 25 Ovulona units
Pilot manufacturing run, 500 units
Clinical trials and promotion, 3 centers
3,525 units available for sale
First shipments for sales revenue
contract negotiated
budget proposed
Startup capital sought: $1.5M - $3.0M

18. bioZhena Corp. 5-year plan The gist
Projected $ numbers
- baseline scenario
US Ovulona sales alone
Year 1
Year 2
Year 3
Year 4
Year 5
Number of Ovulona Units overstated unit cost of $50
7,500
177,000
300,000
450,000
600,000
Total $200/unit
1,350,000
29,806,800
69,990,000
113,640,000
221,160,000
EBITDA
(4,788,000)
(3,227,000)
7,488,000
24,293,000
62,654,000
Operating Cash Flow
prior to financings
(5,854,000)
(6,188,000)
4,085,000
16,997,000
48,763,000
Financings
7,700,000
4,500,000
Cash Balance
1,846,000
158,000
4,243,000
21,241,000
70,004,000
Source: Baseline financial scenario JMW V3-1-WEE.xls.
Assumptions:
Time periods are all post-funding. Initial seed capital of $1.2 million. Then $3.25 million in Month 6 and $3.25 million in Month 10.
Launch into self-help conception market. Total available US market 15 million is conservative cf. 17,579,655 official stats.
Unit manufacturing cost assumed constant at $50, but will fall below $10 at large quantities (~by end of year 2).
Unit price to customers assumed constant at reasonable $200 based on analysis of self-help conception market. (A simplification.)
Sales into birth control market start in year 3, into new products market in year 4.
NOT ACCOUNTING FOR OVULOGRAPH SALES, AND FOR INTERNATIONAL MARKETING AND SALES.

19. Key people at lean startup
FOUNDER an estimated $2.5 MM skin in the game
OPERATION local manufacturing contractor, FDA regulated, startup operations expertise
REGULATORY 2 seasoned FDA experts + BOD member ex-FDA deputy commissioner
MARKETING BOD member ex-Abbott  CMO
FINANCIAL 3 CFO candidates contributed to financial planning
LEGAL courting boutique firm for perfect solution PPM done by Dorsey & Whitney LLP
Lean BOD and BOA

20. OFFER TO STARTUP INVESTOR
Cash repayment via profit sharing while investor keeps shares
Profitability projected for year 3 after funding
1-year Warrant to buy the same number of shares at the same price
Investment protected against dilution by the next round
Projected $ numbers
Year 1
Year 2
Year 3
Year 4
Year 5
Revenues
1,350,000
29,806,800
69,990,000
113,640,000
221,160,000
EBITDA
(4,788,000)
(3,227,000)
7,488,000
24,293,000
62,654,000
Assuming Ovulona sales in U.S. alone, no international sales, no Ovulograph sales. Source: Baseline financial scenario JMW V3-1-WEE.xls.
Option 1: Accrue interest till profitability. After breakeven, we’ll pay you back.
Option 2: Want to be successor CEO?
Experience.
Share vision.
Skin in game.
Decline repayment.
If not, we’ll find one to groom. Post-startup.

21. FIV throughout a woman’s life
Ovulographic FIV monitoring ->HRT 10 20 30 40 50 60 70 80
birth control
sex ed
hormone therapy
cervical cancer screen PMS/PMDD management
conception aid
pregnancy detect &monitor
compute EDD/EDC
baby gender planning
PMS/PMDD management

22. Different peak sizes show the different speed of maturation of the egg in different menstrual cycles
(maturation of dominant follicle)
See the unprecedented wealth of information inherent in the FIV™ signature cyclic profile
These are follicular waves preparing for the next cycle. The number of these waves indicates how fast the woman approaches menopause.
The cyclic pattern exhibits a number of well defined peaks and troughs: … the first post-menstruation minimum (or trough, nadir) occurring typically on day 6, 7, or 8. The signal then rises to a maximum (long-term predictive peak), the highest level of the cycle. Over the next several days, the readings fall toward the minimum before the short-term predictive peak.
Thus, in the recorded 30 days long cycle, the long-term predictive peak is 8 days wide. It is followed by the usually narrow short-term predictive peak, which falls off directly into the trough of the ovulation marker, the lowest reading of the cycle.
We have found the ovulation-marker minimum to correlate with urinary LH and FSH peaks, and we view the marker to be an effect of the steroid hormone switch that occurs at ovulation (estrogen to progesterone). Note that the corresponding basal body temperature (BBT) curve rises, to the post-ovulatory high level, after the ovulation marker. This indicates, to the extent that the BBT can be relied on, that ovulation had, indeed, occurred. The planned sonographic (ultrasound) investigations will confirm this correlation with a better accuracy.
Note that Dr. Benedetto carefully selected baseline subjects for the trial.
Even in these baseline subjects, the classical BBT “biphasic profile” is very unreliable, as is highlighted by the red question marks. The belated rise of the BBT3 curve (of the 27 years old subject) is clearly noticeable and symptomatic of the uncertainty inherent in the basal body temperature measurements.
Ovulation is detected as estrogen control switches to progesterone control
This is the ovarian “I am ready” signal

23. This is an example from real-life –
not a baseline data from a laboratory
This is the dominant follicle maturation peak
See the unprecedented powerful diagnostic capability inherent in the FIV™ signature cyclic profile
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 the ovarian
“I am ready” signal
Two follicular waves
in this cycle

24. Ovulograph™
Unprecedented ability to correlate with folliculogenesis the self-reported symptoms
- and also
other diagnostic data.
GOOD DIAGNOSIS NEEDS THIS CORRELATION
The technology enables the input of symptometric and other auxiliary data in synchrony with the folliculogenesis data, which in turn enables the physicians to provide a better medical help.
This is unprecedented both in terms of providing the longitudinal cyclic profile data, and the correlated auxiliary data needed for effective diagnosis and treatment.
There is nothing like this in the marketplace.
COPE = Calendar Of Premenstrual Experiences
An example of established measurement of symptoms
Differential diagnosis is based on how symptom scores relate to folliculogenesis. E.g., PMS/PMDD vs. clinical depression.

25. Why Do It Impact on public health
Simple affordable powerful personal health management tools
The other two high-level reasons are: 1. Happiness – Pursuit of Pleasure ---FUNDAMENTAL DRIVING FORCE OF PEOPLE EVERYWHERE
and 2. Personalized medicine of 1/2 of humankind --- FUNDAMENTAL NEED OF OBSTETRICS & GYNECOLOGY FOR SOLID DIAGNOSIS
Will help solve costly medical problems with unplanned pregnancies, sub-fertility, STDs, etc., etc.

26. Sure Bet! FIV™ for reproductive management – 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 PEOPLE 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