Скачать презентацию Folliculogenesis In Vivo FIV FROM ADOLESCENCE TO Скачать презентацию Folliculogenesis In Vivo FIV FROM ADOLESCENCE TO

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

Technology FIV is a convergence of: • Life Science • Physical science • Bioprobe Technology FIV is a convergence of: • Life Science • Physical science • Bioprobe microelectronics ) ) ) Ovulona™ for home use BOTH MOBILE PHONE-COMPATIBLE • Software (Saa. S) • IT • Web 2. 0 ) ) ) Ovulograph™ for office use Prototype of Ovulona™ Tissue Biosensor with output for the physicians’ Ovulograph™ data management system

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

What Is Folliculogenesis? The biological foundation of women’s well-being. Women’s health and lifestyle revolve 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. Viable egg: About every 3 – 6 weeks, for about 12 hours or so. • • • 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

What Is Folliculogenesis? It is the biological foundation of a woman’s well-being. 1) It 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.

What ™ FIV does for women and for family planning Try for either gender What ™ FIV does for women and for family planning Try for either gender Try for a boy For birth control, avoid insemination during these 3 days Try for a girl

Fundamental breakthrough MOSTLY BOYS BORN 77% • • • MOSTLY GIRLS BORN 69% Unprecedented 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

Users’ Profile 30% 70% 100% Three statistics tell the story Personalized medicine - diagnostic 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 Pricewaterhouse. Coopers

30% of women/couples cannot conceive 30% of women/couples cannot get pregnant when wanted [Source: 30% of women/couples cannot conceive 30% of women/couples cannot get pregnant when wanted [Source: Fertility and Sterility 2008; 89: e 27– 9. © 2008 by American Society for Reproductive Medicine]

70% of women “would switch” 70% of women who “would buy” the Ovulona, would 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 by cervical cancer, and other gynecological problems, STDs. Plus: 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.

Goal Address the 100% population via the 30% and 70% sub-populations Plan Generate early 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 510 k certified Introduce birth control product in year 3. Next new products in year 4. Self-financed from profits.

Photo of mockup model of our core product prototype Ovulona™ with output for the 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

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

Comparative summary of technologies available to women in the self-help conceptive aid market segment Comparative summary of technologies available to women in the self-help conceptive aid market segment Characteristics Ovulona™ thermometers BBT urine chemistry LH kits magnifying glass Saliva Body fluid Conductivity Low Low Accuracy High Low Reliability High Low Immediacy of results Yes Convenience of use Yes No Low cost Yes No High Low Low Can be used for birth control? Yes No Can be used to preselect baby’s sex? Yes Can it do built-in pregnancy check? Yes Can it compute date of delivery? Yes Folliculogenesis profile for healthcare? Yes Multi-purpose long-term use? Yes Information content The Ovulona provides the Low most No value, the most Yes quality per dollar Yes spent No “Price Is Not An Advertising No No Point In This Category”, No No No “Chief Selling Points Are No No No Simplicity And No No No Accuracy” No No No [marketresearch. com] No No No Low No No

Women’s Health Technology Companies’ Mergers & Acquisitions • • $281 MM FEI Women's Health: Women’s Health Technology Companies’ Mergers & Acquisitions • • $281 MM FEI Women's Health: 3 years after start-up was acquired in 2006 by Barr Laboratories $452 MM Adeza Biomedical: acquired by Cytyc Corporation about 3 years after their 2004 IPO $427 MM 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. 1 MM (8. 4 x) and EBITDA of $39. 0 MM (41 x) 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 -

bio. Zhena Start-up Timeline TASKS VS. MONTHS AFTER FUNDING Ovulona. TM Repackage & Pilot bio. Zhena Start-up Timeline TASKS VS. MONTHS AFTER FUNDING Ovulona. TM Repackage & Pilot Run 01 02 03 04 05 06 07 08 09 10 11 contract negotiated 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 budget proposed First shipments for sales revenue Startup capital sought: $1. 5 M - $3. 0 M 12

 bio. Zhena Corp. 5 -year plan The gist Projected $ numbers - baseline bio. Zhena Corp. 5 -year plan The gist Projected $ numbers - baseline scenario US Ovulona sales alone Year 1 Year 2 Year 3 Year 4 Year 5 7, 500 177, 000 300, 000 450, 000 600, 000 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 0 Cash Balance 1, 846, 000 158, 000 4, 243, 000 21, 241, 000 70, 004, 000 Number of Ovulona Units Sold @ overstated unit cost of $50 Total Revenue @ $200/unit Source: Baseline financial scenario JMW V 3 -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.

Key people at lean startup FOUNDER OPERATION REGULATORY MARKETING FINANCIAL LEGAL an estimated $2. Key people at lean startup FOUNDER OPERATION REGULATORY MARKETING FINANCIAL LEGAL an estimated $2. 5 MM skin in the game local manufacturing contractor, FDA regulated, startup operations expertise 2 seasoned FDA experts + BOD member ex-FDA deputy commissioner BOD member ex-Abbott CMO 3 CFO candidates contributed to financial planning courting boutique firm for perfect solution PPM done by Dorsey & Whitney LLP Lean BOD and BOA

OFFER TO STARTUP INVESTOR Cash repayment via profit sharing while investor keeps shares Profitability 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 V 3 -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.

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

Different peak sizes show the different speed of maturation of the egg in different Different peak sizes show the different speed of maturation of the egg in different menstrual cycles See the unprecedented wealth of information inherent in the FIV™ signature cyclic profile (maturation of dominant follicle) These are follicular waves preparing for the next cycle. The number of these waves indicates how fast the woman approaches menopause. This is the ovarian “I am ready” signal Ovulation is detected as estrogen control switches to progesterone control

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

Ovulograph™ Unprecedented ability to correlate with folliculogenesis the self-reported symptoms - and also other Ovulograph™ Unprecedented ability to correlate with folliculogenesis the self-reported symptoms - and also other diagnostic data. GOOD DIAGNOSIS NEEDS THIS CORRELATION 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.

Why Do It • Impact on public health Simple affordable powerful personal health management Why Do It • Impact on public health Simple affordable powerful personal health management tools Will help solve costly medical problems with unplanned pregnancies, sub-fertility, STDs, etc.

Sure Bet! FIV™ for reproductive management – our first launch product, the Ovulona™ will 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