Self-help medical devices for women's health from adolescence to menopause
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![Folliculogenesis In Vivo™ ,[object Object],[object Object],[object Object],[object Object],[object Object],FROM ADOLESCENCE TO MENOPAUSE](https://image.slidesharecdn.com/000biozhenafivpresentation-031010public-100616141326-phpapp02/85/000-bio-zhena-fiv-presentation-031010-public-1-320.jpg)
![Technology FIV is a convergence of: ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Prototype of Ovulona™ Tissue Biosensor with output for the physicians’ Ovulograph™ data management system BOTH MOBILE PHONE-COMPATIBLE](data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///yH5BAEAAAAALAAAAAABAAEAAAIBRAA7)
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Self-help medical devices for women's health from adolescence to menopause
- 3. What Is Folliculogenesis? The biological foundation of a woman’s well-being. Brain – ovary interactions All the time. Throughout her lifetime.
- 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. Your body has the information. We probe for it. Smart Storage Case™ user-interface via cell phone or TV - for input of symptom data.
- 6. Try for a boy Try for a girl Try for either gender What FIV ™ does for women and for family planning For birth control, avoid insemination during these 3 days
- 8. 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. Goal Address the 100% population via the 30% and 70% sub-populations Plan Please email vaclavkirsner@yahoo.com Prototype already FDA 510k certified
- 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 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] No No No No Yes Multi-purpose long-term use? No No No No Yes Folliculogenesis profile for healthcare? No No No No Yes Can it compute date of delivery? No No No No Yes Can it do built-in pregnancy check? No No No No Yes Can be used to preselect baby’s sex? No No No No Yes Can be used for birth control? Low Low Low Low High Information content No Yes No Yes Yes Low cost No Yes No No Yes Convenience of use No Yes No Yes Yes Immediacy of results Low Low Low Low High Reliability Low Low Low Low High Accuracy Body fluid Conductivity Saliva magnifying glass LH kits urine chemistry BBT thermometers Ovulona™ Characteristics
- 17. bioZhena Start-up Timeline Confidential Please email [email_address]
- 18. bioZhena Corp. 5-year plan The gist Please email [email_address]
- 19. Key people at lean startup Please email [email_address]
- 20. OFFER TO STARTUP INVESTOR Please email [email_address] Note: Seeking investors, not “clever” people who expect to get paid for a promise. Success fee to a middleman is the only doable proposition.
- 21. 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 &monitor compute EDD/EDC baby gender planning PMS/PMDD management conception aid Ovulographic FIV monitoring ->HRT
- 22. 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 control This is the ovarian “I am ready” signal These are follicular waves preparing for the next cycle. The number of these waves indicates how fast the woman approaches menopause. See the unprecedented wealth of information inherent in the FIV ™ signature cyclic profile
- 23. See the unprecedented powerful diagnostic capability inherent in the FIV ™ signature cyclic 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 follicular waves in this cycle. Re: Ovarian aging.
- 24. Ovulograph ™ Differential diagnosis is based on how symptom scores relate to folliculogenesis. E.g., PMS/PMDD vs. clinical depression. COPE = Calendar Of Premenstrual Experiences An example of established measurement of symptoms Unprecedented ability to correlate with folliculogenesis the self-reported symptoms - and also other diagnostic data. GOOD DIAGNOSIS NEEDS THIS CORRELATION
Editor's Notes
- 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.)
- 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).
- 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.
- 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.
- 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