Published on March 9, 2009
Introducing bioZhena Corporation’s core technology Our Ovulona™ sensor is an unprecedented technology that detects the only 3 days in each menstrual cycle during which – and only during which – pregnancy can result from insemination, whether natural or artificial. The old commercially available fertility monitors cannot do this. We illustrate this with the following graphical comparison of the Ovulona 3-day fertile window versus the fuzzy and much wider, uncertain, window indicated by the old techniques. 3-day fertile window versus old methods' fuzzy estimation of fertile period 20 Number of births MEASURE OF 15 FERTILITY Old Method 10 Ovulona 5 0 -5 -4 -3 -2 -1 0 1 2 Days counted from ovulation Because in the Old Methods ovulation was only guessed at, a fuzzy fertile period obtained. Fuzzy and long. Wrong. There is no device in the marketplace that could tell the user, in plain English, “today is your first fertile day” - meaning that sex today is likely to lead to pregnancy. And from our clinical trial results the user of the Ovulona will know that the pregnancy conceived on this first of the fertile days is likely to be a male fetus, a boy. There is no such fertility monitoring device that would subsequently confirm the pregnancy within days – when, after detecting ovulation on the third day, the pregnant woman can no longer register the usual follicular waves, and her Ovulona device interprets that change as pregnancy detected, because that is how the biology works. There is no device that would, in the event of pregnancy, calculate for the user the scientifically predicted EDD, Estimated Delivery Date, so as to spare the woman of the nerves, hassles and expenses associated nowadays with premature trips to the maternity ward, and related hardships. Hardships suffered by expectant mothers because of the old non-scientific way the doctors guesstimate and frequently mismanage the EDD today. bioZhena Corporation 83 Davis Ranch Road, P.O. Box 122, Bellvue, Colorado 80512, USA Vaclav Kirsner, Ph.D., Founder CEO firstname.lastname@example.org 970-484-1272 Copyright Vaclav Kirsner, bioZhena Corporation Page 1 of 5
Again: There is no other device out there that would determine the only 3 days in each menstrual cycle during which – and only during which – pregnancy can result from insemination, whether natural or artificial. Neither can the other fertility monitors detect delayed ovulation (which happens due to stress) or when ovulation does not occur at all. Try for either gender Try for a boy Try for a girl The personal home-use device determines the 3 days during which conception can occur, and it generates a new type of profile for use by the medical profession. The folliculogenesis profile includes, among other things, the maturation of the dominant follicle before ovulation, and follicular waves after ovulation. There is no other comparable tool that would enable the patient and the healthcare system to avoid the expense and hassle of trying to become pregnant with the help of the very costly Artificial Reproductive Technologies at a time when the patient’s dominant follicle maturation is not happening. This can only be achieved with our folliculogenesis-tracking device for home use. The existing ovulation predictors cannot do this because tracking this or that hormone does not determine the fertile window. Both the beginning and the end of the fertile window require a proper orchestration of a multitude of hormonal and neurological stimuli (not just an elevated E or LH, Estrogen or Luteinizing Hormone). Ovulation must be detected, not just assumed from an LH peak as the urinalysis kits do. bioZhena Corporation 83 Davis Ranch Road, P.O. Box 122, Bellvue, Colorado 80512, USA Vaclav Kirsner, Ph.D., Founder CEO email@example.com 970-484-1272 Copyright Vaclav Kirsner, bioZhena Corporation Page 2 of 5
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 infertility treatment money. This cannot be matched by ovulation kits or by any other such product. The bioZhena venture involves an electronic device technology developed to make it possible for every pregnancy to be deliberate, and to impact on women's healthcare and public health in other ways, too. The existing products cannot do that. Rationale: Much in women's health and lifestyle revolves around the menstrual cycle. We monitor in vivo the process that causes the menstrual cycle phenomena. We monitor not just one hormone or two, but the integrated effect of all neuroendocrine inputs on the female reproductive system. We obtain the information from the part of the female body that Mother Nature designed as the master monitor for reproductive management. How do we do it? Picture a vaginal tampon applicator with a small electronic display. User instructions advise use just like a tampon, but only for a few seconds, and for best results bioZhena Corporation 83 Davis Ranch Road, P.O. Box 122, Bellvue, Colorado 80512, USA Vaclav Kirsner, Ph.D., Founder CEO firstname.lastname@example.org 970-484-1272 Copyright Vaclav Kirsner, bioZhena Corporation Page 3 of 5
most every day. If the user skips, she receives a caution that reliability of her fertile window determination is impaired, though still possible. The user is in charge, and she decides whether the fertility status information is to help her achieve pregnancy or to avoid becoming pregnant. We will supply statistical clinical trial evidence for the efficacy of fertility status determination, this already FDA-certified for aiding conception, and we will let the user decide what to do with the fertility status information. Our ovulographic™ technology is the definitive answer to the basic need of women everywhere - natural and affordable reproductive management. Our personal self-help fertility monitoring device, the Ovulona™, will tell the woman in plain English (or Chinese, Italian, Arabic, etc.) whether today is one of the three days that she can become pregnant. A three day window, unless stress causes delayed ovulation or suppresses ovulation completely, either of which is then detected and allowed for, too. (Only detectable by this technology.) Further, since there is evidence for affecting the conceived baby’s gender by timing conception with respect to ovulation, women can and will try to do that: Evidence suggests that boys tend to be conceived on the first day of the fertile window versus girls on the day of ovulation, which we detect separately from the multiple and repeatable anticipation of ovulation. The important anticipation of ovulation is inherent in the sequence of the events comprising the process behind menstrual cycling (folliculogenesis) – the cyclical development of the ovum/egg that is viable only a few hours after ovulation. Prospectively – as planned - with cervical cancer screening automatically going on in the background; and with other uses (such as early pregnancy detection; data-based forecast of the EDD, Estimated Date of Delivery; management of PMS/PMDD; management of hormone therapy, to mention a few…). The device generates and stores (and makes available to physicians) the data on a given woman’s history of menstrual cyclic profiles, a new means of patient profiling - from post- adolescence to peri-menopause. Prospectively from being an aid for sex education in schools, through the family planning years, all the way to peri-menopause management with individualized hormone therapy. (We can also imagine trying this as a biofeedback tool for smoking cessation in women because they find it very hard to quit once addicted, and this tool may help - since they will see the bad effect smoking has on the cyclic profile and their reproductive health…) This technology is not another ovulation kit or similar - it is not only for those who find it difficult to become pregnant. We position the Ovulona to be a product that practically every woman will want to use. The woman of the 21st Century is envisaged to become accustomed to using her daily Ovulona self-check about as routinely as she is using her toothbrush. This vision assumes bioZhena Corporation 83 Davis Ranch Road, P.O. Box 122, Bellvue, Colorado 80512, USA Vaclav Kirsner, Ph.D., Founder CEO email@example.com 970-484-1272 Copyright Vaclav Kirsner, bioZhena Corporation Page 4 of 5
that physicians will come to appreciate the advantage of having historical folliculogenesis profiles of their patients correlated with symptom-registering data - based on which a better diagnosis and better therapy can be provided to their patients. We will offer to physicians a related data management appliance called the Ovulograph™, based on our internal data processing tool for handling data from clinical trials. Ovulograph™ Physicians can correlate symptoms with folliculogenesis Pre-ovulation rise of COPE scores 25 COPE scores and probe 20 readings [uA] 15 COPE score probe reading/10 10 5 Post-ovulation rise of COPE scores 0 25 13 16 19 10 22 25 1 4 7 COPE scores and probe day of cycle 20 readings [uA] 15 COPE score probe reading/10 10 5 0 13 25 10 16 19 22 1 4 7 day of cycle COPE = Calendar of Premenstrual Experiences In this example, the correlation enables differentiation between PMS/PMDD and clinical depression. bioZhena Corporation seeks financing with which to manufacture the first batch of our first marketable Ovulona products within 7 months, the first milestone towards envisaged market dominance in scientific family planning™ (scientific fertility awareness™) and in women’s health monitoring. The prototype for use as a conceptive aid (as opposed to the birth control use and the cervical cancer screen, etc.) has already been FDA-certified. bioZhena Corporation 83 Davis Ranch Road, P.O. Box 122, Bellvue, Colorado 80512, USA Vaclav Kirsner, Ph.D., Founder CEO firstname.lastname@example.org 970-484-1272 Copyright Vaclav Kirsner, bioZhena Corporation Page 5 of 5
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