bioZhena venture

bioZhena’s technology platform is bound to revolutionize women’s healthcare with diagnostic tools for women and their doctors & payers.

Empower women with clear menstrual cycle data vs. drugging healthy women & the iatrogenic consequences.

This is the first (sex-life management) application providing a superior (definitive) tool with which to tackle the ever-growing difficulty of getting pregnant when planned. And using the same tool for hormone-free, non-interventional, pregnancy avoidance. And, making available the 5th vital sign menstrual cycle profile signature to physicians when needed, for better diagnosis and management of health issues.

Also unprecedented and important for public health is our way of monitoring inconspicuously at the same self-check time the woman’s cervical health – at home. This will work in the background of the primary process, not bothering the user unless a tissue aberration is detected consistently several months in a row. This way of innocuous screening, and its affordability, should significantly improve on the Pap smear screening test.

Explore the few slides including the links in some of them: https://biozhena.files.wordpress.com/2017/03/new-mostly-narrated-slides-2017-03e2.pps

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But perhaps – especially if you are a male reader – you may feel that a daily (or almost daily) insertion for the quick self-check is too much to expect of a woman keen on knowing her daily fertility status plus the additional benefits of the routine?

Then our next generation telemetric cervical ring iteration of the same smart sensor is the answer for you. She and her doctor will have a choice.

See the image of a slide and click it to view the slide, grasp the significance:

https://biozhena.files.wordpress.com/2017/05/single-slide-friendly-tech-with-cervical-ring-ovulograph.pps

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But then my gynecology colleague would argue that the other major healthcare front is even more important. Namely, our way of providing to the women’s healthcare professionals access to the menstrual cycle vital sign longitudinal records, which Dr. Kim likened to the cardiologists’ ECG recordings – but with the important advantage of being affordably and routinely generated by patients at home (and saved in the sensor).

This other major front is providing to the healthcare system the means of obtaining a handle on the management of gynecologic and obstetric medical issues that require better diagnostic evidence for more effective and preventative therapies. In brief, we are answering the call and challenge to “Improve the methods and criteria to assess ovulatory dysfunction” (per R.S. Legro MD, 2013), and more.

Current modalities to diagnose preterm labor cannot detect the early biochemical changes of the cervix which result in dilation that leads to preterm births. Once the advanced signs of preterm labor are found, remedies to stop it are often futile and always costly for the healthcare system ($26B annually in USA alone), and frequently have adverse long-term consequences for the prematurely-born child and the family.

https://biozhena.files.wordpress.com/2014/11/impedence-beyond-cervical-length.pdf

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The bioZhena technology will alert the women-users and their healthcare providers on a timely basis to the onset of pregnancy-related conditions such as normal and preterm labor. And the immediate detection of pregnancy, whether intended or unintended, is automatic with the primary routine use of the home-use smart sensor. That is a notable advantage over the current home pregnancy tests!

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Summing up, read an overview Feasibility of the Planned Range of Ovulona™ Applications

https://biozhena.files.wordpress.com/2014/11/feasibility-of-the-planned-range-of-ovulona-applications1.pdf

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And here is now the financial pro forma aspect of bioZhena’s breakthrough non-interventional approach to women’s healthcare.

5-year pro forma assuming $6M funding (5-year Business Plan Summary Financial Projections)

Or, better,

10-year projections:

Minimum Viable Product Scenario (MVS) and Full Value Scenario (FVS)

For better legibility click https://biozhena.files.wordpress.com/2016/09/comparison-mvs-cf-fvs.pps

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From bioZhena’s pitch on EquityNet:

Women’s personal sex-life management tool for the Information Age.

Generating diagnostic vital-sign profiles for doctors and payers.

This first app of proprietary cervical sensor has FDA clearance.

Income from it will support further breakthrough applications.

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The gist of the bioZhena women’s healthcare breakthrough is this:

We monitor the brain – sex organs feedback loop.

Nobody else does.

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See the illustration below. Grasp the significance: The market offers you anything other than what’s needed, which is the monitoring of the feedback brain – ovary interactions.

“To mitigate the startup investment risk, the first app is an already FDA-cleared electronic fertility monitor for women at home…

Our electronic technology platform is bound to revolutionize women’s healthcare with diagnostic tools for women and their doctors & payers.

… will provide for non-interventional reproductive management, aiding conception and natural birth control without hormones, and automatically detecting pregnancy – planned or accidental. …

We will offer early detection of cervical cancer and other STDs as a built-in screen performed innocuously in the privacy of one’s home – automatically in the background of the primary monitoring…

Ovulona™ tracks the female reproductive cycle via the end-organ effect of the brain-ovary feedback loop on the uterine cervix. Numerous benefits ensue…”

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This is a screen shot of slide 4 from a 5-slide set https://lnkd.in/ed9yXUX

(slides take a few moments to open).

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Contra Nescience Contra Insouciance (SM 2015)

The Home Page of bioZhena’s Weblog offers further particulars (click the link, which translates as “Against Ignorance Against Indifference”)

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And yours truly bioZhena founder seeks a well-matched management partner of either gender.

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The fallacy of ovulation calculators, calendars and circulating-hormone detectors

Don’t let them lead you by the nose with likely this and probable that! You need to know for sure.

When it comes to the crucial timing of ovulation, it is astonishing to see the fallacies and delusions propagated on the web – and that this includes even certain generally respected mainstream sources. How they declare, for example: If you’re trying to get pregnant, use this tool to find out when you likely ovulate and are most fertile.

Never mind that “most fertile” makes absolutely no sense because there is no such thing as a little fertile, more fertile and most fertile!

Ladies (and teenage young ladies included!), you either are fertile today or you are not: You either can conceive today or not.

It is either or.

You either are fertile today or you are not. It is not a little bit fertile, or more fertile, or most fertile. Like, you cannot be a little bit pregnant… you either are, or you are not.

Besides which, if you want to conceive a pregnancy, you must know with certainty that ovulation happens when you try to conceive – not merely that it is likely to happen. Unless you are reproductively ill or menopausal, it is always likely to happen at some point but the mere likelihood is not very helpful. Conception absolutely requires ovulation so that the released (ovulated) egg has a chance to be fertilized.

You must have a way of detecting ovulation at home and, based on that instrumentally recorded information, we will also help you with the Expected Date of Delivery (EDD), because that is how it works. Not the LMP (Last Menstrual Period) but the date of the conceptive ovulation — that’s the ovulation with which you became pregnant because your ovulated egg became fertilized. The date of ovulation is the date from which the EDD must be computed.

Ovulation caught on camera by Dr. Donnez – impressive but not a practical method of detecting ovulation

Fast forward to the principle that’s behind the take-home message of this post and that’s systematically arrived at by the end of this post:

Briefly: Tracking systemic effects (hormones in circulation) is not good enough for fertility status determination, especially if the purpose is pregnancy avoidance.

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To be blunt about the language of “likely ovulate” and “most fertile”: Such language simply reflects their inability to be definitive about it – and they therefore resort to guesstimating ovulation, calling it a calculation.

Numerous websites proffer their ovulation calculators when you search online for “ovulation”. A free, printable ovulation calendar and ovulation calculator to help you…, ovulation calculator can help you find the best time to conceive (as if there was some worse time when to conceive!), a calculator to generate your ovulation calendar and determine the best time…, our free Ovulation Calendar helps you predict your most fertile time of the month (ovulation) so that you can achieve pregnancy. Etc.

Notably and significantly, they do NOT promote this for natural (behavioral) pregnancy avoidance (birth control) but only as a tool for assisting conception – as if these were not the two sides of the same coin. They do not because they would get into trouble if they did.

A common approach relies on detecting, in a woman’s urine, the luteinizing hormone (LH) that typically surges on the ovulation day. The LH surge (sharp narrow peak in LH concentration) occurs a few hours before ovulation. Because that is really too late for anticipating ovulation, a related but more sophisticated fertility monitor additionally detects also a metabolite of estrogen, i.e., another hormone, which anticipates the LH surge by about a day.

The worst flaw of systemic hormone monitoring

Fundamentally the most serious detriment is the fact that ovulation as such is not detected by said fertility device or any other such available in the marketplace. Ovulation is merely assumed to occur some hours after the LH surge – but the surge of the LH hormone is merely a trigger signal sent by the brain to the ovary. It says, “ovary, let go of the ovum in our dominant follicle”, but it does not say that the ovary in fact did (or does).

This is a fundamental flaw because ovulation is known to fail to occur in approximately 20% of the follicles. Those follicles, triggered by the LH, undergo the cyclic event of follicle rupture but, despite the rupture, the egg does not come out – there is no ovulation.

In 20% of LH-triggered cases, the egg is not released so ovulation, as photographed here by Dr. Donnez, does not occur

Ovulation also fails to occur with another type of follicles, the so-called luteinized unruptured follicles. Yet, the LH surge can be seen in either case, and is therefore a false indicator.

Furthermore, when stress causes a delay of ovulation or absence of ovulation despite the LH surge signal (signal from the brain to the ovary), this cannot be detected and handled by the urinary hormone-based approach. As you can imagine, with our stressful lifestyle and environment, this is a very serious flaw that results in many disappointments. Our technology will make a big difference in managing the situation.

George Condo – Field of Figures sold for $450,000 at Skarstedt Gallery’s booth Published: June 14, 2011

Since, unlike our Ovulona™ Smart Sensor™ technology, their method depends on biochemical reagents and since the supply of the reagents is limited, their product’s user has to estimate on which day of her menstrual cycle she should start using the hormone-monitoring device when peeing into a cup. She does the estimating based on her previous menstrual cycle(s) as though the length and the timing of the present menstrual cycle were the same as in her previous cycle(s). Alas, that’s not so. Because of the variable lengths of successive cycles in most women, this is a weak feature in their design (even though they are getting away with it).

A key practical problem of the referenced 2-hormone device (the Clearblue® Fertility Monitor) is that the monitored urinary concentration of the estrogen metabolite E3G peaks only about 12 to 24 hours prior to the LH surge. This is not early enough to serve as a marker of the beginning of the fertile phase.

Fertile day 1 not identified

Their research or marketing literature may claim that “a sustained rise in E3G can be used to identify the start of the fertile phase”, referring to the slow gradual increase that eventually becomes the peak of E3G concentration. However, the idea to use an ill-defined rise – rather than the peak in the cyclic profile of the estrogen metabolite – is not a viable solution to the fertile window problem.

Even if the ill-defined E3G rise in the urine were correlated with a clearly defined stage of the egg development towards ovulation, a serious problem is that the rate of the E3G rise differs from cycle to cycle, as do the blood concentrations of E3G. The initially slow increase of the E3G concentration in the urine proceeds at different rates in different cycles, not only at different rates in different women. The E3G rise cannot be predictably associated with the beginning of the fertile period, and it cannot serve as a marker.

Schematic diagram of interaction between the LH and FSH hormone-generating glands in the brain (hypothalamus and pituitary) and those of the ovary (female gonad) generating estrogen and progesterone

The reasons are as follows:

1. Estrogen is known to have both stimulatory and inhibitory effects on LH secretion and, to be effective as a stimulant, it must rise to its peak levels (> 150 to 200 pg/ml) and must remain elevated for at least 36 hours [J. Hotchkiss and E. Knobil in E.Y. Adashi, J.A. Rock and Z. Rosenwaks, editors: Reproductive Endocrinology, Surgery and Technology, Lippincott-Raven Publishers, 1996].

In fact, the E3G rise indicates something else:

2. The E3G profile does not reflect the local interplay of estrogen with progesterone because it only reflects clearance of one of at least 10 metabolites of estrogen from peripheral blood circulation into the urine, after oxidative conversion in the liver.

Whatever the rate of this clearance process in the given woman in the given menstrual cycle, there are “local mechanisms due to which the quantification of ovarian steroids in peripheral blood or in urine is rendered interesting but of little value in predicting the genital end-organ effect” [C.J. Verco, in A.M. Siegler, editor: The Fallopian Tube. Basic Studies and Clinical Contributions, Futura Publishing Company, 1986].

The decades old problem is fundamental

This makes for the same basic flaw as that suffered by other monitors of peripheral hormones whether the hormone be progesterone (BBT monitoring) or estrogen (conductivity of saliva or of vaginal fluids).

Thus, the 2-hormone approach is in the end as inaccurate as the other LH-detecting techniques (the OPKs, Ovulation Predictor Kits). Therefore, like the other hormone monitoring methods, it cannot be approved and proffered for pregnancy avoidance since the failure rate would be unacceptably high. In fact, a law suit ensued in England, when the original developer company did sell the LH-and-estrogen monitor as a “contraceptive system”, and a number of unintended pregnancies resulted to the users.

See also below, under “Smart phone apps with the BBT?” the link about Natural Cycles – the app that got regulatory approval for contraception after their clinical trial with women who purchased the app because they believed they had “regular cycles” of constant cycle length.  Not surprisingly, problems and unwanted pregnancies ensued.

The fundamental point is this: The effects of the local and acute regulatory mechanisms (referenced under 2 just above) remain undetected by the old techniques that work with the peripheral biomarker variables.

Ovarian vein-to-artery exchange of steroids, prostaglandins and other bioactive substances is a local transfer mechanism which enables local regulation of ovarian, tubal and uterine functions. The local, as opposed to peripheral, blood concentrations of the steroid hormones are also believed to work with the innervation of the female genital tract (the cervix in particular).

The effects of these local and acute regulatory mechanisms remain undetected by the old so-called prior art techniques that work with peripheral biomarker variables. In contrast, our Ovulona™ detects them – via the cervix, the natural monitor of the female reproductive system.

Gustav Klimt – Medicine mural – Klimt’s primary subject was the female body

The flawed assumption of similar timing of menstrual cyclic events from one cycle to another has been a problem for the BBT and the BBT thermometers. Since the late sixties, the microprocessor technology has been applied by a number of people to the well-tried basal body temperature [BBT] approach to family planning that was originally hoped to work for pregnancy avoidance.

Smart phone apps with the BBT?

The BBT approach is no longer recognized as medically valid even if it may be acceptable to some of the older physicians, and to the younger buyers of an expensive microcomputerized BBT monitor offered from Europe and/or to the users of the more recent smart phone apps based on BBT monitoring.

This is because the so-called basal body temperature is a systemic variable that reflects, among other things, progesterone rise in peripheral blood after ovulation, usually one or two days later.  It is a very indirect and non-specific biomarker. Even though in some women in some cycles a little-understood dip in the temperature graph may apparently be observed one day before the temperature rise, it is clear that the BBT method is of little value due to its lack of predictive capability and due to its fundamental unreliability. The BBT-rise data is known to have a large error bar since the rise can occur from 3 days before to 3 days after ovulation.

For a more detailed critique of the BBT monitoring approach and a rebuttal of a particular European product, peruse Critique of BBT monitoring – DuoFertility rebuttal. Also read a note on 3 things that differentiate our technique from the smartphone apps and particularly the most recent, Natural Cycles .

Briefly: Tracking systemic effects (hormones in circulation) is not good enough for fertility status determination, especially if the purpose is pregnancy avoidance.

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Purveyors of the old “prior art” technologies get away with it because of the high demand for any help with the serious and growing problem of sub-fertility, more commonly called trying-to-conceive or difficult getting pregnant. When the purveyors publish anecdotal evidence of “efficacy” in the form of thank-you letters from women who did achieve pregnancy, we should keep in mind that the women received help in focusing on trying to hit the fertile period regardless of whether the given technology actually did work or not.

If any of the “prior art” did work reliably, it would be used as a pregnancy-avoidance tool, which is not the case (with the one exception noted above, a reservation included suggesting that only women with self-assessed regular cycles opted to buy the BBT-and-calendar based app with its 11 “unsafe” days offered to the user instead of the true fertile window).

Venus, Cupid, Folly, and Time (also called An Allegory of Venus and Cupid and A Triumph of Venus) is an allegorical painting by the Florentine artist Agnolo Bronzino – circa 1545.  The bearded bald figure to the upper right is believed to be Time…

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Now go see about “Instant detection of pregnancy and of Early Pregnancy Loss, EPL – the adversary of Trying To Conceive, TTC – especially after age 25″ at https://biozhena.wordpress.com/2010/11/11/instant-detection-of-pregnancy-and-of-early-pregnancy-loss-epl-the-adversary-of-trying-to-conceive-ttc-especially-after-age-25/

And should you be an investor and/or wish to find out more, check out  Home Page of bioZhena’s Weblog

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Major studies decades ago revealed variability of menstrual cycles

But people are still naïve about the basic cause of the difficulty to achieve pregnancy

Sex education at school, its quality or otherwise, is likely to have much to do with fertility problems later in life. Many women (men, too, of course) can use the  keyboard with all their fingers (as well as their thumbs!) but have poor understanding of the basic functioning of their reproductive system.

colonial-classroom.jpg

That ignorance is well known, and is underlying the fertility problems. You should see the pregnancy doctors’ tweets – replying to some incredible questions, and then the talk of various mysteries!

A shining example is this tale of “mysterious conception”. For the whole story see the Alphabet of bioZhena under M, “Mysterious conceptions (OR THE NONEXISTENCE THEREOF)” on page 34 or thereabout, from which I cite:

QUOTE:  It appears that we must dwell on this topic, because of stories and notions propagated in various pertinent circles. This writing has been prompted by page 176 in the excellent 1999 book “Woman” by Nathalie Angier, where the Pulitzer laureate relates the story of the mysterious conception of her only child. Mysterious, because it occurred, she believes and makes her readers believe, outside of ovulation and of the fertile window.

The reason for this entry in the Alphabet of bioZhena is that there is NO SUCH THING AS MYSTERIOUS CONCEPTIONS, there is only lack of information, or ignorance of the facts. We might say, intellectual misconceptions lead to “mysteries” in terms of conception, of babies conceived supposedly when conception was biologically impossible, and vice versa, some women have difficulties conceiving for the same fundamental reason. We shall use Ms. Angier’s case to make this point. UNQUOTE.

To drive the point home, here is an excerpt from John J. McCarthy, Jr. and H.E. Rockette, “Prediction of ovulation with basal body temperature”, Journal of Reproductive Medicine, Volume 31 (No.8), Supplement, 742 – 747, 1986.

Referencing particularly large studies from 1967 and 1977, these BBT experts had this to say all those years ago (and never mind their “prediction” in the cited title whereas the BBT is well known to be no predictor):

QUOTE:  Cycle regularity is often assumed by both women and their physicians. The suggestion, that the BBT graph of the previous cycle can be used to identify the day of ovulation in the current cycle, requires nearly absolute cycle regularity. [However, note this:] The data collected by 1,085 women, who provided at least 6 or more charts each, were studied for cycle length variability. … The cycle length range was more than five days for 56% of the women who submitted 6 graphs, and for 75% of those with 12 graphs. … Absolute regularity was not demonstrated in as few as six cycles. Even when the cycle length that deviated the most was eliminated, less than 1% (8 of 1,085 women) had no variation in cycle length. When the number of cycles was extended to 12, no woman had variability of less than two days in cycle length. END OF QUOTE.

In real life, you realize, no cycle can be eliminated from the experience, and every day matters. Two days are very likely to make the difference between conception and the lack of it. And/or cause an unwanted pregnancy, for that matter.

Middendorf  – On the ball

The above findings are therefore the basis on which we can say quite categorically that nobody is as regular as a metronome (and nobody conceives in an anovulatory cycle), that there is no such thing as absolute regularity, whether 28 days or otherwise.

If you are in the sub-fertile category of people finding it difficult to become pregnant, you are likely to have cycle variability of more than 5 days over those months of your fruitless efforts that define your category. More likely than being one of the 0.74% of the population with no variation in cycle length, which under ideal conditions may also mean no variation in the time of ovulation. Persistent monitoring is well advised.

What Women Know, And What They Want To Know About Their Fertility Status

There: What Women Know

Despite the many BBT charting apps and some BBT monitors, and despite the urine analyzing (or the saliva testing) products on the market, here is a fundamental fact:

There is no device in the marketplace today that would tell you, in plain English, “today is your fertile day 1” – meaning that sex today is likely to lead to pregnancy.  And from our clinical trial results you 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 device out there that would detect (not just guess at) ovulation, which will enable you to try to conceive a girl, if that is what you wish for.

There is no such device on the market that would subsequently confirm the pregnancy within a day or two – when, after ovulation on fertile day 3, you or rather your Ovulona device for you – will no longer register the usual follicular waves. Your Ovulona device will interpret that as pregnancy detected, because that is how the biology works.

There is no device out there that would identify the only 3 days in each menstrual cycle during which – and only during which – pregnancy can result from insemination, whether natural or artificial. The commercially available fertility monitors cannot detect either delayed ovulation (which happens due to stress) or when ovulation does not occur at all. Because they do not detect ovulation, they just guess at it.

Because the currently marketed fertility monitors (ovulation predictors) cannot detect ovulation, they merely assume its occurrence due to the particular hormonal marker-predictor of their choice (usually LH, in some cases estrogen, in one case both). But no single hormone, even if it were detected with the accuracy of laboratory methods, determines the fertile window. It’s much more involved than that.

For more on this, go to The post on The Fallacy of Ovulation Calculators, Calendars and Circulating Hormone Detectors at   https://biozhena.wordpress.com/2012/02/13/the-fallacy-of-ovulation-calculators-calendars-and-circulating-hormone-detectors/

Here: What Women Want To Know

Only scarcity of funds keeps us from marketing a device doing all those things not available today.

Our personal self-diagnostic device, the Ovulona™, will tell the woman user in plain English (or any other language) whether today is one of the three days when she can become pregnant.

https://biozhena.files.wordpress.com/2015/09/ovulona-single-slide-3-day-fertile-window.jpg

How? We’ll have the woman monitor at home the process that causes menstrual cycles and is fundamental to women’s health (folliculogenesis). The use of the Ovulona device is very simple, just like a tampon, except that it is inserted for only a few seconds (about 20) to obtain the result, with an instant display of the result.

The Smart Ovulona will display the results electronically interpreted, presented in plain language such as FERTILE DAY 1 while the raw data is stored within the device for optional use by healthcare professionals.

Primary use is for personal reproductive management – that is aiding the achievement of pregnancy, and also aiding fertility-awareness based non-invasive birth control.

But there is much more, including an automatic screening for cervical cancer, management of PMS/PMDD and management of hormone therapy, to name just a few of the applications that will come with the core technology.

We show below the working of the prototyped product using the graphs of the measurement results plotted against the days of the menstrual cycle – and compared with the woman’s basal body temperature for reference. The graphs of the measurement data produce cyclic profiles descriptive of the nuances of the monitored menstrual cycles. None of the old techniques can do that.

These cyclic profiles have important characteristics:

1. The menstrual cyclic profile has numerous repeatable features. It is an electronic signature of the menstrual cycle, which is the female 5th vital sign.

2. The range of measurement values is the same in different cycles and, importantly, also in different women.

3. The profile features are interpretable, and are due to the biological process that causes the menstrual cycle phenomena (folliculogenesis).

The significance of these menstrual cycle profiles goes beyond reproductive management.

To wit: Ours is a unique and disruptive technology.

https://biozhena.files.wordpress.com/2018/05/biozhena-corp-single-slide-3-day-window.pps Click the link or the image for a better view – an animated slide.

Fertile window for birth control

For a better insight, visit the other posts on this blog [https://biozhena.wordpress.com/ ], and check out http://www.linkedin.com/in/vaclavkirsner.

Before you go, see this, to get some sense of what is going on here:  https://biozhena.files.wordpress.com/2018/05/wealth-of-information-in-menstrual-profile-signature.jpg The link opens a larger version of the slide snapshot image.

Better still, click the next link for the animated and narrated slide:  https://biozhena.files.wordpress.com/2016/11/single-slide-narrated-best-wealth-of-info-in-menstrual-cycle-profile-signature.pps

Note the planned use of the follicular waves for early pregnancy detection (the waves disappear; the right term for this is “instant pregnancy detection”), and monitoring for early pregnancy loss (in that unfortunate eventuality, the waves come back; it is advisable – by certain recent medical findings – that the couple should not delay trying to conceive again).

Refer to the following for more about said recent findings: original medical publication in BMJ http://to.ly/9WtG; BMJ editorial comment http://to.ly/9WtI; CNN.com article “Miscarriage? Try again ASAP, study suggests” http://ht.ly/2mlwb; bioZhena’s post http://to.ly/802p “Instant detection of pregnancy and of Early Pregnancy Loss, EPL – the adversary of Trying To Conceive, TTC – especially after age 25”.

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A party with an interest relevant to bioZhena Corporation can be provided with more confidential information upon request (email: vaclav@biozhena.com).

Visit https://www.linkedin.com/in/vaclavkirsner/ .

The Ovulona is not another ovulation kit, my dear

@bioZhena‘s reply to Jennifer K. who wrote: How is this different from the other ovulation kits on the market today? It seems very similar to products I have seen before. QUOTE UNQUOTE

Actually, Jennifer, you are mistaken. There is no such thing available to you in the marketplace today.

bioZhena intro in 10 mostly narrated slides https://v.gd/nq5d2j

Cervical health screening, pregnancy monitoring and other applications will be introduced while generating revenues with the already FDA-cleared minimum-value application of the core Ovulona^TM product.

This blockquote is added in April 2017

ovulona-single-slide-3-day-fertile-window-forexs.pps

None of the ovulation kits – which the Ovulona™ is not – or any other fertility-status monitors on the market today have the required ability to determine fertile day 1, fertile day 2, and fertile day 3 (= ovulation, the last day of the fertile window).

All the existing techniques merely guesstimate the approach of ovulation, and none of them can detect ovulation separately from predicting it. They detect neither the first day nor the last day of your brief fertile window – so, they declare the fertile window to be wider than it actually is.

Let’s try to illustrate this with the following graphical comparison of the Ovulona 3-day fertile window versus the fuzzy and much wider, uncertain window indicated by one of the old techniques. (In this case depicted here it was the so-called Peak mucus method but LH kit and BBT yielded similarly wide and fuzzy fertile periods, that is the days on which intercourse resulted in pregnancy.)

Ovulona 3-day fertile window versus one of the old methods

Because in the Old Method ovulation was only guessed at, a fuzzy fertile period obtained.

Fuzzy and long. Wrong.

There is no device in the marketplace that would tell you, in plain English (or in Spanish, Chinese or maybe even in Czech!), “today is your fertile day 1” – meaning that unprotected sex today is likely to lead to pregnancy. And from our clinical trial results you will know that the pregnancy conceived on this first of the fertile days is likely to be a male fetus, a boy. We base this expectation on the results of other people’s studies, referenced below.

The rationale, briefly, is this: The male sperm live long enough to be available for fertilization when ovulation releases the ovum (egg) from the ovulating ovarian follicle. Whereas the female X-chromosome bearing spermatozoa have a chance to produce a baby girl only if intercourse takes place on the day of ovulation, because of their short lifespan. With the Ovulona, the rationale will have a chance to be tested and/or utilized in real life…

No such powerful tool out there

There is no device that would – subsequent to determining the days of the fertile window – confirm the pregnancy within a day or two. When, after ovulation on fertile day 3 (indicated in the graph here as day 0), your Ovulona would no longer register the usual follicular waves – and the device would interpret that as pregnancy detected, because that is how it works.

In gynecological convention, days of the menstrual cycle are counted from the first day of menstrual bleeding, but the researchers involved in studying the prediction of ovulation use also another counting system. In that counting system, the day of ovulation is day 0 (zero). This is to allow for comparisons of different cycles, because cycle lengths as well as the phases of the menstrual cycle vary from month to month and also, of course, from woman to woman.

Because the sperm can remain viable for several days but the egg can be fertilized only for several hours after ovulation, there are several fertile days before ovulation. Should the egg remain viable for fertilization longer than the believed 12 to 24 hours, there would be also one fertile day after the day of ovulation. Delayed ovulation will have this effect and this is discussed below. Only our menstrual cycle tracking technology can detect delayed ovulation, a very important attribute.

We believe that published evidence from clinical studies of this problem leads to the conclusion that there are only 3 days of high probability of getting pregnant, and that the ovulation day is the last day of this narrow fertile window.

For more on the foundation of this hypothesis (i.e. for the working hypothesis of the 3-day fertile window), see https://biozhena.wordpress.com/2007/12/03/fetal-sex-preselection-%E2%80%93-illustrated/ where we show the outcome of the France et al. study of fetal gender pre-selection superimposed on the menstrual cyclic profile generated by our device in a small clinical trial. This indicates how baby gender pre-selection works or rather how it will work when the Ovulona™ is launched in the marketplace.

This is how come that, in the illustrations above including this one, the days of the fertile window are counted back from ovulation, and hence their negative signs in the graph. Day -2 on this time scale is the first day of the fertile window. It is clearly discerned in our menstrual cyclic profile signature, as shown in the first illustration of this post.

How prior art products and methods fail

If you only detect the ovulation day with your LH kit, it is too late for the previous 2 fertile days. Similarly, if you detect an elevated BBT temperature, which rises and remains elevated after ovulation, it is also too late. The timely determination of the pre-ovulation fertile days has always been THE key problem for NFP [Natural Family Planning] and generally for the Fertility Awareness Based Methods of reproductive management.

There is no 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.

The other fertility monitors – including the more recent smart phone apps – cannot detect delayed ovulation (which happens due to stress) despite the LH hormone signaling that ovulation should go ahead. Neither can the various other monitors warn you when ovulation cannot occur because of the failure of dominant follicle maturation in the present menstrual cycle.

There is no other device that would enable you to avoid the expense and hassle of trying to become pregnant with the help of the costly Artificial Reproductive Technologies when your dominant follicle maturation is not happening – which is only detectable with our folliculogenesis-tracking little device for home use.

Your gynecologist, your family doctor – or your psychiatrist if you suffer badly with PMS (diagnosed as PMDD) – does not have the benefit of the folliculogenesis cyclic profiles stored in the Ovulona memory for better diagnosis and better treatment than you can get today. They do not as yet have the benefit of systematic longitudinal recording of your menstrual cycle vital sign signatures, to facilitate better diagnosis of a health problem such as you may have.

There is no other technology that would – automatically and without bothering you at all – keep track of whether your cervical tissues are healthy, and would issue a warning only when detecting tissue aberration several months in a row – to spare you the anxieties and expenses associated with the Pap smear cervical cancer tests’ frequent false positives. Yes, this too is a functionality planned for the Ovulona in the future.

There is no technology as yet available to all women worldwide with these empowering features at a perfectly affordable cost.

oh yeah

Read also the 2012 article https://biozhena.wordpress.com/2012/02/13/the-fallacy-of-ovulation-calculators-calendars-and-circulating-hormone-detectors/ – The fallacy of ovulation calculators, calendars and circulating-hormone detectors.  Don’t let them lead you by the nose with likely this and probable that! You need to know for sure. Day 1, day 2, day 3. Simple.

Should you want to look deeper into this, do check out the  Home Page of bioZhena’s Weblog

Contact me via email at vaclav@biozhena.com