About bioZhena – tech pitch

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Women’s reproductive health in vivo diagnostics

How we’ll befriend one half (the better half :-)) of humankind… We’ve solved the problem of detecting your daily fertility status – can you get pregnant today or not – by monitoring folliculogenesis in vivo.

In so doing, we have a handle on numerous aspects of women’s health. Read on to appreciate this technique of personalized medicine, and why it is fundamentally different from the existing approaches to fertility monitoring.

The screenshot of the slide below on the left indicates that the user of the Ovulona device will receive interpreted diagnostic results in simple language indicating either FERTILE (with fertile-day number) or – on most days – NOT FERTILE — without the need for any charting, the data evaluation being done electronically, right away.

And the display will also indicate, when appropriate, PREGNANCY DETECTED, or SEE DOCTOR ABOUT CERVIX (this upon detecting cervical tissue aberration during several consecutive menstrual cycles, reproducing the condition before raising the concern).

That we can give the user the interpreted diagnostic results in plain language is thanks to the rich information content of the monitored menstrual cyclic profile, which is the result of our method of measurement.

“Rich information content” refers to the numerous peaks and nadirs in the menstrual cyclic profile – the features associated with the individual stages of folliculogenesis. This information is useful not only for monitoring of daily fertility status but also for the healthcare providers because of the broad diagnostic significance of the menstrual cycle profile data. Much in women’s health revolves around the menstrual cycle, and effectiveness of medical diagnoses and treatments depends on the timing within the cycle.

That’s the basis of proprietary ovulography™, a new technique of practical utilization of the understanding, outlined below, that The Menstrual Cycle is a Vital Sign® with important healthcare (and self-care) implications.

In the screenshot of the slide on the right is an example of the menstrual cyclic profiles (aka folliculogenesis profiles or signatures) generated with our personal home-use monitor by a subject of a small pilot clinical trial. The lower curve is the morning data while the profile with the higher signal amplitudes is the evening data. At the bottom is the woman’s BBT (Basal Body Temperature) data for comparison. See the image larger  along with an excerpt from FDA 510K clearance letter.

Click image for an animation of the 3-day fertile window. Secure URL is:  https://biozhena.wordpress.com/wp-content/uploads/2014/10/ovulona-single-slide-3-day-fertile-window-forexs.pps

The picture on the right shows that during the days of the fertile window (the 3 days marked with the green on the cycle day axis), the AM-PM difference is practically indistinguishable, whereas outside of the fertile period of 3 days the signal grows between the morning and evening hours – as the folliculogenesis process progresses with time.

The BBT or Basal Body Temperature profile, seen in the lower part on the right of the image, was measured by the same woman in the usual manner. The BBT is NOT a part of our monitoring process; it’s shown here merely as a convenient reference that quite a few people are familiar with.

The various features of our menstrual cyclic profile correspond to the various stages of the folliculogenesis process. This includes the dominant follicle maturation in the early pre-ovulation phase of the cycle, and the follicular waves in the post-ovulation, pre-menstrual, phase of the cycle.

In the post script below, you can see the slide enlarged and animated. The fetal gender pre-selection pointers are based on studies discussed elsewhere in bioZhena’s Weblog. (Should your physician raise a doubt about the indicated fetal gender pre-selection principle, then chances are that he or she is not familiar with the studies referenced therein. They should not ignore the fundamentals.)

The bioZhena project involves an electronic device technology developed to make it possible that every pregnancy is deliberate, and to impact on women’s healthcare and public health in other ways, too. The latter because, as mentioned above, much in women’s health revolves around the menstrual cycle.

In 2015 (some years after this tech pitch was first published), I share this diagram, and I emphasize that the market of ovulation predicting and estimating products offers anything else but what is actually needed. Namely, monitoring of the brain-ovary feedback loop (F) indicated in the diagram, i.e. the Hypothalamus-Pituitary-Gonad Feedback Loop.

That is what our tissue biosensor does by interfacing with the cervix uteri, the natural monitor of the interactions between the brain and the ovaries. Those are the interactions that result in the phenomena of menstrual cycle.

Understand the importance of the resulting unique and unprecedented capability to not only anticipate but also detect ovulation. Read up on this in OVULATION DETECTION IS A MUST – BECAUSE BRAIN-OVARY PACEMAKERS SYNCHRONIZATION IS THE PREREQUISITE OF OVULATION (an even more recent addendum to this blog).

Like blood pressure and heart rate, a woman’s menstrual cycle is a vital sign of her overall health. bioZhena’s cervical sensor provides the menstrual cycle signature and is the core of a new technology platform.

Our ovulographic™ technology is the definitive answer to the basic need of women everywhere – natural and affordable reproductive management. Self-care. You can actually know your menstrual cycle progress every day.

Reiterating: The personal self-diagnostic device, the Ovulona™, will tell the woman in plain English (or Spanish, German, Chinese, Arabic, etc.) whether today is one of the three days that she can become pregnant. A three day fertile window, unless stress causes delayed ovulation or suppresses ovulation completely, either of which is detected as highlighted in this old PPS slide (press esc key in upper left to close it).

The adverse effects of stress are frequent, therefore it is important, essential, to have a handle on them. How it’s done is discussed in Stress and Fertility, Fertile Window, Ovulation .

Referring to the above-linked image that highlights the detection of stress effects, we quote the reproductive physiologist Dr. Ferin’s words about how “minimal reduction in GnRH pulse frequency, small undetected defects in the follicular maturation process may occur”. This pertains to the upper part of the above-linked image, and the point is that the defects in the follicular maturation process were undetected by prior art techniques, and they are now detected by the Ovulona monitor. A delay of ovulation with respect to the steroid hormone signalling in the brain-ovary HPG Feedback Loop is one prominent result; others are the quantitative differences (with respect to baseline cycles) in the pre-ovulation and post-ovulation phases of the menstrual cycle profile captured by the Ovulona sensor.

Whereas in the lower image (click for it in an animated slide with my voice), see how  “with a higher degree of pulse inhibition the follicular phase may be prolonged, and luteal phase deficiency [LPD], anovulation, and amenorrhea may develop”, as writes Michel Ferin. And, indeed, we have seen the LPD, the extended follicular phase and short luteal phase, and other aberrations in the cyclic profiles of different women over the years.

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Prospectively, this folliculogenesis-in-vivo™ monitoring will be accompanied by cervical health screening automatically going on in the background of the fertile status monitoring. And from the start – and/or gradually added in due course – there will be additional uses of the measurement data. Such as: Early pregnancy detection (I should say, instant pregnancy detection built-in); data-based forecast of the EDD, Expected Date of Delivery; management of PMS/PMDD; management of hormone therapy, to mention a few. And not to mention fetal sex pre-selection or pregnancy monitoring for better management of birthing.

With the exception of the pregnancy monitoring topic, the other applications of the technology are discussed in the various posts of this bioZhena’s Weblog. You can refer to the Table of Contents = links to bioZhena posts (recommended – if only because Reproductive Health IQ Does Matter).

The longitudinal folliculogenesis data – data acquired over many menstrual cycles and stored in the Ovulona device – can be optionally provided to the woman’s physician(s) and the healthcare system. This represents a novel way of patient profiling. And a telemedicine tool.

The Ovulona is clearly not another ovulation kit 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.

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So, now, right after this pictorial intermezzo with Picasso, Kirchner and Picasso…

         … go to check out the animated pictorial  Tweetroducing bioZhena in 8 slides at https://biozhena.wordpress.com/wp-content/uploads/2020/01/tweetroducing-biozhena-in-8-slides-e19e2on011820.pps

In the third slide you’ll see the above images in their full glory!

In the seventh slide, cervical health testing costs might intrigue you? See the estimates at Costs of the Pap smear test vs. the cost of the Ovulona

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bioZhena Corporation seeks financing with which to manufacture the first batch of our first marketable product within a few months (a prospective contractor has provided a detailed proposal), the first milestone towards market dominance in Scientific Family Planning™.

The first Ovulona application for use as a conceptive aid for women and their physicians (to help achieve pregnancy, as opposed to the birth control use and the cervical health screen) has already been FDA-certified. Profits from the sales of the first application will fund the testing and launch of the next next applications of the Ovulona™ – and of the healthcare providers’ Ovulograph™.

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Post Script

More about the folliculogenesis (menstrual cycling) profile as generated by the Ovulona device

Below here you’ll be offered a hint at the neurological input into the Ovulona cervix monitoring data, unheard of in the existing approaches to estimating ovulation – as opposed to our detecting and pinpointing ovulation and the fertile window.

The purpose of this post script is to give the interested reader a chance to comprehend better the information shared in the introduction above. The slides will appear mostly in the PPS mode, which you can navigate by means of the buttons that appear in the left bottom corner of the PPS screen upon moving the cursor over the screen. Or use the up and down arrow keys of your keyboard.

The Menstrual Cycle is a Vital Sign® (see this ACOG Committee Opinion of 2015) and our technology is unique in that it captures the vital-sign (ACOG reaffirmed in 2017) profile signatures for long-term monitoring of patients by physicians who receive the menstrual cycle data from their patients’ devices. A set of 3 slides tells more (animated slides, progressing automatically but you can pause and navigate back and forth using the arrow keys on your keyboard; PPS slides may take a few moments to open).

I suggest that you might find the narration helpful in the first two slides of this version https://biozhena.wordpress.com/wp-content/uploads/2018/02/wealth-of-info-elucidation-3-animated-slides-2-narrated.pps, while the third slide requires your undivided attention (hence no accented voice!), and should be appreciated – or at least found intriguing –  particularly if folliculogenesis/women’s reproductive medicine is your area of expertise.

If interested further, then you should see the aberrant cyclic profile and its interpretation – for the implication therein of the diagnostic possibilities of this simple-to-use diagnostic tool made to be used by women at home and optionally providing essential data to their physicians when medical help is sought.

Fertile window and LPD and text, 3 slides

Since we’ve now segued into the relevance of the folliculogenesis-in-vivo™ technology for the medical professionals, here is a single slide overview in PDF format (with 6 links to further details) on

How the cyclic profile will help physicians to better help their patients

Should you be curious about how it can be that the Ovulona works the way it does (that it tracks folliculogenesis and thus can do what the commercially available ovulation predicting products and methods cannot do), let me offer you a readable hint.

You can read (or rather could in 2011) in http://science.howstuffworks.com/life/inside-the-mind/human-brain/brain-during-orgasm.htm how “all of the genitalia contain a huge number of nerve endings”. And, “they perform many other functions in the body in addition to providing the nerve supply, and therefore feedback to the brain, during sexual stimulation.”

Of course, said article is not about the Ovulona, but you’ll read that the cervix is serviced by at least three nerves named in the article (hypogastric, pelvic, and vagus). “Excessive activation of the vagal nerve during emotional stress, which is a parasympathetic overcompensation of a strong sympathetic nervous system response associated with stress… affects young children and women more than other groups” ( https://en.wikipedia.org/wiki/Vagus_nerve ).

The vagus nerve is extremely important for our overall health including the processing of emotions, and it plays a major role in women’s fertility issues. You can read up on this in https://upliftconnect.com/12-ways-unlock-powers-vagus-nerve/ .

Let me offer you a chance to eyeball an image that pertains to this neurological aspect of the reproductive tract (this is an update added here in February 2019):

For a decent legibility of the specialist’s text and a sketch of the parasympathetic part of the nervous system that is referenced in the excerpt from the above-cited article, click on this link https://biozhena.wordpress.com/wp-content/uploads/2019/02/uterovaginal-innervation.pps  to open the first of three slides. Advance through the slides by clicking on a slide or use the down- and up-arrow keys to navigate forward or back.

Here is what this amounts to:

Besides the regulation of ovarian function by the sex hormones (that OBGYN doctors and the fertility-awareness people talk about), there are fine-tuning control mechanisms by various neurotransmitter systems.

These neurological mechanisms (summarized and demonstrated in animal studies such as this – click the link) modulate the effects of the gonadotropins on ovulation and on the capacity of the ovaries to secrete the steroid hormones. This, however, the OBGYN doctors and the fertility awareness people do NOT talk about.

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What is the significance of this? It’s profound:

Folliculogenesis is not merely a process involving hormonal signals – it’s a process of integration of all neuroendocrinological inputs, which the cervix monitors. And the Ovulona monitors the cervix.

Click on the image for better legibility

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Last but not least, don’t overlook this implication: Once we get many women to use the Ovulona (and the Halo™ cervical ring) as a reproductive management tool with the cervical health screen going on innocuously in the background (without causing any discomfort or anxiety), we will have put into effect a very important cervical health screening tool that will significantly impact public health and lives of women everywhere.

Contact me if interested – for a good professional reason – via email: vaclav at biozhena dot com .

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