BIOZHENA’S MISSION: A HEALTH TOOL FOR EVERY WOMAN

Our mission is to commercialize a product that practically every woman will want to use. Because most every woman wants to know her fertile status, her menstrual cycle, her cervical health. And will want to have her menstrual cycle  and cervical health data available for her physician when needed.

>>> We provide for that. By tracking the menstrual cycle via the uterine cervix (outer cervix wall), thus recording the diagnostically useful cyclic profile that anticipates and then also detects ovulation.

When ovulation is merely estimated rather than detected, menstrual cycle length is a key diagnostic observable, often wrongly assumed constant (“by both women and their physicians”) and the cycle “normal”. Yet, the variability of menstrual cycle length has been known since major studies decades ago. OBGYN studies have also found that more than 35% of menstrual cycles were abnormal due to asynchrony of ovarian and brain pacemakers.

The importance of tracking menstrual cycles and thus detecting ovulation, in addition to anticipating it quantitatively, cannot be over-emphasized – because synchronization of brain and ovarian pacemakers is a prerequisite of ovulation. The menstrual cycle must be monitored since the prerequisite synchronization is often complicated or even fails – which complicates life.

Because ovulation is now detected – rather than merely assumed based on a predictive signal – is why the technique detects effects of stress on women’s fertility and provides for management of those effects (see below). 

RIGHT UPFRONT, NOTE WELL:

THIS IS NOT ANOTHER OVULATION TEST KIT!

Click the image to enlarge it.

Folliculogenesis in the mature (Graafian) follicle stage is the mechanism of  menstrual cycle, which is monitored by the cervix. And we monitor the cervix.

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Our “elevator pitch” must therefore highlight that bioZhena’s proprietary technology platform is bound to revolutionize women’s healthcare with diagnostic tools for women and for their doctors & payers (insurers).

Sixty years after the introduction of oral contraception many women have grown unhappy with the side effects. Many are turning to fertility awareness, for which there is a large and growing market among the population suffering with sub-fertility, the difficulty to get pregnant.

The bioZhena take on how baby-making late in life evolved into #subfertility & #infertility, difficult #conception, too long #TryingToConceive is (tweet-wise):

https://twitter.com/bioZhena/status/1308509025823272962?s=20 .

By year 2000 the number of births to mothers of optimal age dropped to mere 25%.

We aim to empower every woman with a self-care monitoring tool that provides a clear-cut daily indication of whether she can get pregnant today or not, and we empower doctors with the menstrual cyclic profile signatures thereby recorded by the women at home.

The Menstrual Cycle is a Vital Sign® An Indicator of Overall Health. Sooner or later it will be understood and accepted that preventing the natural process of menstrual cycling is not good for women’s health. Here is one example, one aspect (combined contraceptives impair glucose tolerance and induce chronic inflammation):

https://academic.oup.com/humrep/article/27/10/3046/747255.

Significant benefits to women’s healthcare ensue from the introduction of the vital-sign recording mature-follicle-stage Folliculogenesis-In-Vivo^TM medtech platform, which has a broad applicability because much in women’s life revolves around the menstrual cycle.

Physicians need the means with which to assess the menstrual cycle and its variability, both normal and the many abnormal, which our technology provides.

Everybody benefits from the innocuous screening of cervical health that will take place concurrently with the fertility monitoring – convenient, hassle-free and pain-free, and eminently affordable. Much better as a screen than the Pap smear test.

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While we’ll obviously launch first the FDA-cleared conception-aiding application, many women have told us that they would switch from their current contraception method when our monitor becomes available.

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Click on the image (or here) to view the slide showing how the menstrual cyclic profile defines the daily fertility status, and how it relates to the basal body temperature (BBT), with which you are probably familiar.

The 3-day fertile window is clearly detected by the monthly signature profile generated by the Ovulona™ and translated electronically into indications FERTILE DAY 1, FERTILE DAY 2, FERTILE DAY 3 = OVULATION.

And yes, it is those 3 days – click here for why.

That is, those 3 days unless the menstrual cyclic profile recorded by the Ovulona detects a delay of ovulation with respect to the hormones anticipating ovulation (estrogen and LH) as seen in https://biozhena.files.wordpress.com/2019/01/single-slide-ovulona-detects-delayed-ovulation-w.-links.pdf .

You can also read the blog page at   https://biozhena.wordpress.com/stress-and-fertility-fertile-window-ovulation/  and see that the data was generated in two pilot studies by independent investigators testing the Ovulona prototypes.

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>>> Significantly, as hinted above in the “elevator pitch” block-quote, there is much more to this cervix-monitoring technology:

Not just for achieving pregnancy and not just for avoiding pregnancy. Our core product, the Ovulona™ monitor, is the core of a new women’s healthcare diagnostic technology platform.

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

The woman of the 21st century is envisaged to become accustomed to using her quick and easy daily fertility (menstrual cycle) self-check about as routinely as she is using her toothbrush. Because most women’s cycles vary from one cycle to the next and so does also the ovulation day.

Too many menstrual cycles are irregular due to a mismatch between the brain and the ovarian pacemakers, and it’s also a fact that many “clinically normal cycles” are in fact anovulatory (without ovulation, hence unable to conceive). Here is an illustration of how the Ovulona detects – in fact, anticipates – anovulation:

Ovulona’’s diagnostic power will save infertility treatment money. This cannot be matched by ovulation kits or by any other such product. LPD is a well-known anovulation problem that causes failure to conceive by normal healthy women. It is known to be due to the failure to produce the dominant follicle. The Ovulona detects this by the absence of the preovulatory peaks (where the long-term predictive peak is driven by the maturation of the dominant follicle). Until now, the LPD condition could only be detected too late (in the luteal phase), by the distortion in the BBT temperature profile, which in LPD shows a collapse instead of the usual elevated temperature plateau, normally associated with the occurrence of ovulation.

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See below how this technology will help healthcare providers to better manage women’s menstrual cycle issues.

Click the image for better legibility and animation

(Slide takes a few moments to open.)

>>> And the physicians’ benefit?

Menstrual cycle profile records (Graafian follicle stage Folliculogenesis-In-Vivo records) for better diagnosis – much like the EKGs for heart doctors – but not as “granular”. 

Essential for correct timing of procedures and tests.

The menstrual cyclic profiles are periodically recurring signatures of the 5th vital sign of female patients – diagnostically meaningful and useful especially when correlated with symptometric data (such as charted quantified symptoms enabling differential diagnosis). 

The ovulographic™ in vivo monitoring of mature follicle stage  folliculogenesis is believed to capture the fine-tuning effects of the direct neural control via ovarian and uterine innervation and the acute effects of local (autocrine and paracrine) modulatory actions.

You can see here again the example of detecting  the delay of ovulation which causes the delay of the whole 3-day fertile window. Take this as a hint at the diagnostic possibilities to detect and better manage the many occurrences of ovulatory dysfunction in normal healthy women.

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Those effects cannot be detected by monitoring the systemic peripheral variables such as the BBT (Basal Body Temperature) or the urine levels of hormones monitored by the commercially available home-use technologies.

In contrast to the old methods, see  https://biozhena.wordpress.com/how-the-ovulona-will-help-physicians-manage-womens-health-issues/  for how our technology will help physicians to better help their female patients.

Nota Bene, Note This Well:

The important advantage is that the cyclic profile records – plus the cervical health testing – will be done in the comfort of the home and at a very affordable cost.

And: This is the only way to manage the effects of stress on a woman’s menstrual cycle and fertility.

Provided that you are a well-matched investor or a prospective bioZhena Corporation management team or BOD candidate, please visit   https://biozhena.wordpress.com/and-for-investors-ppm/.