Home Page of bioZhena’s Weblog

First, a précis of bioZhena Corporation

Imagine:

Using the Ovulona™ to monitor menstrual cycle data will be essential not only for a woman’s sex life management by fertility awareness but also for patient profiling with which to manage women’s frequent menstrual and fertility, reproductive and general health problems.

Understand that the Ovulona-generated menstrual cycle profiles provide the only means of recording the cyclically recurring signatures of the newly recognized 5th vital sign of women’s health status. Here is how this will help the physicians to better help their female patients.

The menstrual cyclic profile signatures, recorded at home for fertility awareness, are descriptive of reproductive cycling and relate to a woman’s well-being – similar to how ECG recordings pertain to the health of the heart.

.What is folliculogenesis - like EKG

Click on the image for better legibility

Menstrual cycling is necessary for a woman’s health, and you already know that ovulation is necessary if you want to conceive a pregnancy.

Now we pinpoint A FUNDAMENTAL PRINCIPLE:

IT IS THE REQUIREMENT OF BRAIN-OVARY PACEMAKERS SYNCHRONIZATION,

THE MANDATORY PRECONDITION FOR OVULATION TO OCCUR.

Because in many menstrual cycles the synchronization fails or otherwise complicates reproductive life, ovulation must be detected, not merely predicted.

Our Folliculogenesis-In-Vivo technology™ is the solution.

For a summary brief OVULATION DETECTION IS A MUST BECAUSE BRAIN-OVARY PACEMAKERS SYNCHRONIZATION IS THE PREREQUISITE OF OVULATION go to  https://biozhena.wordpress.com/ovulation-detection-is-a-must-because-brain-ovary-pacemakers-synchronization-is-the-prerequisite-of-ovulation/ . Here is the gist:

Non-baseline cycle w delayed ovulation- algor applied AND next cycle, no ovu delay - e2 (arrests), stars

These two consecutive cycle records of a non-baseline woman are suggestive of two ways of brain-ovary synchronization as THE precondition of ovulation. In cycle 4, 2 days of ovulation delay after the short-term predictive peak; and in cycle 5, 2 days of signal arrests on the descending branch of the dominant follicle maturation peak, with no ovulation delay after the short-term predictive peak.

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Check out the bioZhena mission page: https://biozhena.wordpress.com/biozhenas-mission-a-health-tool-for-every-woman/  BIOZHENA’S MISSION: A HEALTH TOOL FOR EVERY WOMAN (and for her healthcare providers).

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

We’ll empower women with clear menstrual cycle data vs. drugging healthy women and the iatrogenic consequences of contraceptive drugs.

Do peruse the above-linked technology brief particularly if you know women’s health. The final edit of this, with more links to further particulars, is at https://biozhena.files.wordpress.com/2019/09/biozhena-technology-overview-for-people-who-know-womens-health-eee.pdf .

bioZhena Corporation (see project history) is a medical device pre-revenue company with revolutionary home-use diagnostic technology for the women’s healthcare market. This is a substantial market that can lead to multi-billion dollar revenues. Detailed commercial modeling of this technology asset leads to NPVs in excess of $1B.

Demonstrated in proof-of-concept studies, bioZhena’s Ovulona™ is a patented Smart Sensor™, an in vivo monitor of the menstrual cycle process called folliculogenesis, which is the mechanism of menstrual cycles.

And, prospectively, it is a monitor of cervical health – this working in the background of the primary monitoring, not bothering the user unless a tissue aberration is detected consistently several months in a row. This private way of screening, and its affordability, should significantly improve on the Pap smear screening test.

Technology Overview

Click on the image for better legibility

Unlike any other fertility monitor, the Ovulona is intimately involved with the always-present stress responses – through monitoring certain end-organ effects on folliculogenesis. The other techniques monitor only this or that circulating hormone – not good enough. The end-organ effect(s) is what counts. The end organ is the cervix uteri.

As bioZhena gains traction in the vast women’s health and pregnancy markets, the Ovulona will be transformed into an internally worn telemetric cervical ring, the Halo™, for automatic effortless monitoring without the need for daily insertion. See below and this summary slide.

SaaS subscription will be employed for introducing new applications and upgrades, generating recurring income without changing the hardware. Cervical health screening, pregnancy monitoring and other ever so important applications will be introduced while generating revenues with the already FDA-cleared minimum-value application of the core Ovulona product.

Project History Précis is a sketch of how the technology got to where it is today. The outline is stripped of the drama occurring at some points along the way.  But I do make a point here about the first – determined and scientifically erudite – “guinea pig” tester of the proto-Ovulona. Without her, FOLLICULOGENESIS IN VIVO™ would not have come about. She knew what she wanted, and she worked on it and got it. Son and daughter. Libuse (Liba) Kirsner worked on the right thing. More on this in the About page of bioZhena’s Weblog.

The Ovulona personal fertility status self-diagnosis device

Click on the image for a more informative quick introduction

(3 slides)

URL:  https://biozhena.files.wordpress.com/2018/03/ovulona-from-startup-version-to-cervical-ring-implementation.pps

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bioZhena’s 3 days of the FERTILE WINDOW

Understand this about the bioZhena’s 3 days of the FERTILE WINDOW:

The NIH now teaches about the extent of the fertile window what we’ve professed ever since (https://www.nichd.nih.gov/news/resources/links/infographics/ Pages/ovulation.aspx).

The National Institutes of Health statement is that 90% of women don’t know that 2 days before through the day of ovulation is the best time to try to get pregnant.

But then, we say “the only time”, not just “the best time”. We say this because we can. Because we can determine the 3 days. Because we can determine the 3 days even when they are affected – as often happens – by stress, which you can read about in https://biozhena.wordpress.com/stress-and-fertility-fertile-window-ovulation/ .

Whereas none of the commercial ovulation-prediction products can. That is why our Ovulona can aid the practice of natural birth control (with the 3 critical days) whereas the other techniques cannot. See this blog’s page “The fertile window is 3 days wide, not 6, which 6-day belief originated in a flawed 1995 study”.

Until bioZhena’s technology becomes available, it can – or rather it must – be said that 100% of women do not know their 2 days before through the day of ovulation. Because of the variability of menstrual cycles and of ovulation timing, they don’t know which particular 3 days they are in the current menstrual cycle.

Our pre-launch clinical trial will establish with certainty whether in practice the 3 days are absolute or whether in practice the window must be four days.

I say this because ovulations tend to happen at night, and because the egg life span will be determined – for the first time, believe it or not. This can be done only with the information-rich menstrual cyclic profile, generated by the Ovulona in a carefully designed clinical study. See below under MORE ABOUT THE TECHNOLOGY.

Well, Professor Hafez did state in 1973 (see The Ovulona™) that “…the fertile period of the menstrual cycle is not more than 4 days, and probably less”. We’ll do the determination, which requires this technology, once and for all.

Incidentally: Do you like the bioZhena story and do you want to discuss  participating in the bioZhena enterprise? If so, email me: vaclav at biozhena dot com .

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About PPM with business plan see https://biozhena.wordpress.com/and-for-investors-ppm/

 

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MORE ABOUT THE TECHNOLOGY

For you in case of real interest in what this is all about

This may be redundant if you did review the link after the first image above, i.e.  bioZhena’s technology platform

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ovulona-illustrated-in-two-slides1

For a description of the wealth of information contained in the menstrual cyclic profile signature shown on the right above, click

https://biozhena.files.wordpress.com/2016/12/friendly-technology-wealth-of-information-510k-vltava-fda-nih.pps

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And here is how it will help physicians to help their patients with menstrual cycle issues:

Baseline subject’s record flanked by two non-baseline records

baseline-record-flanked-by-2-non-baseline-abnormalities

To make the image more legible (and the two links clickable), click on this link: https://biozhena.files.wordpress.com/2016/12/single-slide-baseline-flanked-by-2-non-baseline-abnormalities.pps

Next generation design

Click here or on the URL below to view the slide where the two links are clickable.
The URL is: https://biozhena.wordpress.com/next-generation-design-2/

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Further illustrations indicative of the diagnostic capability provided by the menstrual cyclic profile

After reviewing the composite image below, do view and listen to the narrated description of the important medical abnormality, the so-called Luteal Phase Defect or Dysfunction (LPD).

The LPD is important because it happens too frequently to otherwise healthy women. The abnormality has been implicated in both infertility and recurrent pregnancy loss, a surprisingly common occurrence.Short luteal phase and LPD examples of the Ovulona(TM)'s diagnostic power

Short luteal phase and LPD examples of the Ovulona’s diagnostic power

https://biozhena.files.wordpress.com/2016/08/short-luteal-phase-and-lpd-examples-of-the-ovulonatms-diagnostic-power.jpg – Click for a somewhat better legibility

For a narrated description of the LPD, click:  https://biozhena.files.wordpress.com/2016/08/lpd-narrated-on-white-background-single-slide1.pps

NOTE: If you did choose to listen to my voice, yours truly and somewhat aged (matured!) boy @bioZhena (the creator of the narrative) should ask to be excused for having referred at the very end to the LPD subject of the pilot study as a 24 years old girl!

The narration cannot be edited…

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The principle behind Folliculogenesis In Vivo(TM) is the F in the image on the left.

It enables the monitoring of the Menstrual Cycle as an Indicator of Overall Health – because The Menstrual Cycle is a Vital Sign®

HPG slide 4 screen shot from 5 slide show

Click here for better legibility and two clickable links.

This is mainly to introduce the registered mark The Menstrual Cycle is a Vital Sign®, and the implications for women’s health. The listed wake up calls postulated by the US DHSS and the NIH.

The URL is: https://biozhena.files.wordpress.com/2015/07/single-slide-hpg-slide-4-from-5-slide-show.pps

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For a better understanding, read about what folliculogenesis is and about our technique of Folliculogenesis-In-VivoTM  https://biozhena.wordpress.com/folliculogenesis-in-vivotm/. View a condensed pictorial summary of how the Ovulona sensor tracks the folliculogenesis process, generating the female 5th vital sign signature (aka menstrual cyclic profile).

And view a refined version of the above schematic of the Hypothalamus-Pituitary-Gonad Feedback Loop, which is a shorthand pictorial expression of this concept:

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.

Hypothalamus-P-G Feedback and innervation panorama with text (stress) .

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The most important practical feature of the Ovulona-generated cyclic profile is this:
1. while certain amplitude thresholds are constants set by the calibration of the sensor electronics,
2. the boundary days of the fertile window (the beginning and the end of fertility in the current menstrual cycle) are variables that change from cycle to cycle as well as from woman to woman.

This is fundamental: While the dynamic range (vertical span of measurement data) is woman- and cycle-independent, the opposite holds for the timing, which the biology causes to vary from cycle to cycle – and we monitor it and work with it.

Unique and unprecedented, the Folliculogenesis In Vivo™ technology provides longitudinal signature records of the menstrual cycle vital sign.

 

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Two Examples of Our Patented Means of Generating and Recording the Menstrual Cycle Vital Sign® Signature

My two patents - title size 48 w4400 text below v2

https://biozhena.files.wordpress.com/2015/06/my-two-patents-title-size-48-w4400-text-below-v2.jpg

For bioZhena’s patent portfolio and patent strategy, click

Patent strategy provides ample protection

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And now for a summary of prospective applications of the technology which are involved in the bioZhena Full Value Scenario, described separately:

Click on the image below to view and listen to a set of 11 narrated slides outlining how we’ll proceed to the Full Value Scenario from the FDA-cleared first application of the Ovulona Cervical Sensor (the Minimum Value Scenario of the bioZhena Business Plan).

Applications of cervical sensor girl w. device and other solutions - panorama1

For better legibility of the composite image, click:  https://biozhena.files.wordpress.com/2016/08/applications-of-cervical-sensor-girl-w-device-and-other-solutions-panorama1.jpg

Do click the above composite image for the 11 mostly narrated slides. The URL is: https://biozhena.files.wordpress.com/2019/09/transforming-female-reproductive-health-management-918-1-ed-919-blue11slides-w.yellowref.to20sl.ppsx One of the slides connects you with the bioZhena Corporation slide deck.

oh yeah

Clickable Table of Contents of bioZhena’s Weblog with snippets of information on what any selected post is about: https://biozhena.wordpress.com/table-of-contents-links-to-biozhena-posts/

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About PPM with business plan see https://biozhena.wordpress.com/and-for-investors-ppm/

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