Home Page of bioZhena’s Weblog
First, a précis of the bioZhena technology project
On the assumption that you know full well that conception (=getting pregnant) cannot happen without ovulation.
The text below this amusing GIF should make it clear that religion has nothing to do with the contents. Okayyyyyyyyyyyyy?
The quick intro read “Natural Family Planning and Fertility Awareness – not the old ‘Rhythm method’!” is a quick preface about this basic terminology to give you a hint at the women’s healthcare context of the bioZhena project.
Now read – and grasp – this:
For fertility awareness to be reliable, hence effective – whether for conception or for contraception – ovulation must not only be predicted but must be also actually detected. Not merely estimated from a predictive signal or bodily sign(s) and assumed that ovulation occurs at the estimated time. Because that does not happen in many menstrual cycles, the estimation without evidence of ovulation fails.
That fundamental inadequacy was, and is, the primary (initial) reason for the bioZhena FOLLICULOGENESIS-IN-VIVO™ invention. Read on.
Right upfront, I am telling you to understand that, like many a woman, the bioZhena innovation rejects #thePill‘s sledgehammer “don’t think just swallow” contraception. Similarly about the other artificial-contraception products out there.
Also inadequate, although for a different reason, are the various smartphone fertility apps. That’s because they computerize the well known Fertility Awareness Method, which requires women to monitor changes in: a) their basal body temperature, b) vaginal fluid wiped from the vaginal opening, and/or c) the position of the cervix self-assessed by fingering in the vagina.
This approach did not solve the natural birth control problem before the smartphone era, and it cannot solve it now even if they include additional subjective self-observations and/or the results of urine testing for one or two sex hormones.
And so, to move on into the bioZhena project,
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 patients’ menstrual cycle profiling, with which physicians can properly manage women’s frequent menstrual and fertility, reproductive and other health problems.
Understand that our Ovulona™-generated menstrual cycle profiles (FOLLICULOGENESIS-IN-VIVO™ records) provide the only means of recording the cyclically recurring signatures of the menstrual cycle, 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 links shown in the bottom part of the image linked above are accessible via https://biozhena.wordpress.com/ovulography-and-the-ovulograph/ .)
The menstrual cyclic profile signatures, recorded at home for fertility awareness, are descriptive of reproductive cycling and they relate to a woman’s well-being – similar to how EKG recordings pertain to the health of the heart.
Click on the image for better legibility
Menstrual cycles are necessary for a woman’s health, and you already know that ovulation is necessary if you want to conceive a pregnancy.
Now, let’s 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 women’s 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”
Here is the gist:
These two consecutive cycle records of a non-baseline (“real life”) woman show 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 self-care tools for women and for their doctors & insurance reimbursement payers (enabling evidence-based decisions).
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.
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 (Software as a Service) 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.
Click on the image for a more informative quick introduction
(3 slides)
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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 (pending capitalization), 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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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 above, i.e. https://biozhena.files.wordpress.com/2019/09/biozhena-technology-overview-for-people-who-know-womens-health-eee.pdf
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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
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
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’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. But probably better than the JPG image is this:
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 below, on the left.
Folliculogenesis In Vivo(TM) technique enables the monitoring of the Menstrual Cycle as an Indicator of Overall Health – because The Menstrual Cycle is a Vital Sign®
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.
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The most important two-fold 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 (that is 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
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For bioZhena’s portfolio of issued patents, click
https://biozhena.files.wordpress.com/2020/09/single-slide-patent-portfolio-from-biozhena-ovulonae284a2-slide-presentation-201903.pps
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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).
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/2020/01/transforming-female-reproductive-health-management-918-1-ed-919-blue11slides-w.yellowref.to20sl-30.pps
Clickable Table of Contents of bioZhena’s Weblog with snippets of information on what any selected post is about (and clickable list of Weblog Pages is in the right-hand margin):
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About PPM with business plan see https://biozhena.wordpress.com/and-for-investors-ppm/
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bioZhena's Weblog 