The bioZhena project

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

We empower women with clear menstrual cycle data interpreted in terms of daily fertility status 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. Automatically detecting pregnancy immediately when conception happens, whether intended or unintended (see below for more, and I should have written pseudo-hormone-free avoidance because that’s what the contraceptives are – not real steroid hormones, which your body needs (and our cervical sensor tracks) but certain patented derivatives).

Basic self-care – from late teenage to menopause. Not available today despite the various conception-aiding products  and fertility awareness methods in the marketplace. Understand the root cause of why that is, Why too many young and not so young ladies could NOT receive flowers on Mothers’ Day: Why so many trying-to-conceive, why so much infertility . Not just a double whammy, it’s a triple whammy on womankind – and thus on humankind.

The bioZhena project aims to help fixing the bad situation by providing a breakthrough self-care tool, the Ovulona. In due course to be followed by the telemetric Halo cervical ring – to give you and your OBGYN a choice.

And, unprecedented and important for women’s healthcare, we’re making the 5th vital sign menstrual cyclic profiles recorded by the Ovulona available to physicians, for better diagnosis and management of health issues.

Understand this: The fertile window is an empirical factor, which should be consistent with the fertilizable lifetimes of the gametes (i.e. the egg and the sperm). The fertilizable lifetimes are uncertain but currently accepted figures are up to 12 (or maybe 24) hours for the egg, and at most 3 days for the sperm. These times must overlap, of course; they are not additive.

With the information-rich cyclic profile produced by the bioZhena’s cervical tissue sensor, it will be possible to bring certainty into this via careful measurement of the fertile window (i.e. the fertilizable lifetimes of the gametes [egg and sperm]). That is only feasible to perform with the bioZhena technology because the menstrual profile features not only anticipate but also pinpoint ovulation, making it possible to tie conceptions to specific cycle days.

For further insight, please refer to the discussion of Folliculogenesis-In-VivoTM that you will find at https://biozhena.wordpress.com/folliculogenesis-in-vivotm/ .

Also unprecedented and important for public health is prospectively 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 monitoring 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.

Ovulona™ slide 1 of 8 slide set

 

Click the image (or the link below) to explore the bioZhena Corporation presentation slides, including the links in some of them:

https://biozhena.files.wordpress.com/2019/01/biozhena-ovulona™-slide-presentation.ppsx

 The same slide deck in printable PDF format (without narration):
https://biozhena.files.wordpress.com/2019/09/biozhena-ovulonae284a2-slide-presentation-201909-forpdf-2.pdf

Navigate these slides with the down and up arrows in upper left. Hover on or click sticky notes for further particulars.

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Regarding the competitive landscape: Perhaps it is clear that the multitude of the recently introduced smart phone apps demonstrates the continued unsatisfied reproductive management (sex life management) market need. Perhaps it is not necessary to point out that, like the other or earlier technologies, they  are not a viable competition (a viable solution) because they are based on physiological indicators that have been discredited in the past as nonviable for birth control.

This is including the BBT, basal body temperature, and the app offered by the Natural Cycles company. Their product is based on clinical trials with self-assessed “regularly menstruating” women who purchased the app. In actual use, the product imposes often a long “unsafe period” (11 days), and it has resulted in unwanted pregnancies.

Conclusion: None of those products offers a practical method of natural pregnancy avoidance as an acceptable alternative to the hormonal and other interventionist contraceptive methods. That is due to fundamental reasons: their inability to delineate the true fertile window and inability to work with abnormal (irregular) cycles challenged by asynchrony of brain and ovarian pacemakers.

For more, see   https://biozhena.wordpress.com/three-things-differentiate-the-biozhena-medtech-from-smartphone-apps-including-particularly-the-most-recent-natural-cycles/ .

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Now, 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 one of three slides and click it to view it, grasp the significance:

Friendly Technology - with cervical ring & Ovulograph

https://biozhena.files.wordpress.com/2018/03/ovulona-from-startup-version-to-cervical-ring-implementation.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’ EKG recordings – 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. Namely:

Monitoring pregnancy and managing labor

For background information refer to “Histobiomechanical Remodeling of the Cervix during Pregnancy: Proposed Framework” at https://www.hindawi.com/journals/mpe/2019/5957432/  (and searchable key words  cervix remodeling).

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.

Abstract of Am J Obstet Gynecol 2012, 207(5), 345–354

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/2019/10/feasibility-of-the-planned-range-of-ovulona-applications-2019.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 for the startup phase)

Or, better,

10-year projections:

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

Here is a comparison of the two scenarios (spreadsheets available upon request) –

FVS compared with MVS

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 third-party payers (insurance).

This first app of the 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 prototype 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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HPG slide 4 screen shot from 5 slide show

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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And so let’s sum up the basics via these clickable JPG images (zoom in for legibility):

What is folli' AND Hypothalamus-P-G loop w. innervation panorama

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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. Here is how it goes:

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Wealth of info w. dom f peak labels AND Elucidation of labels text - horizontal

For better legibility, click on the image and zoom in – and better still, view the PDF of 4 slides (with further clarification in clickable speaker notes) at   https://biozhena.files.wordpress.com/2019/06/wealth-of-info-dom-folli-elucidated-silent-4-slides-animated-ed.-061019-1.pdf

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The final image serves as a segue from baseline into non-baseline menstrual cycles and the bioZhena technology’s ability to address stress effects on fertility, fertile window and ovulation timing.

Non-baseline cycle w delayed ovulation- algor applied AND next cycle, no ovu delay - e1

Please peruse the Weblog page at https://biozhena.wordpress.com/stress-and-fertility-fertile-window-ovulation/ – because:  “Stress can do unwanted things to a woman and her menstrual cycle. In a nutshell, stress can make a woman completely infertile in this menstrual cycle (e.g., LPD), or it can change the timing of her fertile window (the time of ovulation included) within the menstrual cycle.”

And, citing Dr. Michel Ferin,  “with minimal reduction in GnRH pulse frequency, small undetected defects in the follicular maturation process may occur, whereas with a higher degree of pulse inhibition the follicular phase may be prolonged, and luteal phase deficiency, anovulation, and amenorrhea may develop.”

Results obtained with our Ovulona prototypes lead to the conclusion that the technique appears to detect such phenomena as referred to by Dr. Ferin. Visit the above referenced Weblog page.

 

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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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