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, unprecedented and important for women’s healthcare, making available the 5th vital sign menstrual cycle profile records to physicians when needed, 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 (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 bioZhena’s cervical tissue sensor, it will be possible to bring certainty into this, via a carefully designed clinical study to measure the fertile window (i.e. the fertilizable lifetimes of the gametes). For further insight, refer to the discussion of Folliculogenesis-In-Vivo(TM)  https://biozhena.wordpress.com/folliculogenesis-in-vivotm/ .

Also unprecedented and important for public health is 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 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.

Transforming Female Reproductive Health Management prt scr

Explore the few slides including the links in some of them: https://biozhena.files.wordpress.com/2018/09/transforming-female-reproductive-health-management-918.pps

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Regarding the competitive landscape: Perhaps it is clear that the recently introduced smart phone apps demonstrate 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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But 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’ ECG recordings – but 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.

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/2014/11/feasibility-of-the-planned-range-of-ovulona-applications1.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 payers.

This first app of 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 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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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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