Home Page of bioZhena’s Weblog

Précis of bioZhena Corporation

About PPM with business plan see https://biozhena.wordpress.com/and-for-investors-ppm/#_Hlt79928527

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.

Using the Ovulona™ to monitor menstrual cycle data will be essential for patient profiling with which to manage women’s frequent menstrual and fertility, reproductive and general health problems. The menstrual cyclic profile signatures, recorded at home, are descriptive of reproductive cycling and relate to a woman’s well-being – somewhat similar to how ECG recordings pertain to the health of the heart.

bioZhena’s technology platform is bound to revolutionize women’s healthcare with diagnostic tools for women and their doctors & payers. We’ll empower women with clear menstrual cycle data vs. drugging healthy women & the iatrogenic consequences.

bioZhena’s Ovulona™ is a Smart Sensor™, an in vivo monitor of the menstrual cycle process called folliculogenesis, which is the mechanism of the menstrual cycle.

And, prospectively, 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 way of screening, and its affordability, should significantly improve on the Pap smear screening test.

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

(4 slides)

The URL is: https://biozhena.files.wordpress.com/2014/10/ovulona-quick-intro-4-slides1.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 that which 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. 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.

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 the egg life span will be determined – for the first time, believe it or not. Only with the information-rich menstrual cyclic profile, generated by the Ovulona, can this be done. 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 want to participate in the bioZhena enterprise?

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About PPM with business plan see https://biozhena.wordpress.com/and-for-investors-ppm/#_Hlt79928527

 

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MORE ABOUT THE TECHNOLOGY

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

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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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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 future 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 8 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

Remember to click the above composite image for the narrated slides! The URL is: https://biozhena.files.wordpress.com/2016/12/new-set-v7-narrated-slides-edec16.pps

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/#_Hlt79928527

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