Archive for the ‘gynecology’ Category

bioZhena venture

July 9, 2015

A 2017 update.

Transforming Female Reproductive Health Management prt scr

Explore the few slides including the links in some of them: https://biozhena.files.wordpress.com/2017/03/new-mostly-narrated-slides-2017-03e2.pps

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

Empower women with clear menstrual cycle data vs. drugging healthy women & the iatrogenic consequences. That is the first (reproductive management) front, opened along with providing a superior (meaning: definitive) tool with which to tackle the ever-growing difficulty of getting pregnant when planned.

Also unprecedented and important for public health is our way of monitoring 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 screening, and its affordability, should significantly improve on the Pap smear screening test.

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 a slide and click it to view the slide:

Friendly Technology - with cervical ring & Ovulograph

https://biozhena.files.wordpress.com/2017/05/single-slide-friendly-tech-with-cervical-ring-ovulograph.pps

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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 she likened to the cardiologists’ ECG recordings but with the important advantage of being affordably and routinely generated by patients at home.

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 short, we are answering the call and challenge to “Improve the methods and criteria to assess ovulatory dysfunction” (per R.S. Legro MD, 2013).

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.

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 detection of pregnancy, whether intended or unintended, is automatic with the primary routine use of the home-use smart sensor.

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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 (Business Plan Summary Financial Projections)

Or

10-year projections:

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

FVS compared with MVS

https://biozhena.files.wordpress.com/2016/09/comparison-mvs-cf-fvs.pps

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bioZhena’s pitch on EquityNet:

Women’s personal sex management 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.

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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For a fuller description of the project, go to https://www.equitynet.com/c/biozhena-corporation

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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

– one of the materials provided in the EquityNet posting.

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Contra Nescience Contra Insouciance (SM 2015)

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And yours truly bioZhena founder seeks a well-matched management partner of either gender.

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The fallacy of ovulation calculators, calendars and circulating-hormone detectors

February 13, 2012

Don’t let them lead you by the nose with likely this and probable that! You need to know for sure.

When it comes to the crucial timing of ovulation, it is astonishing to see the fallacies and delusions propagated on the web – and that this includes even certain generally respected mainstream sources. How they declare, for example: If you’re trying to get pregnant, use this tool to find out when you likely ovulate and are most fertile.

Never mind that “most fertile” makes absolutely no sense because there is no such thing as a little fertile, more fertile and most fertile!

Ladies (and teenage young ladies included!), you either are fertile today or you are not: You either can conceive today or not.

It is either or.

You either are fertile today or you are not. It is not a little bit fertile, or more fertile, or most fertile. Like, you cannot be a little bit pregnant… you either are, or you are not.

Besides which, if you want to conceive a pregnancy, you must know with certainty that ovulation happens when you try to conceive – not merely that it is likely to happen. Unless you are reproductively ill or menopausal, it is always likely to happen at some point but the mere likelihood is not very helpful. Conception absolutely requires ovulation so that the released (ovulated) egg has a chance to be fertilized.

You must have a way of detecting ovulation at home and, based on that instrumentally recorded information, we will also help you with the Expected Date of Delivery (EDD), because that is how it works. Not the LMP (Last Menstrual Period) but the date of the conceptive ovulation — that’s the ovulation with which you became pregnant because your ovulated egg became fertilized. The date of ovulation is the date from which the EDD must be computed.

Ovulation caught on camera

Ovulation caught on camera by Dr. Donnez – impressive but not a practical method of detecting ovulation

Fast forward to the principle that’s behind the take-home message of this post and that’s systematically arrived at by the end of this post:

Briefly: Tracking systemic effects (hormones in circulation) is not good enough for fertility status determination, especially if the purpose is pregnancy avoidance.

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To be blunt about the language of “likely ovulate” and “most fertile”: Such language simply reflects their inability to be definitive about it – and they therefore resort to guesstimating ovulation, calling it a calculation.

Numerous websites proffer their ovulation calculators when you search online for “ovulation”. A free, printable ovulation calendar and ovulation calculator to help you…, ovulation calculator can help you find the best time to conceive (as if there was some worse time when to conceive!), a calculator to generate your ovulation calendar and determine the best time…, our free Ovulation Calendar helps you predict your most fertile time of the month (ovulation) so that you can achieve pregnancy. Etc.

Notably and significantly, they do NOT promote this for natural (behavioral) pregnancy avoidance (birth control) but only as a tool for assisting conception – as if these were not the two sides of the same coin. They do not because they would get into trouble if they did.

A common approach relies on detecting, in a woman’s urine, the luteinizing hormone (LH) that typically surges on the ovulation day. The LH surge (sharp narrow peak in LH concentration) occurs a few hours before ovulation. Because that is really too late for anticipating ovulation, a related but more sophisticated fertility monitor additionally detects also a metabolite of estrogen, i.e., another hormone, which anticipates the LH surge by about a day.

The worst flaw of systemic hormone monitoring

Fundamentally the most serious detriment is the fact that ovulation as such is not detected by said fertility device or any other such available in the marketplace. Ovulation is merely assumed to occur some hours after the LH surge – but the surge of the LH hormone is merely a trigger signal sent by the brain to the ovary. It says, “ovary, let go of the ovum in our dominant follicle”, but it does not say that the ovary in fact did (or does).

This is a fundamental flaw because ovulation is known to fail to occur in approximately 20% of the follicles. Those follicles, triggered by the LH, undergo the cyclic event of follicle rupture but, despite the rupture, the egg does not come out – there is no ovulation.

Human ovulation caught on camera

In 20% of LH-triggered cases, the egg is not released so ovulation, as photographed here by Dr. Donnez, does not occur

Ovulation also fails to occur with another type of follicles, the so-called luteinized unruptured follicles. Yet, the LH surge can be seen in either case, and is therefore a false indicator.

Furthermore, when stress causes a delay or absence of ovulation despite the LH surge signal (signal from the brain to the ovary), this cannot be detected and handled by the urinary hormone-based approach. As you can imagine, with our stressful lifestyle and environment, this is a very serious flaw that results in many disappointments.

George Condo - Field of Figures

George Condo – Field of Figures sold for $450,000 at Skarstedt Gallery’s booth Published: June 14, 2011

Since, unlike our Ovulona™ Smart Sensor™ technology, their method depends on biochemical reagents and since the supply of the reagents is limited, their product’s user has to estimate on which day of her menstrual cycle she should start using the hormone-monitoring device when peeing into a cup. She does the estimating based on her previous menstrual cycle(s) as though the length and the timing of the present menstrual cycle were the same as in her previous cycle(s). Alas, that’s not so. Because of the variable lengths of successive cycles in most women, this is a weak feature in their design (even though they are getting away with it).

A key practical problem of the referenced 2-hormone device (the Clearblue® Fertility Monitor) is that the monitored urinary concentration of the estrogen metabolite E3G peaks only about 12 to 24 hours prior to the LH surge. This is not early enough to serve as a marker of the beginning of the fertile phase.

Fertile day 1 not identified

Their research or marketing literature may claim that “a sustained rise in E3G can be used to identify the start of the fertile phase”, referring to the slow gradual increase that eventually becomes the peak of E3G concentration. However, the idea to use an ill-defined rise – rather than the peak in the cyclic profile of the estrogen metabolite – is not a viable solution to the fertile window problem.

Even if the ill-defined E3G rise in the urine were correlated with a clearly defined stage of the egg development towards ovulation, a serious problem is that the rate of the E3G rise differs from cycle to cycle, as do the blood concentrations of E3G. The initially slow increase of the E3G concentration in the urine proceeds at different rates in different cycles, not only at different rates in different women. The E3G rise cannot be predictably associated with the beginning of the fertile period, and it cannot serve as a marker.

Hypothalamus-Pituitary-Gonad Feedback Loop

Schematic diagram of interaction between the LH and FSH hormone-generating glands in the brain (hypothalamus and pituitary) and those of the ovary (female gonad) generating estrogen and progesterone

The reasons are as follows:

1. Estrogen is known to have both stimulatory and inhibitory effects on LH secretion and, to be effective as a stimulant, it must rise to its peak levels (> 150 to 200 pg/ml) and must remain elevated for at least 36 hours [J. Hotchkiss and E. Knobil in E.Y. Adashi, J.A. Rock and Z. Rosenwaks, editors: Reproductive Endocrinology, Surgery and Technology, Lippincott-Raven Publishers, 1996].

In fact, the E3G rise indicates something else:

2. The E3G profile does not reflect the local interplay of estrogen with progesterone because it only reflects clearance of one of at least 10 metabolites of estrogen from peripheral blood circulation into the urine, after oxidative conversion in the liver.

Whatever the rate of this clearance process in the given woman in the given menstrual cycle, there are “local mechanisms due to which the quantification of ovarian steroids in peripheral blood or in urine is rendered interesting but of little value in predicting the genital end-organ effect” [C.J. Verco, in A.M. Siegler, editor: The Fallopian Tube. Basic Studies and Clinical Contributions, Futura Publishing Company, 1986].

The decades old problem is fundamental

This makes for the same basic flaw as that suffered by other monitors of peripheral hormones whether the hormone be progesterone (BBT monitoring) or estrogen (conductivity of saliva or of vaginal fluids).

Thus, the 2-hormone approach is in the end as inaccurate as the other LH-detecting techniques (the OPKs, Ovulation Predictor Kits). Therefore, like the other hormone monitoring methods, it cannot be approved and proffered for pregnancy avoidance since the failure rate would be unacceptably high. In fact, a law suit ensued in England, when the original developer company did sell the LH-and-estrogen monitor as a “contraceptive system”, and a number of unintended pregnancies resulted to the users.

The fundamental point is this: The effects of the local and acute regulatory mechanisms (as referenced under 2 above) remain undetected by the old techniques that work with the peripheral biomarker variables.

Ovarian vein-to-artery exchange of steroids, prostaglandins and other bioactive substances is a local transfer mechanism which enables local regulation of ovarian, tubal and uterine functions. The local, as opposed to peripheral, blood concentrations of the steroid hormones are also believed to work with the innervation of the female genital tract (the cervix in particular).

The effects of these local and acute regulatory mechanisms remain undetected by the old so-called prior art techniques that work with peripheral biomarker variables. In contrast, our Ovulona™ detects them – via the cervix, the natural monitor of the female reproductive system.

Gustav Klimt - Medicine mural (complete view)

Gustav Klimt – Medicine mural – Klimt’s primary subject was the female body

The flawed assumption of similar timing of menstrual cyclic events from one cycle to another has been a problem for the BBT and the BBT thermometers. Since the late sixties, the microprocessor technology has been applied by a number of people to the well-tried basal body temperature [BBT] approach to family planning that was originally hoped to work for pregnancy avoidance.

Smart phone apps with the BBT?

The BBT approach is no longer recognized as medically valid even if it may be acceptable to some of the older physicians, and to the younger buyers of an expensive microcomputerized BBT monitor offered from Europe and/or to the users of one of the more recent smart phone apps based on BBT monitoring.

This is because the so-called basal body temperature is a systemic variable that reflects, among other things, progesterone rise in peripheral blood after ovulation, usually one or two days later.  It is a very indirect and non-specific biomarker. Even though in some women in some cycles a little-understood dip in the temperature graph may apparently be observed one day before the temperature rise, it is clear that the BBT method is of little value due to its lack of predictive capability and due to its fundamental unreliability. The BBT-rise data is known to have a large error bar since the rise can occur from 3 days before to 3 days after ovulation.

For a more detailed critique of the BBT monitoring approach and a rebuttal of a particular European product, peruse Critique of BBT monitoring – DuoFertility rebuttal.

Briefly: Tracking systemic effects (hormones in circulation) is not good enough for fertility status determination, especially if the purpose is pregnancy avoidance.

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Purveyors of the old “prior art” technologies get away with it because of the high demand for any help with the serious and growing problem of sub-fertility, more commonly called trying-to-conceive or difficult getting pregnant. When the purveyors publish anecdotal evidence of “efficacy” in the form of thank-you letters from women who did achieve pregnancy, we should keep in mind that the women received help in focusing on trying to hit the fertile period regardless of whether the given technology actually did work or not. If any of the “prior art” did work reliably, it would be used as a pregnancy-avoidance tool, which is not the case.

Venus, Cupid, Folly, and Time (also called An Allegory of Venus and Cupid and A Triumph of Venus) is an allegorical painting by the Florentine artist Agnolo Bronzino. It is now in the National Gallery, London. Artist     Agnolo Bronzino Year     circa 1545 Type     Oil on wood Dimensions     146 cm × 116 cm (57 in × 46 in) Location     National Gallery, London Its meaning, however, remains elusive. Cupid, along with his mother (Venus) and the nude putto, to the right, are all posed in a typical Mannerist figura serpentinata form. The two central figures are easily identified by their attributes as Venus and Cupid. For example, she holds the golden apple she won in the Judgement of Paris, while he sports the characteristic wings and quiver. Both figures are nude, illuminated in a radiant white light. Cupid fondles his mother's bare breast and kisses her lips. The bearded, bald figure to the upper right of the scene is believed to be Time, in view of the hourglass behind him.[2] He sweeps his arm forcefully out to his right. Again, it is difficult to interpret his gesture with any certainty The old woman rending her hair (see detail at right) has been called Jealousy—though some believe her to represent the ravaging effects of syphilis[2] (result of unwise intercourse).

Venus, Cupid, Folly, and Time (also called An Allegory of Venus and Cupid and A Triumph of Venus) is an allegorical painting by the Florentine artist Agnolo Bronzino – circa 1545.  The bearded bald figure to the upper right is believed to be Time…

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Now go see about “Instant detection of pregnancy and of Early Pregnancy Loss, EPL – the adversary of Trying To Conceive, TTC – especially after age 25″ at https://biozhena.wordpress.com/2010/11/11/instant-detection-of-pregnancy-and-of-early-pregnancy-loss-epl-the-adversary-of-trying-to-conceive-ttc-especially-after-age-25/

And should you be an investor and/or wish to find out more, check out  Home Page of bioZhena’s Weblog

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