MedTech Investor: Check Out the Assumptions of Our Minimum Viable Product Scenario

In the present post, we present the bioZhena Business Assumptions. This is to draw attention to the big picture that emerges even in the Minimum Viable Scenario (MVS), the detailed assumptions of which have been worked from bottom up (with due attention to the TAM, SAM and the SOM). bioZhena Corporation’s goal is to implement the Full Value Scenario that was constructed based on the MVS. More on this in the closing paragraph of this post.

Now it’s the latter I am reaching out to. And I refer to Home Page of bioZhena’s Weblog to be reviewed in connection with the business assumptions. (Or Reproductive Health IQ Does Matter, a LinkedIn post.)

Here is a summary of the MVS, the Minimum Viable Product Scenario:

SUMMARY OF MINIMUM VIABLE SCENARIO’S SERVICEABLE AVAILABLE MARKET IN THE U.S. ALONE

US Trying-To-Conceive (TTC) Serviceable Available Market $$ at the TTC mean cost of $2,600 p.a. is $21,320,000,000

US Trying-To-Conceive Serviceable Available Market $$ at the TTC minimum cost of $200 p.a. is $1,640,000,000

US Initial Off-Label Birth Control Serviceable Available Market (SAM) $$ is $82,492,000

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Projection: FIRST PRODUCT SALES IN MONTH 16 POST FUNDING (first product application already FDA-cleared)

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Summary Comparison of Minimum Viable Scenario (MVS) with Full Value Scenario (FVS)

Click on the image for better legibility

(the URL is: https://biozhena.files.wordpress.com/2016/09/comparison-mvs-cf-fvs.pps )

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And now for the assumptions – with pictorial embellishments for dividers between the market segments.

Listing sources of market data (with some comments) followed by the resulting numerical USD market size assumptions.

‘Satyre et Bacchante’ by Jean-Jacques Pradier, marble, Palais des Beaux-Arts, Lille.

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Birth Control (BC) Market

CDC 2014 survey: 61.7% of the 60.9 million US women ages 15-49 practice contraception (= 37.6 million contraceptors), and of these 48.1% use the most common methods (the pill, sterilization, condoms, and long-acting reversible contraceptives). That leaves 38.3% or 23.32 million non-contracepting women.

un.org Trends in Contraceptive Use Worldwide 2015 Report, Annex Table II: Number of US married or in-union women using contraception = 28,600,000. Number of US women who have an unmet need for family planning = 2,560,000. Worldwide number of women using contraception is 758,000,000 and the number of women who have an unmet need for family planning is 142,000,000 (these are median data as of 2015). Couples often desire to control not just the number of children, but also the timing. We address this desire or need by design.

Next, per Guttmacher Institute 2016 fact sheet, nearly half (45% or 2.8 million) of the 6.1 million pregnancies in the U.S. were unintended in 2011 (and 42% of those ended in abortion). Contraceptive failure rate plays a big role in this. Meaning that, for 2.8 million of the 37.6 million contracepting women, their method fails (and they seek a solution). 43 million US women were at risk of unintended pregnancy in 2008. (Public expenditures on unintended pregnancies nationwide were estimated to be $21.0 billion in 2010.)

For this Minimum Value Scenario, the conservative assessment of the number of US women in the birth control market is to choose between the 43 million at risk in 2008 and the 2.8 million of unintended pregnancies in 2011 plus the 2,560,000 who have an unmet need for family planning. We choose the latter, which is much smaller, i.e. 2,800,000 plus 2,560,000 = 5,360,000 as the number of US women in the family planning (BC) market segment for our Serviceable Available Market. This is an indisputably conservative assessment of our Serviceable Obtainable Market in the birth control (BC) market segment in the U.S.

US costs of personal birth control average $1,006/year (Health Aff (Millwood) 2015 and americanprogress.org 2012). Since average ACA saving was 20%, then 100% = $ 251.5 times 5 = $ 1,257.50.  So, $ 1,257.5 – $ 251.50 = $1,006. (ACA = Affordable Care Act.) Double-check the reasonableness via this tweet.

Hence Our Birth Control (BC) Numerical Assumptions For the Minimum Value Scenario Are:

Number of US Women in the family planning (BC) market is 5,360,000

US Serviceable Available Market (SAM) $$ is $5,392,160,000

Worldwide Number of Women in the family planning (BC) market is 758,000,000

Worldwide Total Available Market $$ is very large even with only the unmet-need number of 142,000,000 women

E.g. if the estimate is based on the above US cost average, TAM is $142,852,000,000

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Initial Off-Label BC Market Upon the Ovulona Launch Assumed At 1%

Commercial market research compendium reports: The Trying-To-Conceive (TTC) tests are utilized for the unauthorized off-label use of aiding women’s natural birth control practice.

Quote: “About Half Who Use Tests Do Not Want Pregnancy”.

(http://www.marketresearch.com/Packaged-Facts-v768/Home-Medical-Tests-143386/).

Here we assume only 1% of the 8,200,000 US Fertility-Impaired Women Ages 15-44 (see below the CDC data on the TTC market), which is 82,000 women, translating at the assumed mean annual BC cost of $1,006 into an off-label $82,492,000 SAM upon the Ovulona launch into the TTC Market. To reiterate, we assume that 1% of those in the market for a tech tool aiding conception are in fact in the market to help themselves to avoid pregnancy by fertility awareness and will be off-label Ovulona users as soon as the Ovulona becomes available in the marketplace.

This is a reasonable conservative assumption in view of the 69.5 million US Catholics (the largest religious body in the United States) comprising 22% of the population^[1] as of 2015. The assumed 82,000 women represent a mere 0.1% of the Catholic population. See an example of unsolicited expression of interest in the Ovulona from a US Catholic. Ovulona market research with 5,000 US women revealed that 70% of those who would buy the Ovulona would switch from their present contraception method.

The assumed SAM [Serviceable Available Market] number of $82,492,000  represents 30.5% (but read on) of the annual retail sales of ovulation prediction kits (OPKs or LH kits) in the U.S. as they were reported in 2008/2009 when OPKs outpaced the annual sales of home pregnancy tests. The NYT article at http://www.nytimes.com/2009/04/02/business/media/02adco.html?_r=2 cited the annual OPK sales data of $270 million from IRI (Information Resources, Inc.). They derived it from in-store scanners at the retailer level for all of their major CPG clients (Consumer Packaged Goods companies) except for Wal-Mart. This info courtesy of Edward Saettone (via Linkedin Answers).

At annual growth rate of over 10% for personalized diagnostic tools (per PricewaterhouseCoopers), this suggests a SAM over $560,000,000 in 2016, and the assumed off-label SAM of $82,492,000 then represents ~15% of this documented and extrapolated figure for annual sales of OPKs in 2016. The SAM percentage (~15%) will be further reduced by the sales of the electronic ovulation predictor tests that have entered the market in the last decade or so.

For the worldwide assumption we take as base 6% of the worldwide number (758,000,000) minus the number in least developed countries (60,800,000) because: 1.  Only 6 per cent of married or in-union women worldwide used rhythm or withdrawal in 2015 (per un.org …/trendsContraceptiveUse2015Report.pdf), and 2. it is well known that especially this sub-population of women (and men) keep looking for a better tool to help them practice fertility awareness/natural family planning.  6% of 697,200,000 = 41,832,000.

Hence Our Numerical Assumptions For Off-Label Use In the Minimum Value Scenario Are:

Number of US Women off-label users upon device launch into the TTC Market segment (below) is 82,000

US Off-Label Serviceable Available Market $$ is $82,492,000

Worldwide Number of Women off-label users upon device launch is 41,832,000

Worldwide Total Available Market $$ is very large

E.g. if the estimate were based on the above US cost average, TAM is $42,082,992,000

 

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Trying-To-Conceive (TTC) Market

CDC PUBLIC HEALTH GRAND ROUNDS 2015, slide 36 titled “Impact of Lack of Insurance on Decision-Making”: Non-ART: $200 – $5,000 (and IVF: $10,000 – $15,000). Out-of-pocket costs can be substantial and impact patient decision-making and risk-taking – referring particularly to the IVF. (ART stands for Artificial Reproductive Technologies such as IVF, In Vitro Fertilization). We take $2,600 as the mean annual cost of TTC (Trying-To-Conceive, non-ART).

CDC Reproductive Health data last updated 2015: Number of US women ages 15-44 with impaired ability to get pregnant or carry a baby to term: 6.7 million or 10.9%. Number of US married women ages 15-44 who are infertile (unable to get pregnant after at least 12 consecutive months of unprotected sex): 1.5 million or 6.0%. The sum of the primary and secondary infertility sufferers in the U.S. is 8.2 million women. (Secondary infertility means that the mother has one child but cannot conceive for another.)

NIH Analysis of 277 Surveys 2012: Worldwide in 2010, 48.5 million couples were unable to have a child, of which 19.2 million couples were unable to have a first child (primary infertility), and 29.3 million couples were unable to have an additional child (secondary infertility, and the figure excludes China). Due to population growth, the number of couples suffering from infertility has increased since 1990, when 42.0 million couples were unable to have a child. Also, from WHO Evaluation Of Surveys 2004: More than 186 million ever-married women of reproductive age in developing countries were maintaining a “child wish”, translating into one in every four couples or 25%. We note this but opt for the NIH data, above.

Hence Our TTC Numerical Assumptions For the Minimum Value Scenario Are:

Number of US Fertility-Impaired Women Ages 15-44 is 8,200,000

US Serviceable Available Market $$ (at the TTC mean cost of $2,600 p.a.) is $21,320,000,000

US Serviceable Available Market $$ (at the TTC minimum cost of $200 p.a.) is $1,640,000,000

Worldwide Number of Women Who Are Unable to Have a Child is 48,500,000

Worldwide Total Available Market $$ is very large

E.g. if the estimate were based on the US non-ART cost average of $2,600 (see above), TAM is $126,100,000,000

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In closing, the reader is reminded that the above are the Assumptions for the bioZhena Minimum Value Scenario (Minimum Viable Product Scenario), which scenario represents the proverbial “low hanging fruit”. This is because our core product’s first application has FDA 510k clearance for aiding conception and for generating diagnostic menstrual profiles for physicians.

Our goal is to pursue the Full Value Scenario of the bioZhena Business Plan because of the potential of the bioZhena technology – summarized in the single slide here (the URL is:

https://biozhena.files.wordpress.com/2016/08/single-slide-biozhena-technology-potential-on-white-background1.pps ).

We aim to go well beyond personal reproductive management (which is, admittedly, where it all started, as evident from the whole bioZhena’s Weblog and our other web presence).

And for Investors – About PPM with business plan see https://biozhena.wordpress.com/and-for-investors-ppm/

And for more, you might check out  Home Page of bioZhena’s Weblog

About atrophy, reproductive aging, and how it’s really not nice to fool Mother Nature – or with

I have taken it upon myself to popularize Prof. Erik Odeblad’s classic findings about the biophysics of the tissues and secretions of cervix uteri, and how they translate into reproductive physiology and hence to reproductive medicine – at home and in the doctor’s office.

  Emeritus Professor Erik Odeblad    “The cervix is a precision organ as complex as the eye”

My ulterior motive is that I want to be understood when harking back to the British commercial’s exclamation that warned about too arrogant an attitude towards Mother Nature. Or, maybe I aim at the wisdom of the saying (“It’s not nice to fool Mother Nature!”) to be appreciated particularly within the given field of endeavor and/or endeavour – that is, reproductive management. Even if it were only in a segment of it.

In the Alphabet of bioZhena (which is no Alphabet of Ben Sira, though we model on it somewhat), https://biozhena.files.wordpress.com/2007/11/aaee-the-alphabet-of-biozhena.pdf , there is an entry about Atrophy and what it does to a woman as years go by, how “atrophy of mucosal surfaces takes place, accompanied by several problems.”

Jan Amos Komenský (Comenius) Says Farewell to…

In this blog post I focus on aging – and thus atrophy – of the cervix, leaving aside the inevitable corresponding phenomena in other parts of the reproductive system.

The focus on the cervix is due to bioZhena’s focus on the cervix… which in our scheme of things is the supreme monitor of the complex reproductive goings on that Mother Nature designed in order to cope with all that complexity. After you’ve read the Alphabet article on atrophy, you might scroll down to the entry there about the cervix, which will take you also through cervical cancer and cervical mucus, besides a couple of other things cervical. That will or would be a nice preparation for, or introduction to, what follows.

Two sketches by Emeritus Professor Erik Odeblad to illustrate his saying, “The cervix is a precision organ as complex as the eye”. Click (right-click) on the image to see the details. And read on about the details. The fine structure of the cervical canal wall, schematized on the right, is based on examination of mucus samples obtained with a suction syringe from the various parts of the cervical canal of human volunteers for physico-chemical examination.

When, at the inception of the project, we decided to focus on the given part of the anatomy, Erik Odeblad’s work logically and inevitably became a part of the background. He used the NMR (nuclear magnetic resonance) technique of physical chemistry to perform the complicated investigation of cervical mucus, and he produced the classical evidence for the difference between the “fertile” mucus macromolecules that allow the passage of the sperm, and the “infertile” cross-linked glycoprotein molecular network that does not. (To this day I remember his usage of “undulations”…)

In fact, this early information, which involved the thiol-disulfide (sulphydryl-disulphide) redox couples in the glycoprotein macromolecule, had much to do with our early hypothesis of the mechanism of our measurements. Never mind that his work was in the context of the subjective self-examination used in NFP, which did not work for the female member of the team! Had it worked for her, there would probably not be any Ovulona™ for monitoring folliculogenesis in vivo (FIV™ – which has utility well beyond fertility status determination)!

With atrophy being the general biological aspect of aging (and with the initially very large number of ova or eggs in the young female’s ovaries decreasing as she matures and ages), the cervix similarly “undergoes a natural process of development and aging. The surface area of the cervix that is given over to the mucus secreting glands [“crypts”] gradually diminishes with age.”

Odeblad defines three types of the (endo)cervical glands, which he (and others too e.g. Embryology.CH and Eurocytology.EU since at least the 1970s) calls the “crypts”:

• S crypts produce S mucus, which forms string-like channels and provides transport (“swimming lanes”) for sperm cells. (“Produces a wet, lubricative sensation at the vulva.” That’s for the NFP sympto-thermal method use, the Billings method and/or the Creighton Model NaProEducation Technology method, the classical NFP or FAM – the latter, Fertility Awareness Method, publicized by Ms. Toni Weschler’s 2002 book Taking Charge of Your Fertility .)

• L crypts produce L mucus, which eliminates low-quality sperm and provides a structure to support what he calls the S and the P mucus. P is a reference to the so-called Peak mucus of NFP or FAM.

• G crypts produce G mucus, which is “an impenetrable gestagenic mucus formed in the lowest cervical crypts. Prevents sperm entry to the cervix and is part of the immune system which protects the woman’s reproductive system from infection.” A remark from dictionary.com: gestagen (jěs’tə-jən, -jěn’) n. A substance, such as a steroid hormone, that affects the uterus in a manner similar to progesterone. And a remark from a scientific commentator: This G mucus is characterized by the oxidized state of the mentioned redox couples, causing cross-linking in the glycoprotein mucin, which prevents microbes including sperm from entering. Visualize this as closed -S—S- gates (as opposed to the open gate form -SH   HS- of the “reduced” state of the redox couples; “reduced” meaning “electronated and hydrogenated”, the opposite of “oxidized”).

Mondrian_Evolution

There are three fundamental principles at work.

1. Natural baseline aging, and this is fundamental – a more or less linear decrease in the number of all three kinds of these glands or crypts, at somewhat different rates: S the fastest, L somewhat slower, G slower still.

2. Slow-down of the aging atrophy by pregnancy.

3. Acceleration of the aging atrophy by the Pill [and/or by other endocrine-active compounds, EACs – this is a logical extrapolation, speculative, but must be assumed].

Now, then.

1. Natural baseline aging, fundamental – a more or less linear decrease in the number of all three kinds of these glands or crypts:

“The number of S crypts decreases from teen age. They are first replaced by L crypts starting at the base of the cervix. Later G crypts replace the L crypts.”

Thus, from Odeblad’s graph [rate reckoned from 15 yrs old to 40 yrs old]:

S crypt baseline decrease or diminution (or atrophy) rate:

50% / 25 years = 2% per year.

At 50 years old, S crypts are at some 10%.

Profile of cervical crypts of a baseline woman – never pregnant & never on the Pill

Representative profile of cervical crypts

(percentage of cervix occupied by active crypts)

for a woman who goes through life without pregnancy or use of the Pill.

This is a baseline profile.

Here is Erik Odeblad’s schematic of the crypts on the surface of the cervical canal:

Carefully mapped lateral wall of the cervix of a 20 year old virgin           (reported by Emeritus Professor Erik Odeblad, Department of Medical Biophysics, University of Umeå, S-90187, Umeå, Sweden)

This is Professor Odeblad’s artist’s impression of cervical mucus secretions:

Schematics of cervical mucus secretions

Key to colors:

Blue         = S mucus

Yellow     = L mucus

Red          = G mucus

Green      = P mucus of which there are several sub-types

Pink         = Z granules

Professor Odeblad’s explanatory notes:

Z granules – the enzyme in the Z granules combines with the P mucus to create a liquefying effect.

P mucus – there are a number of sub-types of this mucus, the most relevant for fertility are P2 and P6. P2 could be present as early as the beginning of the fertile phase possibly having a role in liquefying the G mucus. P6 is mostly confined to the upper part of the cervix, occurring close to the Peak of fertility, and having a role in conveying sperm. It creates a very wet and lubricative sensation at the vulva.

F mucus – comes from the cells scattered throughout the length of the cervical canal and has no known special function.

For a recent evidence of four different morphological mucus types, namely L, S, P and G, see “Morphological characterization of different human cervical mucus types using light and scanning electron microscopy” by M. Menárguez, L.M. Pastor and E. Odeblad, Human Reproduction, Vol. 18, No. 9, 1782-1789, September 2003 –  http://humrep.oxfordjournals.org/cgi/content/full/18/9/1782

Citation: “The distribution of crypt zones in the cervix depends on age, number of pregnancies and use of contraception. In a non-pregnant woman, aged 25–30years and not having used contraception, the cervix averages 22 mm in length and 6 mm in diameter at ovulation. The crypt distribution starting from below and moving upwards is as follows: the G crypts dominate in the lowest 4–5 mm; then there is a zone of L crypts occupying the next 9–10 mm; this is followed by the S zone, for 5–6 mm; and the highest 3–4 mm contains the P crypts.”

When you read the paper, you detect that he has a very special knack for sampling the respective mucus types from the said crypts. Hat off! Work with human experimental subjects is no stroll in the park, to put this mildly.

2. Slow-down of atrophy aging by pregnancy:

Profile of cervical crypts of a 4x pregnant woman

Representative profile of cervical crypts

(percentage of cervix occupied by active crypts)

for a woman who goes through life with four pregnancies and no use of the Pill.

Pregnancy – S crypt diminution rate from Odeblad’s graph

[4 pregnancies, no Pill, rate reckoned from 15 yrs old to 40 yrs old]:

30% / 25 years = 1.2% per year.

At 50 years old, S crypts are at some 20%.

3. Acceleration of atrophy aging by the Pill [and/or by other endocrine-active compounds, EACs – a logical extrapolation]

Representative profile of cervical crypts

(percentage of cervix occupied by active crypts)

for a woman who goes through life without pregnancy and uses the Pill for 10 years

Pill – S crypt diminution rate from Odeblad’s graph

[no pregnancy, Pill for 10 years (18 to 28 yrs old), rate reckoned from 15 yrs old to 40 yrs old]:

60% / 25 years = 2.4% per year.

At 50 years old, S crypts are at some 5%.

This includes the slow down of the diminution gradient during the last 12 years of no Pill.

Compare this with diminution/atrophy rate during the 10 years on the Pill:

65% – 25% = 40% / 10 years = 4% per year.

This is double the baseline rate of cervical atrophy.

It’s more than 3 times higher than the pregnancy-slowed atrophy rate.

Three concluding remarks by Prof. Odeblad:

“Regression when taking the Pill is different for estrogen-dependent crypts (L and S) and progesterone-dependent crypts (G) which may in part overdevelop.”

“The study of the effects of contraceptive pills on the cervix is a difficult task. A considerable amount of work is required for each patient and the time required spans many years, up to 10 years or more. Many women also want to change to other pills or to other methods of contraception, or perhaps now want to become pregnant. It also happens that some pills are withdrawn from the market. To these difficulties are added the normal age changes in the cervix and the dynamic processes which are of constant occurrence. After 3 and up to 15 months of contraceptive pill use, there is a greater loss of the S crypt cells than can be replaced.” (“Some Notes on the Cervical Crypts”, Dr E. Odeblad, Bulletin of the Ovulation Method Research and Reference Centre of Australia, Vol 24 No 2 June 1997, p31)

Citations and graphics reproduced from http://www.billings-ovulation-method.org.au/act/cervix/ageing.shtml .

“Complications arising from the use of the Pill are very frequent. Infertility after its use for 7-15 years is a very serious problem. S crypts are very sensitive to normal and cyclical stimulation by natural oestrogens, and the Pill causes atrophy of these crypts. Fertility is impaired since the movement of sperm cells up the canal is reduced. Treatment is difficult.” He also wrote: “After 3 to 15 months of contraceptive pill use, there is a greater loss of the S crypt cells than can be replaced … A pregnancy rejuvenates the cervix by 2-3 years, but for each year the Pill is taken, the cervix ages by an extra year.” Web reference:  http://www.billings-ovulation-method.org.au/act/pill.html .

Comment on implications for treatments of certain symptoms

For example, the suggested method [Weschler, Toni (2002). Taking Charge of Your Fertility (Revised ed.). New York: HarperCollins. p. 52] of thinning cervical mucus to help achieve pregnancy by taking the OTC expectorant drug guaifenesin, which is thought to act by increasing the volume and reducing the viscosity of secretions.

The drug is also used to treat the symptoms of primary dysmenorrhea [severe uterine pain during menstruation ] where another treatment of choice is combined oral contraceptives [COCs]. Such treatments are administered to adolescents as well as to mature women because dysmenorrhea is a very common and serious problem (25% of women and up to 90% of adolescents ).

In both cases, the expectorant and the contraceptives are administered without knowledge of their mechanism of action in the given problem. Focus is on treating symptoms, not the underlying causes. The patient is the detector of any effect. How does the expectorant drug use correlate with the secretions of the different types of cervical mucus on the one hand, and with the folliculogenesis cyclic profile on the other? Is there any connection? If not, what does the drug do to the different crypts? And what the COCs do to them?

Is the expectorant so selective that it might do the right thing? Reduce type G? Enhance type S mucus? Does oxidation of the guaifenesin help reduce the cross-linked mucin type G in the cervical canal? As simple and pretty as that? (Even prettier if guaifenesin were not to be an EAC, an endocrine-active compound … which inactivity does not look likely – http://www.who.int/ipcs/publications/en/ch3.pdf .)

Would it not be nice to have a rationale for how the small guaifenesin molecule can have a good effect on both sub-fertility/infertility and dysmenorrhea?

Could it be that guaifenesin works bioelectrochemically in the same oxidation-reduction (redox) manner on the enzyme cyclooxygenase in the prostaglandin cascade, which is a cascade of redox reactions – producing an anti-inflammatory effect that translates as suppression of pain? (On a personal note, why not capitalize here at least conceptually on our ancient Wellcome Research Labs work, even before receiving – presumably – the first pension money from Glaxo Smith Kline?)

It’s easier to contemplate in general the effect of the contraceptive drug, which will presumably depend on the contents of the estrogenic and gestagenic components (modeling on Odeblad’s findings)…

Is there a connection between pain, cervix and ovaries, ovarian reserves? Maybe an abnormal depletion of, via ovarian cysts? Will the number of follicular waves and/or other features in the Ovulona cyclic profile – and correlated with ultrasound and MRI – show any such abnormality? Might the Ovulona be useful for diagnosis here, convenient, simple (inexpensive)? Wouldn’t that be nice?

Is cyclooxygenase inhibition detected by the cervix, does it show in the cyclic profile? Does said prostaglandin synthesis inhibition alter the number of follicular waves – while reducing the pain?

Answers to questions like these are needed. Keep in mind that ovulation is an inflammatory process, and since we detect it in the cyclic profile, it is reasonable to pose the above prostaglandin theory questions about the COX-2 (cyclooxygenase) inhibition.

Summarizing Odeblad’s results and the take-home message:

Baseline outcome of cervical S crypts aging: S crypts down to 20% at 40 years of age. Here you have the reason why mature age leads to sub-fertility and to infertility.

Atrophy slow-down effect of 4 pregnancies: S crypts down to 40% at 40 years of age. Here you see Mother Nature’s design in action. Pregnancy slows down the inherent rate of cervical aging (atrophy, deterioration). Naturally, this is not to argue for 4 pregnancies per lifetime – it’s merely how the effect was made measurable.

Atrophy acceleration effect of 10 years on the Pill: S crypts down to 10% at 40 years of age. Here is why it’s not nice to fool Mother Nature, why it’s not good to mess with her design. The Pill is an archetypal anthropogenic Endocrine-Active Compound [man-made EAC], and it was brought up in the previous post how there are very many of these EACs, all insulting the female body and health, some – like chemical contraceptives – by design.

While the story of Laodamia and Protesilao is touching, I merely want to ask that girls, ladies and their physicians do not moon the messenger.

STOP PRESS

And now, go and check out the 2012 post “The fallacy of ovulation calculators, calendars and circulating-hormone detectors” at https://biozhena.wordpress.com/2012/02/13/the-fallacy-of-ovulation-calculators-calendars-and-circulating-hormone-detectors/

Folliculogenesis in vivo™ monitoring is far better than current home-use fertility self-help tools

And here is again why

The FIV™-monitoring Ovulona™ is superior compared to existing commercial products in the home-use fertility self-help category, such as the urinalysis hormone (LH) kits or OPKs and their improved electronic iteration, and other such products. Superior on several levels.

Unprecedented user-friendly design coupled with unprecedented accuracy, liberating the user from the vagaries of imperfect ovulation method-based probabilities.

That must be the main one for the TTC [Trying To Conceive] people, but additional attributes are no less significant. Multi-purpose applicability including but not limited to built-in early pregnancy detection and early pregnancy monitoring. That’s to help manage and deal with the inherently high prevalence of early embryonic mortality [EEM], the chief complication of human gestation. (See https://biozhena.wordpress.com/2010/01/10/about-the-added-bonus-of-folliculogenesis-monitoring-automatic-pregnancy-detection .)

When the TTC hurdle is successfully dealt with, the EEM is the next obstacle on the way to overcoming the sub-fertility issue. Just think about this for a moment. The EEM is Mother Nature’s design to deal with problems that quite likely lead to the TTC challenge (aka sub-fertility or even infertility) in the first place…

There is more to the superior attributes of the FIV technology [FIV = Folliculogenesis In Vivo]. Readily thought about is non-invasive natural birth control. The Ovulona is an electronic tool for 21st Century’s NFP and/or FAM. Natural Family Planning and Fertility Awareness Method, both of which we envision under the umbrella of Scientific Family Planning™, SFP™.

Furthermore, once you become aware of how Folliculogenesis In Vivo works, it will be less of a surprise to see that the Ovulona tissue biosensor will also provide a nice and easy cervical cancer screen – and prospectively screening for other pathologies, and their treatment…

Treatment (as opposed to diagnosis), you wonder what that is about? It’s about the vaginal tissues being the most efficient route for administration of medications, and very logical for a topical treatment, wouldn’t you think? Logical and potentially pretty effective for public health, once the tool has become widely used due to its affordability and mass-market acceptance. That’s the vision.

Of course, there are still other applications that the male managers of investment coffers tend to view as women’s issues that are not their concern, such as management of PMS and its debilitating form the PMDD, such as proper evaluation of EDD and EDC (Expected Date of Delivery, and of Confinement), such as hormone therapy and related matters. All these are big issues of public health, the sentiments of said managers of other people’s money notwithstanding.

Now, back to the primary and initial use of the FIV-tracking Ovulona.

Only the Ovulona can determine the three days of the fertile window of opportunity to conceive, unperturbed by the talk out there – by the proponents of the imperfect ovulation measures – about six days, which talk stems from a certain highly publicized and yet flawed study in 1995… A publication (in NEJM) that caused a sensation at the time by shortening the NFP’s prescribed period of abstinence from the previous too long imposition to the less off-putting 6 days).

Detection of the 3 fertile days is possible because the Ovulona monitors the process of folliculogenesis, and it does it by sensing the tissues in the reproductive tract where the site of action is. Where the body integrates and responds to signals from the ovary and from the brain. That is the action, as opposed to the presence of this or that hormone in blood or urine or any other body fluid.

The determination of the three days window is absolutely necessary because only that way can conception be either assisted or avoided with the required accuracy. The existing home-use fertility tracking commercial products cannot do that, and that is why they speak about a longer and fuzzy fertile window. See preceding and older posts in this blog if you want to get a better understanding of all that which is covered by the short word fuzzy. You will also get the long word (peri-ovulation methods) if you delve into the matter that way.

The existing commercial products cannot be used, either, for an attempt at baby gender pre-selection by timing conception with respect to ovulation. They cannot do that because they do not anticipate ovulation accurately and they do not detect ovulation (they merely assume its occurrence).

Joan Miro – Birth World

Consequently, those techniques cannot distinguish between 2 or 3 days before and the day of ovulation. This is to try for a boy or for a girl, respectively, or to TTC, or to avoid conception. The commercially available technologies do not detect ovulation independently of the one predictive element they test for – or two such elements, LH and E2, in the case of the urine-analyzing gadget now sold by Inverness/SPD GmbH. It is not unlike groping in the dark… The other electronic gadget out there, the one offered by Zetek, is tracking indirectly the effect of the same hormone (estrogen) in two body fluids with two probes at two different times during the menstrual cycle. And your old BBT method tracks indirectly the effect of progesterone that you know causes the BBT to go up a bit after ovulation, albeit with a statistical uncertainty of + or – 3 days (and a poor signal to noise ratio at that).

The thing that the old *Imperfect Measures* tools detect is an input in the hormone signaling mechanism they talk about but of which mechanism they monitor merely that one input hormone signal (or two). However, the boundaries of the fertile window are not single hormone events; hormone monitoring (direct or indirect) cannot define the fertile window.

The existing products do not determine the fertile window of 3 days because they monitor this or that remote parameter that only reflects some aspect of the process that culminates in ovulation. They only detect a hormone signal that says “ovulation can happen about now” (LH), or a signal that says “ovulation has occurred” (BBT); or some reflect estrogen (e.g., through saliva appearance). Estrogen elevates before LH but not far enough ahead, and certainly it does not indicate the start of the fertile window nor the end of the window, which is ovulation. A saliva property is a fuzzy detector of estrogen, much like the vaginal fluid’s tactile and visual examination practiced in some circles.

Clock Explosion by Salvador Dali

Significantly, the hormones that anticipate ovulation do not mean that ovulation occurs right away or even at all. They just signal that the body is ready. It is essential to actually detect the occurrence of ovulation independently of prediction, and only our technology does that. Stress often either delays or even prevents ovulation, and only the Ovulona™ detects this. You can again find some earlier posts with more details about this.

There are also earlier posts about the variability of ovulation times from cycle to cycle in the same woman (as well as across a population), and the variability can be more than the width of the fertile window, more than the said 3 days. That 3 day span tends to also be the statistical uncertainty of the old techniques referenced here, plus or minus 3 days.

Serious consequences ensue for the users of the old *Imperfect Measures* techniques, whether employed to achieve pregnancy or to avoid it. Look at the small example from a small test-of-concept study by an independent NFP research-and-teaching group.

In the four recorded cycles of a childless 41-years old patient, the Ovulona prototype captured 3 delayed ovulations out of the 4 recorded cycles. In only one of the four cycles did the LH agree with our ovulation marker while Peak Mucus indication was one day late in that cycle. In the three cycles with delayed ovulation, the delays were:

In cycle 1:  4 days after LH kit positive and 3 days after Peak Mucus.

In cycle 3:  3 days after LH kit positive and 2 days after Peak Mucus.

In cycle 4:  1 day after LH kit positive and 2 days after Peak Mucus.

In another post in this blog, we showed how the test data divides the NFP clinic patients’ results into two categories that we termed regular and irregular (challenged). To avoid confusion with the traditional usage of the term regular/irregular in the context of menstrual cycles, we shall refer to the two categories as ordinary and challenged, respectively. Cycle 2 is an ordinary cycle (with LH and Peak mucus within 1 day of ovulation marker day) versus the other records showing challenged cycles with delayed ovulation.

The other challenged cycles from the study are tabulated below here, and you will note that they are quite numerous even in the small study of just 10 women with 2 cycle records each. Even in that small population of real life women, 45% cycles were challenged. You also see that the ovulation delays occur at any age (here from 19 to 41 years of age), and regardless of parity (that is, regardless of whether the woman has ever borne children or not):

In the table of ovulation days indicated by the three techniques, O stands for the ovulation marker of Ovulona prototype, LH means LH kit (OPK) positive result, and Pk means Peak Mucus result (as taught by NFP teachers).

As noted above, LH and Pk are in all these cycles lower than the O values, which relationship defines the category of challenged cycles (ovulation delayed with respect to given hormone signal). The delays in this small sample from a small pilot study are from 2 days to 4 days with respect to LH, and from 2 to 3 days with respect to Pk; two cycles are without any LH surge detection.

We also note that our self-diagnostic process – while generating the detailed folliculogenesis profile data for optional analysis by the woman’s healthcare provider – is not unpleasant as is urine sampling, and is not cumbersome, confusing or prone to subjective misinterpretation of results as the other technologies tend to be.

We can and we do envisage the Ovulona to become a friendly routine for the women of the 21st century, everywhere. The existing home-use fertility monitoring products could not aspire to play that role. Hormones in body fluids are only of temporary utility for TTC. Against that, FIV (or Folliculogenesis In Vivo) is not only a superior tool for TTC but it goes beyond that first use – to be of unprecedented and unique service in personalized women’s healthcare for years to come.

See earlier posts in this blog about how symptoms (such as PMS symptoms) vary depending on the day of cycle and on the health conditions of any woman. It is known that female patients respond to therapy differently in relation to their menstrual cycle, i.e., in relation to folliculogenesis. That relationship to the FIV profile is THE fundamental guiding principle of personalized medicine for women.

A new era of obstetrics and gynecology in the offing.

Folliculogenesis in vivo for women’s healthcare – the vision  (from Space perspective, courtesy of NASA)

Yes, dear, contingent upon funding…

        STOP PRESS

For more information go to the 2012 post “The fallacy of ovulation calculators, calendars and circulating-hormone detectors” at https://biozhena.wordpress.com/2012/02/13/the-fallacy-of-ovulation-calculators-calendars-and-circulating-hormone-detectors/

Critique of birth control efficacies in NFP as published by Marquette University researchers

Comments on a report of two studies http://www.usccb.org/prolife/issues/nfp/cmr_winter-spring09.pdf – they report on what we will call peri-ovulation methodologies.

JUST LIKE THEIR PREVIOUS REPORT IN 2003 [http://www.nccbuscc.org/prolife/issues/nfp/cmrsumfl01.htm ] OF A STUDY WITH THE PERSONA MONITOR, “LIMITATIONS” OF THE TWO STUDIES THEY REPORT ON ARE POINTED OUT BY THE AUTHORS.

Michelangelo – The Drunkenness of Noah

Excerpts from their first study:

The retrospective study involved 204 couples (i.e., women with a mean age of 28.6 and their male partners, with a mean age of 30.3) who were taught NFP (by health professionals, physicians and nurses) at four sites in the United States

Table 1. Twelve months total unintended pregnancy rate [number of unintended pregnancies out of the number of couples in given group using the indicated method of NFP]

BBT + mucus                                    5/76                     7%

Monitor + mucus                               4/69                     6%

Mucus only                                       1/29                      3%

BBT + mucus + monitor                     2/25                      8%

Monitor only                                      0/5

Second study excerpts:

The participants for this study came from the same four clinic sites as the previous study and involved 313 couples who were taught how to avoid pregnancy with the EHFM [Monitor] plus CVM [Mucus], and another 315 who used CVM only … The researchers found a total of 28 unintended pregnancies with the EFHM plus CVM group and 41 with the CVM only group… (during 12 months of use)

Monitor + mucus                          28/313                        9%

Mucus only                                  41/315                        13%

QUOTE: “both studies have limitations in that they were not randomized clinical trials”.

In their 2003 study report, they similarly noted study limitations, but there was also the following: “Of interest is the authors’ statement that only 1% of reproductive age women in the Netherlands use NFP as a means to achieve or avoid pregnancy. The respondents in this study were mostly women who previously used oral hormonal contraception. This seems to indicate that a new technological device such as Persona could attract new couples to use NFP.” QUOTE UNQUOTE.

Quite right. Their statement of what “this seems to indicate” is consistent with what we had found (without any financial backing by a large investor like Unilever) in a survey of 5,000 American women at about the time when the Persona was new to the market in Britain. Out of those who would purchase our self-diagnostic electronic device (which does NOT require any chemical reagents and daily peeing for in vitro diagnostic measurement with imperfect measures), 70% were users of artificial contraception – they would switch to our device. This outcome was separate from anecdotal evidence of numerous letters and later emails asking if they could purchase our device for their use in NFP.

With the above quote in mind, we would broaden the conclusion – about new technology attracting new couples – beyond NFP use, and we would refer instead (i.e. more broadly) to fertility awareness based methods.

Now, before someone should glance at the above reported outcomes of the two studies and quickly jump to a conclusion, we must make some common sense observations about those statistics. Some little words.

Kandinsky – Little Words

Should someone want to declare that the above Marquette University reported Monitor had a zero failure rate, then it must be noted that, unfortunately, this was zero out of merely 5 cases. Not comparable with anything else in their publication – and hardly very useful for that reason (and because of the small sample size, too).

Similarly: Table 1 might be read as showing that mucus only is better than BBT + mucus + monitor. This could be “legitimately” considered a valid conclusion since the sample sizes are sort of comparable – if “sort of comparable” were considered good enough (76 and 69, respectively, a 10% difference). But the sample size of mucus only (29) is significantly lower than the sample sizes of the BBT + mucus and of the Monitor + mucus groups.

While the unintended pregnancy outcome of the BBT + mucus + monitor group (8%) is sort of comparable to the outcomes of the two groups with the much larger sample sizes where mucus is accompanied by either BBT or by monitor (7% and 6%, respectively), the only really legitimate conclusion or comment is that sample size matters. That is, if we do not want to compare 25 apples with 72.5 oranges (+/- 3.5) and thus come to questionable conclusions.

If all the groups had sample size of 5 and the percentage outcomes were the same, then the conclusion would be fairly legitimate about the superiority of the monitor – except for the equally legitimate complaint that the sample size of 5 is too small.

Michelangelo – The Battle of Cascina

Statistics are supposed to be about large numbers. At least about sufficiently large numbers. Sample size of 5 is hardly sufficiently large, although it would do for a proof of concept, which here the concept would be that Monitor alone is by far the best. I would go with that hypothesis BUT I WANT IT TESTED RIGOROUSLY IN PROPERLY DESIGNED CLINICAL TRIALS.

The outcomes of the second reported study contradict the outcomes of the first, with Mucus only now showing the highest failure rate of them all (13%), and, topping it off, Monitor + mucus is now even higher than in Table 1 (9% vs. 6%).

Since the sample size is now much larger than in Table 1 (313 vs. 69, i.e., 4.5 times larger) it is legitimately concluded that the second study carries more weight and therefore the failure rate of the Monitor + mucus methodology is more likely 9% than 6%. This is rather unsatisfactory but still better than Mucus alone at the whopping 13% unintended pregnancy rate. The 13% failure rate with 315 couples is more believable than the 3% failure rate with 29 couples in Table 1. About 10.862068965517241379310344827586-times more believable – to be light-hearted about it, per jocum dixi.

Then again, remotum joco: All this makes for a kind of arithmetic that should not occur in medical research.

The following is a graphical demonstration of how numbers can distort perception and understanding. The same Michelangelo’s Battle of Cascina (since he did not do any battle of statistics or technologies!) after an effect that allows the data on the periphery to dominate or simply affect disproportionally that which was in the center of focus.

See in the picture above the man looking intently toward us from the middle of the melee? Now (below) he is tiny compared to what’s around him; much like when – in a study of birth distributions as a function of the day of cycle on which conception took place – the data point outliers are doing the same to the high birth counts, because of inaccurate means of ovulation detection (actually mere estimations) employed in said study.

Michelangelo – The Battle of Cascina – Fish Eye effect -30

While such distortions happen with all imperfect measures of ovulation, the study by John France et al. was discussed in an earlier post at https://biozhena.wordpress.com/2007/12/03/fetal-sex-preselection-%E2%80%93-illustrated/ and in the document attached to that post, https://biozhena.files.wordpress.com/2007/12/fetal-sex-preselection-illustrated.pdf .

We subsequently showed, in https://biozhena.wordpress.com/2008/10/06/ovulona-is-not-another-ovulation-kit/, the effect of doing away with the outlier data points by means of the following diagram, which can be likened to removing the Fish Eye Effect -30 from the distorted Michelangelo picture just above to get back his undistorted Battle of Cascina (with all those naked Florentine soldiers surprised by the enemy while bathing).

Ovulona 3-day fertile window versus old methods’ fuzzy estimation of the fertile period

Now, one more citation from the paper under discussion. QUOTE: The EHFM [Monitor] is a hand held device that reads a threshold level of urinary metabolites of estrogen (estrone 3 glucuronide) and luteinizing hormone (LH; on test strips) and provides the user with a low, high, and peak reading of fertility. The monitor is sold in the United States as a method to help couples achieve pregnancy but can be used as an aid to track fertility. QUOTE UNQUOTE

This statement reflects the thinking in those circles. But note: Because no single hormone determines the beginning and no single hormone determines the end of the fertile window (whether they know this or not) they have to speak of low, high and “peak reading of fertility”. We have previously referred to this as a fuzzy delineation of the fertile window [https://biozhena.wordpress.com/2008/10/06/ovulona-is-not-another-ovulation-kit ].

A little bit fertile, then more, and a peak? That is merely a reflection of not having the accuracy to determine the boundaries of the fertile phase.

Salvador Dali – Metamorphosis of Narcissus

Just like you cannot be only a little bit pregnant, you either can conceive today or not. No such thing as low fertility, only the uncertainty of “low reading”, and of all their readings – including their subjective self-observations. Subjective self-observations refer to the mucus appearance and feel in NFP practice – and if they used that too, the same limitation applies to palpating the cervix.

The most succinct word about all this is as follows:

The old approaches to detecting fertility status are to be referred to as peri-ovulation methods. Where the prefix refers not to the Peri of Persian folklore (earlier regarded as malevolent!) but to the Greek meaning of about, around, near or enclosing – in this case ovulation. Surely, peri-ovulation or peri-ovulatory is a more palatable word than fuzzy.

STOP PRESS

And now, go and check out the 2012 post “The fallacy of ovulation calculators, calendars and circulating-hormone detectors” at https://biozhena.wordpress.com/2012/02/13/the-fallacy-of-ovulation-calculators-calendars-and-circulating-hormone-detectors/

Why people cannot achieve pregnancy

In many cases – if not most – it is NOT because of clinical infertility.

Basic cause of “apparent” infertility

This article is about the basic cause of most disappointed efforts at achieving pregnancy. The basic cause of the disappointment is that intercourse is had at a wrong time. That is, not during the kairos time of your menstrual cycle, the right time, during which – and only during which – fertilization can occur and result in conception (that may lead to successful pregnancy).

Note that we are not talking here about the relatively few cases of real clinical infertility that are caused by certain organic problems such as, say, blocked fallopian tubes or similar.

We are referring here to what is termed by experts (medically classified) as reduced fertility or sub-fertility. This refers to the predicament of people who cannot achieve pregnancy for too long. We would say that even this terminology is misleading but it is well established in OBGYN medicine, so let’s work with it.

Of course, “cannot achieve pregnancy for too long” is medically expressed more quantitatively by postulating the number of months during which the attempts to conceive a baby turn out to be fruitless, disappointing. (Do we need to add that, as a consequence, what is supposed to be a significant physio-pleasure then often becomes a chore, with the stress only exacerbating the painful disappointment and the actual problem?) Yes, stress enhances the problem.

For many years, the number of months during which unprotected intercourse does not result in pregnancy (and is classified as sub-fertility/reduced fertility) was defined as up to 12 months. For 12 months of fruitless attempts to get pregnant you were sub-fertile, suffering reduced fertility. Only after a year, you became a case of clinical infertility.

More recently, as the prevalence of these problems increases, some medical authorities have extended this period of “advised patience” to as long as 2 years. Only after this extended period of advised patience in trying to conceive would the woman and/or couple be put into the clinically infertile category.

The basic cause of most failed efforts to become pregnant is simply wrong timing, wrong time within the menstrual cycle when the unprotected intercourse occurs with the intent to conceive a baby. This wrong time has much to do to with the continued belief, carried over from earlier times, that most menstrual cycles are “regular”. This is one of the myths. The exact opposite is true.

You can see evidence of that in data from 10 women attending a Natural Family Planning clinic. Differences from -5 to +3 days were recorded in this small sample, and these were differences between ovulation days in just two successive menstrual cycles (where cycle lengths ranged from 23 to 35 days). The variability becomes more extensive when more cycles are reviewed.

In fact, there is no such thing as cycle regularity. It is therefore essential to perform persistent monitoring, as the phrase goes nowadays, to determine the right time for a conceptive intercourse.

It was found decades ago that most women experience changes of even more than five days in the length of their consecutive menstrual cycles, and therefore also changes in the day of ovulation from one menstrual cycle to the next.

This fact of life is basic to the predicament of finding it difficult to achieve pregnancy – because you can get pregnant ONLY during the very narrow fertile window of 3 days; that is the day of ovulation plus the 2 days just before ovulation.

To read more about this, go to  https://biozhena.wordpress.com/the-fertile-window-is-3-days-wide-not-6-which-6-day-belief-originated-in-a-flawed-1995-study/. 

Fact:

Less than 1% of women would be found with no variation at all even for short sequences of only a few menstrual cycles, and absolutely no-one would be regular in twelve cycles. [Ref.: John J. McCarthy, Jr. and H.E. Rockette, “Prediction of ovulation with basal body temperature”, Journal of Reproductive Medicine 31 (No.8), Supplement, 742 – 747, 1986; also – and particularly – see refs. therein to the largest studies, i.e., to R.F. Vollman, “The menstrual cycle”, 1977, and A.E. Troelar et al., “Variation of the human menstrual cycle through reproductive life”, 1967.]

The research involved thousands of BBT [Basal Body Temperature] records obtained from correspondingly high number of women. The research was carried out when the hope was that the then new technology of the micro-computerized thermometer would provide the answer to the quest for a definitive tool for reproductive management. Well, it did not.

The BBT is not the answer, it cannot be. It’s not the solution because it is notoriously unreliable, whether micro-computerized or measured with an ordinary thermometer. Simply put, the BBT is affected by too many things, and it has been found to rise anywhere from 3 days before to 3 days after ovulation, despite the expected rise immediately after ovulation.

Comment:

The sympto-thermal method of NFP practice, also known as the Billings method, gets around the notorious lack of reliability of the BBT by having women perform certain anatomical observations “down there” and observations of the appearance of the fluid wiped off “down there”.

Subjective as this enhancement is, in reviewing a sufficient number of cycle records you would see that it is more likely the sympto- observations than the thermal measurements that, when lucky enough, are associated with recorded pregnancy-test positive. Basically, any of this helps the woman to stay focused, and the lack of accuracy is made up for by an as high frequency of intercourse as practical or desirable. Like shooting in the dark with an automatic weapon… (but then, if there is no target in the dark…)

I got off on this tangent, and should come back to the inherent variability of menstrual cycles and ovulation times in another post. To impress on you that this basic fact of life is particularly important when you are finding it difficult to get pregnant – probably because you are past the most fertile years, which are – or, rather, were – the early twenties of your life.

What Women Know, And What They Want To Know About Their Fertility Status

There: What Women Know

Despite the many BBT charting apps and some BBT monitors, and despite the urine analyzing (or the saliva testing) products on the market, here is a fundamental fact:

There is no device in the marketplace today that would tell you, in plain English, “today is your fertile day 1” – meaning that sex today is likely to lead to pregnancy.  And from our clinical trial results you will know that the pregnancy conceived on this first of the fertile days is likely to be a male fetus, a boy. There is no device out there that would detect (not just guess at) ovulation, which will enable you to try to conceive a girl, if that is what you wish for.

There is no such device on the market that would subsequently confirm the pregnancy within a day or two – when, after ovulation on fertile day 3, you or rather your Ovulona device for you – will no longer register the usual follicular waves. Your Ovulona device will interpret that as pregnancy detected, because that is how the biology works.

There is no device out there that would identify the only 3 days in each menstrual cycle during which – and only during which – pregnancy can result from insemination, whether natural or artificial. The commercially available fertility monitors cannot detect either delayed ovulation (which happens due to stress) or when ovulation does not occur at all. Because they do not detect ovulation, they just guess at it.

Because the currently marketed fertility monitors (ovulation predictors) cannot detect ovulation, they merely assume its occurrence due to the particular hormonal marker-predictor of their choice (usually LH, in some cases estrogen, in one case both). But no single hormone, even if it were detected with the accuracy of laboratory methods, determines the fertile window. It’s much more involved than that.

For more on this, go to The post on The Fallacy of Ovulation Calculators, Calendars and Circulating Hormone Detectors at   https://biozhena.wordpress.com/2012/02/13/the-fallacy-of-ovulation-calculators-calendars-and-circulating-hormone-detectors/

Here: What Women Want To Know

Only scarcity of funds keeps us from marketing a device doing all those things not available today.

Our personal self-diagnostic device, the Ovulona™, will tell the woman user in plain English (or any other language) whether today is one of the three days when she can become pregnant.

https://biozhena.files.wordpress.com/2015/09/ovulona-single-slide-3-day-fertile-window.jpg

How? We’ll have the woman monitor at home the process that causes menstrual cycles and is fundamental to women’s health (folliculogenesis). The use of the Ovulona device is very simple, just like a tampon, except that it is inserted for only a few seconds (about 20) to obtain the result, with an instant display of the result.

The Smart Ovulona will display the results electronically interpreted, presented in plain language such as FERTILE DAY 1 while the raw data is stored within the device for optional use by healthcare professionals.

Primary use is for personal reproductive management – that is aiding the achievement of pregnancy, and also aiding fertility-awareness based non-invasive birth control.

But there is much more, including an automatic screening for cervical cancer, management of PMS/PMDD and management of hormone therapy, to name just a few of the applications that will come with the core technology.

We show below the working of the prototyped product using the graphs of the measurement results plotted against the days of the menstrual cycle – and compared with the woman’s basal body temperature for reference. The graphs of the measurement data produce cyclic profiles descriptive of the nuances of the monitored menstrual cycles. None of the old techniques can do that.

These cyclic profiles have important characteristics:

1. The menstrual cyclic profile has numerous repeatable features. It is an electronic signature of the menstrual cycle, which is the female 5th vital sign.

2. The range of measurement values is the same in different cycles and, importantly, also in different women.

3. The profile features are interpretable, and are due to the biological process that causes the menstrual cycle phenomena (folliculogenesis).

The significance of these menstrual cycle profiles goes beyond reproductive management.

To wit: Ours is a unique and disruptive technology.

https://biozhena.files.wordpress.com/2018/05/biozhena-corp-single-slide-3-day-window.pps Click the link or the image for a better view – an animated slide.

Fertile window for birth control

For a better insight, visit the other posts on this blog [https://biozhena.wordpress.com/ ], and check out http://www.linkedin.com/in/vaclavkirsner.

Before you go, see this, to get some sense of what is going on here:  https://biozhena.files.wordpress.com/2018/05/wealth-of-information-in-menstrual-profile-signature.jpg The link opens a larger version of the slide snapshot image.

Better still, click the next link for the animated and narrated slide:  https://biozhena.files.wordpress.com/2016/11/single-slide-narrated-best-wealth-of-info-in-menstrual-cycle-profile-signature.pps

Note the planned use of the follicular waves for early pregnancy detection (the waves disappear; the right term for this is “instant pregnancy detection”), and monitoring for early pregnancy loss (in that unfortunate eventuality, the waves come back; it is advisable – by certain recent medical findings – that the couple should not delay trying to conceive again).

Refer to the following for more about said recent findings: original medical publication in BMJ http://to.ly/9WtG; BMJ editorial comment http://to.ly/9WtI; CNN.com article “Miscarriage? Try again ASAP, study suggests” http://ht.ly/2mlwb; bioZhena’s post http://to.ly/802p “Instant detection of pregnancy and of Early Pregnancy Loss, EPL – the adversary of Trying To Conceive, TTC – especially after age 25”.

———————————————————————————————————-

A party with an interest relevant to bioZhena Corporation can be provided with more confidential information upon request (email: vaclav@biozhena.com).

Visit https://www.linkedin.com/in/vaclavkirsner/ .

Hello world!

This was originally said to be an alternative or introductory About. But, really: Written as a post when getting into this blogging, getting the hang of it here… Thank you to WordPress.com. (Notice how I have not corrected the automatically provided default title of this first post! It misses the comma, and never mind that the omission is the order of the day, some kind of a modernism. Hey you there!)

Please do visit the About page, for a more informative introduction to bioZhena. And don’t overlook the clickable Table of Contents, provided for readers’ convenience.

In one brief sentence: We have invented the new technology of ovulography™, fundamental to women’s health and lifestyle.

We have a personal fertility status monitor for home use by women, and a data management system for physicians who can receive the folliculogenesis data from their patients.

Our personal self-diagnostic device, the Ovulona™, tells the woman in plain English whether today is one of the three days that she can become pregnant.

How? We monitor the process that causes menstrual cycles and is fundamental to women’s health. Primary use is for reproductive management: birth control and aiding the achievement of pregnancy. Pregnancy will be automatically detected within a day or two – not two weeks at additional cost and dubious reliability.

But there is much more, including an automatic screening for cervical cancer and other STDs (cervical tissue aberration), management of PMS/PMDD and management of hormone therapy, to name just a few uses that come with the core technology.

To wit: Ours is a unique and disruptive technology.

Only this Ovulona device can provide to the woman at home the interpreted fertile status results in plain language for an immediate use, and provide data of unequaled accuracy. This is why ours is the only diagnostic tool that can be used for birth control.

Only our technology can perform an automatic cervical cancer screen in the background, free of anxiety, discomfort and high cost (as associated with the Pap smear). We also plan to incorporate a therapeutic function into the Ovulona device. All this will add to the consumer appeal of our core product line, already well documented.

bioZhena is a medical consumer electronic technology developer, with a significant intellectual property. We plan on having a marketable product ready within 7 months of funding, and profitability within 2 years. Another version of the business plan is more conservative: 16 months and 33 months, respectively.  Adequate funding is referenced here… (and it’s not an exorbitant amount because the first launched product will provide funds for the other applications’ testing and straightforward additional programming).

Ovulography™ also referred to as FOLLICULOGENESIS IN VIVO™ or FIV™

The contact email in the last slide needs correction: vaclav@biozhena.com

Friendly Technology

Click on the image to view a short set of mostly narrated slides produced in December 2016