About

Bio of blogger Vaclav Kirsner, PhD (with the short form about.me here): 

Raised and educated initially in Prague (Praha) when it was still capital of Czechoslovakia. Managed to get away from the then commie regime. Postgrad in UK (PhD). Postdoc in USA, and another fellowship in London.

Started entrepreneurial career after ten stimulating years in exploratory research at a big pharmaceutical company in the UK (Wellcome Foundation Ltd., now GSK).

The industrial experience added to the academic background, enabling the development of what was initially THE definitive solution to the challenge of reproductive management – an accurate method of anticipating and (we significantly added) detecting ovulation.

This approach helped us to prove that “sterile marriage” was a wrong diagnosis; two children, a boy and a girl, were the proof… I expand on this further down in what I call the non-tweeting narrative, in the section EXISTING WARES ARE NO GOOD – HENCE WHY WE STARTED.

Detection of ovulation is essential for fertile window determination, and it is also without precedent among the existing devices and methods. Right upfront, I suggest that you rid yourself of any thoughts along the lines of “It seems similar to products I have seen before.”

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The Ovulona™ – our core product

The Ovulona™ is not another ovulation kit. There is no such thing as the Ovulona in the marketplace today. The fallacy of ovulation calculators, calendars and circulating-hormone detectors.

Further: You should understand from reviewing this About page that the applicability of bioZhena’s Folliculogenesis In Vivo™ technology goes well beyond fertility – because folliculogenesis is fundamental to women’s health, and because of the particular in vivo manner that we employ for fertility monitoring. That’s the way to the easy, painless and affordable cervical health screening in the privacy of one’s home. Besides other important applications.

For a quick pictorial summary see 5 slides about the menstrual cycle profile. The first slide is shown here. –

By 2015, medical authorities recognized menstrual cycle as a new vital sign. Ours is the only means of capturing the vital sign’s signature with the details of the ovarian cyclic profile as they vary from cycle to cycle.

The variability is illustrated by the 3 examples whereby a baseline profile is flanked by two non-baseline profile records. Those exemplify two different deviations from baseline that occur in real life (delayed ovulation and short luteal phase, respectively).

View this image as a slide with the two links clickable – click https://biozhena.files.wordpress.com/2016/12/single-slide-baseline-flanked-by-2-non-baseline-abnormalities.pps

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Toward the cervical ring format of the sensor

In 2015 (some years after this bio was first published), I also add a couple of points, namely a link to an article titled Reproductive Health IQ Does Matter – “Yet, most people’s reproductive-health IQ is pitiful” (https://www.linkedin.com/pulse/reproductive-health-iq-does-matter-vaclav-kirsner-phd), and an image:

Click image for better legibility
The short URL in the image is https://lnkd.in/embUva3
(QUICK INTRO 4 SLIDES) – click the URL, see the 4 slides!

Like blood pressure and heart rate, a woman’s menstrual cycle is a vital sign of her overall health. bioZhena’s cervical sensor provides the menstrual cycle signature and is the core of a new technology platform. The Menstrual Cycle is a Vital Sign® (promoted by National Institutes of Health, re-affirmed by American Congress of Obstetricians and Gynecologists), and our technology captures the vital-sign signatures for long-term monitoring by physicians. The above-the-first-image referenced set of 5 slides tells more (animated slides, progressing automatically but you can pause and navigate).

For a quick look at the science of the core product as opposed to the issues addressed by bioZhena, try About bioZhena – tech pitch. Women’s reproductive health in vivo diagnostics & informatics. And, as you’ve noticed above the stuff  I have added to this years-old About page, I’ll let you know what’s in preparation: It’s how to possibly use our cervical monitor to enhance natural birth control (if desired) with a dose of aspirin or another NSAID over-the-counter medication, which would have to be taken acutely at the right time in relation to ovulation. If you wanted to make doubly sure about the bioZhena way of non-hormonal pregnancy avoidance. Working with your menstrual cycle, not against it.

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Other important applications of the cervical sensor

One more additional aspect is to be mentioned, broadening the scope of the proclamation that the applicability of bioZhena’s FIV™ monitor goes well beyond fertility tracking. Here is a pictorial hint at some other problems that the cervical monitor is expected to help solving:

Click on the image to enlarge it: Single slide – Other Prospective Solutions (just a hint).

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My Purpose

I seek the right investors for bioZhena Corporation, having brought the venture to the position of minimal risk: 1) We have FDA certification on file, and 2) strong barriers to entry. 3) Profits from the sales of the first Ovulona conception-aiding version, the first app, will finance the testing and the launch of the next product applications. 4) bioZhena has a small but strong team of experts. Having expended a great deal of money and dedicated myself wholly to the project, I plan to replace myself with a successor CEO as and when appropriate, hopefully from within the team.

We discovered the core bioZhena technique when we couldn’t get pregnant. My biologist wife decided that we should be qualified to try and help ourselves, and she was right – about the right-time prerequisite for conception. The 3-day fertile window came out of the private R&D. As did our son and our daughter.

But enough about yours truly, this blog is about bioZhena.

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Following after the (2016 updated, so really no longer) elevator-pitch styled gist, the non-tweeting narrative below will be divided into the following sections:

THE BIG PROBLEM THAT WE ADDRESS WITH A DEFINITIVE SOLUTION

BIOZHENA CORPORATION’S MISSION

EXISTING WARES ARE NO GOOD – HENCE WHY WE STARTED

UNIQUELY POSITIONED TO CHANGE PARADIGM

HERE IS WHERE EXISTING PRODUCTS FAIL

BUT THAT’S ONLY THE BEGINNING

IN ONE BRIEF SENTENCE, AND THEN SOME (CLARIFICATIONS)

REITERATING, TO ENSURE UNDERSTANDING

CERVICAL CANCER SCREEN – BEYOND REPRODUCTIVE MANAGEMENT

HEALTHCARE SIGNIFICANCE

FURTHER INFORMATION

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The gist (even if rather verbose):

While getting pregnant has become a widespread difficult challenge, at the same time unplanned pregnancies are a big problem for US healthcare. The trouble with unplanned pregnancies has much to do with the failure rates of the current birth control methods. Yet, those hard-to-achieve and the unwanted pregnancies are the two sides of the same coin, as the saying goes. We add: The coin is your lack of knowledge of your fertility status today.

Addressing both the challenges is where we come in, although we do have a significantly broader definition of our mission. For a good reason, just read on – and don’t miss the point about non-interventional behavioral reproductive management in public health and in medical education.

The potential for automatic monitoring of cervical health – innocuous screening for STDs including cervical cancer – might interest you, too. If implemented, it would be superior to the Pap smear on several counts.

There, that was it in a nutshell, for openers. So, if the “elevator pitch” is your communication preference, our uncommonly easy-to-use electronic diagnostic devices will be the definitive answer to the need to know your “fertile window” — 3 days wide or rather narrow, and most always occurring on different days from one menstrual cycle to the next. We work with this variability whereas the “prior art” existing products do not, a very important difference.

Plus, our breakthrough technology is fundamentally important for women’s health care, “not only” for reproductive management. The breakthrough is in monitoring the right thing – the integrated effects of all the hormones and nerve inputs. We do the monitoring via the tissues on the outside of the cervix (an elegant sensor inserted like a tampon, but only for a few seconds; for user’s convenience, it will be transformed into a cervical ring telemetrically sending data).

This in vivo monitoring is in contrast to the old and imprecise monitoring of a single hormone (or two) in urine or saliva or sweat, or via the basal body temperature. For the woman at home, the most surprising will be the unheard of user-friendliness: The display in plain English such as FIRST FERTILE DAY or PREGNANCY DETECTED or SEE DOCTOR ABOUT CERVIX.

Healthcare industry will get a new industry standard, too. Read on to learn about additional, non-obvious and important, attributes and applications of FIV™, FOLLICULOGENESIS IN VIVO™.

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The non-tweeting narrative:

THE BIG PROBLEM THAT WE ADDRESS WITH A DEFINITIVE SOLUTION

This is the era of an infertility epidemic (“one-third of women who reach forty have not yet had a baby”). There are many Trying-To-Conceive women and couples (TTC). Women’s health needs help, not more chemicals. Medicine depends on diagnostic tools. Personalized medicine. Evidence based medicine. Reproductive medicine that does not over-treat.

The many visits of certain topics on this blog (e.g. about cervical atrophy, or about clomiphene) do suggest that you, the public, pay attention to the possibility and adverse effects of over-treatment. It would also be most sensible if we all considered this: Only because really mature women can nowadays have babies, that does not mean it’s the right thing to do. Conceiving at an advanced age is difficult, and difficult conception is tied to pregnancy complications, which are not without consequences.

While getting pregnant has become a widespread difficult challenge, at the same time unplanned pregnancies are a big problem for US healthcare. “Almost half of all pregnancies in the U.S.—some 3.1 million a year—are unintended… Among unmarried women in their twenties, 7 out of 10 pregnancies are unplanned.  In 52% of the cases, couples used no birth control at all. Cost is a factor…”. Not knowing any better is a big factor, too.

That’s where we come in, although we do have a broader definition of our mission. For a good reason, read on.

BIOZHENA CORPORATION’S MISSION (with a 2017 mission statement here)

bioZhena Corporation is  dedicated to improving the quality and reducing the cost of women’s healthcare with easy-to-use electronic diagnostic devices. We are a medical-consumer electronic diagnostic technology developer, with an associated informatics technology for healthcare professionals and the healthcare system.

The core sensor product, the Ovulona™ for private use by women, has been prototyped and then the testing was done by independent medical researchers, to avoid bias. The prototype was FDA-certified, at my predecessor company, for use as a conceptive aid, to help Trying-To-Conceive women get pregnant. With its precisely determined fertile window, some will be interested in trying with it to pre-select desired baby gender.

If you want to see and hear what a lady gynecologist said about this personal monitoring – and that was before miniaturization of the clinical study prototype – check out a 1-minute video clip at http://www.youtube.com/watch?v=yYJMJ7MAI98 . At the time, we did not yet know that the post-ovulation part of the cyclic profile is the follicular waves, which would afford instant pregnancy detection and relate to ovarian aging toward menopause.

A photo of the miniaturized rapid prototyping model of the Ovulona device is shown below. (This is a mock up to give you an idea but not showing any exact details, you understand.) We share here elements of our minimum value scenario focused on management of reproduction.

EXISTING WARES ARE NO GOOD – HENCE WHY WE STARTED

The old techniques out there are nothing like this. We (two biomedical scientists) got into the ovulographic™ development because those of the methods, which she tried at the time, did not work for the mother-to-be. It was not nice at all to be labeled a sterile marriage! Well, that was a wrong diagnosis, and a med tech advance came out of that. (In addition to our son and our daughter…)

It must be said that starting the R&D with a distinctly non-baseline subject (which the first “guinea pig” was) did not make things easy. In retrospect, it seems almost miraculous that the first features of the cyclic pattern did bring us to the complete understanding of FIV. In fact, the big deal was the baseline-subjects’ data later obtained from the first independent investigator testing our device prototypes.

Not really miraculous: This is how things go. I just wanted to make a point 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. Libuse (Liba) Kirsner worked on the right thing.

UNIQUELY POSITIONED TO CHANGE PARADIGM

And so, now I share a salient point from the bioZhena vision statement, which appears in our Private Placement Memorandum [PPM]: bioZhena Corporation is in a unique position to be instrumental in establishing non-interventional behavioral reproductive management in public health and in medical education, which cannot be achieved by the old focus on systemic hormone monitoring.

OK, translation: “non-interventional behavioral reproductive management” means no intervention with chemicals and other invasive, interventional, things and procedures. Besides hormonal contraceptives, think of IUDs, and think of ARTs on the other side (especially on the other side of 30). We are referring to both the contraceptive and the proceptive (promoting conception) methods of regulating reproduction. That is: avoiding conception, spacing conceptions i.e. the intervals in between, and aiding conception.

“Behavioral reproductive management” means that instead of, say, remembering to pop the Pill every day, we do better for ourselves by controlling our behavior. We could say, simply, “a natural method” but then there may be a connotation to the simple “natural” word, and the long phrase is actually precise. Precision being our credo.

HERE IS WHERE EXISTING PRODUCTS FAIL

Now: You know that systemic is not the same as systematic. The word “systemic” refers to monitoring peripheral circulating hormones (or rather their metabolites or their systemic effects like the BBT or the so-called ferning). That is what the various ovulation predictors or fertility-tracking products and methods out there aim to detect.

This is THE basic flaw of all those techniques, kits and monitors. They track one or two circulating hormones or hormone metabolites that will have passed through organs like the liver, and cleared into the urine. They do not detect the genital end-organ effect, which is why they do not have the precision to be useful for pregnancy avoidance (their use as conceptive aids, for women trying to conceive, is not considered as critical – hence it is permitted and promoted).

The old techniques make up for their lack of precision by producing extended fertile windows for their users; one of the posts on this blog talks about that. Sometimes they can come up with even more than 6 “fertile days”. That’s because they only guesstimate the approach of ovulation. So, we call them peri-ovulation methods.

For a more explicit statement and discussion, 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/

BUT THAT’S ONLY THE BEGINNING

The Ovulona is not just a superior fertility status determination tool, far from it. The thing to realize is that our entry into the sub-fertility self-help market segment is only the beginning, and it’s to our advantage because we will generate revenues from early on – within months of funding. This is a significant aspect of the value of the bioZhena proposition, and it’s reflected in the relatively small required funding on the one hand and the high gross margin % and operating income metrics on the other. Income from the early sales will be important in funding the introduction of additional applications of the technology.

We seek funds with which to start manufacturing for web retail and some also via healthcare professionals, our initial distribution channels – product launch in the last month(s) of the first year after funding. Product distribution via wholesale partners is in our distribution mix a little bit later, particularly in relation to growing market penetration as we enter additional market segments with the additional uses of the technology.

An associated technology is provided for optional use by medical professionals. It is the Ovulograph™, which receives the data from the Ovulona units and is designed to facilitate data management over any number of menstrual cycles of any number of patients.

In a nutshell: We plan on having a marketable Ovulona product ready within x months of funding, and profitability within y years. We are located in the Fort Collins, Colorado area of the U.S., building a company with a global outlook. Will share more with a serious compatible investor.

IN ONE BRIEF SENTENCE, AND THEN SOME (CLARIFICATIONS)

In one brief sentence: We have invented the new technology of ovulography™, AKA Folliculogenesis In Vivo™ or FIV™ for short, which is fundamental for women’s health and lifestyle.

The ovulographic technique of monitoring folliculogenesis in vivo is based on the patented discovery that the key component of the reproductive system monitors the neuroendocrine signals that control the mechanism of menstrual cycles, which mechanism is central to women’s health and lifestyle. We harvest (obtain, pick up, capture, transduce) the information from the cervical tissues electronically in an innocuous and easy-to-use manner, and will display the interpreted results in plain language for immediate use in terms of “FERTILE DAY number so-and-so”.

No other technique of ovulation prediction can do this, as a matter of principle. The principle is that only the in vivo monitoring of folliculogenesis makes this possible since it yields an information-rich cyclic profile that not only anticipates ovulation quantitatively and more than once, but it also detects ovulation (the all-important stage of folliculogenesis).

The detection of ovulation is an absolute requirement for the determination of the fertile window – as opposed to guessing at it based on a single ovulation-predicting hormone biomarker (or even two such) as the older methods do.

The fertile day number is either 1, or 2, or 3 = ovulation day. Unless stress or another complication interferes, which is detected and dealt with; ovulation can be delayed or completely absent – despite the LH and/or estrogen signaling “go”. Another example of such plain-language presentation of FIV measurement results is: “Pregnancy detected”. Courtesy of the monitored folliculogenesis cyclic profile.

REITERATING, TO ENSURE UNDERSTANDING

We not only anticipate ovulation, we also detect it – which is ESSENTIAL. The detection of ovulation is unique among home-use fertility monitoring products, and it is what Folliculogenesis In Vivo™ is about. It includes the inherently instant detection of pregnancy, and the ability in principle to again immediately detect early embryonic mortality (spontaneous pregnancy loss), the most serious and frequent problem on the path to successful pregnancy once conception is achieved. This diagnostic feature has to do with the disappearance and reappearance, respectively, of the follicular waves in the third (luteal phase) part of the cyclic profile, schematized below.

The old techniques of tracking this or that hormone in a body fluid (including the BBT temperature monitoring of progesterone effect on the body) do not and cannot do this.

To wit: Ours is a unique (and, some would say, 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. Never mind that others tried, with their tracking one or two hormones. They only got into trouble because too many women got pregnant when told that it was “safe” to have sex without consequences (conception consequences). That was bound to happen because – emphasizing again – no single hormone determines and marks the beginning of the small fertile window, and no single hormone determines the end.

CERVICAL HEALTH SCREEN – BEYOND REPRODUCTIVE MANAGEMENT

But then, that is NOT all there is to it, to FIV™. Because of the particular way of in vivo sensing, our technology can perform an automatic cervical tissue health screen in the background of the primary monitoring process, free of anxiety, discomfort or pain, and high cost (as associated with the Pap smear). Making cervical cancer screen accessible (affordable) to all women worldwide is most important since in many countries cervical cancer remains a big killer of women.

The need for regular screening is by no means diminished by HPV vaccination – keep that in mind.

We can also envisage incorporating a therapeutic function into the Ovulona device. This will have a beneficial impact on women’s healthcare beyond reproductive medicine. The innovation applies to delivering all medications and not only those targeted to the reproductive system.

HEALTHCARE SIGNIFICANCE

The potential of this FIV diagnostic technique for the healthcare professionals is no lesser than for the women who may become patients, because much in women’s health (not only much in women’s lifestyle!) revolves around folliculogenesis.

A tweetingly quick example: #Monitoring #menstrual cycles to see #fertile window, we detect Luteal Phase Defect. LPD prevents #conceiving, causes #infertility. Giving #OBGYNs a handle on Luteal Phase Defect is very important for Early #Pregnancy Loss and for #infertility management. The URLs are: http://emedicine.medscape.com/article/254934-overview and http://emedicine.medscape.com/article/260495-overview .

Let’s interject a reference to the bioZhena vision focused on high-level perspective of women’s healthcare, formulated as follows: The bioZhena thesis is that “abstracting” the data generated by our breakthrough (yet simple-to-use and simple-to-manufacture) technology will enable “actionable decisions” that will contribute to the right trend toward Value-Based Women’s Healthcare. See About bioZhena’s Vision ( https://biozhena.files.wordpress.com/2016/11/about-biozhenas-vision-e1-source.pdf ).

Here is a schematic diagram of the proprietary ovulographic™ cyclic profile, also referred to as Folliculogenesis In Vivo™ menstrual cycle vital sign signature. It involves the indicated three parts, the three phases, of all menstrual cycles:

1. The dominant follicle maturation peak in the infertile phase before ovulation;

2. The short-term predictive peak with the ovulation-marker dip (nadir, minimum) in the short fertile phase of the menstrual cycle; and

3. The follicular waves in the infertile phase after ovulation.

“A product everybody wants and nobody has” (as once aptly expressed by the rich and famous Paul Getty)

“…will displace a number of things in use today” (said Noor Ahmed-Ebbiary, MD, FRCOG, MFFP, DGO, D.Obst.RCPI )

FURTHER INFORMATION

For Tweetroducing bioZhena in 8 slides (a 2020 update of the slide set) click https://biozhena.files.wordpress.com/2020/01/tweetroducing-biozhena-in-8-slides-e19e2on011820.pps.

Here is this blogger’s profile on the LinkedIn network:

https://www.linkedin.com/profile/preview?locale=en_US&trk=prof-0-sb-preview-primary-button

or

More about the various aspects of the bioZhena subject matter can be found, of course, also in the posts and other pages of this blog. A clickable list of the links to the posts of the blog is on the page titled Table of Contents.

In summary:

The “Why Do It” was once offered as a sort of “take-home message” for the investor that we seek. The Pursuit of Pleasure… (sure bet!) is not about whether 3-day abstinence or barrier contraception. Let the user decide.

As though unaware of relevant facts (as opposed to propaganda), one irate uncouth male correspondent from the finance world was indignant about my apparently promoting unprotected sex. Unaware that non-propagandist data show clearly that there is no perfect or even satisfactory barrier protection against promiscuity (only about 50% reduction of risk at best). Unaware that data show that people simply don’t like the barriers (condoms, diaphragms, etc.) and tend not to use them properly and consistently; that there is a high failure rate.

Of the two consequences for women, our technology can certainly help minimize the chances of unwanted pregnancy. It will also help minimize the deadly and otherwise adverse effects of sexually transmitted infections by early detection of cervical tissue aberration.

Further, the use of the Ovulona may help the young ladies of all ages realize that prevention by behavior control (the power of knowing) is better than ignorance and abandonment to blind hope that “it will not happen to me” (or ignorance and faith in protection with which it is a 50-50 toss up at best…). For, clearly, neither an individual nor society – and indeed the health of humankind – benefits from unplanned pregnancies, from difficult conceptions, from sexually transmitted diseases. Serious long-term consequences ensue from any of those. bioZhena’s purpose is to help minimize those bad consequences.

Connecting, let alone engaging, with a well-matched investor is not trivial.

Contact me via email please using my company email address. (Not via the contact form at our company website because it gets abused by scammers phishing for a victim. That’s how it goes…)

And, if you are up to it (wow! pane jo!), I share:

„Chlapečku bosý,
nebe dlaň o tebe opřelo si
kapičkou rosy,
aby nespadlo."
http://cs.wikisource.org/wiki/Host_do_domu/Pokora
A tento pokorny pridavek od nebasnika:
“Holcicko bosa,
z kvitecku mladeho sklouzla ona rosa,
po lete rozmarnem podzim nastane
a padla kosa.
Tak holt to chodi
odjakziva.”

To jen tak mezi nami devcaty. Bez diakritickych znamenek od nebasnika. Srpen 2011, listopad 2013.