The capability to anticipate ovulation well in advance, and to then detect ovulation independently of the predictive signals, is unique to the bioZhena technology. This unique capability results from the mode of action, further discussed in the Alphabet of bioZhena under Modus operandi (MO). http://biozhena.wordpress.com/2007/11/28/the-alphabet-of-biozhena See also under Mysterious conceptions - or the non-existence thereof. From the MO also follows the broad applicability of the technology, which is another feature that distinguishes the Ovulona from any other product addressing fertility status and ovulation monitoring. For a potential impact of the technology on public health, see under Sexually transmitted diseases, and also under Cervical cancer and under Smoking. It could be argued that the greatest aspect of the bioZhena project is the idea of introducing – via the affordable personal fertility monitoring method – a general, routinely usable, women’s health tracking and diagnostic tool, with the potential to impact on several important areas of public health.

1. Prototypes of Ovulona™
Table of Contents
Overview......................................................................................................... 2
Old Mark 1 prototype ...................................................................................... 3
Old Mark 3 prototype ...................................................................................... 4
Designer’s rendition and a photo of prototype of marketable product.............. 5
Examples of results obtained with both Mark 1 and Mark 3 prototypes ........... 6
Contact: Vaclav Kirsner, Ph.D.
CEO, bioZhena Corporation
83 Davis Ranch Road
P.O. Box 122
Bellvue, Colorado 80512
U.S.A.
E-mail: vaclavkirsner@yahoo.com
Phone: 970-484-1272
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2. Overview
• Old Mark 1 prototype
Analog version, tested at the First Gynecology Clinic of University of Turin by Dr.
Chiara Benedetto, MD, PhD, after extensive in-house studies.
• Old Mark 3 prototype
Digital version, tested at the Natural Family Planning Clinic of Marquette University
School of Nursing, results published: R.J. Fehring and W.D. Schlaff, J. Nurse-
Midwifery 43(2), 117, 1998. The picture is from the publication.
• Designer’s rendition and a photo of marketable product prototype
Digital microcomputerized version as planned for product launch.
• Examples of results obtained with both Mark 1 and Mark 3 prototypes
a) Example 1 of a baseline cycle from the Turin study using Mark 1 prototype.
b) Three non-baseline cycles from in-house studies using Mark 1 prototype.
c) One of the three cycles shown alone, illustrating features.
d) A non-baseline cycle from the Marquette study using Mark 3 prototype.
e) Example 2 of the baseline cycles from the Turin study using Mark 1 prototype.
f) Example 3 of the LPD aberration in one of the cycles of the Turin baseline subjects.
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3. Old Mark 1 prototype
Old Mark 1 prototype
Analog version, tested at University of Turin
Old Mark 1 prototype
bioZhena
The first hand-held prototypes were made once we determined which of the numerous
parameters, systematically investigated with our bench-top equipment, were optimal for the
performance of the monitor.
The engineering was performed by a contractor ignorant of the purpose of the device, using
off-the-shelf parts, and having scratched the labeling on the electronic components,
protecting the confidentiality of the technology. That is why the decidedly non-medical
appearance of the Mark 1 prototype, which I carried around inside a custom-made case
similar to a clarinet case.
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4. Old Mark 3 prototype
Old Mark 3 prototype
Digital version, FDA 510(k), tested at Marquette U.
bioZhena
Photo copied from the publication by Drs. Fehring and Schlaff: Richard J. Fehring and
William D. Schlaff, quot;Accuracy of the Ovulon fertility monitor to predict and detect ovulationquot;,
Journal of Nurse-Midwifery 43 (No. 2), 117 - 120, 1998.The name used then for the clinical-
test prototype was “Ovulon”, but later on we decided the feminine form “Ovulona” is more
fitting for the decidedly feminine (small and beautiful) user-friendly product shown in the next
illustration.
Note: No recharging transformer and no boxy handheld for the marketable product, which
must be elegantly feminine and elegantly user-friendly, if I put it in so many words!
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5. Designer’s rendition and a photograph
of marketable product prototype
bioZhena
The industrial designer’s rendition of our miniaturized device is on the left, including the
storage case. In one of my patents, I have protected the concept of a “smart storage case”, in
which the outside of the case includes a keypad, reminiscent of a TV remote control, or of a
cell phone. Using this device, a woman user of the NFP (Natural Family Planning)
procedures will have the option of displaying the data, accumulated in her Ovulona device,
on the screen of her TV set, and also of inputting symptometric data correlated with
folliculogenesis.
This way, even if not a computer user, the woman will have access to her stored data, in a
paperless manner. I refer to this as the Ovulovision(TM), to differentiate from the more
sophisticated Ovulograph(TM) for medical professionals (not shown - very different).
Offering to the market of subfertility/infertility the combo of quot;non-smartquot; Ovulona plus quot;smartquot;
storage case is envisaged - before we launch the quot;smartquot; Ovulona technology.
Off-label use by NFP afficionados can be expected, before we address them with the smart
Ovulona... Because bootstrapping can only go so far, we have not yet produced the quot;smartquot;
technology.
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6. From a trial performed by Dr. Chiara Benedetto, MD, PhD
at University of Turin, Italy using Mark 1 prototype
([DPSOH
Trial performed by
Dr. Chiara Benedetto, MD
at 1st Gynecology Clinic,
U. of Turin, Italy
using Mark 1 prototype
bioZhena
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7. Above are the morning and evening cyclic profiles from one of several baseline subjects
studied by Dr. Benedetto, who reported the results in the form of raw data. The morning and
evening curves were later superimposed, as shown, on the day of the ovulation marker, and
this superimposition was done by someone other than Dr. Benedetto.
Another gynecologist interpreted the early follicular-phase (pre-ovulatory) data as tracking
the maturation of the dominant follicle (the long-term predictive peak).
The data show a remarkable similarity between the morning and evening cyclic profiles.
The data also suggest that we see evidence of subtle quantitative differences: higher
dominant-follicle-driven data in the evening, and also a properly developed first follicular
wave (in the post-ovulatory part of the profile), with all three waves higher in the PM data
than in the AM data.
While these outcomes are examples of results that “make sense”, we emphasize again that
the independent investigator reported the raw data, and the comparison of the morning and
evening results, as well as of the data from different subjects, was examined later by
someone else. This circumstance (no possible bias or fudging) was one of the factors that
helped me to appreciate what a remarkable technology we had discovered, and to make the
change from an employee of a big pharma firm to an entrepreneur dedicated to the
commercialization of the technology.
Note that we did not have access to baseline subjects prior to the pilot study in Turin. Below
is an example of the in-house data with which the project started, and in which we first
observed the repetitive features of the cyclic pattern. The pattern recognition exercise was
not made particularly easy by the non-baseline character of the first subject(s) of study, but it
is important to note that the differences between baseline and non-baseline are quantitative,
not qualitative, and that the deviations from baseline are explicable.
Below is an example of three non-baseline cycles superimposed in the usual manner.
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8. One of the three cycles is shown below. The follicle-maturation peak is discernible despite
the missing data points. And we see an example of delayed ovulation (3 days instead of 1).
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9. Similar non-baseline data were later generated in another pilot study at the Natural Family
Planning Clinic of Marquette University, and an example is shown below.
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10. Marquette University (Milwaukee, WI) confirmed Turin
results with Mark 3 prototype (digital)
R.J. Fehring and W.D. Schlaff, J. Nurse-Midwifery 43 (2), 117, 1998
bioZhena
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11. Below is another example of the beauty discovered in the results of the experiments of Dr.
Benedetto. On advice of the late Professor Trevor Slater (doyen of free radical medicine), we
sent several prototypes to the gynecologist Dr. Chiara Benedetto in Turin, for her to test the
technology on baseline subjects. Slater and Benedetto were looking for a better cervical
cancer screen, and this pilot study was designed to produce a baseline for a prospective
investigation of early cancer detection.
Note that we did not have access to baseline subjects prior to this. I also stress again that the
independent obgyn investigator reported raw data. Only later did we perform the comparison
of individual cycles, superimposing the curves on the ovulation marker day.
At the time, there was no interpretation available for the follicular waves in the postovulatory
part (luteal phase) of the profiles. Follicular waves were discovered much later, and for some
time were believed to occur only in animals (separately, we had the waves data from cows
and pigs, initially unaware of the follicular wave interpretation [which was put forward later by
a Kansas veterinary school professor]).
Another gynecologist interpreted for me the dominant follicle maturation meaning of the long-
term predictive peak. The interpretation was assisted by the aberrant results generated by
one of Chiara Benedetto’s baseline subjects, and interpreted as a case of LPD (luteal phase
defect). LPD is known to be a randomly occurring cause of the frequent failure to conceive by
healthy young women. In LPD, the dominant follicle fails to mature, and we detect the failure
early in our measurement results (anticipating the defect that occurs in the second half of the
cycle); see Example 3.
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12. Example 2
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13. Example 3
The abnormal cycle record in this example illustrates Ovulona’s capability to recognize
irregularities (here: Ovulona anticipates LPD by detecting the absence of the long-term
predictive peak, which represents the failure of dominant follicle maturation. In the
corresponding BBT curve, the collapse of the rising temperature profile is symptomatic of
LPD.)
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