Three things differentiate the bioZhena medtech from smartphone apps including particularly the most recent, Natural Cycles

1.

The bioZhena smart sensor technique is not only for helping to avoid or to achieve pregnancy – reproductive self-management, the logical primary use. Reproductive self-management is the only women’s healthcare market segment where competition exists, almost entirely in the helping-to-conceive part of it.

There is no precedent and no competition in the other important areas of applicability of the bioZhena cervix monitoring technology – especially with the next generation of the sensor, the cervical ring.

As an example see https://biozhena.files.wordpress.com/2017/05/ovulograph-single-slide-menstrual-cycle-diagnosis-r-legro-ref.pps  and/or for a narrative go to  https://biozhena.wordpress.com/ovulatory-dysfunction/

2.

Unlike all of the existing competition, the bioZhena technique does not merely estimate ovulation based on a systemic peripheral physiological variable such as the notoriously unreliable BBT, the Basal Body Temperature. Our unprecedented detection of ovulation is all important for effective performance in fertility management whether contraceptive or proceptive.

The competition techniques do not and cannot detect ovulation – and the BBT does not anticipate it, either. The Natural Cycles app gets around this by invoking the calendar and assuming regularity (repeatability) – like in the olden days… Not surprisingly, they have problems as users have unwanted pregnancies.

None of those products offers a practical method of natural pregnancy avoidance as an acceptable alternative to the hormonal contraceptive Pill. That is due to fundamental reasons: their inability to delineate the true fertile window and to work with abnormal cycles challenged by asynchrony of brain and ovarian pacemakers.

For more, see   https://biozhena.wordpress.com/2012/02/13/the-fallacy-of-ovulation-calculators-calendars-and-circulating-hormone-detectors/

3.

This makes for a major differentiating factor in the contraceptive arena where the Natural Cycles study of their BBT-based algorithm concluded that 50% of their “typical use” failures to avoid pregnancy were due to the user error of having unprotected intercourse during the postulated “unsafe period” (i.e. warning ignored by user).

The good news is that the reported failure rate of some 7% is comparable with that of the oral contraceptive pill. Their Pearl Index puts fertility awareness on a comparable footing with hormonal contraception.

That is good news but their conclusion blaming human failure fails to take into account the lack of reliability in the BBT rise as an indicator of ovulation having taken place (plus or minus 3 days). In their published studies this inherent feature was obscured by the fact that the studied women had apparently mostly regular cycles – which may suggest that such women find the Natural Cycles app compatible with the apparent regularity, which is why they purchased the app.

However, most of the female population are NOT “regular”, and the variability of ovulation timing inevitably leads to failure to avoid unwanted pregnancy. As you can read in another Weblog post: The data collected by 1,085 women, who provided at least 6 or more BBT charts each [revealed that] the cycle length range was more than five days for 56% of the women who submitted 6 graphs, and for 75% of those with 12 graphs. … Absolute regularity was not demonstrated in as few as six cycles. … When the number of cycles was extended to 12, no woman had variability of less than two days in cycle length. END OF QUOTE.

I discussed the notorious lack of reliability previously with another BBT app, which however did not have the regulatory approval – and was not promoted – for contraceptive use (still, the critique applies here too): https://biozhena.files.wordpress.com/2017/01/critique-of-bbt-monitoring-duofertility-rebuttal.pdf.

But then, the reported reason for a half of the contraceptive failures is – and always will be – equally likely the result of the Natural Cycles’ conservatively postulated 11 unsafe (red) days as described in their Eur J Contracept Reprod Health Care 2016 publication. This long an “unsafe” period was historically the reason for the failure of natural birth control to be adopted by the general population.

Their described study protocol suggests that only women with self-assessed regular cycles opted to buy the BBT-and-calendar based app with its 11 “unsafe” days offered to the user instead of the true fertile window. Yes, their study involved women who purchased their app.

And recall the class-action lawsuit when what is now the Clearblue monitor came on the market as the Persona Contraceptive System and many of its users became pregnant. No, bioZhena will not fall into that category!

The bioZhena cervical tissue monitor, besides offering multiple utility at home and in physicians’ offices, uniquely identifies the only few days of the fertile window: FERTILE DAY 1, 2 and 3 = OVULATION. That is unless ovulation is delayed, or unless ovulation does not occur at all in the present menstrual cycle, either of which is  detected by our technique.

A very different proposition.

.

Note:  The Ovulona™ will provide the display indications of the three fertile days in plain English (e.g. FERTILE DAY 1 as opposed to most days’ INFERTILE in each menstrual cycle), letting the user decide how she uses the information. The consumer information in the package insert of the Ovulona product will include the summary of the initial clinical trial performed prior to the launch of the product. The expectation for the outcome of the trial is based on the outcome of a France et al. study of fetal gender preselection superimposed on the menstrual cyclic profile generated by our device in a pilot clinical trial. 

 

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