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bioZhena

 

We have an FDA-cleared electronic fertility monitor for women at home, with data sharing for the healthcare providers. We provide an affordable, simple-to-use means of self-monitoring women’s reproductive status via folliculogenesis (the mechanism of menstrual cycles), around which revolves much in women’s health and lifestyle. A strong demand exists in a well developed market that we will disrupt. bioZhena’s breakthrough technology will provide for non-interventional reproductive management, which means aiding conception and “natural” birth control, automatically detecting pregnancy and also the important early pregnancy loss (contributor to the pain of sub-fertility). It will then become the tool of choice for cervical health screening (cervical cancer and other sexually transmitted diseases).

The personal home-use device will indicate in plain language the only 3 days during which conception can occur.

Company Overview

Our earlier proof-of-concept studies demonstrated a simple-to-use personal sensor device that will help women get pregnant by reliably determining the only 3 days (the “fertile
window”) during which pregnancy can be achieved – or avoided. The electronic sensor with said unprecedented ability is ready to be manufactured and launched in the
large Trying-To-Conceive Market, and it also has the unique feature of automatically detecting pregnancy right after conception. The superior characteristics will mean that we shall largely displace the currently-available inferior fertility tools (ovulation predictor kits and monitors) – and not only that. Because of the way our sensor works, it will also offer unheard of applications such as built-in screening for cervical cancer and other STDs. In fact, we are introducing not a single product but a medical technology platform with numerous applications (yes, much like the smart phones

Problem

Womens’ healthcare lacks high quality diagnostic tools for use at home. The difficulty to conceive a child has become a big problem in the decades after the introduction of the
contraceptive pill in the 1960s. As has the epidemic of sexually transmitted diseases.

Currently available fertility testing products offer only partial and imperfect solutions and under-serve the market. Existing conception-aiding products generally have low levels of
accuracy, reliability and information content.

There is no competition for our personal sensor technology in the market segment of fertility awareness for birth control.

Cervical health screening is a complex, very unpleasant and expensive clinical procedure, with no home-use tools available

There are no other products with the attributes of our Ovulona (for personal use) and of our Ovulograph (for professional use).

Solution

Our core technology, the  Ovulona personal fertility monitor for home use, is a combination of a proprietary tissue biosensor and proprietary algorithm based on a unique way of
tapping into the mechanism underlying menstrual cycling. Unlike any fertility tracking product, the Ovulona anticipates ovulation quantitatively and then detects ovulation, a fundamental breakthrough Also fundamental is the high profit margin inherent in the Ovulona design. The Ovulona will cost less than $20/unit (even less than $10) to make while the sale price will be on the order of $200/unit

The derivative technology of the Ovulograph is a data management system for optional use by medical professionals (downloaded data from patients). Menstrual cycling history in
terms of folliculogenesis is much more meaningful than the old BBT temperature profiles.

In order to expedite the time to positive cash flow, our technology will initially be offered as a pregnancy-aiding device to the many couples trying to conceive.  After the first year of sales, the product use will be expanded as a tool for natural birth control, and gradually positioned as a management tool for other conditions, as regulatory requirements are met and new applications clinically tested, including the automatic cervical health screen in the background of the primary fertility-monitoring use.

Photo of a rapid prototyping model of the Ovulona™
Personal Fertility Smart Sensor™ with embedded intelligence and output for the
healthcare providers’ Ovulograph™ tool

 

Market

US personalized medicine is a $232 billion market, and fertility alone is $3.5 billion [PwC 2010]. There are over 60 million reproductive-age women in the U.S., and well over 400 million just in the advanced countries around the world. There are more than 15 million US women who have been trying to get pregnant for more than 3 or 4 months, and  many miscarried – our first target.Worldwide, it is medically estimated that every third couple will need help with achieving pregnancy at some point in their lives. There are over a billion Catholics in the world looking for a Vatican-approved reliable non-chemical birth control tool; similarly with the other large religions.

Annual retail sales of ovulation prediction kits (OPKs or LH kits) in the U.S. totaled more than $272 million in 2008/2009 and have outpaced the annual sales of home pregnancy tests, a further indication of the growing demand to better manage the difficulties intrying to conceive.

 

Funding

We are a pre-revenue company seeking to raise in three $2 million tranches a total of $6 million in order to realize early profitability – within less than 2 years post funding. The first
$2 million will finance the first product launch including product manufacturability and pre-launch testing, and the production of 3,525 Ovulona units for initial web distribution. This proof of sales will facilitate strategic agreements with wholesale distributors. Sustained commercial operation, first with our FDA/GMP qualified manufacturing contractor, requires
an additional $4 million whereupon the planned additional product applications will be financed by income from the sales of the first product(s). Break-even is projected for month 8 of year 2 post-funding. bioZhena is a privately held Colorado C-corporation

The Team

Vaclav Kirsner,
PhD is the Founder CEO of bioZhena (seeking successor CEO). He is a seasoned scientist-entrepreneur and the inventor-developer of the bioZhena technology and intellectual property.

Thomas Duffy CFO 23 yrs in finance

Susan Harms Marketing VP

Vladimir Makarov,
MBA PhD, VP-Info Tech. He developed information system strategy at Amgen,

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