bioZhena is an early-stage medical device and informatics company.

Our vision is to revolutionize women’s healthcare with uniquely powerful and user-friendly diagnostic tools for women to use at home and in unison with their healthcare providers. The bioZhena technology has the potential to change the way women and their physicians manage reproductive and general health, not just conception.
Women’s Fertility Breakthrough:

3-day fertile window determined, and more

Ovulona Ovulona Personal Fertility Smart Sensor


›› bioZhena Innovation
(Learn more about bioZhena’s innovation of Folliculogenesis in Vivo™, PDF, ca.90KB)


Problem to be solved

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

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 manufacturing cost of the Ovulona will be less than about 10-20% of its retail price.

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

Business Opportunity

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).


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

Chart: a pilot study record shows a woman’s morning and evening menstrual cyclic profiles (folliculogenesis in vivo).


›› bioZhena Technology
(Learn more about our breakthrough technology, PDF, ca.500KB)

›› bioZhena Slides Reviewed
(Transforming Female Reproductive Health Management, PDF, ca.1MB)

›› bioZhena Slideshow
(10-slide narrated MSPowerPoint slideshow, PPS, ca.10MB)



The Market
  • United States personalized medicine is a $232 billion market, fertility alone is $3.5 billion.
  • There are over 60 million reproductive-age women in the United States, and well over 400 million just in the advanced countries around the world.
  • There are more than 15 million United States 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 in trying to conceive.

bioZhena Company Status

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.
Management

Vaclav Kirsner
PhD is the Founder CEO of bioZhena
Vaclav is a seasoned scientist-entrepreneur and the inventor-developer of the bioZhena technology and intellectual property.
  Thomas S. Duffy
MBA, CFO of bioZhena,
Thomas is a consummate capital-raiser having served as CFO for private and public companies, and he is Founder of private equity firm Venture Capital International.
 
Sara Harms
BS MBA, VP-Marketing.
Sara has led marketing teams launching products for a variety of medical device manufacturers including Bausch & Lomb, Teledyne Water Pik, Cochlear Americas and Steris Corp.
  Vladimir Makarov
MBA PhD, VP-Info Tech.
Vladimir developed information system strategy at Amgen, built an on-line marketplace for contract research at Pfizer, co-founded Peristat Group developing a telemedicine diagnostic test.
     
Michael D. Halleck
BSEE
Michael is President of our manufacturing contractor HWI Mfg. involved in custom development of FDA-regulated products with emphasis on the manufacturability prerequisite of commercialization.
   


Board of Medical Advisors

John J. Sciarra
MD, PhD, FACOG
Professor and Chairman Emeritus of Northwestern University Obstetrics and Gynecology, President FIGO, Treasurer of Soc. Family Planning, WHO board member, ACOG International Aff’s.
  Patricia M McShane
MD
Assistant Professor at the University of Colorado, Founder Reproductive Science Center, Director Integramed, a reproductive endocrinology – infertility practice management company.
 
Lee P. Shulman
MD, FACMG, FACOG, Anne R. Lapham
Professor and Chief of Reproductive Genetics, Northwestern University, Chair Trustees Central Assoc. of OBGYNs.
   


Board of Directors

Martin von Dyck
Medical technology businessman, Hydromer, Biosearch Medical Products, CapNostics.
  EJ Dieterle
President & CEO of YES Partners, Inc. (Global Executive Search)
 
Hugh Sharkey
Seasoned medical device developer, CEO and BOD member of numerous Silicon Valley startups.
  Bonabes de Rouge
Medical technology entrepreneur and regulatory expert.



Connect With Us

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›› bioZhena Weblog 
›› bioZhena Technology (PDF)
›› bioZhena Slides (PDF)
›› bioZhena Slideshow (PPS)

bioZhena Corporation
Vaclav Kirsner, Ph.D.
2908 Killarney Drive
Laporte, CO 80535 USA
Phone (970) 484-1272


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