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™ Personal Fertility Smart Sensor™
›› bioZhena Innovation
(Learn more about bioZhena’s innovation of Folliculogenesis in Vivo™, PDF, ca.90KB)
3-day fertile window determined, and more
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.
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).
›› 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)
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. 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.
Management
Board of Medical Advisors
Board of Directors
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. |
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. |
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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. |
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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. |
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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) |
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Bonabes de Rouge Medical technology entrepreneur and regulatory expert. |
Connect With Us
›› bioZhena Weblog
›› bioZhena Technology (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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By submitting information to bioZhena via e-mail (or these web pages), you agree that the material will not contain content that is unlawful or unfit for publication, and you will use reasonable efforts to screen for and remove viruses or other contaminating or destructive content before submission.
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Reproduction, transfer, distribution or storage of the contents on our web site, in whole or in part, without our prior written consent is prohibited. However, we consent to your browsing this web site on your computer or printing or downloading excerpts from it for your personal use only and not for redistribution.
The web site contents are provided as a convenience to you on an "as-is" and "as available" basis. We do not warrant that the information on the site will be uninterrupted or error-free. We reserve the right to add, revise or withdraw pages at any time.
This site may contain information related to various health and medical conditions and their treatment. These pages are not intended to provide medical advice and the information on this website is not meant to be a substitute for the advice of your physician or other medical professional. Do not use the information contained on this website for diagnosing a health problem or disease. You should always consult a medical professional to determine what courses of treatment, if any, may be appropriate for you.
We will use reasonable efforts to include up-to-date and accurate information in this Internet site, but make no representations, warranties, or assurances as to the accuracy, currency, or completeness of the information provided. We shall not be liable for any damages or injury resulting from your access to, or inability to access, this Internet site, or from your reliance on any information provided at this Internet site, even if we have been advised of the possibility of such damages.
This web site may include links to sites on the Internet owned and operated by unaffiliated third parties. By linking to third-party sites, you agree that bioZhena does not have control over, and cannot assume any responsibility for, the content of such sites. The presence of links to third-party sites does not imply that we endorse any such site or the products and services referenced on it. Any links to other sites are provided merely as a convenience to the users of our web site.
The trademarks, service marks, trade names, trade dress and products in this Internet site are protected in the United States and internationally. No use of any of these may be made without our prior, written authorization, except to identify our products or services.
Any personally identifiable information in electronic communications to this Internet site is governed by this site's Privacy Policy. The owners of this site shall be free to use or copy all other information in any such communications, including any ideas, inventions, concepts, techniques or know-how disclosed therein, for any purposes. Such purposes may include disclosure to third parties and/or developing, manufacturing and/or marketing goods or services.
By submitting information to bioZhena via e-mail (or these web pages), you agree that the material will not contain content that is unlawful or unfit for publication, and you will use reasonable efforts to screen for and remove viruses or other contaminating or destructive content before submission.
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INTELLECTUAL PROPERTY It is the policy of bioZhena to protect its intellectual property rights. All product names, regardless of whether or not they appear in large print, bold print, or with the trademark symbol, should be understood to be trademarks of bioZhena unless otherwise noted.
ACCURACY OF INFORMATION bioZhena will make a reasonable effort to include accurate information on this web site. However, bioZhena makes no warranties or representations as to the accuracy or completeness of the information presented on this web site. Information may be changed or updated without notice. bioZhena shall not be responsible for any action taken that is based on the information presented on this web site. Users of this web site do so at the user's own risk. Neither bioZhena nor any other party involved in creating, producing or delivering this web site shall be liable for any direct, incidental, consequential, indirect, or punitive damages arising out of the user's access, use or inability to use the web site, or any errors or omissions in the content of this web site.
LINKS TO OTHER RESOURCES/SITES As a convenience to users, bioZhena may provide links or references to other web sites not affiliated with bioZhena. However, bioZhena has no control of the information presented at other web sites. Accordingly, bioZhena assumes no responsibility for information presented at such web sites. bioZhena is not responsible for their content and shall not be liable for any damages or injury arising from users' access to or inability to access such sites.
INTELLECTUAL PROPERTY It is the policy of bioZhena to protect its intellectual property rights. All product names, regardless of whether or not they appear in large print, bold print, or with the trademark symbol, should be understood to be trademarks of bioZhena unless otherwise noted.