005 bioZhena Presentation 15 Slides

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Information about 005 bioZhena Presentation 15 Slides

Published on October 31, 2008

Author: vaclavkirsner

Source: slideshare.net

Description

A set of 15 bioZhena Corp. slides highlights what matters the most at this stage (not a formal presentation). Best to view it in the Slide Show mode. The Speaker Notes contain some additional information.

Ovulona™ detects the 3 days in each menstrual cycle during which – and only during which – pregnancy can result Because in the Old Methods ovulation was only guessed at, a fuzzy fertile period obtained. Fuzzy and long. Wrong.

Predicts and detects ovulation = birth control/conception aid Innocuous cervical cancer screen - better than Pap smear Will help to privately pre-select gender of baby Detect pregnancy and calculate delivery date Assist management of PMS/PMDD, and of hormone therapy Generates fundamental data for optional use by physicians PMS = Pre Menstrual Syndrome PMDD = Pre Menstrual Dystrophic Disorder Photo of our core product prototype Ovulona™ Personal Fertility Monitor – with output for the physicians’ Ovulograph™

Predicts and detects ovulation = birth control/conception aid

Innocuous cervical cancer screen - better than Pap smear

Will help to privately pre-select gender of baby

Detect pregnancy and calculate delivery date

Assist management of PMS/PMDD, and of hormone therapy

Generates fundamental data for optional use by physicians

PMS = Pre Menstrual Syndrome PMDD = Pre Menstrual Dystrophic Disorder

Tracks folliculogenesis in vivo . (The maturation of the ovulating ovarian follicle is monitored inside the body.) Ovulograph is data management tool for optional use by physicians. No such technology is available on the market today. What does Ovulona do? Fertility Awareness System = Ovulona™ + Ovulograph™

The Ovulona determines the fertile window. The Ovulona is a tool aiding conception. The Ovulona is a tool aiding birth control. See how in the next slide.

Try for a boy Try for a girl Try for either gender For birth control, avoid insemination during these 3 days

The Ovulona determines the fertile window. The existing ovulation products do not. The Ovulona is a tool for birth control. And more. The existing ovulation products are not. The Ovulona is NOT another ovulation kit! We position Ovulona as a lifelong companion for all women.

Three baseline subjects’ data from trial performed by Gynecologist Clara Benedetto, MD at 1 st Gynecology Clinic, University of Turin, Italy Baseline cyclic profiles from proof of concept study

Marquette University trial confirmed Turin results – this time with non-baseline subjects (as in real life). R.J. Fehring and W.D. Schlaff, J. Nurse-Midwifery 43 (2), 117, 1998 Ovulation kit indicates ovulation on 2 days (not just one!) and “Peak mucus” on yet another day – THAT IS NOT GOOD AT ALL ! Data showed superiority over ovulation kit and “Peak mucus” use.

Absence of the peaks anticipates failure to ovulate. Ovulona anticipates LPD = Luteal Phase Defect, which often causes failure to conceive – by normal healthy women Ovulona’s diagnostic power will save infertility treatment money. This cannot be matched by ovulation kits or by any other such product.

Market USA alone: 150 million women 25 million 30+ years old, our initial main target group 39 million women in birth control market 15 million US women in self help conception market 28 million US women used synthetic HRT hormones The cost of inadequate fertility awareness in the U.S.= $2.6 billion Ref.: Centers for Disease Control and Prevention, 2000 We have at least 5 years lead time over future competition

25 million 30+ years old, our initial main target group

39 million women in birth control market

15 million US women in self help conception market

28 million US women used synthetic HRT hormones

Milestones Achieved Predicate prototype FDA 510(k) approved. Number K973860 Proof of concept data was correlated with conventional indices of ovulation, in published and unpublished studies 10 patents: 4 issued, 3 pending, 3 ready for filing. Additional submissions in preparation Manufacturing development contract secured (approx. $300K; 7 months to marketable product)

Predicate prototype FDA 510(k) approved.

Number K973860

Proof of concept data was correlated with conventional indices of ovulation, in published and unpublished studies

10 patents: 4 issued, 3 pending, 3 ready for filing. Additional submissions in preparation

Manufacturing development contract secured

(approx. $300K; 7 months to marketable product)

Next Milestones Statistical-size multi-center clinical studies to prime the market for product launch Achieve solid sales revenues within 2 years Achieve profitability by year 3 Provide excellent ROI for shareholders

Statistical-size multi-center clinical studies

to prime the market for product launch

Achieve solid sales revenues within 2 years

Achieve profitability by year 3

Provide excellent ROI for shareholders

Use of Funds         > 500 units of marketable product will be completed within 7 months of funding (a $350K contract) Clinical trial with 500 units will prime the market for product launch

Different peak sizes show the different speed of maturation of the egg in different menstrual cycles (maturation of dominant follicle) Ovulation is detected as estrogen control switches to progesterone control This is the ovarian “I am ready” signal These are follicular waves preparing for the next cycle. The number of these waves indicates how fast the woman approaches menopause. See the unprecedented wealth of information inherent in the bioZhena cyclic profile

See the unprecedented powerful diagnostic capability inherent in the bioZhena cyclic profile This is the ovarian “ I am ready” signal This is the long-term predictive peak And here the sensor detects delayed ovulation – in this case delayed by 2 days. No other product can do this for women at home -and for their physicians. This is an example from real-life – not a baseline data from a laboratory

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