Ovulona TM A revolutionary women’s health product & technology platform Personal monitor of cervix uteri © bioZhena Corporation From teen age to menopause.

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Presentation transcript:

Ovulona TM A revolutionary women’s health product & technology platform Personal monitor of cervix uteri © bioZhena Corporation From teen age to menopause

bioZhena’s Offering Personal Reproductive Health Management Tampon-like insertion for a few seconds not needed in next generation design

Friendly Technology From Home to Healthcare Providers From patients’ Ovulona™ units to a physician’s Ovulograph™ – when needed

Ovulona™: A unique technology that uses Folliculogenesis In Vivo™ to map out the entire menstrual cycle (folliculogenesis) Fertile ~3 days Infertile follicular phase VARIABLE DURATION Infertile luteal phase CONSTANT DURATION ~14 DAYS Dominant Follicle Maturation Follicular Waves TYPICAL CYCLIC PROFILE Cyclic profiles are saved automatically over many months, years

Ovulona TM monitors the end-organ effect of all reproductive effectors by measuring bioelectronic admittance of the outer-cervix tissue Ovulona TM basic concept model (NOT showing real features): Ovulona TM monitors admittance of the exocervix, the outside of the end organ which integrates the effects of all key reproductive effectors. We call this FIV TM, or Folliculogenesis In Vivo TM Key to FIV™: Cervix uteri receives endocrinological and neurological signals controlling reproduction Unlike other methods, FIV TM anticipates AND detects ovulation, and reflects processes that affect or are related to menstrual periodicity Posterior Fornix The woman inserts the Ovulona™ device much like a tampon with its tip extending to the Posterior Fornix. Planned modification will be a telemetric vaginal insert obviating daily insertion. FERTILE DAY 1

Next Generation Design Much like the NuvaRing® but without the hormones.NuvaRing® “We’ll help you control your fertility with 21st Century tools” Much like the Ovulona™ but without the need for daily insertion.Ovulona™

Ovulona TM : A revolutionary women’s health technology. Reliable, accurate and immediate, uniquely user-friendly Accurately detects the days of the fertile window – Helps in planning and achieving pregnancy – Allows hormone-free birth control Detects pregnancy immediately & automatically and will diagnose pregnancy-associated conditions: preterm labor and normal labor onset Detects Early Pregnancy Loss (must try to conceive a.s.a.p.) Detects anomalies and cervical tissue aberration Already has FDA 510(k) clearance for the proceptive use Multiple patents issued and several in process Substantial market that can lead to $1B revenues

Female Reproductive System Ovary Fallopian Tube Uterus Cervix Vagina Detecting the fertile window requires integration of all inputs into the system, received from the ovaries and from the brain Hormone levels in blood circulation during menstrual cycle Estrogen Follicle-Stimulating Hormone Luteinizing Hormone Progesterone The fertile window results from a complex interplay of multiple variables including signals from the brain, on which the ovary is “obligatorily dependent 1,” sensitive to stress 2 and affecting the timing and intensity of the mid-cycle LH surge 3 Reproductive organs have a dense innervation and are under a local regulation of hormones, prostaglandins and other effectors The cervix is central to experiencing the results of the interplay of all these variables Monitoring the cervix yields information that circulating body-fluid hormones can’t provide All commercial products track only a single circulating hormone (or two in one case), and do so indirectly fertile window 1 "The hypothalamic pulse generator: The reproductive core,” J. Hotchkiss and E. Knobil, Chapter 7 in Reproductive Endocrinology, Surgery, and Technology, (editors: Adashi, Rock, and Rosenwaks) Lippincott - Raven, (1)124 – 162, “Brain opioid peptides and menstrual cyclicity,” P.R. Gindoff and M. Ferin, Seminars in Reproductive Endocrinology 5(125), "The gonads: Development & function of the reproductive system,” W. F. Ganong, Review of Medical Physiology, 17th edition, Chapter 23, Appleton & Lange, 1995

Patient generates graph for herself and her physician: fertile window Ovulona TM device genesis & capabilities Profiling Ovulona TM Commercial concept rendition of the previously tested and FDA approved pre-production prototype Smart Ovulona TM Commercial concept rendition of the planned Smart Ovulona TM, which will interpret data for the woman user All of the capabilities of the Profiling Ovulona TM plus: Immediate readout of “INFERTILE” or “FERTILE DAY 1 (2, 3)” with possibility to try for conceiving a boy on DAY 1, or a girl on DAY 3 Pregnancy detection results in “PREGNANT!” Abnormal Ovulona TM scans result in “SEE DOCTOR” indication Wireless transfer of Ovulona TM FIV TM data to computer or smart phone Option to transfer data securely to physician for expert assessment – for use with Ovulograph™ Ovulona™ transformed into cervical ring Ovulona TM device readout in  A, transferrable to computer Software produces Ovulona TM cycle graphs Patient or physician can interpret Symptometric & other concurrent data can be added (for example, BBT, LH kit or monitor indications, and any others) FERTILE DAY  A

Ovulona TM commercialization strategy Profiling Ovulona TM (POv) Smart Ovulona TM (SOv) funding availability Year 1 Year 2 Year 3 KOL initiative (POv prototypes) Prototype & clinical POv manufacture POv advertisement (media, sales reps & pubs) Continued KOL interaction as appropriate Commercial POv manufacture POv commercial sales Clinical studies for enhanced capabilities SOv software development SOv manufacture SOv commercial sales SOv advertisement (media, sales reps & pubs) Initial clinical study

Phase 2 Phase 1 Ovulona TM clinical strategy Clinical studies for enhanced capabilities Initial clinical study Provide statistically significant data to finalize the Smart Ovulona™ algorithms for chip coding Subjects of several categories: –Baseline-type 1 –Women with difficulty to conceive –Women with positive Pap smear test All subjects desiring to conceive, committed to the study protocol Study population divided into groups trying to conceive on specific days of menstrual cycle Days of menstrual cycle defined by Ovulona™ data point coordinates Effect of conception on Ovulona™ cyclic profile Conceived baby gender and conception day of cycle compared for feasibility of fetal gender pre-selection Demonstrate faster time to pregnancy with Smart Ovulona™ technology Built-in immediate detection of pregnancy and of early pregnancy loss Ovulona™: pregnancy monitoring for parturition alarm, prematurity, PTL, PTD Screening of cervical health for cancer & other STDs innocuously with routine FIV monitoring FIV™ history: study to help in management of peri-menopause FIV™ profiling in management of PMS/PMDD FIV™ for the management of menstrual cramps, dysmenorrhea, PCOS & other issues Ovulona™ as a tool in teen sex education & behavior changes such as smoking-cessation 1 Baseline subjects: Healthy adults younger than 35, non-smokers, no contraception, no medication. [Note: Healthy implies normal Pap smear test. ]

Existing Patent Expiries Ovulona TM patent strategy provides ample protection  8,821,407 Fertility Status Diagnosis System ,152,735Diagnosis of fertility status 2028  7,771,366Vaginal fertility probe ,427,271Diagnosis of fertility status by folliculogenesis monitoring in the vagina 2023  5,916,173Methods and apparatus for monitoring fertility status in the mammalian vagina 2017  D393,311Mammalian fertility probe ,753,247Method and apparatus for monitoring redox reactions EXP IDUS PatentTitle Expiration Drafted Applications Funding In 2014   New Patent Expiries In addition, PCT applications are planned to provide international IP protection 2045 Anticipated Applications

Ovulona TM in bioZhena pro forma financial summary Financial planning starts with US market only and the Minimum Viable Scenario (MVS), from which we build the Full Value Scenario. The Rest of the World models are built from the US-only models. All assumptions are listed in the Excel financial spreadsheets. We seek to finance the Full Value Scenario, which calls for $19.9 million (in defined tranches). Full Value Scenario (FVS) - takes the MVS and adds a birth control (BC) capability; promotion via 66 sales reps to physicians who prescribe BC, and via the internet. FVS funds additional uses. Minimum Viable Scenario (MVS) - commercial model using only the current proceptive 510(k) clearance: TTC use only, US Users 3.67 M, RoW Users 8.6 M, Total Global NPV = $334 M. Health insurance payers are expected to benefit from the use of patients’ Ovulona profiling, and from Ovulona impact on management of various conditions, including course of pregnancy. TTC stands for Trying To Conceive (16.6 M women in USA)

Ovulona TM & Folliculogenesis in vivo™ technology platform Ovulona™ (from bioZhena Corporation, Fort Collins, CO) is a personal multi use intravaginal monitor that utilizes measurements of bioelectronic admittance of the outer tissues of the cervix. This defines the fertile window for the woman at home by correlating stages of folliculogenesis with the days of the user’s current menstrual cycle. The data for any number of cycles is provided to healthcare providers when needed, correlated with symptoms and other auxiliary data. Cervical health will be screened in the process. Pregnancy progress will be monitored in the same way.