Ovulona TM

A revolutionary women’s health product & technology platform

Personal monitor of cervix uteri

© bioZhena Corporation

From teen age to menopause

bioZhena’s OfferingbioZhena’s Offering

Personal Personal ReproductivReproductiv

e Health e Health ManagemenManagemen

tt

Tampon-like insertion for a few seconds

not needed in next generation design

Friendly Friendly TechnologyTechnology

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

Infertilefollicular phase

VARIABLE DURATION

Infertileluteal phase

CONSTANT DURATION ~14 DAYS

Dominant Follicle Maturation Follicular Waves

TYPICAL CYCLIC PROFILE

Cyclic profiles are saved automatically over many months, years

OvulonaTM monitors the end-organ effect of all reproductive effectorsby measuring bioelectronic admittance of the outer-cervix tissue

• OvulonaTM basic concept model (NOT showing real features):

• OvulonaTM monitors admittance of the exocervix, the outside of the end organ which integrates the effects of all key reproductive effectors. We call this FIVTM, or Folliculogenesis In VivoTM

• Key to FIV™: Cervix uteri receives endocrinological and neurological signals controlling reproduction

• Unlike other methods, FIVTM

anticipates AND detects ovulation, and reflects processes that affect or are related to menstrual periodicity

PosteriorFornix

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 DesignNext Generation Design

Much like the NuvaRing® but without the hormones.

“We’ll help you control your fertility with 21st Century tools”

Much like the Ovulona™ but without the need for daily insertion.

OvulonaTM: 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

CervixVagina

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

EstrogenFollicle-Stimulating Hormone

Luteinizing HormoneProgesterone

• The fertile window results from a complex interplay of multiple variables including signals from the brain, on which the ovary is “obligatorily dependent1,” sensitive to stress2 and affecting the timing and intensity of the mid-cycle LH surge3

• 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

fertilewindow

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, 19962 “Brain opioid peptides and menstrual cyclicity,” P.R. Gindoff and M. Ferin, Seminars in Reproductive Endocrinology 5(125), 19873 "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:

fertilewindow

OvulonaTM device genesis & capabilities

Profiling OvulonaTM

Commercial concept rendition of the previously tested and FDA approved pre-production prototype

Smart OvulonaTM

Commercial concept rendition of the planned Smart OvulonaTM, which will interpret data for the woman user

• All of the capabilities of the Profiling OvulonaTM 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 OvulonaTM scans result in “SEE DOCTOR” indication

• Wireless transfer of OvulonaTM FIVTM 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

• OvulonaTM device readout in A, transferrable to computer

• Software produces OvulonaTM 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 1

143.5 A

OvulonaTM commercialization strategy

ProfilingOvulonaTM

(POv)

SmartOvulonaTM

(SOv)

fundingavailability

Year 1Year 1 Year 2Year 2 Year 3Year 3

KOL initiative (POv prototypes)KOL initiative (POv prototypes)

Prototype & clinical POv manufacture

Prototype & clinical POv manufacture

POv advertisement (media, sales reps & pubs)POv advertisement (media, sales reps & pubs)

Continued KOL interaction as appropriateContinued KOL interaction as appropriate

Commercial POv manufactureCommercial POv manufacture

POv commercial salesPOv commercial sales

Clinical studies for enhanced capabilitiesClinical studies for enhanced capabilities

SOv software developmentSOv software development

SOv manufactureSOv manufacture

SOv commercial salesSOv commercial sales

SOv advertisement (media, sales reps & pubs)SOv advertisement (media, sales reps & pubs)

Initial clinical studyInitial clinical study

Phase 2Phase 2

Phase 1Phase 1

OvulonaTM clinical strategy

Clinical studies for enhanced capabilitiesClinical studies for enhanced capabilitiesInitial clinical studyInitial clinical study

• Provide statistically significant data to finalize the Smart Ovulona™ algorithms for chip coding

• Subjects of several categories:– Baseline-type1

– 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

1Baseline subjects: Healthy adults younger than 35, non-smokers, no contraception, no medication. [Note: Healthy implies normal Pap smear test. ]

Existing Patent ExpiriesExisting Patent Expiries

OvulonaTM patent strategy provides ample protection

8,821,407 Fertility Status Diagnosis System 2028

8,152,735 Diagnosis of fertility status 2028

7,771,366 Vaginal fertility probe 2023

7,427,271 Diagnosis of fertility status byfolliculogenesis monitoring in the vagina 2023

5,916,173 Methods and apparatus for monitoringfertility status in the mammalian vagina 2017

D393,311 Mammalian fertility probe 2017

4,753,247 Method and apparatus for monitoring redox reactions EXP

ID US Patent Title Expiration

2015 2020 2025 2030 2035 2040

DraftedApplications

FundingIn 2014

New Patent Expiries New Patent Expiries

In addition, PCT applications are planned to provide international IP protection

2045

AnticipatedApplications

OvulonaTM 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)

OvulonaTM & 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.