TRUSCREEN GROUP LIMITED logo

Truscreen Registers Product Disclosure Statement

Capital Raise10 November 2020TRUIndustrials

TRUSCREEN
GROUP LIMITED

Product

Disclosure

Statement

for an offer of

ordinary shares

in TruScreen

Group Limited.

(formerly TruScreen Limited)

10 November 2020

This document gives you important information about this

investment to help you decide whether you want to invest.

There is other useful information about this offer at

www.companiesoffice.govt.nz/disclose. TruScreen Group Limited has

prepared this document in accordance with the Financial Markets

Conduct Act 2013. You can also seek advice from a financial adviser

to help you to make an investment decision.

2/TRUSCREEN GROUP LIMITED PRODUCT DISCLOSURE STATEMENT 2020
What is this?

This is an offer of ordinary shares. Ordinary shares in

TruScreen Group Limited ("TruScreen”) will give you a stake in

the ownership of TruScreen. You may receive a return if

dividends are paid, or TruScreen increases in value and you

are able to sell your ordinary shares at a higher price than

you paid for them.

If TruScreen runs into financial difficulties and is wound up,

you will be paid only after all creditors have been paid. You

may lose some or all of your investment.

About TruScreen Group Limited

TruScreen Group Limited (“TruScreen” and “the Company”)

was incorporated on 9 August 2013. TruScreen manufactures

and owns all rights to the TruScreen Cervical Cancer

Screening System. The system comprises a medical device

and Artificial Intelligence- supported (AI) process designed to

detect the presence in real time of pre-cancerous and

cancerous tissue on the cervix.

TruScreen is a patented cervical cancer detection system

with distribution agreements in 23 countries. The Company’s

current key focus is China which accounts for over 50% of

sales. Its products have been sold to Vietnam, Russia,

Zimbabwe, Mexico, India, Zimbabwe and Saudi Arabia.

TruScreen is further described in Section 2: TruScreen and

what it doesand Section 7: TruScreen’s financial information.

Purpose of this Offer

The purpose of the Offer is to raise not less than NZ$1 million

and not more than NZ$2 million of new capital through the

issue of up to a maximum of 28,571,428 million new ordinary

fully paid shares in TruScreen. The Offer will not proceed if

applications for a minimum of NZ$1 million (14,285,714 million

new shares) are not received.

The money raised under the Offer will be applied towards the

following initiatives:

• Pay for the costs associated with the offer;

• Pay for the costs associated with the dual listing of

TruScreen’s Shares on the ASX;

• Reduce the cost of the product via R&D initiatives;

• Investment in business expansion and team capabilities;

• Increasing working capital.

1. Key Information

Summary

TRUSCREEN GROUP LIMITED PRODUCT DISCLOSURE STATEMENT 2020/3
Key terms of the offer

The above dates are subject to change at the discretion of

the Board of Truscreen, subject to compliance with NZX

Listing Rules.

Description of the equity securities Ordinary fully paid shares

PriceNZD 7 cents per Share, or AUD 6.5 cents per Share

Intended date Offer opens

(“Opening Date”)

26 November 2020

Intended date Offer closes

(“Closing Date”)

18 December 2020

Number or amount of the equity

securities being offered

A minimum of 14,285,714 new Shares are being offered, representing 4.1% of the total

number of ordinary shares on issue immediately after the issue.

A maximum of 21,428,571 new Shares are being offered, representing 6.1% of the total

number of ordinary shares on issue immediately after the issue.

The Board of TruScreen has the discretion to accept oversubscriptions of up to a

maximum of 7,142,857 new Shares ($500,000). If the Board resolves to accept

oversubscriptions to the maximum level, the maximum number of Shares that can be

offered under the Offer is 28,571,428 Shares, representing 8.2% of the total number of

ordinary shares on issue.

Any oversubscriptions received shall be apportioned as between the two geographic

pools referred to below, in the same proportions as each of the two geographic pools

represent as a percentage of the total Offer.

Structure of the OfferThe Offer has been divided in to two geographic pools. A pool of 14,285,714 new

Shares (NZ$1 million) for subscription by Australian Residents (“Australian Pool”). A pool

of 7,142,857 new Shares (NZ$500,000) for subscription by New Zealand Residents (“NZ

Pool”).

In the event that one of the geographic pools is undersubscribed, then the balance

of that pool may be allocated to the other pool for subscription.

ScalingTruScreen may scale applications at its sole discretion.

Liabilities, fees and chargesExcept for the payment of the price for the new Shares, a subscriber for new Shares

has no liability to make further payments or to pay fees or charges relating to the

new Shares.

Conditional OfferThis Offer is conditional upon the ASX approving the admission of the Company to

the official list of the ASX as an ASX Foreign Exempt Listing and for quotation of the

Shares on the ASX on or before that Closing Date (as that date may be varied from

time to time). In the event that this condition is not satisfied, then this Offer will not

proceed, and all application moneys received by the Company will be refunded to

investors in full and without deduction within 5 business days.

TRUSCREEN GROUP LIMITED PRODUCT DISCLOSURE STATEMENT 2020 / 3

4/ TRUSCREEN GROUP LIMITED PRODUCT DISCLOSURE STATEMENT 2020
How you can get your money out

TruScreen intends to quote these Shares on the NZX Main

Board and the ASX. This means you may be able to sell them

on the NZX Main Board or the ASX if there are interested

buyers. You may get less than you invested. The price will

depend on the demand for the Shares.

An application will be made to ASX after this PDS has been

lodged on the Offer Register for TruScreen to be admitted to

the official list of ASX as an ASX Foreign Exempt Listing and

for quotation of the Shares on the ASX. If Truscreen is

admitted to the official list of ASX, then those Australian

investors will have their Shares quoted on the ASX.

If you wish to sell your Shares on the NZX Main Board or the

ASX (as the case may be), you will need to open a share

trading account with a NZX Market Participant, or an

Australian share brokerage firm, or a share trading platform,

through whom your share sale may be facilitated.

Key drivers of returns

TruScreen considers that the current and future aspects of its

business that have, or may have, the most impact on the

financial performance of the business, and the key strategies

and plans for those aspects of the business, can be

summarised as follows:

TRUSCREEN GROUP LIMITED PRODUCT DISCLOSURE STATEMENT 2020/5
Aspects of TruScreen’s business that may impact

on financial performance

Key strategies and plans

The Company’s ability to generate sales revenues from the

sale of its products

The financial performance of the business will be driven by

the Company’s ability to generate sales revenues from the

sale of its products.

TruScreen is seeking to develop its sales and distribution

channels to facilitate the increase in sales of its products in its

targeted jurisdictions.

Preservation of working capital

The Company must preserve its working capital carefully

to ensure it can trade as a going concern until it is

cashflow positive.

TruScreen is constantly monitoring adherence to its cashflow

model to ensure the Company has adequate financial

resources to undertake its commercial operations.

Rollout of the TruScreen technology solution in China,

Russia, and Vietnam

The ability of TruScreen to develop its sales channels for its

products (i.e with a view to increasing sales and revenues)

in China, Vietnam, Russia, Eastern Europe, India, Latin

America and Africa taken individually or collectively will

have a material impact upon the financial performance

of TruScreen.

TruScreen has adopted three key steps in its strategy to

develop its sales channels in these markets, as follows:

• Appointment of a distributor(s) and the gaining of

regulatory approvals for the sale of TruScreen’s products.

• Gaining key opinion leader (KOL) support.

• Commenced commercial activity in those jursidictions.

Further information about the above strategies is provided on

page 19.

The establishment of a manufacturing facility in China

The establishment of a manufacturing facility in China will

achieve a lower manufacturing cost, and by registering

TruScreen as a domestic product will remove the bias

against foreign products for use in public health programs

in China.

The Company is negotiating with a Chinese company which

is ISO13485 accredited to manufacture the Truscreen device

in Shenzhen, China.

Further information regarding the aspects of TruScreen’s business that may impact on the financial performance of the

Company can be found in pages 17 and 18 of this PDS.

6/TRUSCREEN GROUP LIMITED PRODUCT DISCLOSURE STATEMENT 2020
Key risks affecting this investment

Investments in shares are risky. You should consider if the

degree of uncertainty about TruScreen’s future performance

and returns is suitable for you. The price of these Shares

should reflect the potential returns and the particular risks of

these Shares. TruScreen considers that the most significant

risk factors that could affect the value of the Shares are:

• Early stage nature of the TruScreen’s Commercialisation

While the TruScreen technology is well advanced, the roll

out of its commercial business model is still at an early

stage. TruScreen’s commercialisation is not currently the

subject of any fixed term contractual arrangements and

there are no guaranteed recurring regular income

streams for the TruScreen business.

TruScreen currently operates at a loss. TruScreen’s

operating losses may continue as TruScreen continues to

expend resources to commercialise its current products,

obtain regulatory clearances or approvals in new

jurisdictions, and expand its marketing, sales,

manufacturing and finance capabilities.

• Cash flow

TruScreen may require substantial additional capital to

commercialise its current products and to develop new

products, including completing new product testing

and clinical trials, obtaining all required regulatory

approvals and clearances, scaling up manufacturing,

and marketing its products into particular jurisdictions.

Ultimately, like all businesses, if the Company is unable to

fund its commercial operations, the future viability of the

Company would be in doubt.

• Intellectual Property

TruScreen’s future success heavily depends on its ability

to maintain the proprietary nature of its technology. If

any of TruScreen’s rights or ability to manufacture its

products was to be limited, TruScreen’s ability to

continue to manufacture and market its products could

be adversely affected.

• Manufacturing Risk

TruScreen relies on a number of third party suppliers to

manufacture certain parts of the device and the

disposable Single Use Sensor

1

(SUS) production. As such,

TruScreen cannot guarantee control over the

manufacturing of all components of its products in a

timely fashion. Difficulties TruScreen may encounter in

manufacturing scale-up, or a failure to maintain its

manufacturing facilities in accordance with good

manufacturing practice regulations, international

quality standards or other regulatory requirements,

could result in a delay or termination of production,

which could have a material adverse effect on

TruScreen’s financial performance.

• Competition

TruScreen competes with numerous other developers

and suppliers of cervical cancer screening product

offerings and services. TruScreen is susceptible to being

overtaken by other more established and larger

organisations. It is possible that one or more

pharmaceutical or other health care companies will

develop therapeutic drugs, treatments or other products

that will substantially reduce the prevalence of cancers

or otherwise compete with, or render TruScreen’s

products obsolete.

• Unsuccessful Marketing

Despite the best endeavours of TruScreen and its

distributors, it is possible that TruScreen’s initiatives to

market its products could fail, which would have an

adverse impact on the financial position and

performance of TruScreen.

Further Risks

This summary does not cover all the risks of investing in

TruScreen Shares. You should also read Section 8 of the PDS

(Risks to TruScreen’s business and plans) and the other places

in the PDS that describe risk factors (for example, risks arising

for investors from the nature of the Shares).

Where you can find TruScreen’s financial

information

The financial position and performance of TruScreen are

essential to an assessment of this Offer. You should also read

section 7 of the PDS – TruScreen’s Financial Information. A full

set of the financial statements for TruScreen can also be

found on the Disclose Register at www.business.govt.nz/

disclose, offer number OFR12990.

1 The Single Use Sensor (SUS) is a disposable sheath that is the only point of contact between the TruScreen device and any bodily fluids or tissue from the

patient. A new SUS has to be used for each patient test.

TRUSCREEN GROUP LIMITED PRODUCT DISCLOSURE STATEMENT 2020/7
1.Key information Summary2

2.TruScreen and what it does9

3.Purpose of the offer27

4.Key dates and offer process27

5.Terms of the offer28

6.Key features of Shares29

7.TruScreen’s financial information30

8.Risks to TruScreen’s business and plans31

9.Tax32

10.Where you can find more information33

11.How to apply33

12.Contact information34

Table of contents

8/TRUSCREEN GROUP LIMITED PRODUCT DISCLOSURE STATEMENT 2020
Dear Investor,

On behalf of the Directors of TruScreen Group Limited, it is my pleasure to introduce this Product Disclosure Statement

(PDS) to you.

TruScreen aims to improve the wellbeing of women with the latest AI-based technology in cervical cancer screening by

providing real-time, accurate detection of pre-cancerous and cancer cells.

In FY2020, we remained focused on the commercialisation of our proprietary electro-optical technology, which is

distributed in over 23 countries. China remains our primary focus. Since commencing an evaluation with Chinese

Obstetricians and Gynaecologists Association (COGA), we have increased the Company’s presence in China. Demand in

China has grown throughout FY2020, with further device installations and stronger Single Use Sensor (SUS) pull through.

We have also expanded our global distribution outside of China. In particular, we have grown our presence in Vietnam

and the African and Russian markets, established our African HIV initiative, and expanded into the Middle East, gaining

product registration in Saudi Arabia and Israel.

The Company continues to focus on building its presence in China and strengthening its international distribution in low

and middle income countries (LMIC’s) through strong relationships and partnerships with hospitals, governments and

non-government organisations

2

(NGO’s). TruScreen recently received recognition from UNITAID, the World Health

Organisation and the Clinton Health Access Initiative for its ability to provide point-of-care cervical cancer screening

services in these countries.

This capital raising in conjunction with the dual listing of the Company’s shares on the Australian Securities Exchange

(ASX) will provide the Company with the resources it needs to capitalise on the base the Company has established.

This Offer is conditional upon the ASX approving the admission of the Company to the official list of the ASX as an ASX

Foreign Exempt Listing and for quotation of the Shares on the ASX on or before that Closing Date (as that date may be

varied from time to time). In the event that this condition is not satisfied, then this Offer will not proceed, and all

application moneys received by the Company will be refunded to investors in full and without deduction within 5

business days.

We believe that a dual listing on the New Zealand and Australian Securities Exchanges will add value to all our

shareholders, and I recommend this Offer to you.

Yours sincerely

Tony Ho

Chairman

Letter from the Chairman of

TruScreen’s Board of Directors

2 NGOs are usually non-profit and sometimes international organisations independent of governments and international governmental organisations (though often

funded by governments) that are active in humanitarian, educational, health care, public policy, social, human rights, environmental, and other areas to effect changes

according to their objectives

TRUSCREEN GROUP LIMITED PRODUCT DISCLOSURE STATEMENT 2020/9
TruScreen

Group

Limited

(NZX Listed)

TruScreen

S.de R.L.

de CV

(Mexico)

TruScreen

Pty

Limited

(Australia)

TruScreen

Limited

(UK)

Overview

TruScreen manufactures and owns all rights to the TruScreen Cervical Cancer Screening System. The system comprises

a medical device and process designed to detect the presence in real time of pre-cancerous and cancerous tissue on

the cervix.

TruScreen is a unique cervical cancer detection system with distribution agreements in 23 countries. The Company’s current

key focus is China which accounts for over 50% of sales. Its devices have been sold to Vietnam, Mexico, Zimbabwe, Russia,

India and Saudi Arabia.

The diagrams below illustrate the group and the organisational structure of TruScreen.

TruScreen Group Limited (New Zealand) was incorporated on 9 August 2013. TruScreen Pty Limited (Australia) was

incorporated on 26 August 2013. TruScreen Limited (UK) was incorporated on 11 July 2013. TruScreen S de R.L de C.V (Mexico)

was incorporated on 17 August 2017. Truscreen Group Limited is listed on the NZX Main Board, and it is proposed that it will

also be dual listed on the ASX following the completion of this Offer.

2. TruScreen and

what it does

10/TRUSCREEN GROUP LIMITED PRODUCT DISCLOSURE STATEMENT 2020
Description of the TruScreen group of companies

• TruScreen Group Limited (New Zealand):This company

is the parent company of the TruScreen group and its

Shares are currently quoted on the NZX Main Board.

TruScreen Group Limited does not undertake any

commercial trading operations in its own right. It does

however own 100% of the shares on issue in TruScreen

Pty Limited (Australia) which in turn owns 100% of the

shares in TruScreen Limited (UK) and TruScreen S de R.L

de C.V (Mexico).

• TruScreen Pty Limited (Australia): This company is an

Australian incorporated company and carries out the

commercial activities referred to below.

• TruScreen Limited (UK):This company is incorporated in

the United Kingdom and holds the CE Mark.

• TruScreen S de R.L de C.V: This company is incorporated

in Mexico and is currently not operating.

NATURE OF TRUSCREEN’S OPERATIONS

AND MAIN ACTIVITIES

What is TruScreen’s business model?

TruScreen Pty Ltd manufactures the TruScreen cervical

cancer screening system. The system consists of a Hand Held

Device and Cradle and a disposable Single Use Sensor (SUS).

A new SUS is used for every patient test. TruScreen sells

those devices and SUS’s to distributors in the countries in

which TruScreen is approved for sale. Those distributors then

sell the TruScreen device to Government and Private

hospitals and clinics, individual doctors and government and

non-government health programs.

TruScreen has a strategy to focus on the promotion and sale

of TruScreen cervical cancer screening system to those large

developing countries (eg China and Russia) and those low

and middle income countries (LMIC’s) which lack a national

cervical cancer screening infrastructure.

Key attributes of the model comprise:

• Supporting existing and appointing additional

distributors to sell TruScreen to the large developing

countries and LMIC’s;

• Maintaining international medical device manufacturing

certification – ISO13485

3

- and the right to use the CE

Mark

4

as prima facie proof of the efficacy of the

TruScreen cervical cancer screening system;

• Conducting up to date clinical performance evaluations

to validate the efficacy of the TruScreen cervical cancer

screening system;

• Securing and maintaining all regulatory licenses to

support the deployment of TruScreen’s products in the

various international jurisdictions it targets;

• Developing trusted relationships with international

Governments, regulators and other key industry

participants;

• Promoting TruScreen to key Non-Government

Organisations who have an interest in the health of

women in the developing world and who fund screening

programs in LMIC’s.

What has TruScreen done to date?

The Company’s history

TruScreen’s development was driven by two leading medical

academics from Sydney University.

Professor Malcolm Coppleson, an international leader in

colposcopy and cervical cancer, sought to establish

objective technology that could improve on the conventional

Pap smear test

5

, which has limitations in population-based

screening due to its subjective nature and its need of

laboratory facilities and qualified personnel to read results.

His partner Dr. Bevan Reid believed that it should be possible

to distinguish between normal and abnormal tissue by

measuring changes in physical properties, such as electrical

potential.

After extensive and intensive research and development

(R&D), the TruScreen ‘Opto Electrical’ Technology for the

detection of precancerous and cancerous cells was

developed. The TruScreen Cervical Cancer Screening System

is built on this technology and comprises a unique medical

device, AI-based (Artificial Intelligence) algorithm technology

(see outline of “TruScreen Sophisticated Algorithm

Framework below) and processes designed to detect the

presence, at the time of screening, of precancerous and

cancerous tissue on the cervix.

Following the restructuring of the business, TruScreen Pty Ltd,

a subsidiary company of TruScreen Group Limited (NZ), was

formed in August 2013 to hold all TruScreen assets, including

IP, and to act as the operations heart of the TruScreen

business.

In 2016, the TruScreen Ultra2 second-generation device was

launched. This encapsulated world-class medical

technology and contained many new and unique features

including a significantly increased processing capacity and

faster processing which improved performance and user

experience.

The TruScreen technology is at the forefront of the

development of objective opto-electric tissue differentiation

and it’s key intellectual property is a protected trade secret.

3 ISO13485 is an International Organization for Standardization (ISO) standard which represents the requirements for a comprehensive quality management system for

the design and manufacture of medical devices.

4CE markis a certification markingthat indicates conformity with health, safety, and environmental protection standards for products sold within the European

Economic Area (EEA). The CE markingis also found on products sold outside the EEA that are manufactured in, or designed to be sold in, the EEA

5 A Pap smear test is performed by opening the vaginal canal with a speculum and collecting cells at the outer opening of the cervix at the transformation zone (where

the outer squamous cervical cells meet the inner glandular endocervical cells). The collected cells are examined under a microscope to look for abnormalities which could

indicate the incidence of cervical cancer

TRUSCREEN GROUP LIMITED PRODUCT DISCLOSURE STATEMENT 2020/11
Product Overview

TruScreen utilises technology to detect precancerous

change, or cervical intraepithelial neoplasia (CIN), by optical

and electrical measurements of cervical tissue.

A pen-like wand touches various spots on the cervix to send

and receive back electrical and optical signals from the

cervical tissue. A single use sensor (SUS) with precision lens

and electrodes is used to interface with the cervix and

protect against cross-infection.

The TruScreen device collects the data, processes it with a

proprietary AI-based algorithm and provides an immediate

result, enabling the physician to immediately plan

appropriate patient care.

Unlike cytology

6

, TruScreen does not only examine surface

epithelial cells. LED light at specific frequencies is transmitted

through cervical tissue identifying changes in the basal and

stromal layers. This includes increases in blood circulation

and variations in blood vessels that occur with precancerous

change.

The TruScreen system also assesses the electrical properties

and response of the cervical tissue. The electrical

measurements are stimulated by the delivery of a very small

impulse (about one volt) in millisecond pulse sequences that

repeat 14 times per second. The decay response curve will

vary according to the capacitance of the tissue – a

measurement of the ability of the tissue to either hold or

dissipate a charge. Different tissue types and the properties

of the tissue have different capacitance.

The device runs an AI-based algorithm (see reference to

TruScreen Sophisticated Algorithm Framework below)

trialled on a database of 2,000 patients from wide

geographic and ethnic backgrounds with differing

histological diagnoses. A sophisticated proprietary

algorithm framework has been developed to distinguish

between normal and abnormal (cancerous and

precancerous) tissue.

Features and Benefits

TruScreen cervical cancer screening system offers an

alternative approach to traditional cervical cancer

screening, resolving many of the ongoing issues with Pap

smear tests including failed samples, poor patient follow

up, patient discomfort and the need for supporting

laboratory infrastructure.

As well as being accurate, the TruScreen cervical cancer

screening system provides an instant report, thus

preventing the risk of losing contact with the patient

because of the delay associated with transportation of

samples to laboratories for analysis and reporting.

TruScreen cervical cancer screening system is portable

and is an objective, self-checking AI-supported digital

system that can be used with minimal training of medical

or paramedical staff, and without the infrastructure and

resource costs associated with cytology-based screening.

TruScreen is also more acceptable to women than a Pap

smear test because no cervical tissue needs to be taken

during the test, meaning no scraping of the cervix, minimal

discomfort, and real time results are provided.

FeatureBenefitClinical Advantage

Real-time resultsImmediate feedback to patient and

operator.

Patient can be treated if necessary at

time of visit. Patient not lost to follow-

up with delayed reporting.

Objective resultHigh degree of accuracy.

7

Reproducible, consistent results to

confirm accuracy. Eliminates human

error in interpreting results.

No lab facility neededGreater access to women in remote

communities. Easy to use.

No qualified cytologists needed.

Suitable for remote areas and

developing countries. Cost savings in

resources / overheads.

High sensitivityAssured level of performance. High

standard of cervical screening.

Improved ability to early detection of

disease and save lives.

Automated device and error-checking

during examination

Consistent and accurate results.Minimises the chance of an

unsatisfactory result.

Tissue samples NOT collectedMinimises pain or discomfort to the

patient.

Patient more likely to return for repeat

screen.

6 Cytology is the examination of cells from the body under a microscope

7 Qi Weihong, Zhang Wei et al. Clinical Observation of Cervical Cancer Screening System TruScreen in 1030 Cases. Electronic Journal Of Practical Gynecologic

Endocrinology. Nov. A. 2019 Vol.6, No.31. Results: TS: 91.0%, 81.25%; LBC: 69.6%, 73.75%. Subjects: 1030 Published 2019

12/TRUSCREEN GROUP LIMITED PRODUCT DISCLOSURE STATEMENT 2020
Product Development History

Pioneering research and development on the TruScreen

cervical cancer screening system for real-time cervical tissue

differentiation has involved close collaboration with leading

clinicians and hospitals across the world.

TruScreen’s development was driven by two leading medical

academics from Sydney University, that began in 1986,

who sought to establish objective technology that could

improve on the conventional Pap smear test. They believed

that it should be possible to distinguish between normal and

abnormal tissue by measuring changes in physical

properties, such as electrical potential.

After an extensive and intensive R&D phase, between 1986

and 1999, TruScreen cervical cancer screening system was

developed using the ‘Opto Electrical’ Technology for the

detection of pre and cancerous cells on the cervix. TruScreen

technology contains a sophisticated algorithm framework

that has been developed in collaboration with the Australian

Government’s applied research division, CSIRO. The

algorithm was researched and developed from data sets

collected from the Auckland Hospital, Royal Hospital for

Women (Sydney) and The Whittington hospital London

between 1998 to 2000.

The first generation Truscreen was commercialised and

launched to the market in 2014.

The R&D phase to develop the new device commenced with

a series of independent design houses in Feb 2014 and a

pilot production version was available for the granting of the

CE mark in April 2016.

In 2016, the TruScreen Ultra2 second-generation device was

launched. This built on TruScreen’s world class medical

technology with a number of improvements including

significantly increased processing capacity, faster processing

and significantly improved performance. In addition, the

handpiece is now wireless and the enhanced device offers

wi-fi connectivity, extended battery life and an LCD

touchscreen.

TruScreen holds the following patents which affords the

Company certain proprietary protections in respect of its

intellectual property rights that it has developed:

Both of the above patents concern the first generation

device T1 or second generation T2 (Ultra) as they are

equivalent in their outputs both electrically and optically.

The 'multiple measurement' refers to the data sets both

optical and electrical that are obtained when each spot on

the cervical tissue is probed - 15 to 30 spots can be taken

depending on the size of the cervix. The Algorithm from the

data derived can recognise the tissue type and determine

whether the tissue is precancerous or cancerous.

Additional research and development is also planned to

improve the manufacturing processes to reduce the cost of

manufacture of the products to improve gross margins. This

would be integrated with the planned relocation of

manufacturing of the products to China. See page 16 for

further information. Research and development is

undertaken both by external third party contractors

engaged by the Company and also in-house. For the year

ended 31 March 2020 the Company spent $1,584,292 on

research and development. Of this amount:

• $462,240 was attributed to TruScreen personnel costs

deployed on research and development activities;

• $300,317 was paid to external third party contractors;

and

• $820,916 was attributed towards materials, prototypes,

equipment and overhead.

The Company is planning to undertake a greater percentage

of research and development in-house as it strives to reduce

the cost of production of both the TruScreen device and

Single Use Sensor.

In recent use this device has been shown to have a high

degree of accuracy.

8

Clinical and in-field evaluations have

shown TruScreen Ultra2 device to be a unique and valuable

screening test for cervical cancer.

TruScreen sophisticated algorithm framework

More than 23 man-years were spent on algorithm

development and testing to arrive at the current version of

the TruScreen Ultra classifier algorithm. During development,

numerous algorithms methodologies were trailed. The current

TruScreen Ultra algorithm was selected following trials of 5

competing algorithms.

The TruScreen Ultra algorithm uses a trained multi-

dimensional probabilistic tissue features classification engine

to provide a binary classification result (Normal or Abnormal)

with a high degree of Sensitivity and Specificity (see page

16). The data sets used to train the algorithm consist of

patient specific clinical data combining clinical diagnosis

information from colposcopy, cytology, and histology (where

available) and were collected over many years of clinical

studies. The training data set consists of more than 7,500

multi-probing data sets, from patients of varying ethnicities

with differing histological diagnoses.

8 Qi Weihong, Zhang Wei et al. Clinical Observation of Cervical Cancer Screening System TruScreen in 1030 Cases. Electronic Journal Of Practical Gynecologic

Endocrinology. Nov. A. 2019 Vol.6, No.31. Results: TS: 91.0%, 81.25%; LBC: 69.6%, 73.75%. Subjects: 1030 Published 2019

Name of Patent HeldNature of the Patent

Apparatus for tissue type

recognition using multiple

measurement techniques

Held in the name of

TruScreen Pty Ltd for

the USA.

Apparatus for Tissue Type

Recognition Using Multiple

Measurement

Held in the name of

TruScreen Pty Ltd for China.

TRUSCREEN GROUP LIMITED PRODUCT DISCLOSURE STATEMENT 2020/13
Markets

TruScreen’s cervical cancer screening device is Certified for

use throughout Europe (the CE Mark) and NMPA

9

approved

for sale in China. It is currently available in multiple markets

around the world.

After in-depth market study and evaluation, TruScreen has

determined that the optimal commercialisation strategy is to

first target those large developing markets and Low and

Middle-Income Countries (LMIC’s) where no large-scale

cervical cancer screening programs and infrastructure are in

place. In parallel to this commercialisation, the Company is

obtaining the academic endorsement of Key Opinion

Leaders to assist in both current and future global

marketing efforts.

There are two main market segments for each country:

• population based screening; and

• general clinical use in hospitals and clinics.

The screening programs are mainly funded through

Government public health procurement programs equating

to large screening populations but in many countries, there

are also significant NGO and Corporate funded screening

programs. (TruScreen cervical cancer screening system was

recently featured in a Cervical Cancer Technology

Landscape released by Unitaid, the World Health

Organisation and the Clinton Health Access Initiative –

See page 14).

The government screening programs are the key to success

for TruScreen in developing markets. TruScreen appoints

distributors based on their ability to demonstrate a solid

relationship with Key Opinion Leaders and having strong

Government contacts.

The World Health Organisation’s (WHO) draft strategy to

eliminate cervical cancer worldwide, once approved by

member countries, would provide a significant market

opportunity for its real-time screening technology for cervical

cancer.

The “Draft Global Strategy Towards the Elimination of

Cervical Cancer as a Public Health Problem”

10

, provides a

favourable macro environment for the Company’s screening

technology. The strategy calls for a comprehensive global

approach to put the 184 WHO member countries on the

same path to eliminate cervical cancer by the end of the

century and proposes screening targets for the period

2020-2030.

WHO notes that to achieve this target, innovative and

optimal service delivery models need to be adopted,

particularly in low- and middle-income countries (LMICs)

where cervical cancer incidence and mortality rates are

high.

10

TruScreen is currently the only electro-optical real-

time cervical screening method available in LMICs.

Concurrent to TruScreen’s efforts to maximise the sales of its

products in its primary target markets the Company is also

engaged in the process of selecting the second phase of

target markets and identifying suitable distributors to work

with in those markets. This process has been initiated in India,

Central and Latin America, Eastern Europe, the Middle East

and Africa.

The global market potential for TruScreen is significant. At

saturation, hundreds of millions of women could benefit from

this accurate, real time and relatively affordable cervical

cancer screening system.

However, the single most important potential benefit from

the global commercialisation of TruScreen is the saving of

human life – and especially the lives that will be saved in the

developing world. Approximately 300,000 women die from

cervical cancer each year. Of which, over 85% are from the

developing world.

11

The Board considers that it is important to note that, in

respect of the market in which TruScreen operates:

• The medical devices/cervical cancer screen market is,

like most medical sectors, a particularly competitive

market. There are a number of existing market

participants that provide cervical cancer screening

solutions, and there is always the prospect of new

technologies being developed by trade competitors

that will directly compete with the TruScreen solution

and could ultimately potentially supersede the

TruScreen technology in the market place, or have a

material adverse impact upon the ability of TruScreen to

generate meaningful revenues. Further detail about this

particular risk factor is provided in section 8 on page 32;

and

• TruScreen is heavily reliant on being able to successfully

market its solution and products to the market

participants and consumers within the cervical cancer

screening market. In the event that TruScreen is unable

to effectively market its solution and products to the

participants within this market, then this development

would have a direct and adverse impact upon the ability

of TruScreen to generate revenues from this market

sector. Further detail about this risk factor is provided in

section 8 on page 32.

9 National Medical Products Administration (Previously known as CFDA(China Food and Drug Administration)

10 https://www.who.int/publications/m/item/draft-global-strategy-towards-eliminating-cervical-cancer-as-a-public-health-problem

11 WHO, 2019, Human papillomavirus (HPV) and cervical cancer, viewed 28 August 2020, https://www.who.int/en/news-room/fact-sheets/detail/human-

papillomavirus-(hpv)-and-cervical-cancer

14/TRUSCREEN GROUP LIMITED PRODUCT DISCLOSURE STATEMENT 202014/TRUSCREEN GROUP LIMITED PRODUCT DISCLOSURE STATEMENT 2020
Summary of Capital Raising Initiatives and

Commercial Milestones

During the course of the period commencing on 6 September

2018 and ending on the date of this PDS, TruScreen has

undertaken four external capital raisings, the details of which

are as follows:

• In April/May 2020 TruScreen issued 104,860,021 new

shares at 5 cents per share raising $5,243,001. The raising

comprised a Share Purchase Plan (“SPP”) raising $2

million, and the placement of an oversubscription of

$1,128,001 to shareholders pursuant to the SPP, and a

further placement of $2,115,000 to both retail and

wholesale investors.

• On 12 July 2019 and 3 September 2019, TruScreen issued

9,677,363 and 1,000,000 new shares respectively, at 10.6

cents per share (with one free option issued for every

share subscribed for, which option is exercisable at 13

cents per option on or before 12 July 2021. This

placement raised a total of NZ$1,131,800;

• On 9 October 2018, TruScreen issued 7,411,964 new shares

at 21c per share under a Share Purchase Plan (SPP). The

SPP raised NZD $1,556,500;

• On 6 September 2018, TruScreen issued 7,142,856 Shares

at 21c per share. This placement raised NZD $1,500,000.

All of the shares issued pursuant to the above placements

were issued to shareholders and/or “wholesale investors”

as that term is defined in the Financial Markets Conduct

Act 2013.

These funds have been used to fund further research and

development of the product $2,915,361 in the two years to 31

March 2020 (TruScreen Annual Report March 2020),

developing markets for TruScreen sales $720,902 in the two

years to 31 March 2020 (TruScreen Annual Report 31 March

2020), and for general working capital.

TruScreen’s forward plans are to raise up to NZ$2.0 million

associated with the dual listing of its shares on the ASX.

These funds will be earmarked to strengthen team

capabilities to deal with an expanding business, further

research and development to reduce the costs of

manufacturing the Company’s product, for costs of the dual

listing and for general working capital.

Key Strengths of TruScreen

• Only device of its type – CE Mark and NMPA (China)

approved for standalone screening of cervical cancer:

TruScreen cervical cancer screening system uses both

optical and electrical tissue differentiation to identify

precancerous and cancerous changes to the cervix.

TruScreen has been approved for use in Europe

(certificate number G1 15 11 86519 0007 ) and China

(certificate number国械注进20152181279 ). TruScreen is

the only opto-electric cervical cancer screening device

currently commercialised to hold these approvals.

• The TruScreen device and system has been

clinically validated

TruScreen has been extensively tested in numerous

studies around the world, with results showing its

performance is equal to, or better than, high quality

cytology tests within the same study.

12 13 14 15

• The TruScreen solution does not require supporting

laboratory infrastructure

The TruScreen cervical cancer screening system is a real

time device that provides a result at the point of

examination. No biological samples are taken for

analysis and thus, unlike the Pap smear test or HPV DNA

analysis there is no need for a laboratory to examine a

tissue sample to produce a result.

• Recognised by WHO as an option for screening in Low

and Middle Income countries

In May 2019, TruScreen announced that it had been

acknowledged in a joint publication released by Unitaid,

the World Health Organisation and the Clinton Health

Access Initiative. The report, titled Cervical Cancer –

Screening and Treatment of Pre-Cancerous Lesions –

Technology Landscape was presented at the 72nd

World Health Assembly in Geneva, Switzerland, on 20

May, 2019.

A copy of the report can be found using the link below:

http://TruScreen.com/wp-content/uploads/2019/06/

Cervical_Cancer_Technology-landscape-2019.pdf

Whilst TruScreen does have two principal key strengths,

these positive factors need to be carefully considered and

read in the context of the risk factors also associated with

the TruScreen business.

The key risks relating to the TruScreen operations are

disclosed in greater detail in sections 1 on page 6 and in

section 8.

TruScreen device and system have been extensively

validated with multiple studies. Below is the summary of the

key studies run in a number of different countries.

12 Comparing Study of cervical cancer screening System and liquid-based cytology test in the screening of cervical lesions – Lu Siji and associates, East Hospital, Tongji

University, Shanghai- Published Obstet Gynecol, Feb, 2009, Vol.18, No.2 (China). https://truscreen.com/wp-content/uploads/2014/08/TruScreen-Comparing-Study-of-

cervical-cancer-screening-System-and-liquid-based-cytology-test-in-the-screening-of-cervical-lesions.pdf

13 Optoelectric Scanner TruScreen in Diagnostics of Cervical Squamous Intraepithelial Lesions – Sukhikh G.T. & Associates, Federal State Scientific Centre of obstetrics,

gynaecology and perinatology after academician V.I. Kulakov, Moscow, Russia., https://truscreen.com/wp-content/uploads/2014/08/TruScreen-electric-Scanner-

TruScreen-in-Diagnostics-of-Cervical-Squamous-Intraepithelial-Lesions.pdf

14 Korean Journal of Obstetrics and Gynecology Vol. 53 No. 10 October 2010, The efficacy of a real-time optoelectronic device as a diagnostic tool of over cervical

intraepithelial neoplasia 1 lesion Hyeong Soo Lim, https://www.researchgate.net/publication/266908378_The_efficacy_of_a_real-

time_optoelectronic_device_as_a_diagnostic_tool_of_over_cervical_intraepithelial_neoplasia_1_lesion

15 OPTO−ELECTRONICS REVIEW 19(4), 478–485 DOI: 10.2478/s11772−011−0040−4, Optoelectronic method for detection of cervical intraepithelial neoplasia and cervical

cancer D. PRUSKI1,2, M. PRZYBYLSKI1, W. KĘDZIA1,2, H. KĘDZIA3, J. JAGIELSKA−PRUSKA2, and M. SPACZYŃSK, https://truscreen.com/wp-content/uploads/2014/08/

TruScreen-Optoelectronic-method-for-detection-of-cervical-intraepithelial-neoplasia-and-cervical-cancer.pdf

TRUSCREEN GROUP LIMITED PRODUCT DISCLOSURE STATEMENT 2020/15TRUSCREEN GROUP LIMITED PRODUCT DISCLOSURE STATEMENT 2020/15
YearCountryInvestigatorNo. of patientsResults

(sensitivities, specificity)

1. 2019Henan/China

16

Dr. Baojin Wang315TS: 82. 76%, 76. 67%; LBC: 65. 52%, 30.

00%; HPV: 75. 86%, 43. 33%

2. 2019Beijing/China

17

Dr. Wei Zhang1030TS: 91.0%, 81.25%;

LBC: 69.6%, 73.75%

3. 2019Herbei/China

18

Dr. Yanhong Jia320TS: 78.8%, 79.5%;

LBC: 59.6%, 82.5%

4. 2018Beijing/China

19

Dr. Huixia Yang2730TS: 76%, 69%

5. 2017Mexico

20

Dr. Ricardo Lua 521TS: 78% (CIN2+)

Cytology: 36% (CIN2+)

HPV DNA: 56% (CIN2+)

6. 2016Chongqing/China

21

Dr. LI Pei,

Dr. Jin-sheng Wang

368TS: 93.2%, 100%, Positivity rate 76%

LBC: 75.0%, 64.7% Positivity rate: 55.7%

7. 2015Turkey

22

Dr. Özgü E285TS: 86%, 35%,

NPV: 89% PPV: 28%

8. 2011Poland

23

Dr. Pruski293TS: 90%(CIN2+)

Spec: 90% PPV: 63% NVP: 90%

9. 2011Guangdong/China

24

Dr. Li Xia500TS: 95%, 63%

Pap: 80%, 76%

10. 2010Guangdong/China

25

Dr. He Xiu-Kui392TS: 74%, 78%

Pap: 42%, 93%

TCT: 32%, 94%

HPV DNA: 47%, 84%

11. 2010Shandong/China

26

Prof Fengnian Rong532TS: 75%, 85%

TCT: 43%, 98%

12. 2010Korea

27

Dr. Hyeong Soo Lim292TS: 82.8%, 81.4%

LBC:75.9%, 83.3%

13. 2009Hubei/China

28

Prof Ding Ma302TS: 87%, 75%

Thin Prep: 75%, 92%

15. 2008Poland

29

Dr. Pruski234TS: 85%, 82%

15. 2003UK/Aus

30

Prof A. Singer651TS: 70%, 81%;

Pap: 69%, 95%

16/TRUSCREEN GROUP LIMITED PRODUCT DISCLOSURE STATEMENT 202016/TRUSCREEN GROUP LIMITED PRODUCT DISCLOSURE STATEMENT 2020
16 WANG Baojin,MA Qian,ZHAO Xinxin,et al. Application Value of TCT,HPV and TruScreen in Screening Cervical Disease. Journal of Practical Obstetrics and

Gynecology 2019 Nov.Vol. 35,No. 11

17 Qi Weihong, Zhang Wei et al. Clinical Observation of Cervical Cancer Screening System TruScreen in 1030 Cases. Electronic Journal Of Practical Gynecologic

Endocrinology. Nov. A. 2019 Vol.6, No.31

18 Yanhong Jia. The Clinical Effectiveness of Cervical Cancer Screening System TruScreen in Cervical Cancer Screening. Electronic Journal Of Practical Gynecologic

Endocrinology. Nov. A. 2019 Vol.6, No.31

19 Huixia Yang, Xinmiao Zhang, et al. The diagnostic accuracy of a real-time optoelectronic device in cervical cancer screening A PRISMA-compliant systematic

review and meta-analysis. Medicine (2018) 97:29

20 Ricardo Lua, et al. Comparison of an Optoelectronic Scan of the Cervix, Cervical Cytology and HPV Genotyping for CIN Screening. Journal of Lower Genital Tract

Disease. Vol 21, Number 2, Supplement 1, April 2017.

21 Li Pei, Jinsheng Wang et al. Application Effect of TruScreen System in Cervical Cancer Screening.

22 Özgü E, Yıldız Y, Özgü BS, Öz M, Danışman N, Güngör T. Efficacy of a real time optoelectronic device (TruScreen™) in detecting cervical intraepithelial pathologies: a

prospective observational study. J Turk Ger Gynecol Assoc. 2015;16(1):41-44. Published 2015 Mar 1. doi:10.5152/jtgga.2015.15199

23 Pruski, D., Przybylski, M., Kędzia, W. et al. Optoelectronic method for detection of cervical intraepithelial neoplasia and cervical cancer. Opto-Electron. Rev. 19, 478

(2011).

24 LIXia,YE Qing et al. Clinical research on fluorescence microscopy technology combined with cervix pap smear in cervical cancer screening. IMHGN,November

2011,Vo1.17 No.24

25 HE Xiu-kui, LUOXi-ping et al. An optoelectronic cervical cancer screening system for screening cervical cancer: comparison with cervical cytology. China

Reproductive Health 2013,24(1):9-11

26 CUI Ying-ying, ZHANG Bei ,RONG Feng-nian. The application value of cervical cancer screening system and thinprep cytological test in the screening of cervical

lesion during the women's health screenings.

27 Hyeong Soo Lim, M.D., et al, Korean Journal of Obstetrics and Gynecology Vol. 53 No. 10 October 2010, The efficacy of a real-time optoelectronic device as a

diagnostic tool of over cervical intraepithelial neoplasia 1 lesion

28 Zheng Hongbing, Ma Ding et al. Comparing Study of Truscreen® and Liquid Based Cytology Test in the Screening of Cervical Lesions.

29 D. Pruski,. Et al, The assessment of a real-time optoelectronic method for the detection of cervical intraepithelial neoplasia (‘CIN’), Volume107, Issue S2, Abstracts of

XIX FIGO World Congress of Gynecology and Obstetrics, October 2009,

30 Singer A, Coppleson M, Canfell K, et al. A real time optoelectronic device as an adjunct to the Pap smear for cervical screening: a multicenter evaluation. Int J

Gynecol Cancer 2003;13:804-11

For the purposes of the above table, the following terms have

the following meanings:

• Sensitivitymeasures correctly a positive result for

patients who have the condition that is being tested for

(also known as the “true positive” rate). A test that’s

highly sensitive will indicate patients who have the

disease.

• Specificitymeasures correctly a negative result for

people who don’t have the condition that is’ being

tested for (also known as the “true negative” rate). A

high-specificity test will correctly rule out patients

who do not have the disease.

• TSmeans TruScreen

• LBCmeans Liquid-based cytology. LBC is a method of

preparing samples for examination in cytopathology.

The sample is collected, normally by a small brush, in the

same way as for a conventional smear test, but rather

than the smear being transferred directly to a

microscope slide, the sample is deposited into a small

bottle of preservative liquid. At the laboratory, the liquid

is treated to remove other elements such as

mucus before a layer of cells is placed on a slide. The

technique improves specimen adequacy. It's been widely

used in developed countries (and China) but not in

developing countries like Vietnam and India.

• HPVmeans HPV DNA Test. The HPV DNA Test includes a

range of techniques used to test for the presence of high

and low risk HPV types in the cervical tissue. These

techniques may include PCR and Hybrid Capture. For

cervical cancer screening, it is the high risk strains of HPV

which may cause cervical cancer that is to be detected.

Since FDA approved Roche's HPV DNA testing to be used

in primary screening in 2014, it became the mainstream

primary screening method in all major screening

guidelines (e.g. WHO, EU, Australia etc).

• PPVmeans Positive predictive value. PPV is the

probability that subjects with a positive screening test

truly have the disease. Negative predictive value is the

probability that subjects with a negative screening test

truly don't have the disease.

BUSINESS INDUSTRY AND SECTOR
TruScreen is focused on the export of the TruScreen cervical

cancer screening system to large developing countries and

low and middle income countries (LMIC’s) which lack national

cervical cancer screening infrastructures.

TruScreen is used in these countries for women of Screening

age – typically 25 to 65 years. While guidelines vary from

country to country, according to WHO, these women should

be screened every 2 to 3 years

31

.

TruScreen is a device for the primary screening of cervical

cancer. That means that it is suitable for use for every

woman of screening age. If a patient has an abnormal

TruScreen result, (or pap smear or HPV DNA test) she is then

typically referred for a second opinion. Subject to different

countries requirements, this is usually performed using a

colposcope

32

to provide a magnified view of the cervix. If the

patient has a normal ‘TruScreen’ result she is typically sent

home and advised to return for her next TruScreen test in 2 or

3 years’ time.

However, as a real time device TruScreen system can be used

to facilitate ‘See and Treat’ screening in regions where there

is no access to reliable colposcopy and pathology services.

In this model if a patient has an abnormal TruScreen result

then she may be immediately treated by use of cryotherapy

33

or thermal coagulation

34

. This mitigates the risk of a patient

not returning for, or being unable to be located for,

colposcopy.

The table on the right shows the number of women of

screening age in our key target markets. TruScreen is

targeting to reach 5% of the addressable screening

population in our key markets with a potential revenue value

of up to NZ$166 million.

35

Screening Population by Country

Millions

China402

36

Russia42

38

Africa260

39

India318

40

Middle East75

41 42 43 44

Latin America

(including Mexico)

181

45

Vietnam24

46

Total1,302

CURRENT AND FUTURE KEY ASPECTS OF BUSINESS

The current and future aspects of TruScreen’s business that

have, or may have, the most impact on the financial

performance of the business are:

• The ability to generate sales revenues:Ultimately the

financial performance of the business will be driven by

the Company’s ability to generate sales revenues from

the sale of its products or licence technology that it has

developed through its research programmes to date.

The Company is planning further research and

development programs to further reduce the cost of

manufacture of its products. This will be an ongoing

process, and the Company will continue to assess ways

in which its products can be manufactured more cost

effectively.

31 World Health Organisation, 2013, Guidelines for screening and treatment of precancerous lesions for cervical cancer prevention, visited 28 August 2020, https://

www.who.int/reproductivehealth/publications/cancers/screening_and_treatment_of_precancerous_lesions/en/

32 A colposcope is a medical device used to examine an illuminated, magnified view of the cervix as well as the vagina and vulva

33 Cryotherapy, sometimes known as cold therapy, is the local or general use of low temperatures in medical therapy. Cryotherapy can be used to treat a variety of tissue

lesions

34 Thermal coagulation is a form of heat ablation used to treat CIN

35 This determination has been made by the Directors on the basis of an estimated penetration of each market (between 1% and 8% with an average of 4%) divided by 3

(each patient scanned every 3 years) multiplied by selling price if one SUS.

36 Central Intelligence Agency, The World Fact Book, CHINA, People and Society, Female ages 25-64 Years, visited 28 August 2020, https://www.cia.gov/library/

publications/the-world-factbook/geos/ch.html

38 Central Intelligence Agency, The World Fact Book, RUSSIA, People and Society, Female ages 25-64 Years, visited 28 August 2020, https://www.cia.gov/library/

publications/the-world-factbook/geos/rs.html

39 United Nations, Department of Economic and Social Affairs, Population Dynamics, Population by age and Sex (thousands) Africa, Female, 25-69 years, 2020, visited 28

august 2020, https://population.un.org/wpp/DataQuery/

40 Central Intelligence Agency, The World Fact Book, INDIA, People and Society, Female ages 25-64 Years, visited 28 August 2020, https://www.cia.gov/library/

publications/the-world-factbook/geos/in.html

41 Central Intelligence Agency, The World Fact Book, EGYPT, People and Society, Female ages 25-64 Years, visited 28 August 2020, https://www.cia.gov/library/

publications/the-world-factbook/geos/eg.html

42 Central Intelligence Agency, The World Fact Book, IRAN, People and Society, Female ages 25-64 Years, visited 28 August 2020, https://www.cia.gov/library/publications/

the-world-factbook/geos/ir.html

43 Central Intelligence Agency, The World Fact Book, TURKEY, People and Society, Female ages 25-64 Years, visited 28 August 2020, https://www.cia.gov/library/

publications/the-world-factbook/geos/tu.html

44 Central Intelligence Agency, The World Fact Book, SAUDI ARABIA, People and Society, Female ages 25-64 Years, visited 28 August 2020, https://www.cia.gov/library/

publications/the-world-factbook/geos/sa.html

45 United Nations, Department of Economic and Social Affairs, Population Dynamics, Population by age and Sex (thousands) Latin America, Female, 25-69 years, 2020,

visited 28 august 2020, https://population.un.org/wpp/DataQuery/

46Central Intelligence Agency, The World Fact Book, VIETNAM, People and Society, Female ages 25-64 Years, visited 28 August 2020, https://www.cia.gov/library/

publications/the-world-factbook/geos/vm.html

TRUSCREEN GROUP LIMITED PRODUCT DISCLOSURE STATEMENT 2020/17TRUSCREEN GROUP LIMITED PRODUCT DISCLOSURE STATEMENT 2020/17

18/TRUSCREEN GROUP LIMITED PRODUCT DISCLOSURE STATEMENT 2020
In the event that the Company is unable to implement its

business strategy and ultimately generate sales revenues

through the sale of its products, then such an occurrence

would have a material adverse impact on the financial

performance of TruScreen.

• Preservation of working capital until positive cashflow

achieved:During the period from the date of this

document to the period in which it is able to generate

positive cashflow, the Company must preserve its

working capital carefully to ensure it can continue to pay

its debts as they fall due in the ordinary course of

business, and to ensure that the value of its assets

exceed the value of its liabilities.

In the event that the Company ran out of financial

resources to be able to continue to fund its commercial

endeavours then such an occurrence would have a

material adverse impact on the financial performance of

TruScreen.

• Development of increased sales channels for the

distribution of the TruScreen technology solution in

China, Vietnam, Russia, Eastern Europe, India, Latin

America and Africa:The ability of TruScreen to

effectively develop its sales channels (i.e with a view to

increasing sales and revenues) in China, Vietnam, Russia,

Eastern Europe, India, Latin America and Africa taken

individually or collectively will have a material impact

upon the financial performance of TruScreen.

• Establishment of manufacturing in China: The

establishment of a manufacturing facility in China will

achieve a lower manufacturing cost, and by registering

TruScreen as a domestic product will remove the bias

against foreign products for use in public health

programs in China. The Company is negotiating with a

Chinese company which is ISO13485 accredited to

manufacture the TruScreen device in Shenzhen, China.

The Company is also negotiating with its current Sydney

based contract manufacturer to project manage and

facilitate the transition of the manufacturing to the

proposed contract manufacturer in China. The

changeover of manufacturing of the device is planned

for the June 2021 quarter.

KEY STRATEGIES AND PLANS FOR KEY ASPECTS

OF THE BUSINESS

TruScreen has developed the following key strategies and

plans for the above aspects of the business:

Revenue Generation

TruScreen has developed and is implementing an extensive

business plan and strategy that if optimally executed will

ultimately lead to the Company generating increased

revenues from the sale of the products it develops and

manufactures, and ultimately to generate profits from those

commercial operations.

The key strategies being implemented by the Company to

achieve these objectives are as follows:

• Efficient roll-out in established core markets.

China is the priority market and TruScreen is targeting to

double the number of hospitals where TruScreen system

will be available for patients within the next year. Russia

is another large market of focus where our distributor

has been implementing best in class educational

programmes reaching 2,000 doctors across the country

and has prepared a robust plan for further roll-out.

• Relentless focus on product quality and innovation.

Product quality remains an absolute priority. Recently

implemented electronic systems of quality assurance

control will provide significant efficiency in this area.

TruScreen are aligned with our customers’ (distributor)

and our customers customer (the hundreds of doctors

and nurses working with the TruScreen Ultra2 device)

needs, and plan further improvements based on their

feedback and requirements for a medical screening

device.

• Focus on commercial efficiency.

As a growing company TruScreen needs to invest to

support a significant increase in product sales in 2021.

While growing revenues, we will remain focus on

improving gross margin through manufacturing

efficiency, R&D programs aimed at reducing costs of

manufacture and the benefits of increasing sales

volumes.

• Expanding clinical support.

TruScreen and its distributors have invested heavily in

clinical trials in a number of countries. Publication of the

positive results achieved in these trials in respected

medical journals is key to clinical advocacy of the

TruScreen cervical cancer screening device. The

publication of the study undertaken at the Royal

Hospital of Women, Sydney, under our Medical Advisory

Committee supervision is expected in the 2021 FY will

provide support for the accuracy and reliability of our

system in a leading teaching hospital environment. To

support our commercial roll-out framework TruScreen

will be launching an on-line education program with

certification for health care professionals, initially to be

piloted in Vietnam. This approach will enable our team

to manage complex commercial roll-outs with a need to

educate simultaneously many doctors in different

countries starting their journey with TruScreen.

• Enhance team capabilities.

TruScreen have a strong and capable team and will add

talented professionals with expertise in medical devices

& LMICs in line with business requirements and projected

business growth.

Management of working capital resources

TruScreen has a detailed cashflow model to chart required

capital and operational expenditure and is constantly

monitoring adherence to that cashflow model to ensure the

Company has adequate financial resources to undertake its

commercial operations.

The Company’s scalable model also means capital for

expansion and development can be committed as the

economics justify it.

Money raised from this Offer will also ensure TruScreen is well
capitalised to implement its business plan and strategies

referred to above.

Development of increased sales channels for the

distribution of the TruScreen solution in China,

Vietnam, Russia, Eastern Europe, India, Latin

America, and Africa

TruScreen has adopted three key steps in its strategy to

develop its sales channels in these markets, as follows:

1. Appointment of a distributor(s) and the gaining of

regulatory approvals for the sale of TruScreen’s products.

TruScreen has distribution agreements in 23 countries,

including the world’s two largest screening populations,

China and India.

2. Gaining key opinion leader (KOL) support.

TruScreen has engaged with key opinion leaders and

conducted evaluation programs in the largest of its

markets, including programs with the China

Obstetricians and Gynaecologists Association. This

program is due to conclude in 2020.

3. Commenced commercial activity.

The majority of TruScreen’s sales are expected to come

from China, with Russia, Mexico, Zimbabwe and Vietnam

making up the majority of the balance of TruScreen’s

sales. Eastern Europe and India are expected to form the

next group of countries to start generating meaningful

revenues for the Company.

The Board would consider these initiatives to be effective if

TruScreen achieved the following, in respect of each market:

• year on year growth by country in the number of

installed (and operational) devices by country and a

broader acceptance by the number of hospitals.

• achievement of positive trial results;

• implementing good customer/distributor training

initiatives and service support;

• assisting distributors to reach and converting new

customers.

A summary of TruScreen’s current status and plans for growth

in our key markets is as follows:

China

China is TruScreen’s largest, most established market and is

the Company’s primary commercial focus. It has over 400

million women of screening age and accounts for over 20% of

all cervical cancer diagnoses worldwide

47

, presenting a

significant market opportunity for TruScreen. TruScreen has

been present in China since 2014, with the region accounting

for over 65% of the Company’s sales in FY2020.

The Company’s long-term goal is to have TruScreen added

to various national cervical screening guidelines and

procurement lists. Clinical validation and Key Opinion Leader

(KOL) support is the key to achieving this goal and has been

our overriding focus since market entry.

In 2018 TruScreen commenced a large-scale evaluation with

the Chinese Obstetricians and Gynaecologists Association

(COGA), to screen up to 20,000 women across 10 provinces.

The size of the trial has since been reduced to 10,000

patients due to the interruption from COVID-19 lockdowns

during the first quarter of calendar year 2020. The trial, the

largest TruScreen has done, aims to have TruScreen

introduced into 100 top-tier teaching hospitals throughout

China, forming part of the organisation’s cervical cancer

screening guidelines. COGA represents over 100,000

obstetricians and gynaecologists throughout China, focusing

on the management, education, regulation and certification

of these specialists. Since starting the evaluation TruScreen

has gained KOL support from various levels of the

organisation at both a provincial and national level. The trial

is due for completion in late 2020, with results expected to be

published in 2021.

The 3,000 patient clinical evaluation with the Women’s and

Children’s Division of China’s Centre for Disease Control

(CDC) commenced in late 2018 however has been suspended

by CDC until further notice. The evaluation has been

suspended due to the Company’s sub-distributor responsible

for the oversight of this evaluation suffered financial

difficulties. If the suspended clinical evaluation is terminated,

sale of TruScreen cervical cancer screening device will

reduce the access, but not exclude sales to those hospitals

managed by the CDC. The termination of this clinical

evaluation would not have a material adverse impact on the

financial or operational position of the Company.

In addition to our focus on clinical studies, TruScreen has

been building its commercial user base in both public and

private hospitals. The TruScreen technology is currently in

commercial use in 18 provinces throughout China, with further

government procurement projects underway. TruScreen

targets to double its presence in Chinese hospitals and reach

100 hospitals threshold in next 12 months. TruScreen is

working closely with its distribution network to increase each

hospital’s monthly SUS usage for each installed device. This

commercial base is consistently growing, as market

acceptance of the technology increases, and forms a strong

foundational support for TruScreen clinical initiatives within

the country.

47 Weim, et al, 2018, ‘Rising Mortality Rate of Cervical Cancer in Younger Women in Urban China’, J Gen Intem Med, vol. 34, no. 2, p.281-284, viewed 28 August 2020, https:/

/link.springer.com/content/pdf/10.1007%2Fs11606-018-4732-z.pdf

TRUSCREEN GROUP LIMITED PRODUCT DISCLOSURE STATEMENT 2020/19

Russia
The Russian Federation is TruScreen’s key market. Cervical

Cancer is the fourth most common cancer for women in

Russia. With a screening population of 42 million women and

no organised cervical cancer screening

48

, TruScreen is well

positioned in this market as a primary screening solution.

TruScreen has been present in Russia since 2015, and after

bringing on a new distribution partner in early 2019 the sales

in the region grew, accounting for 20% of FY2019 sales.

The Company’s focus in Russia over the last 2 years has been

market education and acceptance, and KOL endorsement.

In early 2020 TruScreen’s regional distributor launched a

nationwide TruScreen education campaign in partnership

with Russia’s top KOL on cervical cancer, the President of the

Russian Association of Gynaecological Diseases and

Neoplasia. This educational seminar engaged over 2,800

doctors and specialists, across 18 cities. The outcome of the

campaign has seen a high acceptance of the technology

within the group, with significant support for formal adoption

as a primary screening tool. TruScreen targeted to

commence large pilot projects in key regions like

Chechenskaya Republic in Q2’2020 but was delayed by

COVID-19 outbreak.

TruScreen is currently in preparations for a clinical evaluation

with Federal State Budgetary Institution "National medical

and surgical center named after N. I. Pirogov" (NMSC) of the

Ministry of Health of the Russian Federation ( 105203 Moscow,

Nizhnyaya Pervomayskaya str., 70). This study will be run by

Prof. Kira Evgeny Fedorovich, Head of the Department of

women's diseases and reproductive health at NMSC,

Academician of the Russian Academy of Sciences, Member

of the Presidium of the Russian society of obstetricians and

gynaecologists (ROAG).

Vietnam

Vietnam forms the basis of TruScreen’s South-East Asian

strategy, successful market establishment in the region will be

used to establish market entry in other SE Asian countries.

Vietnam has 24 million women of screening age

49

, and

currently has no centralised national cervical screening

program. TruScreen has been in Vietnam since 2016, with

early efforts focussed on KOL and Ministry of Health (MOH)

education programs.

In late 2019 TruScreen commenced a pilot study at the

largest gynaecological hospital in Vietnam, Ha Noi Obstetrics

and Gynaecology Hospital (HOGH), in partnership with

MOH’s appraisal committee. The pilot study screened almost

1,000 women, comparing the TruScreen device to the

conventional Pap test. In early 2020 the MOH appraisal

committee reviewed the results of the trial and endorsed and

approved the TruScreen device for use in Vietnam. After the

successful pilot study HOGH signed a contract committing to

large scale monthly TruScreen cervical cancer screening

within the hospital.

Following MOH approval, TruScreen’s local distributor has

begun a marketing and education campaign in the South of

Vietnam. The education campaign is focussed on 10 top-

level teaching hospitals, enhancing the doctor’s overall

understanding of cervical cancer, and introducing the

TruScreen cervical cancer screening system as the primary

screening tool.

Expanding TruScreen’s presence outside of the

key markets

TruScreen’s ability to provide accurate real-time results

without access to pathology infrastructure means it is the

ideal screening solution for LMICs. TruScreen continues to

grow its presence in other regions, including Africa, Mexico,

India, the Middle East, and Central Eastern Europe.

19 out of 20 countries with the highest cervical cancer burden

are in Africa.

50

There are 260 million women of screening age

in Africa, with 13.3 million women suffering from HIV.

51

Our

African strategy is focused on sub-Saharan Africa, where HIV

has a high prevalence. Women who suffer from HIV are 5

times more likely to be diagnosed with Cervical Cancer. In

2018 TruScreen partnered with Zimbabwe’s National Aids

Council for a cervical cancer screening project aiming to

reach approximately 15,000 women throughout Zimbabwe.

Mexico is TruScreen’s entry point into Latin America, and

accounted for 11% of sales in FY2020. Mexico has a screening

population of 31 million, with cervical cancer being the third

most common cancer in the region.

52

TruScreen has been

present in Mexico since 2015, having recently signed a new

distribution agreement in 2020. TruScreen has been utilised

in novel ways to reach the rural communities of Mexico. In

2017 & 2018, TruScreen was selected for use in Mexico’s

famous Health Train, El Tren de la Salud. The health train

operates in 22 Mexican states, bringing advanced medical

screening technologies to women living in remote

communities.

India is home to a screening population of over 300 million

women.

53

Cervical cancer is the second leading cause of

cancer death in women in the country.

54

TruScreen has been

present in the region since 2017. In 2018 & 2019 the national

All India Institute of Medical Sciences (AIIMS) conducted a

TruScreen trial, screening 645 women over 13 months. The

trial outcomes showed TruScreen to be more accurate at

detecting cervical cancer than the conventional Pap-test.

The results are expected to be published in 2021 with

commercial sales to start once covid-19 restrictions are lifted.

In 2020 the Company rationalised its distribution portfolio in

Central and Eastern Europe (CEE), appointing a prominent

medical device distributor to cover Czech Republic, Slovakia

and Poland. The Company also appointed a Europe based

commercial representative to drive our strategy for the

48 Central Intelligence Agency, The World Fact Book, RUSSIA, People and Society, Female ages 25-64 Years, visited 28 August 2020, https://www.cia.gov/library/

publications/the-world-factbook/geos/rs.html

49 Central Intelligence Agency, The World Fact Book, VIETNAM, People and Society, Female ages 25-64 Years, visited 28 August 2020, https://www.cia.gov/library/

publications/the-world-factbook/geos/vm.html

50 United Nations, Department of Economic and Social Affairs, Population Dynamics, Population by age and Sex (thousands) Africa, Female, 25-69 years, 2020, visited 28

august 2020, https://population.un.org/wpp/DataQuery/

51 World Health Organisation, Number of women living with HIV increases in each region of the world, 2004, visited 28 August 2020, https://www.who.int/3by5/news34/en/

52 ICO/IARC Information Centre on HPV and Cancer, Mexico, Human Papillomavirus and Related Cancers, Fact Sheet 2018, 2019, viewed 28 August 2020, https://

hpvcentre.net/statistics/reports/MEX_FS.pdf

53 Central Intelligence Agency, The World Fact Book, INDIA, People and Society, Female ages 25-64 Years, visited 28 August 2020, https://www.cia.gov/library/

publications/the-world-factbook/geos/in.html

54 The George Institude for Global Health India, Cervical Cancer in Idia: Challenge and Opportunities, 2018, viewed 28 August 2020, https://www.georgeinstitute.org/

cervical-cancer-in-india-challenges-and-opportunities

20/TRUSCREEN GROUP LIMITED PRODUCT DISCLOSURE STATEMENT 2020

TRUSCREEN GROUP LIMITED PRODUCT DISCLOSURE STATEMENT 2020/21
region. Although in the early stages of development,

TruScreen views the CEE region as an important market

opportunity for TruScreen.

Establishment of manufacturing in China

TruScreen is well advanced in its planning to have its device

assembled in China for the Chinese market, and to have its

device registered as a domestic product manufactured in

China.

55

This will lower manufacturing costs due to lower

labour and component costs. The registration of TruScreen

as a domestic product in China will also remove the bias

against foreign products in the Company’s most important

market.

To date, TruScreen has taken the following steps towards its

planning to manufacture the device in China include:

Appointment of an experienced engineer consultant for six

months to lead the project;

The Company is working with the current Sydney based

manufacturer in preparing a scope of work for the transition

of manufacture;

The proposed Chinese manufacturer is ISO13485 accredited ;

In view of COVID-19, the Company is establishing procedures

to ensure transition to China notwithstanding limitations on

travel.

For more information please refer to Section 7

(TruScreen’s Financial Information). A full set of the financial

statements for TruScreen can also be found on the Disclose

Register at www.business.govt.nz/disclose, offer number

OFR12990.

DIRECTORS AND SENIOR MANAGERS

The Directors of TruScreen are Anthony Ho, Christopher Horn,

Chris Lawrence, and Juliet Hull.

The senior managers of TruScreen are Victoria Potarina,

Edmond Capacelea, Guy Robertson, Dr Jerry Tan, Paul

Curran, Dr Zhenglin Wang.

Board of Directors

Biographies for each of the directors are provided below:

Anthony (Tony) Ho

Independent Non-Executive Chairman

B.Com UNSW, CA, FCIS, FAICD, FGIA

Tony has a Bachelor of Commerce degree from The

University of New South Wales, Sydney, and is a Member of

The Institute of Chartered Accountants in Australia and New

Zealand, a Fellow of the Australian Institute of Company

Directors, a Fellow of the Institute of Chartered Secretaries

and Administrators, and the Governance Institute of

Australia. He has also completed post graduate studies in

Marketing at the University of Technology, Sydney. He was a

past Fellow of the Australian Marketing Institute.

Tony holds numerous non-executive directorships with a

number of ASX and NZX listed companies. He is currently the

non-executive chairman of Bioxyne Limited (ASX:BXN),

Greenland Minerals Limited (ASX:GGG), and Cannasouth

Limited (NZX:CBD).

Tony was executive director of Arthur Yates & Co Limited,

retiring from that position in April 2002. He was previously a

director of Yates New Zealand Limited. Prior to joining

commerce, Tony was a partner of Cox Johnston & Co,

Chartered Accountants, which has since merged with Ernst &

Young.

Christopher Horn

Non-Executive (Independent) Director

B.Com UNSW, FCA

Chris Horn has been involved with TruScreen for a number of

years. He is an experienced business executive and has

acted in a number of management roles including 20 years

as a senior partner of KPMG and its predecessor firms. He is a

director of a number of private companies across a broad

range of business activities including corporate advisory,

financial services, and funds management.

Chris is a Commerce graduate from the University of New

South Wales, Sydney, Australia and a Fellow of the Institute of

Chartered Accountants in Australia and New Zealand.

Chris is also the Chair of TruScreen’s Audit, Finance and Risk

Committee.

Chris Lawrence

Non-Executive (non-independent) Director

Chris Lawrence is a successful New Zealand businessman

and a significant investor in life science and biotechnology

businesses including TruScreen. He has spent a substantial

part of his career in small business where he has had proven

success in leading marketplace disruption, and translating

new business models into sustainable profitable businesses.

In the latter part of his career, he has dedicated a large

share of his time to governance and advisory roles.

Most recently Chris’ focus has been on high growth

companies, with a particular focus in the biotech industry.

Juliet Hull

Non-Executive (Independent) Director

B. Nurse ATI, MBA MGSM

Juliet Hull has an MBA from the Macquarie Graduate School

of Management, Sydney Australia, and a Bachelor of Nursing

from the Auckland Technical Institute.

Juliet Hull is the NZ General Manager/Country Director for

Johnson & Johnson Medical in New Zealand and has held

various roles in Johnson & Johnson in Australia and New

Zealand since 2012.

Juliet Hull has more than twenty years’ experience working in

Asia and Pacific markets in Healthcare, in sales, Marketing

and leadership.

55 Please also refer to the paragraph titled “Establishment of Manufacturing in China” on page 18.

22/TRUSCREEN GROUP LIMITED PRODUCT DISCLOSURE STATEMENT 2020
Senior Managers

Biographies for each of the senior managers are provided

below:

Victoria Potarina

Chief Executive Officer,

M. App Ling (Hons), GAICD

TruScreen appointed Ms Victoria Potarina as Chief Executive

Officer, commencing 2 March 2020.

Victoria Potarina has a Master in Applied Linguistics and is a

Graduate member of the Australian Institute of Company

Directors. Victoria is an MBA candidate with Macquarie

Graduate School of Management.

Ms Potarina brought more than twenty years’ commercial

experience, previously working at Johnson & Johnson (J&J) in

both the UK and across Europe. In addition, she has held

positions at multiple multinational companies in the FMCG,

over-the-counter, medical devices and healthcare sectors.

While at J&J UK, Ms Potarina was Business Unit Director of

the UK and Ireland Diabetes Care Division which comprised

of two business units, including; LifeScan, a diagnostic

systems manufacturer focusing on the diabetes market

specifically blood glucose monitoring systems, and Animas,

which specialises in making insulin pumps for diabetes.

Victoria was the Statutory Director or Johnson & Johnson UK

& Ireland.

Prior to this, she was LifeScan Marketing Director of Eastern

Europe, a US$200 million turnover business. During her time in

this position, Ms Potarina successfully facilitated a market

share turnaround in Russia and consistent year-on-year

double-digit growth in Eastern Europe.

Edmond Capacelea

Chief Technology Officer,

M.Sc Eng Physics

Edmond Capcelea has a Masters degree in Engineering

Physics.

Mr Capcelea is a senior medical device executive with more

than 25 years of experience in medical device design and

development. His expertise includes leading multidisciplinary

Class II and implantable medical device product

development and technology teams, both locally and

overseas.

Mr Capcelea’s previous roles include Divisional Director Head

of Implants Design & Development and Divisional Director

Head of Externals R&D at ASX listed Cochlear Limited, and

Senior Vice President of R&D at Saluda Medical. He has

extensive experience in leading complex R&D projects from

concept to commercialisation and has led the end to end

product development of a wide range of Medical Devices

ranging from Class II to Class III.

Guy Robertson

Company Secretary/Chief Financial Officer,

B. Com (Hons) CA

Guy Robertson has a Bachelor of Commerce degree and is a

member of the Institute of Chartered Accountants in

Australia and New Zealand.

Guy has over 30 years of management and leadership

experience. He has extensive experience as a finance

executive in Australia and Asia across a broad range of

industries, in both private and listed companies.

Mr Robertson is currently a director of ASX listed Hastings

Technology Metals Limited and Metal Bank Limited.

Dr. Jerry Tan

General Manager

General Manager Commercial,

MBBS, M.Com, CPA

Dr. Jerry Tan holds a degree in Medicine and Surgery and is a

qualified Gynaecologist from China. He also holds a Master

degree in commerce from Macquarie University and is a

Certified Practising Accountant in Australia. He is fluent in

English and Mandarin.

Dr. Tan has extensive knowledge of the TruScreen product

and has been involved in establishing the market in China,

including, identification of distributors, product registration,

market evaluation, and the conduct of clinical trials.

Dr. Tan heads up TruScreen’s operations in China, Vietnam,

Mexico, and India.

Paul Curran

General Manager – Regulatory/Compliance Affairs,

B.Sc Eng

Mr. Paul Curran has a Bachelor of Science, specialising in all

areas of Medical Device Licensing, including Quality

Assurance for New Product Development, Technical File

development and Audit and Risk Assessment.

He is experienced in Healthcare Compliance and the

control of manufacturing, including subcontractors, for the

delivery of a quality assured product on time.

Mr. Curran has been involved with the TruScreen product for

many years and is responsible for registrations and quality

assurance.

Dr. Zhenglin Wang

Manager - Electro-Optical Production,

PhD (Laser), B. Sc (Opto) M. Optics

Dr Wang has a Bachelor of Science in Optoelectronic, Master

degree in Optics and a PhD in Laser Physics. He previously

managed the manufacture and development of a range of

optical technologies including ophthalmic lasers and

wavelength selective switch systems for communication

technologies.

TRUSCREEN GROUP LIMITED PRODUCT DISCLOSURE STATEMENT 2020/23
Dr. Wang led the establishment of, and now manages, the

TruScreen Electro-Optical fabrication facility based in the

Industry Collaboration Hub at the Commonwealth Scientific

and Industrial Research Organisation (CSIRO), in Lindfield.

Medical Advisory Committee

The TruScreen Medical Advisory Committee’s role is to advise

the directors and executives of TruScreen on clinical,

scientific and medical matters. This includes the review of

clinical trials, monitoring developments in the screening,

diagnosis and treatment of cervical cancer, advising on

screening and referral paradigms and patient management

protocols.

In addition, the Medical Advisory Committee advises on

additional applications of the existing TruScreen technology

and any other technologies that may be of interest to

TruScreen.

The members of the TruScreen Medical Advisory Committee

are:

Colonel (Dr.) Assoc Prof Michael J. Campion

RAAMC, CStJ, KM, KCHS, KLJ

The TruScreen Medical Advisory Committee is led by Colonel

(Dr.) Assoc Prof Michael J. Campion. Dr Campion is a Senior

Staff Specialist and Head of the Pre-Invasive Clinic at the

Gynaecological Cancer Centre of the Royal Hospital for

Women in Sydney and is a Conjoint Associate Professor,

School of Women’s and Children’s Health, at the University of

New South Wales. He has over 30 years’ experience as an

eminent medical practitioner and over 20 years of

experience as an expert colposcopist.

In addition, Assoc Prof. Campion is the Director, Health

Services Army Reserve – Eastern Region for the Royal

Australian Army Medical Corps and is both a Board member

and National Hospitaller, St John Ambulance, Australia.

Assoc Prof. Campion has written numerous peer

reviewed papers and chapters on cervical cancer, including

papers on the TruScreen cervical cancer screening

technology.

Professor Neville Hacker AM

Clinical Advisory - Professor of Gynaecology

Professor Hacker is Conjoint Professor of Gynaecological

Oncology at the University of New South Wales and recently

retired from clinical practice after 32 years as the director of

the Gynaecological Cancer Centre, Royal Hospital for

Women in Sydney, where he continues to serve as an

Emeritus consultant.

He is a past President of the Society of Pelvic Surgeons,

a past President of the International Gynaecological Cancer

Society, former Chairman of the Oncology Committee of the

RANZCOG, and a former Chairman of Examiners for

Gynaecologic Oncology, RANZCOG.

Table of substantial shareholders and of relevant
interests held by directors and senior managers, etc

Substantial product holders prior to the Offer

Product Holders with

relevant interests in 5%

or more of a class of

relevant securities

Legal ownership or other nature of

the interest

Number

of

relevant

securities

held

% of relevant

securities held

Robert Hunter

(registered holder:

Consolidated Nominees Pty

Limited)

Controller of registered holder39,602,400 11.92

Browns Island Holdings

Limited

Legal and beneficial22,400,0006.74

Waitara Trustees LimitedLegal and beneficial 18,622,222 5.6

Total80,624,62224.26%

Substantial product holders after the Offer

Product Holders with

relevant interests in 5%

or more of a class of

relevant securities

Legal ownership or other nature of

the interest

Number

of

relevant

securities

held

% of relevant

securities held

56

Robert Hunter

(Registered holder:

Consolidated Nominees Pty

Limited)

Controller of registered holder39,602,400 10.97%

Browns Island Holdings

Limited

Legal and beneficial22,400,0006.21%

Waitara Trustees LimitedLegal and beneficial18,622,222 5.16%

Total80,624,62222.34%

56 The percentages in this column of the table have been calculated on the assumption that the maximum number of 28,571,428 new ordinary Shares are issued

pursuant to the Offer.

24/TRUSCREEN GROUP LIMITED PRODUCT DISCLOSURE STATEMENT 2020

Relevant interests of each director, proposed director, senior manager
and proposed senior manager of the issuer prior to and after the offer

Interest HolderLegal

ownership or

other nature

of the interest

Prior to the OfferImmediately after the issue

57

Number of

relevant

securities held

% of

relevant

securities

held

Number of

relevant

securities likely

to be held

% of

relevant

securities

likely to be

held

Anthony Ho

Legal and

beneficial

3,500,0001.05 3,500,0000.97%

Christopher Lawrence

Beneficial

(registered holder

is Brown Island

Holdings Limited)

22,400,0006.74 22,400,0006.21%

Christopher Horn

Legal and

beneficial

2,050,0000.62 2,050,0000.57%

Guy Robertson

Legal and

beneficial

102,1700.03 102,1700.03%

Timin (Jerry) Tan

Legal and

beneficial

100,0000.07 100,0000.03%

Paul Curran

Legal and

beneficial

88,5300.026 88,5300.02%

Total28,240,700 8.53628,240,700 7.82%

Name of recipientNumber of optionsExercise priceVestingExercise Date

Anthony Ho (Director)2,000,000

1,000,000

15 cents

13 cents

Vested

Vested

Exercisable on or

before 27 August 2022

Exercisable on or

before 12 July 2021

Guy Robertson

(Chief Financial

Officer)

500,000 15 centsVestedExercisable on or

before 27 August 2022

Christopher Horn

(Director)

1,000,00015 centsVestedExercisable on or

before 27 August 2022

Christopher Lawrence

(Director)

1,000,00015 centsVestedExercisable on or

before 27 August 2022

Zhenglin Wang

(Manager,

Manufacturing)

500,00015 centsVestedExercisable on or

before 27 August 2022

The following Directors and senior managers also hold options to acquire shares in the Company:

57 The calculations in this column assume that the maximum number, 28,571,428, of new shares are issued pursuant to the Offer.

TRUSCREEN GROUP LIMITED PRODUCT DISCLOSURE STATEMENT 2020/25

Options to acquire shares in the Company
There are a total of 19,677,363 options to acquire ordinary shares in TruScreen on issue in the Company. There are two classes of

options, the details of which are as follows:

Interests of directors and senior managers

Director remuneration and benefits

The table below sets out:

• the total of the remuneration and the value of other benefits received by each director of TruScreen in respect of the

Company or any other member of TruScreen during the most recent period; and

• the nature of any services provided by each director to which that remuneration or those benefits relate (other than services

provided in that person’s capacity as a director).

Class of OptionNumber of options

on issue

Exercise priceVestingExercise Date

TruScreen executive

options

9,000,000 15 centsVestedExercisable on or

before 27 August 2022

Placement Options 10,677,36313 centsVestedExercisable on or

before 12 July 2021

Director Total remuneration and

value of other benefits

received

Nature of services

provided

Expected differences in

remuneration or

benefits for FY 2021

Anthony Ho$110,000Non-executive ChairmanDuring the financial year

ended 31 March 2020, the

annual directors fee payable

to the director was $80,000

per annum. During this year

the Chairman was paid an

additional fee of $30,000 for

acting as an executive

chairman, pre appointment

of a new CEO.

Christopher Lawrence$40,000Non-executive DirectorDuring the financial year

ended 31 March 2020, the

annual directors fee payable

to the director was $40,000

per annum.

Christopher Horn$50,000 Non-executive DirectorDuring the financial year

ended 31 March 2020, the

annual directors fee payable

to the director was $40,000

per annum. Mr Horn received

an additional $10,000 per

annum for chairing the Audit,

Finance and Risk Committee

of Directors.

Juliet HullNilNon-executive DirectorDuring the financial year

ending 31 March 2021, the

annual directors fee

proposed to be paid to the

director will be $40,000 per

annum.

26/TRUSCREEN GROUP LIMITED PRODUCT DISCLOSURE STATEMENT 2020

Opening Date26 November2020
Closing Date 18 December2020

Settlement and allotment of

Shares

30 December2020

Earliest expected mailing of

holding statements

30 December2020

Anticipated date of

quotation of the new Shares

on NZX Main Board and the

quotation of all Shares on

ASX

6 January2021

In addition to the above payments, the Company also issued

the following options to each director as part of the

TruScreen Employee Share Option Plan:

• Anthony Ho: 2,000,000 options, the details of which are

provided in the Table on page 25.

• Christopher Horn: 1,000,000 options, the details of which

are provided in the Table on page 25.

• Christopher Lawrence: 1,000,000 options, the details of

which are provided in the Table on page 25.

Employee remuneration over $100,000 per annum

As at the date of this PDS, the following employee not being

a director of the Company, will receive remuneration and

other benefits in their capacity as an employee, that in value

exceeds NZ$100,000 per annum.

Purpose of the offer

The purpose of this offer is to raise a minimum of

NZ$1,000,000 of new capital, and a maximum of

NZ$2,000,000 of new capital for TruScreen, which capital

will enable the Company to implement its strategic

business plan.

In the event that a minimum of NZ$1,000,000 is not raised

pursuant to this offer, the Offer will not proceed, and no new

shares will be issued pursuant to this Offer.

The money raised under the Offer will be applied as follows

1

:

The intended key dates for the offer are:

This timetable is indicative only and the dates may change.

TruScreen reserves the right to vary any of the above dates

as required from time to time.

An investor who wishes to subscribe for new shares in

TruScreen must return their application form, together with

payment of the application monies to the Registrar on or

before 5pm on the date on which the Offer closes. If a valid

application and payment is not received by this date, an

investor’s application will not be accepted by TruScreen.

Conditional Offer

This Offer is conditional upon the ASX approving the

admission of the Company to the official list of the ASX as an

ASX Foreign Exempt Listing and for quotation of the Shares

on the ASX on or before that Closing Date (as that date may

be varied from time to time). In the event that this condition is

not satisfied, then this Offer will not proceed, and all

application moneys received by the Company will be

refunded to investors in full and without deduction within 5

business days.

Particulars of how each intended use of funds relates to the

strategies and plans of TruScreen’s business is provided in

Section 2. The funds will be applied towards the

aforementioned purposes irrespective of whether the

minimum of NZ$1 million, or the maximum amount of NZ$2.0

million is raised under this Offer.

No underwrite

The offer is not underwritten.

1

In the event the raise is less or more than $1.5 million then

one or more categories could be indexed lower or higher

accordingly.

Remuneration bracketNumber of employees

NZ$200,000 - $220,000 1

NZ$300,000 - $310,0001

3. Purpose of the offer

4. Key dates

and offer process

TRUSCREEN GROUP LIMITED PRODUCT DISCLOSURE STATEMENT 2020/27

Investment in team capabilities for

business expansion

$200,000

Establish device manufacturing in

China for Chinese operations

$300,000

Reduce the cost of the product via

R&D initiatives

$300,000

Market development through market

access/medical affairs capability

$200,000

Costs associated with the offer

and dual listing

$300,000

General working capital$200,000

Total$1,500,000

Description of the equity securitiesNew ordinary fully paid shares in TruScreen
PriceNZ 7 cents per share, or AU 6.5 cents per Share

Number or amount of the equity

securities being offered

A minimum of 14,285,714new Shares are being offered, representing 4.1%of the

total number of ordinary shares on issue immediately after the issue (assuming

only 14,285,714new shares are issued).

A maximum of 21,428,571 new Shares are being offered, representing 6.1%of the

total number of ordinary shares on issue immediately after the issue (assuming all

21,428,571 new shares are issued).

The Board of TruScreen has the discretion to accept oversubscriptions of a up to

a maximum of 7,142,857 new Shares representing a maximum of $500,000. In the

event that the Offer is fully subscribed and the Board resolves to accept

oversubscriptions to the maximum level, the maximum number of Shares that

can be offered under the Offer is 28,571,428 new Shares, representing 8.2% of the

total number of ordinary shares on issue immediately after the issue (assuming all

28,571,428 new shares are issued).

Any oversubscriptions received shall be apportioned as between the two

geographic pools referred to below, in the same proportions as each the two

geographic pools represent as a percentage of the total Offer.

Offer Opening (“Opening Date”)26 November2020

Offer Closing Date (“Closing Date”)18 December2020 TruScreen has the right at its discretion to close the Offer prior

to the Offer Closing Date.

Structure of the OfferThe Offer has been divided in to two geographic pools. A pool of 14,285,714 new

Shares (NZ$1 million) has been set aside for subscription by Australian Residents

(“Australian Pool”). A pool of 7,142,857 new Shares (NZ$500,000) has been set

aside for subscription by New Zealand Residents (“NZ Pool”).

In the event that one of the geographic pools is undersubscribed, then the

balance of that pool may be allocated to the other pool for subscription.

ScalingTruScreen may scale applications at its sole discretion.

RefundsIf TruScreen does not accept your application (whether because of late receipt

or otherwise) or accepts it in part, all or the relevant balance of your application

money received will be repaid to you as soon as practicable and, in any event,

no later than 5 Business Days after the Issue Date.

No interest will be paid on refunds.

Minimum application amounts10,000shares and multiples of 1,000 shares thereafter

How to applyApplication instructions are set out in section 11 of this PDS

(How to apply).

TruScreen reserves the right to refuse all or any part of any application for Shares

under the Offer without giving a reason.

Liabilities, fees and chargesWith the exception of the payment of the Issue Price, a holder of ordinary shares

has no liability to make further payments, or to pay any fees or charges relating

to those ordinary shares.

Conditional OfferThis Offer is conditional upon the ASX approving the admission of the Company

to the official list of the ASX as an ASX Foreign Exempt Listing and for quotation

of the Shares on the ASX on or before that Closing Date (as that date may be

varied from time to time). In the event that this condition is not satisfied, then this

Offer will not proceed, and all application moneys received by the Company will

be refunded to investors in full and without deduction.

5. Terms of the Offer

28/TRUSCREEN GROUP LIMITED PRODUCT DISCLOSURE STATEMENT 2020

The constitution of TruScreen, which prescribes the terms of
the Shares, may be obtained from the Companies Office

website (www.companies-register.companiesoffice.govt.nz),

or from the Offer Register.

ASX listing

An application will be made to the ASX after this PDS has

been lodged on the Offer Register for TruScreen to be

admitted to the official list of the ASX as an ASX Foreign

Exempt Listing and for quotation of the Shares on the ASX.

If TruScreen is admitted to the official list of the ASX as a

Foreign Exempt Listing, it will need to comply with the NZX

Listing Rules (other than as waived by NZX) but will not need

to comply with the vast majority of the ASX Listing Rule

obligations. Rather, TruScreen will need to comply only with

the rules specified in ASX Listing Rule 1.15 which are relatively

procedural in nature. TruScreen will not be subject to

substantive ASX Listing Rule requirements such as the rules

on continuous disclosure, periodic reporting, shareholder

approval of share issuances, escrow, transactions with

persons of influence and significant transactions.

Under ASX Listing Rule 1.15, TruScreen must immediately

provide to ASX all the information that it provides to the NZX

that is, or is to be, made public. Such information will appear

on TruScreen’s announcements platform on the ASX website

at www.asx.com.au.

ASX takes no responsibility for the contents of this PDS or for

the merits of the investment to which this PDS relates. The

fact that the ASX may admit TruScreen to the official list of

the ASX and quote the Shares on the ASX is not to be taken

as an indication of the merits, or as an endorsement by the

ASX, of TruScreen or the Shares. The ASX is not a licensed

market under the FMCA.

For the avoidance of any doubt, TruScreen is currently, and

will still be, bound by the NZX Listing Rules regardless of the

outcome of this Offer and the Foreign Exempt Issuer Listing

application made to ASX.

Selling restrictions

The Offer is only being made to New Zealand residents and

Australian residents. The Offer is being made in Australia in

reliance on the trans-Tasman mutual recognition scheme

under Chapter 8 of the Corporations Act 2001 (Cth) and the

Corporations Regulations 2001 (Cth).

The Shares

All Shares issued under the Offer will be fully paid ordinary

shares in TruScreen Group Limited which rank equally with

each other and all other ordinary shares in the Company on

issue. The key features of the Shares do not differ from those

that apply to other ordinary shares in a company generally.

Each Share gives the holder the right to:

• attend and vote at a meeting of TruScreen, including the

right to cast one vote per Share on a poll (subject to any

voting prohibitions under the Listing Rules);

• an equal share with other Shares in any dividends

authorised by the Board;

• an equal share with other Shares in the distribution of

surplus assets in any liquidation of TruScreen;

• be sent certain information to shareholders by

TruScreen; and

• other rights as a shareholder conferred by the

Companies Act 1993 and TruScreen’s Constitution.

Dividends and Dividend Policy

Dividend payments in respect of the Shares are not

guaranteed, are at the discretion of the Directors, and will be

declared only after TruScreen has been found to meet the

appropriate solvency requirements.

The Company’s Board currently has no intention to declare

dividends, and has no expectation that the Company will

pay a dividend until such time as it is trading profitably.

No guarantee of Shares

No person or entity guarantees or undertakes any liability in

respect of the Shares of TruScreen or the future value or

performance of them.

Consequences of Insolvency

No holder of TruScreen Shares will be liable to pay any further

amounts to the Company or any other person in respect of

those Shares if TruScreen becomes insolvent.

In a liquidation of the Company, the claims of TruScreen

shareholders will rank equally with each other, and after the

claims of:

• persons to whom preferential payments must be made;

• secured creditors; and

• unsecured creditors.

Alteration of Shares

The rights attaching to the Shares are governed by

TruScreen’s constitution, the Companies Act 1993 and the

terms under which they have been issued. The constitution

may only be altered by special resolution of shareholders

subject to the rights of interest groups under the Companies

Act 1993, or in certain circumstances by Court Order. A

special resolution of shareholders must be approved by 75%

of shareholders who are entitled to vote and are voting on

that resolution. In certain circumstances, a shareholder

whose rights are affected by a special resolution may require

TruScreen to purchase their Shares.

6. Key features of

TruScreen Shares

TRUSCREEN GROUP LIMITED PRODUCT DISCLOSURE STATEMENT 2020/29

These tables provide key financial information about the
TruScreen group. Full financial statements are available on

the Offer Register at www.business.govt/disclose. If you do

not understand this financial information, you can seek

advice from a financial adviser or an accountant.

Selected financial information

No prospective financial information provided

This Product Disclosure Statement does not contain any

prospective financial information.

In the opinion of the directors of TruScreen, after due enquiry

by them, the inclusion of prospective financial information

into this Product Disclosure Statement would be

inappropriate as such information would be likely to deceive

or mislead existing TruScreen shareholders, new investors in

this Offer, and the general investing public. The reasons for

this opinion are:

1 The result for the year ended 31 March 2020 includes a one off non cash impairment of intangibles in the amount of $2,380,000

and a non cash expense of $306,000 in respect of share based payments.

7. TruScreen’s financial

information

Financial informationFinancial year ended

31 March 2018

Financial year ended

31 March 2019

Financial year ended

31 March 2020

Revenues804,0621,862,9491,288,242

EBITDA(3,632,815)(2,786,946)(2,146,832)

Net profit after tax(4,168,792)(3,380,454)(5,196,721)

1

Dividends on all equity

securities of the issuer

NilNilNil

Total assets12,166,84912,545,7657,241,067

Cash and cash equivalents1,212,4541,737,7751,024,153

Total liabilities550,9671,224,956832,843

Total debtNilNilNil

Net cash flows from

operating activities

(3,729,191)(2,678,321)(1,634,499)

• TruScreen is an early stage business.

• TruScreen does not generate significant revenue as at

the date of this Product Disclosure Statement, and has

no significant contractual arrangements in place which

provide for the generation of revenues in the future;

• TruScreen has not been trading for a sufficiently long

period of time to establish a regular and established

financial performance history that can be extrapolated

out as being likely to be indicative of future financial

performance.

30/TRUSCREEN GROUP LIMITED PRODUCT DISCLOSURE STATEMENT 2020

Risk Overview
Investments in shares are risky. You should consider if the

degree of uncertainty about TruScreen’s future performance

and returns is suitable for you. The price of these Shares

should reflect the potential returns and the particular risks of

these Shares. TruScreen considers that the most significant

risk factors that could affect the value of the Shares are:

Early stage nature of the TruScreen’s

Commercialisation

While the TruScreen technology is well advanced, the roll out

of its commercial business model is still at an early stage.

TruScreen’s commercialisation is not currently the subject of

any fixed term contractual arrangements and there are no

guaranteed recurring regular income streams for the

business. Because limited historical information is available

on TruScreen’s revenue trends and operations for

TruScreen’s cancer detection programs it is difficult to

evaluate TruScreen’s commercial prospects. The Company’s

prospects must be considered in light of the substantial risks,

expenses, uncertainties and difficulties encountered by

entrants into the medical device industry. These risks would

include significant cost of market access entry, risk of

changes in local market regulations, risks of new products

emerging, risks of COVID-19 impacting health budgets, and

difficulties in gaining acceptance over established

alternative cervical cancer screening methods.

TruScreen currently operates at a loss. TruScreen’s operating

losses may continue as TruScreen continues to expend

resources to commercialise its current products, obtain

regulatory clearances or approvals in new jurisdictions, and

expand its marketing, sales, manufacturing and finance

capabilities. The further development and commercialisation

of TruScreen’s products will require substantial development,

regulatory, sales and marketing, manufacturing and other

expenditures. TruScreen has only generated limited revenues

to date from product sales.

Cash flow

There is a risk that TruScreen may not have the funding to

implement its business plan if there are significant cost over

runs incurred by the Company in the execution of its business

plan.

TruScreen may require substantial additional capital to

commercialise its current products and to develop new

products, including completing new product testing and

clinical trials, obtaining all required regulatory approvals

and clearances, scaling up manufacturing, and marketing its

products into particular jurisdictions. TruScreen has currently

financed its operations though the generation of limited

revenues from the sale of its products, the proceeds received

from Australian Research and Development tax offsets, and

the issue of new shares to raise fresh capital. Any failure to

achieve adequate funding in a timely fashion would delay

TruScreen’s development programs and could lead to

abandonment of one or more of TruScreen’s development

initiatives. Ultimately, like all businesses, if the Company is

unable to fund its commercial operations, the future viability

of the Company would be in doubt.

Intellectual Property

TruScreen’s future success heavily depends on its ability to

establish and maintain the proprietary nature of its

technology. If any of TruScreen’s rights or ability to

manufacture its products was to be limited, TruScreen’s

ability to continue to manufacture and market its products

could be adversely affected. For Intellectual Property

protection, TruScreen relies on trade secrets and proprietary

know-how, which it seeks to protect, in part, through

confidentiality and proprietary information agreements. The

other parties to these agreements may breach these

provisions, and TruScreen may not have adequate remedies

for any breach. Additionally, the Company’s trade secrets

could otherwise become known to or could be independently

developed by competitors. If the Company was unable to

protect its intellectual property rights in its product, and a

trade competitor was able to construct a product similar to

the Company’s product, then the Company’s product

offering would lose its advantage in the market as

competitors would also be able to compete with the

Company using a product the same or similar to the

Company’s offering. This could have a material adverse

impact upon the ability of the company to sale product. The

Board considers this eventuality to be unlikely to occur.

Manufacturing Risk

While TruScreen has established an in house manufacturing

capability for its key component ( the Electro Optical

Assembly) to enable it to make products in the volumes that

would be necessary for it to achieve significant commercial

sales it relies on its suppliers for other parts of the device and

the disposable Single Use Sensor production. TruScreen may

not be able to maintain and expand a reliable, efficient, full

scale manufacturing facility at commercially reasonable

costs in a timely fashion. Difficulties TruScreen may encounter

in manufacturing scale-up, or a failure to maintain its

manufacturing facilities in accordance with good

manufacturing practice regulations, international quality

standards or other regulatory requirements, could result in a

delay or termination of production.

Since TruScreen relies on sole source suppliers for several of

its product components, any failure of those suppliers to

perform would harm its operations as the Company would

be unable to manufacture its products to satisfy sales

demand from its customers. This would in turn impact on the

sales revenues to be generated by the Company.

Several of the components used in TruScreen’s products are

available from only one supplier, and substitutes for these

components may not be obtained easily or would require

substantial modifications to its products. Any significant

problem experienced by one of TruScreen’s sole source

suppliers may result in a delay or interruption in the supply of

components to TruScreen until that supplier corrects the

problem or an alternative source of the component is

located and qualified.

8. Risks to TruScreen’s

business and plans

TRUSCREEN GROUP LIMITED PRODUCT DISCLOSURE STATEMENT 2020/31

Tax can have significant consequences for investments. If you
have queries relating to the tax consequences of the

investment in TruScreen Shares, you should obtain

professional advice on those consequences.

9. Tax

Any delay or interruption would likely lead to a delay or

interruption in TruScreen’s manufacturing operations. For

TruScreen’s products that require premarket approval, the

inclusion of substitute components could require TruScreen to

qualify any new supplier with the appropriate government

regulatory authorities. Alternatively for products that qualify

for regulatory approval, the substitute components must

meet TruScreen’s product specifications.

Competition

TruScreen competes with numerous other developers and

suppliers of cervical cancer screening product offerings and

services. Competition from other service providers is

significant and changes in the composition and extent of

competitors has the potential to present opportunities,

and/or impact on TruScreen’s market share and profitability.

TruScreen is susceptible to being overtaken by other more

established and larger organisations if they aggressively

expand and integrate new competing technologies.

Furthermore, TruScreen’s competitors may succeed in

developing, before TruScreen fully commercialises its

products, devices and technologies that permit more

efficient, less expensive, non-invasive or less invasive cancer

detection. It is also possible that one or more

pharmaceutical or other health care companies will develop

therapeutic drugs, treatments or other products that will

substantially reduce the prevalence of cancers or otherwise

render TruScreen’s products obsolete.

Unsuccessful Marketing

TruScreen may not be able to generate sufficient sales

revenues to sustain its growth and strategic plans.

TruScreen sets annual growth targets which are reviewed

regularly in the light of prevailing market conditions. Despite

the best endeavours of TruScreen and its distributors, it is

possible, however, that TruScreen’s initiatives to market its

products could fail or not produce the projected levels, which

may have an adverse impact on the financial position and

performance of TruScreen.

TruScreen’s products are based on new methods of cervical

cancer screening. If TruScreen’s products do not achieve

significant market acceptance and results, its sales will be

limited and its financial condition may suffer. Physicians and

individuals may not recommend or use TruScreen’s products

unless they determine that these products are an attractive

alternative to current tests that have a long history of safe

and effective use.

To date, TruScreen’s products (when compared to its major

competitors, the Pap Smear and HPV DNA analysis) have

been used by only a limited number of people, and the lack

of recent independent studies limits the ability of doctors or

consumers to compare TruScreen’s products to conventional

products. If TruScreen is unable to compete effectively in the

highly competitive medical device industry, TruScreen’s future

growth and operating results will suffer.

The medical device industry in general and the markets in

which TruScreen expects to target are intensely competitive.

Many of TruScreen’s competitors have substantially greater

financial, research, technical, manufacturing, marketing and

distribution resources than TruScreen does and have greater

name recognition and lengthier operating histories in the

health care industry. TruScreen may not be able to effectively

compete against these and other competitors.

A number of competitors are currently marketing traditional

laboratory-based tests for cervical cancer screening and

diagnosis. These tests are widely accepted in the health care

industry and have a long history of accurate and effective

use. Further, if TruScreen’s products are not available at

competitive prices, health care administrators who are

subject to increasing pressures to reduce costs may not elect

to purchase them. Also, a number of companies have

announced that they are developing, or have introduced,

products that permit non-invasive and less invasive cancer

detection. Accordingly, competition in this area is expected

to increase.

Ultimately, should the Company not be able to successfully

market its products to the consumers of its products, this

eventuality would have a material adverse impact upon the

ability of the Company to generate sales revenues and

impact negatively on the future viability of the Company as

a going concern. The Board is optimistic, having regard to

current experiences to date with distributors and potential

consumers of the Company’s product that there is a genuine

market for the Company’s products.

Reliance on Distributors

TruScreen’s commercial model relies on its distributors to act

as the agent for registration and to create the sales of the

product in their respective territories. Should the distributors

fail to meet those agreed targets or to achieve product

registration then TruScreen’s cash flows will be negatively

impacted. In addition, TruScreen’s distributors act as its

Customer Service representatives in their markets and poor

customer service performance in a distributor’s market will

result in a loss of reputation for TruScreen in that market, and

a subsequent loss of sales.

32/TRUSCREEN GROUP LIMITED PRODUCT DISCLOSURE STATEMENT 2020

If you wish to participate in the Offer, you have to do so
online at www.truscreenshareoffer.co.nz

NZ Residents

If you are a New Zealand Resident, you may apply for Shares

in the NZ Pool comprised within the Offer.

If you are a New Zealand resident and wish to apply for

Shares in the Offer, you must complete the online NZ

Residents Application Form, and pay online on

www.truscreenshareoffer.co.nz before 5pm on the

Closing Date.

Australian Residents

If you are an Australian Resident, you may apply for Shares in

the Australian Pool comprised within the Offer.

If you are an Australian resident and wish to apply for Shares

in the Offer, you must complete online Australian Resident

Application Form, and pay online on

www.truscreenshareoffer.co.nz before 5pm on the

Closing Date.

General

All applications made are made subject to the terms and

conditions that accompany, and are comprised within the

respective online Application Form.

11. How to apply

Further information relating to TruScreen or the Shares (for

example, the Company’s constitution and financial

statements) is available on the Offer Register. A copy of the

information on the offer register is available on request to the

Registrar (email applications@linkmarketservices.com or

phone +64 9 375 5998. The Offer Register can be accessed at

www.business.govt.nz/disclose, offer number OFR12990.

Further information relating to TruScreen is also available on

the public register at the Companies Office of the Ministry of

Business, Innovation and Employment. His information can be

accessed on the Companies Office website at

www.business.govt.nz/companies

TruScreen is required to make half-yearly and annual

announcements to NZX and (once listed on ASX) to ASX and

such other announcements as required by the NZX Listing

Rules and the ASX Listing Rules from time to time. You will be

able to obtain this information free of charge by searching

under TruScreen’s stock code “TRU” on NZX's website at

www.nzx.com and ASX's website at www.asx.com.au.

The following information relating to TruScreen or its ordinary

shares is available on request, free of charge:

• the most recent financial statements of TruScreen and

all documents that are required to be incorporated in or

attached to, or to accompany, those financial

statements;

• TruScreen’s constitution.

This information can be obtained by writing to TruScreen at

the address specified in section 12 (Contact information).

10. Where you can find

more information

TRUSCREEN GROUP LIMITED PRODUCT DISCLOSURE STATEMENT 2020/33

TruScreen Group LimitedRegistered Office
c/- HLB Mann Judd Limited

Level 6, Equitable House

57 Symonds Street

Grafton

Auckland, 1010

New Zealand

Telephone: +64 9 303 2243

Email: hlb@hlb.co.nz

Securities RegistrarLink Market Services Limited

Level 11

Deloitte Centre

80 Queen Street

Auckland 1010

New Zealand

Telephone number: 09 375 5998

Legal AdvisorsSean Joyce - Corporate Counsel

P O Box 105 745

Auckland 1143

New Zealand

Addisons

Level 12

60 Carrington Street

Sydney NSW 2000

Australia

AuditorsRSM Hayes Audit

Level 1 1 Broadway

Newmarket

Auckland 1023

New Zealand

12. Contact information

34/TRUSCREEN GROUP LIMITED PRODUCT DISCLOSURE STATEMENT 2020

AImeans artificial intelligence
Application Form – Australian Residentsmeans the online

Application Form to be completed by Australian residents

Application Form – New Zealand Residents means the online

Application Form to be completed by New Zealand residents

Australian Pool means the pool of 14,285,714 Shares to be

made available for subscription by Australian Residents.

Australian Residentmean an investor who is ordinarily

resident in Australian, and who has an Australian address

ASXmeans the ASX Limited, or the financial market operated

by ASX Limited (Australian Securities Exchange), as the

context requires

ASX Listing Rulesmeans the listing rules of ASX, as in force

from time to time

Boardmeans the board of directors of TruScreen Group

Limited

Business Day means a day upon which the NZX Main Board is

open for trading

CE Markmeans a certification marking that indicates

conformity with health, safety, and environmental protection

standards for products sold within the European Economic

Area (EEA). The CE marking is also found on products sold

outside the EEA that are manufactured in, or designed to be

sold in, the EEA

Closing Datemeans 18 December 2020

Colposcopemeans a medical device used to examine an

illuminated, magnified view of the cervix as well as the

vagina and vulva

Companymeans TruScreen Group Limited

Cytologymeans the examination of cells from the body

under a microscope

Cryotherapy, sometimes known as cold therapy, means the

local or general use of low temperatures in medical therapy.

Cryotherapy can be used to treat a variety of tissue lesions

Electro Optical Assemblymeans the assembly of electrical

engineering, electronic engineering, materials science, and

material physics involving components, devices (e.g. Lasers,

LEDs, waveguides etc.) and systems which operate by the

propagation and interaction of light with various tailored

materials

FYmeans financial year

HPVmeans HPV DNA Test

ISO13485means an International Organization for

Standardization (ISO) standard which represents the

requirements for a comprehensive quality management

system for the design and manufacture of medical devices

Glossary of Terms

LBCmeans Liquid-based cytology

Material Informationmeans information which is material to

an assessment of the position and prospects of TruScreen

Negative predictive valuemeans the probability that

subjects with a negative screening test don't have the

disease

New Zealand Residentmean an investor who is ordinarily

resident in New Zealand, and who has a New Zealand

address

NMPANational Medical Products Administration (Previously

known as CFDA(China Food and Drug Administration)

Non-government organisations (NGO’s)means

organisations that are usually non-profit and sometimes

international organisations independent of governments and

international governmental organisations (though often

funded by governments) that are active in humanitarian,

educational, health care, public policy, social, human rights,

environmental, and other areas to effect changes according

to their objectives

NZ Poolmeans the pool of 7,142,857 Shares to be made

available for subscription by New Zealand Residents.

NZ$means figures are in New Zealand dollars

NZXmeans NZX Limited

NZX Main Boardmeans the main equity trading platform

operated by NZX Limited

Offermeans the offer of Shares made by TruScreen under

this PDS to residents of New Zealand and Australia

Opening Datemeans 26 November 2020

Pap smear testmeans the opening of the vaginal canal with

a speculum and collecting cells at the outer opening of the

cervix at the transformation zone (where the outer squamous

cervical cells meet the inner glandular endocervical cells).

The collected cells are examined under a microscope to look

for abnormalities which could indicate the incidence of

cervical cancer

PDSmeans this Product Disclosure Statement

Registrarmeans Link Market Services Limited

Sharesmeans the ordinary fully paid shares in the capital of

TruScreen

Single Use Sensor (SUS) means a disposable sheath that is

the only point of contact between the TruScreen device and

any bodily fluids or tissue from the patient. A new SUS has to

be used for each patient test

SUSmeans Single Use Sensor

TruScreenand TSmeans TruScreen Group Limited

Thermal coagulationis a form of heat ablation used to

treat CIN

TRUSCREEN GROUP LIMITED PRODUCT DISCLOSURE STATEMENT 2020/35

Data sourced from publicly available filings. Our datasets may not be complete. Automated analysis can produce errors. If you believe any data on this page is incorrect, please contact us at hello@nzxplorer.co.nz. For informational purposes only. Not investment advice.