Truscreen Registers Product Disclosure Statement
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.