Truscreen July 2019 Stakeholders Newsletter

TRUSCREEN CONTINUES ITS
COMMERCIAL PROGRESS IN
KEY MARKETS AND
ANTICIPATES CONTINUED
SALES GROWTH IN FY2020

As we entered the second quarter of
the financial year, TruScreen
successfully completed a capital
raise of NZ$1.1 m, from a private
placement. These funds will provide
working capital for TruScreen to
continue to meet growing demand
from countries where we have
established distributorships. The
funds also enable TruScreen to
develop new markets for its product,
with a focus on partnering with
global non-government
organisations.

A major achievement for TruScreen
has been the recognition by WHO,
Unitaid and the Clinton Health
Access Initiative of TruScreen as a
technology for screening women in
low- and middle-income countries.

In this financial year, TruScreen will
continue to focus on building our
relationships with NGOs to give us
greater access to global cervical
cancer screening programmes.

In June, TruScreen completed the
quality accreditation audit of our
London entity to meet compliance
requirements under ISO 13485:2016
and the European Device Regulation.
This ensures ongoing validity of our
CE Mark for the TruScreen device and
technology. These certifications form
the prima facie evidence for
TruScreen’s global suite of regulatory
approvals.

SUS sales, total sales and total
revenue grew substantially 31 March
2019 year-on-year. Total sales grew
132%, and total revenue grew 42%
year-on-year.


Martin Dillon
Chief Executive Officer
SIGNIFICANT EVENTS YEAR-TO-DATE:
• Inclusion in WHO, Unitaid, and CHAI joint publication on
cervical cancer screening technologies
• Strong 31 March 2019 year-on-year sales growth of 132%
• Completed quality accreditation audit of our London entity,
ensuring ongoing validity of our CE Mark for the TruScreen
technology
• Grew our presence in China, expanding our distribution
network to include Chengdu in Sichuan Province
• Arranged a meeting between Unitaid programme managers
and the National Institute of Cancer of Mexico, with a focus on
TruScreen in the public health sector
FY20 STRATEGIC GOALS:
• Continue current rate of sales growth
• Maintain focus on China as our key market
• Continue to maximise device pull-through of the disposable
Single Use Sensor (SUS) - focus on China
• Leverage volumes to reduce SUS costs and increase margins
• Expand TruScreen inclusion in government and NGO
programmes, particularly in Africa, India and Latin America
TRUSCREEN INCLUDED
IN JOINT CERVICAL
CANCER TECHNOLOGY
LANDSCAPE

As announced in late May,
TruScreen was included in a
World Health Organisation
(WHO), Unitaid, and Clinton
Health Access Initiative (CHAI)
joint Cervical Cancer Technology
Landscape: Screening and
Treatment of Pre-Cancerous
Lesions for Secondary Prevention
of Cervical Cancer.

TruScreen’s inclusion in this
landscape is a milestone for the
company. It is the first time that
WHO has recognised
TruScreen’s second-generation
device and will provide great
exposure for TruScreen to
Ministries of Health and Non-
Government Organisations
(NGOs) globally.

To view the publication in full,
click here.

A key strategic goal for TruScreen
in FY2020 is continuing to build our
connections and working
relationships with global Non-
Government Organisations
(NGOs).

Following the inclusion of
TruScreen in the cervical cancer
Technology Landscape, TruScreen
arranged a meeting in Mexico
between Unitaid strategy and
programme managers, and the
National Institute of Cancer
(INCan). INCan is a decentralised
organisation operating under
Mexico’s Ministry of Health,
providing specialised medical care
to cancer patients. INCan is
considered to be the governing
body of cancer treatment in
Mexico.

Facilitated by our local distribution
network, the meeting took place on
24 July 2019 at INCan. In
attendance were Unitaid
programme manager Smiljka De
Lussigny, Unitaid technical strategy
manager Dr Anna Laura Ross,

INCan head of colposcopy Dr Salim Barquet, and INCan gynaecologist
Dr Gonzales.

Discussions centred on Mexico’s strategy for cervical cancer screening
and the value of TruScreen in government-
funded and other public health sector
screening programmes.
Left to right: Smiljka De Lussigny (programme manager Unitiad); Dr Anna Laura Ross, PhD
(technical manager strategy Unitaid); Dr Gonzales; and Dr Salim Barquet (head of colposcopy
INCan) discuss the TruScreen device.


STAKEHOLDERS NEWSLETTER
JULY 2019

TACKLING CERVICAL CANCER
HOW TRUSCREEN IS SAVING LIVES WITH BETTER SCREENING

Cervical cancer is the fourth most common cancer among women globally, with 570,000 new cases and 311,000 deaths annually. However, cervical cancer is
one of the most preventable and curable forms of cancer if it is detected early through screening programmes.
Cervical cancer is one of the leading causes of death for women in low- and middle-income countries (LMIC). This population accounts for over 85% of
cervical cancer-related deaths every year.
TruScreen’s real-time, accurate and portable screening system can be used with minimal clinical training and does not rely on the same laboratory
infrastructure as traditional screening. These features make the TruScreen device the right screening tool in a resource-limited setting.


CHINA



CHINA REMAINS TRUSCREEN’S PRIMARY
FOCUS. CHINA HAS A SCREENING
POPULATION OF OVER 400 MILLION
WOMEN AND ACCOUNTS FOR
APPROXIMATELY 30% OF THE WORLD’S
REPORTED CASES OF CERVICAL CANCER

TRUSCREEN DELEGATION VISIT TO CHINA

TruScreen’s general manager of China, Dr Jerry Tan, travelled to
China at the end of June, spending all of July working with our
local distribution network. Dr Tan helped install devices,
conducted clinical training, met key opinion leaders (KOLs), and
attended conferences.

This trip focussed on the continuation of device rollout and
training for the COGA (Chinese Obstetrics and Gynaecology
Association) programme. It included meetings with KOLs and the
new provincial distrubor in Sichuan Province. Sichuan has 20
hospitals participating in the COGA programme.

Expanding TruScreen’s distribution network to include Chengdu
is an important milestone for us in the region. Sichuan has a
population of over 87 million. Dr Tan conducted product training
and attended the 4
th
Annual Tianfu Forum of Gynaecologic
Oncology, a national conference attended by KOLs and China’s
leading professors. The conference included a TruScreen 2.5hr
satellite meeting, which launched the COGA programme for
Sichuan province.



CHINESE OBSTETRICS AND
GYNAECOLOGY ASSOCIATION
(COGA) EVALUATION

As previously announced, TruScreen has
commenced a large-scale evaluation with
COGA. This evaluation will screen over
20,000 women in 100 top-tier public
hospitals across 10 provinces in China.
The COGA programme is progressing
well, with nine out of the 10 participating
provinces having held their launch
programme, and 52 hospitals having
commenced the screening of women. The
evaluation is anticipated to continue
throughout the financial year. Results are
expected to be released in FY2021.
The COGA Annual Congress, to be held
in Jiangsu in August 2019, is a crucial
event for TruScreen in China. Our local
distributor is a major sponsor for the
event, and TruScreen will be holding a
satellite meeting that includes the final
provincial launch in Jiangsu.

‘TWO CANCER’ CENTRES
ROLLOUT

During FY2019, TruScreen was chosen as
the primary screening solution for a chain of
high-tech ‘Two Cancer’ centres. Privately
owned and operated, these clinics provide a
‘one stop’ screening diagnosis and treatment
centre for breast and cervical cancer. Most
clinics are to be located in government
hospitals. Sixteen centres out of the
planned 50 are established, with TruScreen
installed.

As part of the rollout, TruScreen’s local
distributors and sub-distributors have been
holding promotional meetings with key
decision-makers, highlighting the success of
TruScreen in the 16 centres already
established.


BUILDING ON TRUSCREEN
AWARENESS IN CHINA

An important focus for TruScreen’s partners
and management team is building
awareness of the TruScreen technology in
markets. Expos, conferences and
association meetings are important
opportunities to present our product to key
decision-makers and clinicians.

Recently, TruScreen has presented at the
following events in China:

- 1
st
July, Guilin, Guangxi :TruScreen
Introduction Meeting, including
installation of the first TruScreen in the
city
- 5
th
July, Hengyang, Hunan:
Colposcopy and Cervical Disease
Academic Meeting
- 13-14
th
July, Xiangtan, Hunan: West
Hunan Gynaecology Forum
- 17-19
th
July, Chengdu, Sichuan:
COGA colposcopy training sponsored
by TruScreen distribution partner,
including a two-hour introduction of
TruScreen technology to 108 doctors
from the region
- 20-21
st
July, Chengdu, Sichuan
Province: 4
th
Tianfu Forum of
Gynaecologic Oncology, including a
2.5 hour TruScreen satellite meeting
with local and national KOLs
- 19-21
st
July, Suzhou, Jiangsu:
Chinese Medical Equipment
Association Annual Exhibition,
including free TruScreen exams and a
satellite meeting on ‘Two Cancer’
centres of Tianjian
- 26-28
th
July, Liuzhou, Guangxi:
Guangxi Provincial Gynaecologic
Oncology Annual Academic Meeting


Left to right: TruScreen national distributor representative; Women &
Babies Medical Centre owner Dr Felix Wong; and TruScreen China GM
Dr Jerry Tan.

RUSSIA UPDATE

In early March 2019, TruScreen announced
that it has signed a new distribution
agreement for the Russian market with
IMSystems JSC (IMS).
The new agreement includes an initial sale of
multiple TruScreen devices and Single Use
Sensors (SUS) worth an estimated
NZ$364,000.
More recently, in June, TruScreen conducted
clinical training with our distributor and local
key opinion leaders, including doctors at the
State Research Institute for Medical
Innovations. IMS has started presenting
TruScreen at international gynaecology
and oncology conferences attracting
regional key opinion leaders.

TruScreen is currently working on a software
translation to facilitate sales in the
government market.



REGULATORY APPROVALS

In recent months, TruScreen gained further
product registrations, in Saudi Arabia and Israel.

As we enter new markets, we work with our
distribution partners to ensure compliance with
local medical device regulations. Typically, this
includes product registration with the region’s
governing health body. These regulatory
approvals facilitate sales and market
penetration.
Gaining regulatory approval in Saudi Arabia is
an exciting step for TruScreen - it is the
foundation of our pan-Arab distribution partner.
TruScreen is currently planning to commence
clinical training with our distributor and key
opinion leaders in the region.
We anticipate beginning the regulatory approval
process for the United Arab Emirates, Kuwait,
and other Gulf States during this financial year.
In June 2019, TruScreen also gained regulatory
approval in Israel.





TRUSCREEN SALES CONTINUE TO
INCREASE, WITH STRONG FY2019
YEAR-ON-YEAR GROWTH FOR TOTAL
SALES, AND SINGLE USE SENSOR
(SUS) SALES
Overall sales in FY2019 grew substantially compared to
sales in the prior year – up by approximately NZD $1m or
132%. Total revenue, including research & development
tax offset, increased by 42%, from NZD$2.2m to
NZD$3.1m.

The TruScreen device utilises a disposable Single Use Sensor
(SUS) for every patient exam. As device installation and usage
grows, so too will demand for SUS.

TruScreen estimates for every 100 devices fully deployed in a
Chinese hospital environment, the company will generate a
sustainable income stream of approx. NZ $1.1m annually. In
FY2019, China accounted for approximately half of overall SUS
sales.
TruScreen anticipates sales growth to continue through FY2020
as we leverage our key partnerships; endorsements from key
opinion leaders and global NGOs; and government adoption.

KEY DATES

27 August 2019
Annual General Meeting

30 September 2019
FY2020 Half Year End

December 2019
Half Year Results

December 2019
Half Yearly Report

31 March 2020
FY2020 Year End

This Stakeholders Newsletter has
been provided to keep our
shareholders informed of our
progress and complements our
formal communications such as
our shareholder reports, results
announcements and annual
meeting. Further information on
our products and on cervical
cancer can be found on our
website www.truscreen.com.
3,400
14,260
12,240
16,200
21,290
22,860
25,560
38,700
0
5,000
10,000
15,000
20,000
25,000
30,000
35,000
40,000
45,000
Q1Q2Q3Q4
FY2018FY2019
SUSSales Growth
0
200
400
600
800
1000
1200
1400
1600
1800
2000
FY16FY17FY18FY19
NZD $ 000

VIETNAM’S MINISTRY OF HEALTH
APPROVES COMMENCEMENT OF
TRUSCREEN PILOT PROGRAMME

In June, following on from a TruScreen delegation
visit to the region, the Vietnam Ministry of Health’s
Professional Advisory Committee approved the
commencement of a TruScreen pilot programme,
based at the Hanoi Obstetrics and Gynaecology
Hospital.

In June, a TruScreen delegation, led by the
Chairman of the Company’s Medical Advisory
Committee, Prof. Neville Hacker, visited Vietnam.
Prof. Hacker and the Company’s Clinical Affairs
and Training Manager, Dr. Carolina Velasquez,
met with key medical advisers to the Ministry of
Health, including the Director of Hanoi Obstetrics
and Gynaecology Hospital, Prof. Anh, to discuss
the national adoption of TruScreen.

Vietnam does not have a national cervical
cancer-screening programme despite having
a screening population of 26 million women
and over 4,000 new cases of cervical cancer
each year, making it the 7
th
most frequent
cancer among women in the region. The pilot
programme’s objective is to evaluate the
TruScreen technology, prior to a national
rollout of the device as the primary screening
method.

Dr. Carolina Velasquez visited Vietnam in late
July 2019 to conduct an intensive clinical
training course with doctors participating in
the 1,000 patient pilot programme. The
completion of Clinical training marks the
commencement of the pilot study, with local
media coverage expected.


INTRODUCING PROFESSOR
NEVILLE HACKER, AM,
CHAIRMAN OF TRUSCREEN’S
MEDICAL ADVISORY BOARD

Professor Neville Hacker, AM, has led
the TruScreen Medical Advisory Board
for over 10 years. He is Conjoint
Professor of Gynaecological Oncology
and the University of New South
Wales. He 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 also past President of the Society
of Pelvic Surgeons and a past
President of the International
Gynaecological Cancer Society, and
former Chairman of the Oncology
Committee (RANZCOG), and a former
Chairman of Examiners for
Gynaecologic Oncology Committee of
RANZCOG.


FOR MORE INFORMATION CONTACT:

TruScreen
Martin Dillion
CEO
martindillion@truscreen.com
TruScreen
Guy Robertson
CFO
guyrobertson@truscreen.com
Investors
WE Buchan
Phone: +61 2 9237 2805
TruScreen@we-buchan.com
TruScreen is a Cervical Cancer Screening Device which offers the latest technology in cervical screening, providing real-time, accurate detection of pre-cancerous and cancerous cervical cells to help
improve the health and well-being of women around the world. TruScreen’s real-time cervical cancer technology utilises a digital wand which is placed on the surface of the cervix to measure electrical
and optical signals from the surrounding tissues. A sophisticated proprietary algorithm framework is utilised to detect pre-cancerous change, or cervical intraepithelial neoplasia (CIN), by optical and
electrical measurement of cervical tissue. TruScreen offers an alternative approach to cervical screening, resolving many of the ongoing issues with Pap tests including failed samples, poor patient
follow up, patient discomfort and the need for supporting laboratory infrastructures. As such, TruScreen target market is developing countries where no large scale cervical cancer screening programs
and infrastructure are in place, such as; China, Mexico, Africa, Russia and India. TruScreen’s cervical cancer screening device is EC certified for use throughout Europe and CFDA approved for sale in
China. Truscreen gained recognition from Global NGO’s WHO and Unitaid in a joint Cervical Cancer Technology Landscape released at the 72nd World Health Assembly.

Left to right: Dr Phunc (Head of Cancer department), Dr Chuong (Head of Research and Development and Training
department), Mr Gorton(GHS), Dr Thuong, Mr Tran An(GHS), Prof Anh (Director of Hanoi OBGYN Hospital), Prof Hacker,
Dr Velasquez, Mr Chanh(GHS), Dr Thuy (Head of High Service Gynaecology Examination), Dr Thanh, Dr Hanh, Mrs
Thao (GHS), Mr Ngo (GHS)