TruScreen December Newsletter

NZX and Media Release 4 December 2018

TruScreen December Newsletter

Please find attached a copy of TruScreen Limited’s December 2018 Shareholder Newsletter. This
provides an update on TruScreen’s performance and highlights key initiatives underway.
TruScreen has achieved significant growth in sales during the first half of the 2019 financial year.
Highlights include:
• Sales for the six months ending 30 September 2018 top NZD $1.4 million (unaudited)
• 523% increase in sales on the corresponding period last year
• Gross margin increasing as in-house manufacturing lowers unit costs


The Shareholder Newsletter is available for viewing on the company website
http://truscreen.com/investor-centre/newsletters/

-ENDS-

For more information visit www.truscreen.com or contact:
Martin Dillon
TruScreen Chief Executive Officer
Email: martindillon@truscreen.com
Media Liaison
Jackie Ellis
Email: jackie@ellisandco.co.nz
Phone: +64 27 246 2505
About TruScreen:
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 tissue. A sophisticated proprietary
algorithm framework distinguishes between
normal and abnormal (cancerous and
precancerous) tissue to identify precancerous
change, or cervical intraepithelial neoplasia
(CIN). A Single Use Sensor (SUS) is used for
each patient to protect against cross-infection.

TruScreen has achieved
significant growth in sales
during the first half of the
2019 financial year.
Highlights include:
• Sales for the six months
ending 30 September 2018 top
NZD $1.4 million (unaudited)
• 523% increase in sales on the
corresponding period last year
• Gross margin increasing
as in-house manufacturing
lowers unit costs
Sales of devices and Single Use
Sensors are tracking well ahead of last
year, with ongoing demand from China
and other markets.
Demand in China remains strong and a
number of initiatives are underway. Our
device has been selected as the primary
screening tool for up to 50 planned women’s
health clinics and TruScreen has now been
installed in the first eight of these. We have
also commenced a large scale evaluation
with The Women’s and Children’s Division of
the Centre for Disease Control. This involves
screening of a minimum of 12,000 women
across eight provinces and 16 hospitals in
China. In addition, we have announced a
major programme in Xinjiang Province, which
will see TruScreen installed in 190 hospitals.
In Africa, an initial sale of approximately
NZ$450,000 has been supplied to the
National Aids Council (NAC) of Zimbabwe,
which is supporting the use of TruScreen as
the preferred screening method for cervical
cancer of HIV affected women. African
countries represent a major untapped
market opportunity for the company as many
have little or no laboratory infrastructure or
existing screening programmes or methods.
TruScreen’s portability and real time
diagnosis means it is perfectly suited
to the developing countries within the
African Continent.
The company’s new enhanced manufacturing
facility, commissioned in June this year,
is now fully operational and delivering
significant improvements in output and unit
cost reduction. The facility produces the key
technical diagnostic (front end) component
of the Truscreen device and involves
unique and sophisticated opto-electric and
biomedical engineering skills and techniques.
We recently completed a capital raising
programme to strengthen our balance sheet
and fund commercial growth. We would like
to thank investors and shareholders for their
support for the $1.5 million Placement and
Share Purchase Plan, which together raised
$3 million to support our future strategy.
We are excited about the opportunity in
front of us. While China remains our primary
market, we have a number of commercial
opportunities in other large scale markets
and remain confident of achieving our goals
for the year.
Martin Dillon
Chief Executive Officer
TRUSCREEN:
TACKLING
CERVICAL
CANCER
Cervical cancer is the fourth
most common cancer in women
worldwide with about 569,000 new
cases diagnosed annually and
311,000 women dying every year
from the disease. Eighty-five percent
of those deaths are in developing
countries. Cervical cancer has
a precancerous phase, which is
believed to last for approximately
10 years on average. Early detection
through screening programs is
crucial to reducing mortality and the
incidence of cervical cancer.
In emerging and developing
countries, there is often a lack of
laboratory infrastructure and expert
technicians, as well as transient
populations and people living in
remote areas, who have little or
no access to the minimal health
infrastructure that does exist.
TruScreen’s real time, accurate,
low cost and portable diagnostic
system is the answer, and can be
used with minimal clinical training,
and without the infrastructure and
resource costs associated with
traditional screening. TruScreen is
now available in many countries for
the screening of cervical cancer.
SHAREHOLDER NEWSLETTER
DECEMBER, 2018
EXECUTIVE
UPDATE

I am pleased to to be taking
on the role of Chairman
of TruScreen.
I was appointed to the Board at the 2018
Annual Meeting in October and took on the
role as Chairman shortly after, replacing
Robert Hunter who had advised he was
stepping down. Robert is the founder of
TruScreen, a significant shareholder and
remains a valued member of our Board.
I am an experienced company director
and a chartered accountant. I have worked
across a number of different industries,
particularly the biotech and life sciences
sectors in New Zealand and Australia.
I am based in Australia and currently hold
a number of non-executive director roles.
Prior to becoming a professional director,
I held senior management roles with ASX
listed companies.
I am excited about the opportunity ahead for
TruScreen. I am pleased to see that the
TruScreen technology is gaining acceptance
as a viable screening process for cervical
cancer in women in countries where access
to laboratory infrastructure is limited. Over
300,000 women are reported to die from this
disease each year, with many more deaths
going unreported. Our simple and effective
TruScreen technology, allowing for early
detection, will reduce the mortality rate
attributed to cervical cancer in women.
FY19 STRATEGIC PRIORITIES:
• Expand inclusion in Government
programmes and sales in Africa,
Latin America and India
• Generate operational efficiencies,
particularly by bringing manufacturing
processes in house
• Leverage volumes to reduce
production costs
SIGNIFICANT EVENTS
YEAR TO DATE:
• Commissioned new manufacturing facility
• Commenced large scale evaluations
in China
• Gained approval for pilot screening
programme in Zimbabwe
• Signed new distribution agreement
for the Middle East
• Year on year growth of sales
for the first 6 months of 523%
• Successful capital raise
• Appointment of new Chairman
A WORD FROM
THE NEW
CHAIRMAN:
EXPANDING OUR FOOTPRINT
MIDDLE EAST:
Cervical cancer is the number 2 cancer
for women in the Middle East. Recently,
TruScreen entered a new distribution
agreement, augmenting existing distribution
channels in the region.
A consortium of companies will market and
distribute TruScreen across the Middle East.
The initial focus will be on UAE, Saudi Arabia
and Kuwait which comprise a total of 8
million women of screening age. In two years’
time, it is planned to expand to 12 countries
within the Middle East with a screening
population of over 71 million women.
SRI LANKA AND PAKISTAN:
TruScreen has begun the process to gain
regulatory approval for its unique device
in Pakistan and Sri Lanka. Initial sales
orders have been received and training
has commenced. With a total screening
population of over 50 million women,
these new regions allow TruScreen
to expand its presence in Southern
and Eastern Asia.
Tony Ho, Chairman
2018 ANNUAL
SHAREHOLDERS
MEETING
The TruScreen Annual Meeting
of Shareholders was held in
Auckland on 27 September 2018.
All resolutions were passed by
shareholders:
• Authorise Directors to fix
the auditor’s remuneration
• Re-election of Mr Robert
Hunter as a Director
• Election of Professor
Ronald Jones as a Director
• Election of Mr Chris
Lawrence as a Director
• Election of Mr Kelly (Con)
Hickey as a Director
• Election of Mr Anthony Ho
as a Director
The Annual Meeting presentations
and voting results can be viewed
at http://truscreen.com/investor-
centre/shareholder-meetings/.
SRI LANKA
MIDDLE EAST
PAKISTAN

The Royal Hospital of
Women (RHW) in Australia has
recently completed a clinical trial
comparing TruScreen to liquid
based cytology and HPV DNA
testing, both of which require high
quality laboratory settings.
An abstract of the results
was presented at the recent
International Papillomavirus
Conference (IPVC) 2018 in
Sydney. This is one of the leading
events for researchers, clinicians
and health professionals striving
to achieve global control of
HPV disease.
In summary, the RWH clinical
evaluation demonstrated
TruScreen had comparable
sensitivity to high quality cytology
conducted in a hospital clinical
setting, as well as specificity
and sensitivity approaching HPV
DNA in an approximate primary
screening setting.
TruScreen has the advantage
of producing an immediate
result, low training and does
not need laboratory equipment.
This device, utilising optical
and electrical technology, can
potentially become an important
tool in the prevention of cervical
cancer, particularly in developing
countries and resource-limited
settings.
The abstract was presented
by Dr. Michael Campion, a
member of the TruScreen Medical
Advisory Committee and the
Lead Investigator in the trial.
Full publication of the outcome
of the clinical trial is expected in
the near future.
INTRODUCING COLONEL (DR.) MICHAEL J.
CAMPION. MEMBER TRUSCREEN MEDICAL
ADVISORY BOARD
The TruScreen Medical
Advisory Board’s role is to
advise the directors and
executive of TruScreen
on clinical, scientific and
medical matters.
Colonel (Dr.) Michael J.
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. He is
also a Conjoint Associate
Professor at the School
of Women’s and Children’s
Health, University of New
South Wales.
Dr Campion has over
30 years’ experience
as a qualified medical
practitioner and has
expertise in obstetrics,
gynaecology and oncology.
Dr Campion has been
working with the TruScreen
product for over 20 years,
including his involvement
in the original data
collection. More recently,
Dr Campion has been the
lead investigator of the
TruScreen Clinical Trial
held at The Royal Hospital
for Women.
CLINICAL EVALUATION CONFIRMS
TRUSCREEEN’S ADVANTAGE IN
DEVELOPING COUNTRIES
LARGE SCALE EVALUATIONS
NOW UNDERWAY IN CHINA
THE WOMEN’S AND
CHILDREN’S DIVISION OF
THE CENTRE FOR DISEASE
CONTROL (CDC):
The large-scale evaluation with The
Women’s and Children’s Division of the
Centre for Disease Control (CDC) in China
is now underway.
Its aims are multi-fold: to have TruScreen
included in the CDC’s screening guidelines
for the 3,000 hospitals run by its Women’s
and Children’s Health Division, and to have
the CDC recommend TruScreen for inclusion
in the Central Government’s Ministry of
Health screening guidelines for all 12,000
government hospitals in China. As part of the
evaluation, TruScreen will also be assessed
for use as a first choice screening technology
in rural areas in China.
Product installation and training has been
completed in all 16 sites. The evaluation is
now at its half way point, with completion
anticipated by the end of 2018, followed by
analysis of the data.
INSTALLATION COMMENCED
IN NEW CHINESE BREAST
AND CERVICAL CANCER
CENTRES:
Earlier this year, TruScreen was chosen as
the primary screening solution for a rollout
of a chain of high tech female health clinics
to be established in 50 municipal hospitals
in China. Privately owned and operated, the
majority of these clinics are be located in
government women’s hospitals.
The clinics provide a ‘one stop screening,
diagnosis and treatment centre’ for breast
and cervical cancer.
TruScreen has already been installed in the
first ten of these specialist clinics. A trial
has commenced to assess how TruScreen
will best fit into the clinical processes within
the clinics.
CHINESE OBSTETRICS
AND GYNAECOLOGY
ASSOCIATION (COGA):
The first stage of this multi-centre project
is now complete. 1,100 patients across
six hospitals have been screened using
TruScreen and data is now being analysed.
At the recent National Congress, the
Chairman of COGA announced the
commencement of the second stage
of the project, and COGA is now in the
process of selecting hospitals to participate.
More than 20,000 patients, across 10
provinces, are expected to be involved
in the full clinical trial.

STAY IN TOUCH
KEY DATES
Half Year End:
30 September 2018
Half Year Results Announcement:
December 2018
Half Yearly Report:
December 2018

CONTACT US
Level 1, 1 Jamison Street
Sydney, Australia
GPO Box 3904, Sydney, NSW 2001
T +61 2 9091 7475
E info@truscreen.com
www.truscreen.com
TRUSCREEN HIV
AFRICAN INITIATIVE
Cervical cancer is the number
one cause of cancer-related
deaths in women in eastern
Africa. Women with HIV
are six times more likely to
develop cervical cancer and
having HIV nearly doubles
the risk of dying from
cervical cancer.
Zimbabwe has the fifth highest cervical
cancer rate in the world and the sixth highest
rate of HIV globally, with an estimated
720,000 women living with HIV. Across Africa,
more than 13 million women are living with
HIV. As most women of Zimbabwe live in
rural environments, the lack of resources and
infrastructure are major contributing factors
to the high rate of cervical cancer, with
almost 95% of patients diagnosed at late or
end stage disease.
TruScreen will be adopted for use as part
of the National Aids Council (NAC) of
Zimbabwe’s response to HIV and AIDS
within the country, including the fight against
‘AIDS defining cancers’. An initial order to
the value of approximately NZ$450,000 has
been provided to the NAC as part of a pilot
programme that is the first step in bringing
advanced screening technology to Africa.
TruScreen’s Clinical Affairs Manager,
Dr. Carolina Velasquez, recently visited
Zimbabwe for a series of meetings, with
support for the pilot programme gained from
the Permanent Secretary of the Ministry
of Health and Child Care, the Director of
Reproductive Health of the Ministry of
Health and Child Care, and the National
AIDS Council.
She said: “Both the Ministry of Health and the
NAC are very excited about our TruScreen
device becoming a part of Zimbabwe Cervical
Prevention and Control Strategy. They have
given their absolute support for TruScreen
moving forward as the national cervical
cancer screening method.
“Zimbabwe is a Key Opinion Leader in Eastern
Africa and we anticipate that the successful
implementation of this innovative programme
will lead to other countries embracing
TruScreen as a solution to their own cervical
cancer screening needs.”
Zimbabwe: L to R - Director of the Ministry of Health’s
Family Health Division Dr. Madzima, TruScreen’s
Clinical Affairs Manager Dr. Carolina Velasquez, and
CEO of TruScreen’s local distributor, Herbert Ndoro
OUT AND ABOUT WITH TRUSCREEN
An important focus for TruScreen’s partners
and management team is building awareness
of the TruScreen technology in markets
around the world. Expos, conferences
and association meetings are important
opportunities to present our product to key
decision makers and clinicians.
INDIA: TruScreen training and demonstration
at the Army Medical Research Centre (AMRC)
in Bhopal, with Veni Sethi (TS Trainer), Col.
Gargi, and Lt. Col. Reema
CHINA: TruScreen being presented at the
annual COGA conference
This Shareholder 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.