TruScreen January Newsletter

NZX and Media Release 31 January 2018

TruScreen January Newsletter

TruScreen Limited has provided a copy of its January 2018 Newsletter. This Newsletter is also available
for viewing on the company website http://truscreen.com/investor-centre/reports-presentations/.


-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.

---

NEWSLETTER
JANUARY, 2018
EXECUTIVE UPDATE
2018 is looking to be a year of
positive traction for TruScreen as
we capitalise on the progress being
made across commercial programs,
product development
and manufacturing.
The latest major achievement for our
company has been the receipt of Chinese
Food and Drug Administration (CFDA)
approval for our TruScreen2 device. This
allows us to market and sell our second
generation device in China and we are
moving quickly to capitalise on this with
TruScreen2 sales to China now commenced.
(For more details on our China plans, please
see page 2).
Recent highlights include:
• CFDA Approval for TruScreen2.
• Development of a Chinese Language
version of TruScreen2’s operating system
and browser interface to increase usability
and adoption in China.
• TruScreen director Professor Ron Jones
led a delegation to India to establish a
collaboration between the All India Institute
of Medical Science (AIIMS) and TruScreen
to conduct a program whose aim is to
evaluate TruScreen2 for recommendation
to the central and state governments for
use in government screening programs.
Professor Jones observed that India is a
huge potential market for TruScreen.
• Confirmation of a meeting in Mexico with
that country’s Cuadro Basico committee
to consider TruScreen’s inclusion in
their government purchasing catalogue.
This is a key step in opening the door to
participation in government programs
and tenders.
• Recommendation by key medical advisers
to have TruScreen included in the clinical
guidelines for the Russian Society of
Obstetricians and Gynecologists.
• Initial results from the clinical performance
valuation of TruScreen2 at the Royal
Hospital for Women in Sydney indicate that
TruScreen2 is a significant improvement
on TruScreen1.
• TruScreen has been approved by the
PNG Ministry for Health for use in a pilot
study of cervical cancer screening in two
regional centres, Lae and Kundiawa.
• TruScreen2 has been featured at major
women’s health conferences in China, Latin
America, Asia and Europe.
• TruScreen has been approved for a private
health insurance rebate in Jordan, a first
for our company globally. Whilst Jordan is
only a small market, we will use this as a
precedent for similar applications in
larger markets.
Interest in the TruScreen2 device is strong
and, while some approvals have taken longer
than initially anticipated, we expect to see
sales grow as early adopters transition to
commercial users across broader private
and public sectors.
To meet this increased demand TruScreen
is working with key suppliers to establish
our own device manufacture factory
and to significantly increase our current
manufacturing capacity. We are also
researching the establishment of offshore
assembly of the TruScreen device in
key markets where this is necessary for
government adoption.
TruScreen has continued to improve the
quality of both the TruScreen2 device and
the disposable Single Use Sensor, including
improved tooling, manufacturing techniques
and components
As indicated at the annual meeting, we are
currently reviewing the skills and capabilities
the company needs as we move into this
phase of our journey. In line with this, the
TruScreen board has been refreshed with
the replacement of two long serving directors
by new directors, Professor Ron Jones and
Chris Lawrence.
TruScreen is well positioned to continue
progressing in its commercial journey. Our
commercial performance in the first two
quarters of FY18 is roughly in line with that
of FY17; however, with the receipt of CFDA
and increased traction in other markets, we
are now witnessing a growth in sales. We
will continue to invest in our company, with
revenue expected to grow significantly faster
than expenses in the remainder of FY18.
THE ROAD TO COMMERCIALISATION
2018: Current stage of commercial journey
Research and
Development
Distribution

Partnership
Awareness and
Acceptance
Adoption and

Initial Sales
Mature Sales
• Development of first and
second generation devices
and algorithm
• Clinical validation
• Identify and partner with
reputable distributors
which have existing

in-country networks
and contacts
• Build awareness and
acceptance of TruScreen
• Rollout of commercial
programme
• Adoption by Key

Opinion Leaders
• Clinical trials and in-market
validation
• Presentation at major
conferences and
congresses
• Initial sale of

TruScreen devices
• Low initial usage of Single
Use Sensors per device
• Expand user base with
increased device sales and
installations, and training
of users
• Building usage as

Doctor and Patient
acceptance grows
• Continued expansion
of user base via device
sales and installation
• Ongoing, repeat sale
of Single Use Sensors
as usage per device
increases
TruScreen’s Current Phase of Growth

REFRESH FOR
TRUSCREEN BOARD
TruScreen’s board has been
refreshed with the inclusion
of two new members –
Professor Ron Jones and
Mr Christopher Lawrence.
Professor Jones is a world renowned
expert on cervical disease, and Chris
Lawrence is a significant investor in life
science and technology businesses,
including TruScreen.
TruScreen’s Chairman Robert Hunter had
previously highlighted to investors the need
to refresh the board, and the resignation
of two long term directors has enabled
TruScreen to appoint two new directors.
Both Ron and Chris are enthusiastic about
TruScreen’s future and about working
with their fellow directors to deliver the
company’s goals for 2018 and beyond.
CFDA APPROVAL
FOR TRUSCREEN2
WILL EXPAND
REACH INTO CHINA
China Food and Drug
Administration (CFDA) approval is
required for companies to market
and sell their products in China
and is, by global standards, an
extremely rigorous validation
process which certifies the
engineering, quality and efficacy
of our product for use in our
major market.
TruScreen2 provides a significant
improvement in performance, speed and
capability and we expect to see a step-up
in sales in China for both our devices and
for Single Use Sensors now that CFDA
approval has been obtained. Existing
customers will be upgraded to the new
technology over time and initial orders
for TruScreen2 are already confirmed.
With 400 million women of screening
age, China remains the primary market
opportunity for TruScreen. TruScreen is
now being used in several of China’s most
prestigious hospitals, including the Army’s
PLA General Hospital which now conducts
over 1000 TruScreen tests per month.
TruScreen has also recently announced a
major new sub-distributor agreement with
BioChem Group in China. BioChem has
entered into agreement with the Women’s
and Children’s Healthcare Division of the
Centre for Disease Control (CDC) in China
to evaluate TruScreen. The goal is to have
the CDC recommend TruScreen for use
in major central government screening
programs and for TruScreen to be included
in the list of basic medical equipment for
the over 30,000 community healthcare
centres throughout rural China.
This is an important commercial milestone
for TruScreen in China and, with a
number of customers already in place,
we are well positioned to strengthen our
existing presence and increase usage of
our technology.
HEALTH INSURANCE
REIMBURSEMENT
IN JORDAN SETS
PRECEDENT FOR
OTHER MARKETS
Jordanian women are the first in the world
to be able to receive a health insurance
reimbursement for TruScreen following the
decision of a major private health insurer
to include TruScreen in its list of approved
procedures for cervical cancer screening.
This achievement will allow TruScreen to be
more affordable for patients and compete on a
level health insurance footing with subsidised
pathology based competitors such as the
60-year old cytology option (the Pap smear).
RECOMMENDATION FOR
INCLUSION IN RUSSIAN
CLINICAL GUIDELINES
TruScreen’s testing methodology has been
recommended by key medical advisers to
be included in the clinical guidelines of
the Russian Society of Obstetricians and
Gynecologists. This endorsement is expected
to be a key to opening up major sales, not
just in Russia, but in many of the surrounding
countries that once formed the Soviet Union.
TRUSCREEN GOES
MOBILE IN MEXICO
TruScreen has again been selected for use
in Mexico’s famous Health Train – El Tren de
la Salud. Organised by the Fundacion Grupo
Mexico as a charity initiative, the privately
sponsored Health Train operates in 22 Mexican
states, bringing advanced medical screening
technologies to people in remote Mexican
communities.
More than 5,000 women have already been
successfully screened and, following the success
of the first tour, TruScreen will continue
to be used to screen women in remote
Mexican communities.
TRUSCREEN CLOSES IN
ON KEY GOVERNMENT
ACCEPTANCE IN
MEXICO
The Mexican Government have confirmed
that TruScreen’s Mexican representatives
will meet with the Cuadro Basico Technical
Committee (Junta Tecnica) in February to
present TruScreen’s case for allocation of a
government purchasing number and inclusion
in the catalogue of preferred medical products
for public health institutions and programs. If
the presentation is successful, the allocation
of the purchasing number is expected to be
confirmed within the next quarter.

RESEARCH COLLABORATION
WITH ALL INDIA INSTITUTE
OF MEDICAL SCIENCE (AIIMS)
Collaboration with All India Institute
Of Medical Science (AIIMS) to
conduct screening research in India
renews unique NZ-India ties.
Following a visit to India by a TruScreen
delegation led by Professor Ron Jones,
the All India Institute of Medical Science
(AIIMS) has agreed to collaborate with
TruScreen to validate our unique real-time
opto electric technology for the screening
of Indian women.
The AIIMS TruScreen project will be
conducted in both urban and rural settings.
Screening will be conducted in the AIIMS
hospital in Delhi, and CHRSP Ballabgarh, a
satellite of AIIMS that services 28 villages in
Haryana State.
AIIMS
The All India Institute of Medical Science
is an autonomous institution regulated
by its own Act of Parliament. AIIMS was
established following a £1 million gift from
the New Zealand Government in 1952 and is
the peak body in India for medical education
and research and a key body advising the
Government of India on health policy.
Dedicated to improving standards of
education for undergraduate and post
– graduate medical teaching across all
its branches in India, AIIMS conducts
education and research across 42 healthcare
disciplines, and publishes over 600 research
papers each year.
CERVICAL CANCER
IN INDIA
India carries one third of the global burden
of deaths from cervical cancer and cervical
cancer is the leading cause of cancer
mortality in the country. (1) Lead Investigator
for the AIIMS – TruScreen project, Professor
J B Sharma, stressed the need for improved
cervical cancer screening. “It is estimated
that every 8 minutes one woman in India
dies of cervical cancer. Since survival rates
improve if the condition is diagnosed and
treated early, screening for cervical cancer is
important” said Professor Sharma.
There are over 300 million women of
screening age in India. Professor Ron Jones,
after viewing firsthand India’s lack
of screening infrastructure, commented that
“I reiterate, India is a huge potential market
for TruScreen”.
PAPUA NEW GUINEA (PNG) GOVERNMENT
APPROVES TRUSCREEN PILOT STUDIES
FOR CERVICAL CANCER SCREENING
The Health Department in PNG has
approved two pilot clinical studies
with 1,000 patients each in two
sites. Located in the highlands at
Kundiawa, and on the coast at Lae,
these clinical studies will evaluate
the effectiveness, applicability,
safety and cost of TruScreen in
comparison to Pap smears, with a
view to having TruScreen adopted
for screening in other remote areas.
PNG has one of the highest rates of cervical
cancer worldwide and this is increasing
yearly. Unfortunately, the country has limited
resources and no permanent or successful
cervical cancer screening programmes.
Laboratory facilities are limited and this
restricts access to pap smears, with all
cytology being sent to just one laboratory in
the country. Thus results can take months to
be returned to the doctor and patient. With
its lack of traditional screening infrastructure,
PNG faces the problem of how to screen
its large rural population. TruScreen is the
world’s best solution for this problem and,
subject to government and other funding,
would bring great benefits to the country.
This project is the first time that TruScreen
has had a National Ministry of Health
endorsement for study and, if successful, we
expect this model to be reproducible not just
in PNG but in all countries that have remote
regions with limited access to
health services.
Professor Ron Jones and Professor JB Sharma
alongside the plaque commemorating the
foundation of AIIMS and the link to the
New Zealand Government
WORLD
RENOWNED
MEDICAL
SPECIALIST
LEADS
DELEGATION
TO INDIA
In November, TruScreen
Director, Professor Ron Jones
led a TruScreen delegation to
India, where his NZ government
relations were critical to gaining
the collaboration of the All India
Institute of Medical Science
(AIIMS), in a project to validate
the use of TruScreen in urban
and rural settings.
AIIMS was established by a grant from the
NZ Govt in 1952, and is the peak body in India
for medical research and training.
Prof Jones has been involved with the
TruScreen technology since the very
beginning and was the Principal Investigator
for a 1998 study at National Women’s
Hospital in Auckland, one of the key clinics
used to gather early data for what was then
the Cervical PolarProbe (and has now evolved
into TruScreen). The data generated in that
study was used to “inform” or “train” the
tissue differentiating algorithm that was first
placed into the TruScreen device.
His international profile and his extensive
experience and expertise will, as it has in
India, be a significant advantage for our
company as we look to expand and build on
our global footprint.

TruScreen2 and the benefits of Real
Time Opto-Electric cervical cancer
screening have been featured in
many major international, national
and regional conferences including:
CHINA
Annual Conference of China Medical
Equipment Association. Suzhou, 20 to 23 July
National Annual Colposcopy and HRA
Technology Training Course and Workshop.
Shanghai, 28 – 30 July 2017
COGA Hunan. Hunan Conference of China
Obstetrician and Gynecologist Association.
Changsha, August 6 - 7
COGA 2017. Annual Conference of China
Obstetrician and Gynecologist Association.
August 18 – 20 Chengdu
EUROPE
EUROGIN 2017. European Research
Organisation on Genital Infection and
Neoplasia. Amsterdam, October 8-11
ASIA
AOGIN 2017. Asia-Oceania Research
Organisation in Genital Infection and
Neoplasia. Tokyo, October 18 -19
LATIN AMERICA
FLASOG 2017. Federation of Latin American
Societies of Obstetrics and Gynaecology.
Cancun Mexico, September 5 - 9
MEXICO
COMEGO 2017. Mexican College Gynaecology
and Obstetrics. Mexico City, June 26 29
TRUSCREEN2 FEATURED
INTERNATIONALLY
TRUSCREEN’S
CONTINUOUS
IMPROVEMENT
PROGRAM
As part of TruScreen’s continuous
improvement program, TruScreen
has made several improvements to
its TruScreen2 technology.
Release of new operating firmware
TruScreen recently tested and released
updated operating firmware. This included
improvements in power management, wi fi
connectivity and changes necessitated by
the release of Mircrosoft’s new Windows
10 operating system which many of our
customers now use.
Release of Chinese
Language Version
In preparation for the CFDA approval to
market TruScreen2 in China, a Chinese
language version of both the TruScreen2
device graphics and computer browser
screens was developed and recently
released. All TruScreen2 devices sold

in China now have this new home
language version.
Manufacturing Processes
TruScreen has also introduced several
improvements to the processes of
manufacturing and testing the TruScreen2
device, especially the calibration of the
electro-optical interface.
TRUSCREEN
RECEIVES TICK
OF APPROVAL
FOR QUALITY
In November 2017 TruScreen was audited
by international quality auditor, TUV SUD,
and had both its EC certification (CE MARK)
for the TruScreen2 device, and international
ISO 13485 accreditation as a designer and
manufacturer of medical devices affirmed.
Other quality and regulatory highlights
include the granting of CFDA approval to
market the TruScreen2 device in China,
and conformity with changes to both the
electrical safety standard, ISO 60601-1 and
the new European Medical Device Directive.
TRUSCREEN MOVES TO INCREASE
ITS MANUFACTURING CAPABILITY
With the increase in sales following
CFDA approval and increased
traction in other markets TruScreen
has taken steps to both secure
and increase the supply of its
TrusCreen2 devices.
We have recently reached agreement with our
key suppliers to assist TruScreen to establish
our own factory, and to significantly increase
TruScreen’s current TruScreen2 device
manufacturing capacity.
In addition, TruScreen and its manufacturing
partners are also working together to develop
plans to have TruScreen2 assembled in key
offshore markets where this is a requirement
for adoption in government programs.

TRUSCREEN2 DELIVERS
PROMISING INITIAL RESULTS
IN CLINICAL EVALUATION
TruScreen’s Medical Advisory
Committee are currently conducting
a clinical performance evaluation
at the Royal Hospital for Women in
Sydney and at two regional clinics
in Australia. The initial results have
been promising and reconfirm the
ability of TruScreen2 to be a unique
and valuable screening test for the
prevention of cervical cancer.
The evaluation indicates that TruScreen2 is
a significant improvement upon TruScreen1,
with an improved Negative Predictive Value,
the key measure in Primary Screening. Whilst
the evaluation has not been completed,
preliminary results show TruScreen having a
Negative Predictive Value greater than 90%
for women in a screening environment.
These results reinforce the results of a 2016
study in Mexico (Lua et al) which showed
TruScreen to be significantly more sensitive
to high grade pre-cancerous changes than
both Pap and HPV testing in this setting.
This higher sensitvity, combined with
TruScreen’s real time, objective capability,
reinforce the advantage of TruScreen over
the Pap smear in developing countries and
indicate that TruScreen will be a substantially
more accurate screening method in our
target markets.
Explanation of terms:
The usefulness of diagnostic tests, that is
their ability to detect a person with disease or
exclude a person without disease, is usually
described using terms such as sensitivity,
specificity and predictive values.
• Validity: The extent to which a test
measures what it is supposed to measure,
in other words, the accuracy of the test
• Sensitivity: The ability of the test to
accurately identify disease when it is
present
• Specificity: The ability of the test to
accurately classify an individual as
‘disease-free’ when disease is not present
• Negative Predictive Value:
The percentage of patients with a negative
test who do not have the disease. A 90%
NPV is an excellent result.
CIN2 are moderately abnormal cells which are found on the surface of the cervix. CIN 2 is usually caused by certain types of human papillomavirus (HPV) and is found when a cervical
screen is done. CIN 2 is not cancer, but may become cancer and spread to nearby normal tissue if not treated. TruScreen2’s main focus is to accurately detect disease and this is supported
by the high Negative Predictive Value interim result of >90% in the study.
TruScreen Performance
Interim results RHW (2017): Excellent. >90% Negative Predicative Value
Truscreen in the real world - Sensitivity to CIN2+ Guadalajara 2016
TruScreen 78%HPV DNA 56%PAP 36%

TRUSCREEN REMAINS
WORLD’S BEST OPTION FOR
DEVELOPING COUNTRIES
TRUSCREEN VERSUS HPV DNA TESTING
HPV stands for Human
Papillomavirus, a common virus
that affects both males and
females, passed from person to
person through sexual contact.
HPV can stay in the body,
causing changes to cells that
can lead to HPV-related cancers
and disease in males and
females. Different types of HPV
can affect different parts of the
body, and some types are more
harmful than others.
However, just having an HPV infection does
not mean that a patient will go on to develop
cervical cancer. According to the Australian
Government Department of Health, four out
of five people will have an HPV infection at
some point in their lives.
A 2016 clinical trial from Mexico revealed
that, at any point in time, 12% of women of
screening age had a current HPV infection
of a type known to be associated with
cervical cancer.
While several companies have developed
tests for identifying the presence in cervical
samples of various strains of HPV, TruScreen
does not view HPV DNA testing a direct
competitor for several reasons:
Single visit screening and treatment
programs are genuinely needed in many
countries which lack laboratory infrastructure
or adequate patient recall procedures.
TruScreen is a real time test providing an
immediate screening result and requires no
laboratory infrastructure; whereas HPV DNA
tests need to be sent away for analysis and
the patient called back for reporting of results.
TruScreen is an objective test where the
accuracy is inherent in the device and not
subject to human error. The more steps in the
diagnostic process, the more chances there
are that the accuracy may be compromised
unless strict protocols are follows.
TruScreen is a one step diagnosis process.
HPV DNA does not look at cell changes, but
rather the mere presence of a precursor HPV
infection. A positive HPV DNA test must be
followed by a Pap Smear or colposcopy to
determine whether or not the patient actually
has any disease, which adds to the cost.
The vast majority of HPV infections
will spontaneously resolve without ever
progressing to CIN 1, CIN 2, CIN 3 or cervical
cancer. TruScreen2 accurately identifies

CIN2 cells.
The HPV vaccine is not the cure-all for cervical
cancer screening. The introduction of the
HPV vaccine does not eliminate the need for
screening as it does not protect against all
HPV types nor does it have an established
lifetime inoculative effect. Plus in many
countries the vaccine is too expensive and
has non broad community application. Thus,
in both developed and developing countries,
the role of and need for primary screening and
triage for cervical cancer has not diminished.
TruScreen is better
than HPV Testing in our
target markets:
• Real Time - no loss of
patients to follow up
• Enables ‘single visit’ cervical
cancer screening
• No need to build expensive
laboratory infrastructure
• No need to train a cohort
of expert lab technicians
• No need to create a sample
transport, handling and
storage system
• No need for a results
reporting system
• Tests for actual pre
cancerous changes,
not the relatively common
HPV infection
• No overloading of scarce
colposocpoy and histology
resources due to the latent
incidence of HPV in the
female population.