TruScreen June Newsletter
NZX and Media Release 6 June 2018
TruScreen June Newsletter
TruScreen Limited has provided a copy of its June 2018 Shareholder Newsletter. This provides an update
on TruScreen’s performance and highlights key initiatives underway.
In particular, the company is now seeing its efforts translating into commercial progress and recent sales
indicate that it has reached a major turning point.
The FY18 preliminary results will be released shortly and whilst commercial sales were a modest increase
on FY17, sales since year-end have shown month on month growth. This is mainly as a result of gaining
CFDA approval for the TruScreen2 device in China, as well as growing recognition and validation for the
benefits the TruScreen technology brings.
The Shareholder Newsletter will also be 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.
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EXECUTIVE UPDATE: JUNE 2018
We are heading into a new financial year after 12 months of significant
progress that has seen increased uptake of our technology in China and
other established markets.
Pleasingly, we are now seeing our efforts translating into commercial
progress and recent sales indicate that we have reached a major turning
point for the company.
The FY18 preliminary results will be released shortly and whilst
commercial sales were a modest increase on FY17, sales for the months
since year-end have shown month on month growth. This is mainly as a
result of gaining CFDA approval for our TruScreen2 device in China, as
well as growing recognition and validation for the benefits our
technology brings.
While the increasing sales of the TruScreen device provides welcome and
valuable sales revenue, it is important to remember that a growing
portion of our future revenue will come from the sale of the TruScreen
Single Use Sensor (SUS). These consumable sales provide an annuity
income stream and will become an increasingly large proportion of our
revenue as we grow the number of devices in use.
Technically, each device has a useful life of up to 10 years and can
conduct up to 1,000 tests per month in a mass screening environment. However, we expect an average of
150 tests per month per device in a clinical hospital environment once users are properly trained and fully
operational. We are pleased to note that TruScreen’s current average for devices currently deployed in
China is slightly in excess of this figure.
In this newsletter, we have provided an update on our various markets, especially China, which is our
primary focus. Other key markets are Mexico and India, which are in early commercialisation stage, but are
of great interest and potential commercial value.
We also provide an update on the establishment of our own optical front-end manufacturing and assembly
facility in Sydney, which will allow us to meet the expected future demand for our TruScreen device. This
facility is expected to be commissioned within the coming months.
We are pleased to announce a further revitalisation and continued improvement to the skill set of the
board with the recent appointment of Ms Marie Ficarra as our first female director. You can read more
about Ms Ficarra’s impressive skill set in this newsletter.
Our staff and advisers have worked tirelessly over recent years to bring the company to the cusp of
commercial reality. With shareholders’ ongoing support, we are confident that we can deliver value to all
those involved.
IN THIS NEWSLETTER:
Executive Update
TruScreen’s competitive
advantage
China Progress
Indian evaluation underway
Purchasing approvals on way in
Mexico
Expanding our global footprint
New manufacturing facility to
boost production
Cancer marketing executive
joins TruScreen Board
Building global awareness of
TruScreen
TRUSCREEN’S COMPETITIVE ADVANTAGE
Recognition of the advantages of the TruScreen cervical cancer screening solution in developing countries is
emerging. These are:
FEATURE BENEFIT
Real-time results Immediate feedback to patient and operator – no
patient follow up required to deliver results.
Objective result Accurate, reproducible results.
No laboratory facility needed Allows greater access to women in remote
communities and easy to use.
High sensitivity Assured level of performance, providing a high
standard of cervical screening.
Automated device and error-checking during
examination
Clinical confidence in the accuracy and
consistency of results
No collection of tissue samples No pain or discomfort to the patient, leading to
higher screening participation rates.
CHINA PROGRESS
With 400 million women of screening age, China remains our primary market opportunity and we are
making solid progress.
Our goal is to have TruScreen added to various National Cervical Screening guidelines and procurement
lists. Inclusion in the guidelines is a long term strategy. It is an important step in accessing Government
screening programmes, and when successful it is expected to lead to significant yearly test opportunities.
Clinical validation is key and we are proposing two major trials:
Women’s and Children’s Healthcare Division of the Centre for Disease Control (CDC): Over 10,000 women
are expected to be involved in this trial. Successful completion will further our relationship with the
Women and Children’s Healthcare Division and facilitate potential access to their 3,000 centres.
Chinese Obstetrics and Gynaecology Association (COGA): A 10,000 patient trial to evaluate clinical use
across 15 hospitals and which has commenced in six hospitals.
As we work towards our goal, we are identifying early adopter provinces, such as Xinjiang which is currently
evaluating the TruScreen cervical cancer screening solution. In addition, TruScreen is commercially active in
a further 16 provinces. Achieving CFDA approval of TruScreen2 in late December 2017 was a major
milestone for our company and will help us encourage adoption in other provinces throughout China.
INDIAN EVALUATION UNDERWAY
India has the second largest population of women in the world, with approximately 300 million women of
screening age. It accounts for nearly one third of global deaths from cervical cancer and lack of access to
cervical screening is a major factor in this abnormally high mortality rate.
TruScreen, which needs no laboratory infrastructure, is an ideal solution to the need to roll out a screening
programme across the nation, particularly in rural and regional India. There are estimated to be more than
30,000 Primary and Community Health Centres in India and TruScreen is targeting possible installation in
these centres.
The India Prime Minister has instructed both the central government (GOI) Ministry of Health and Family
Welfare and the states to create programmes to screen every woman over 30 in India. This represents a
significant opportunity for our company.
Recently, TruScreen commenced a research collaboration with All India Institute of Medical Science
(AIIMS), to validate our unique real-time opto electric technology for the screening of Indian women, and
to have this highly reputable medical science institution recommend TruScreen to the Government of
India’s (GOI) Ministry of Health and Family Welfare for use in nationally funded screening programs.
We have identified three other key areas of opportunity which have a much shorter timeline to yield sales:
1. To have TruScreen included in screening programs run by the state Ministries of Health (there are
29 States in India);
2. To have TruScreen adopted for use in hospitals run by major public institutions, such as the Army,
Air Force, Railways and Employees Insurance; and
3. To have TruScreen adopted by major private and public hospital groups.
We have commenced presentations to Army and State owned hospitals and expect that these efforts will
convert to sales in FY19 and that India will emerge to become one of the top three markets for TruScreen in
the world.
These are strategies which have been successfully pursued in our roll out in China.
PURCHASING APPROVALS ON WAY IN MEXICO
In Mexico, we are seeking registration from the Cuadro Basico Committee and inclusion in the Mexican
Government’s purchasing catalogue of preferred medical devices for public health. This will enable
participation in Federal government tenders for supply to the public sector. This registration process has
taken over 12 months, with a decision expected shortly. We would then expect sales growth to accelerate
over the next two years as the public sector adopts the technology.
EXPANDING OUR GLOBAL FOOTPRINT
Indonesia is a new market opportunity for TruScreen, with an estimated 66 million women of screening
age. There are no formal screening programmes or guidelines in the country, and it lacks any significant
health infrastructure, making TruScreen the ideal solution. We have partnered with a medical products
distributor which is currently assisting with our product registration.
The Pacific Islands is also a new opportunity for us. We are collaborating with experts in Public Health from
the University of New South Wales to have TruScreen evaluated by women’s health officials in Fiji as a
solution for government cervical cancer screening in the Pacific region.
South Africa: Cervical cancer is the second most common cancer among South African women, with a high
prevalence of HIV/AIDS increasing the rates of pre-invasive and invasive cervical cancer. TruScreen recently
exhibited at the Gauteng Department of Health Innovation and R&D Summit with a positive and
encouraging reception.
We are now working to gain acceptance by the Gauteng Health Department, the most populous province
(population 12.3 million) and the highest funded regional authority in South Africa. We are gearing up to
launch a program within this health department as a test scenario. If successful, this will set the benchmark
for the rest of the country.
Zimbabwe: TruScreen has been selected for evaluation by the Zimbabwe Ministry of Health for use as a
government solution to its need for a cervical cancer screening technology. This evaluation is being
conducted in association with Zimbabwe’s National Aids Council, who seek to address the high rate of
cervical cancer among HIV positive women.
NEW MANUFACTURING FACILITY TO BOOST PRODUCTION
The TruScreen device is a sophisticated and highly engineered medical device. The manufacturing,
assembly and quality control process is time-consuming with considerable lead times.
Historically, TruScreen outsourced the majority of its device production, and was limited to a maximum
manufacturing capacity of 50 devices per month.
In January this year, we commenced the establishment of our own manufacturing facility to meet the
expected increase in demand for our TruScreen devices.
This new facility has an initial maximum capacity of 100 devices per month but is scalable up to 200 devices
per month. It is located within the Commonwealth Scientific and Industrial Research (CSIRO) in outer
Sydney and co-locates TruScreen with a number of other emerging technology companies that interface
with CSIRO facilities, technology know-how and experience.
The new production line is currently being commissioned and is expected to commence full operation
shortly.
CANCER MARKETING EXECUTIVE JOINS TRUSCREEN BOARD
As TruScreen’s commercial journey has evolved, we have looked to broaden the Board’s skill set to be more
relevant. We were pleased to recently announce the appointment of Ms Marie Ficarra to the board.
Marie has a detailed knowledge of cervical cancer and various cancer screening options, having specialised
in the sales and marketing of medical products and diagnostics primarily associated with cervical
cancer. Her background in government provides an insight into health regulatory processes including the
introduction of new cancer screening techniques, and she has the highest level of political, government and
corporate health connections worldwide
Marie has had a highly successful corporate health career, having served in senior corporate roles with
large diagnostic organisations. During her time at Cytec, she was responsible for the market introduction of
the Thin Prep Pap Test (liquid based cytology for the detection of abnormal cervical cells). In addition, she
has held a senior advisory role to Merck Sharp and Dohme (Australia) for the introduction and
reimbursement of the cervical cancer vaccine program and served on NSW Parliamentary Committees
responsible for Health and Medical Research.
Marie will provide an all-important female perspective on the board as an independent member and will be
a major asset as we enter the full-scale commercialisation of our unique real-time cancer detection device.
BUILDING GLOBAL AWARENESS OF 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. Recently, TruScreen has been
represented at the following events:
In China, TruScreen was presented at the Annual Meeting of the Cervical Disease and Cytology Division of
COGA in March and attended the International Medical Equipment Fair in April. In May TruScreen will be
featured at the Annual Conference of the Chinese Society for Colposcopy and Cervical Pathology.
Cervical cancer expert and member of the TruScreen Medical Advisory Board Colonel (Dr.) Michael J.
Campion visited Vietnam in March, to present TruScreen to senior health officials, and to the Obstetrics
and Gynaecology department at Hung Vuong Hospital in Ho Chi Minh City. Following this visit, a delegate
from Vietnam proposes to visit TruScreen in Sydney to evaluate TruScreen for use in government cervical
cancer screening in Vietnam.
In South Africa, TruScreen’s trainer conducted demonstrations and presentations to several hospitals and
organisations. This has helped to create awareness of TruScreen and initiate new relationships for our
distributor. In addition, TruScreen was presented to 300 attendees at the Gauteng Department of Health
Innovation and R&D Summit in South Africa.
In Mexico, TruScreen was represented at the National Colposcopy Conference in February and at the
Innovation Olympics.
We have a further series of target events and conferences lined up throughout the rest of 2018.
STAY IN TOUCH
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
KEY DATES
End FY18 Financial Year: 31 March 2018
2018 Results Announcement: June 2018
2018 Annual Report: By end-July 2018
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.
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.