TruScreen Markets Update

NZX/ASX Announcement

12 November 2024.
TruScreen – Key Markets Update

Highlights

• Unit sales of Single Use Sensors (SUS) to China exceeded 6 months budget by
>55%
• World Health Organisation (WHO) invites TruScreen to present at its global (by
invitation only) AI cervical cancer screening conference in Edinburgh
• Indonesia product registration completed
• Uzbekistan product registration commenced to enable evaluation of TruScreen
for national screening program
• TruScreen included in Russian Cervical Cancer Screening Guideline
• UNITAID features TruScreen in its Cervical Cancer Screening Landscape report
• Summary of published study reports in 2024 including new report by leading
research journal, Germany’s Stringer Nature
TruScreen Group Limited (NZX/ASX:TRU) is pleased to provide an update of its key
markets and target markets.

Global recognition by national Governments and NGOs
Following recent inclusions in UNITAID and Russian screening guidelines TruScreen is now
included in guidelines published by the World Health Organisation (WHO), UNITAID
(including the Clinton Health Access Initiative and Australia’s Daffodil Foundation), The
Chinese Obstetricians and Gynaecologists Association (COGA), the China Society for
Colposcopy and Cervical Pathology (CSCCP), Cofepris public health approval in Mexico,
the Vietnam Hospital national Technical List and the Russia Cervical Cancer Screening
Guideline.
WHO invites TruScreen to present at (by invitation only) an AI cervical cancer
screening conference at Edinburgh
TruScreen CEO Marty Dillon is to present at the World Health Organisation conference in
November at Edinburgh to further the use of Artificial Intelligence (AI) tools for visualization
of the cervix for cervical screening and treatment. The WHO invitation recognises the
advancement and adoption of TruScreen AI enabled technology by several national
government’s screening guidelines, notably China, Vietnam, Mexico and Russia.
Global Markets
China continues to be TruScreen’s key focus, but exciting opportunities are emerging from
other markets outlined below.

China
Number of Women of Screening Age: 476,599,793*
• Strong SUS Sales: Consumable sales (SUS) in China reached 90,720 units in the
first half of FY2025, exceeding budget by 55.6%.
• Software Upgrade: We have completed documentation for China’s NMPA registration
variations, enabling software upgrade on Chinese devices. The upgrade will improve
the user experience for doctors and clinicians and will extend the device’s in-use
service interval.
• Private Sector Expansion: Building on success in the public hospital system, our
distributor Beijing Siweixiangtai Tech Ltd. Co (SWXT) is targeting the growing China
private health sector.
In Jiangsu province, after the initial installation of TruScreen in the Affiliated hospital
of Nantong University, eight further private hospitals have confirmed the adoption of
the TruScreen technology, with an estimated monthly SUS usage of 300-500 per
device per month. This is more than twice the current average SUS usage per device
per month in China. Jiangsu Province, with a population of 85 million is a key growth
market for TruScreen and SWXT. The successful market expansion program will
continue to other populous provinces of Zhejiang and Guangdong.
Vietnam
Number of Women of Screening Age: 35,887,201*
• Ho Chi Minh City Screening Program: TruScreen is selected as the exclusive
screening method for a city-wide program in Ho Chi Minh City, commencing in early
2025. The decision by the Ho Chi Minh City Public Health Association (HPHA) is based
on the success of smaller-scale programs conducted by our distributor GHS. CEO,
Marty Dillon and Head of Commercial, Dr. Jerry Tan will meet with the Chair of the
HPHA on 15 November to implement the program and conclude the agreement
between TruScreen, HPHA and GHS.
• Public Hospital Adoption: With the streamlined public hospital approval process,
four major public hospitals in Vietnam have obtained procurement approval and are in
the process of installing TruScreen for their cervical cancer screening programs. Two
more hospitals are expected to follow shortly.
• Austrade Collaboration: TruScreen and GHS, are working with Austrade to engage
with Hanoi based sub-distributors to focus on the north of Vietnam as a key expansion
market. A social media campaign is also being developed to increase awareness of
women of Ho Chi Minh City and Hanoi on the need for cervical cancer screening.

Mexico
Number of Women of Screening Age: 45,983,174*
• Public Sector Focus: Distributor Sunbird is actively engaging with the newly elected
government officials to introduce TruScreen to the public sector.
Two projects are being pursued by Sunbird S.A de C.V for sales expansion:
• Mobile checkup units in Mexico City: (with a potential for up to 20 devices to be
installed with strong SUS pull through over a two-year period.) TruScreen is also being
considered as an ‘opto-electronic’ screening technology to enable the delivery of a
mobile cervical cancer screening program to the women of Mexico City and surrounds.
• Leveraging the government's focus on AI in medicine to highlight TruScreen's AI
capabilities.
In addition, Sunbird has commenced a series of cervical cancer screening webinars
to increase sales to gynaecologists in the private health sector in Mexico.
Uzbekistan
Number of Women of Screening Age: 11,617,411*
• National Screening Program: TruScreen continues to work with the Ministry of
Health in Uzbekistan to develop a national cervical cancer screening program. Product
registration of the TruScreen Cervical Cancer Screening Device is in progress and is
a pre-requisite for a pilot screening program in Tashkent to commence in Q1 CY2025.
A successful completion of the pilot is expected to result in 14 primary healthcare
clinics in Tashkent adopting the TruScreen’s technology. The next stage is to extend
cervical screening programs to Uzbekistan nationally.
Indonesia
Number of Women of Screening Age: 95,961,293*
• Registration Complete: TruScreen has successfully completed product registration
in Indonesia. TruScreen is collaborating with Austrade to connect with distributors and
key stakeholders in the public and private hospital sectors. Training with a key
stakeholder's team is scheduled for December, with commercial sales expected to
begin in Q1 CY2025.
Zimbabwe
Number of Women of Screening Age: 5,152,773
• Ministry of Health Re-Validtion: The Zimbabwe Ministry of Health is expected to
complete its periodic re-validation of TruScreen in December. Thereafter tenders
would be called for national screening in metropolitan and regional Zimbabwe.

Thailand, Malaysia and Singapore
Number of Women of Screening Age: 38,391,281
• Distribution Agreement Signed: TruScreen has appointed Intega Pte Ltd- a
Singapore based medical technology distributor, to market and distribute the
TruScreen Cervical Cancer Screening Device and SUS in Singapore, Malaysia, and
Thailand. The partnership marks a significant milestone for TruScreen as it completes
a continuous vertical East Asian market, from Indonesia in the south, north through
ASEAN (Association of South East Asian Nations) region, then Vietnam and China in
the north. ASEAN is the fastest growing economic regional bloc in Asia.
Jordan, Palestine and Rwanda
Number of Women of Screening Age: approx. 8,849,008
• Sadaf Medical, TruScreen’s distributor in Jordan, Palestine and Rwanda has recently
featured TruScreen in seminars and trade shows in all three countries. The first
TruScreen devices are expected to be installed in Jordan and Rwanda by December,
and in Palestine in Q1 CY2025.
TruScreen in Jordan

TruScreen in Rwanda


Recent global publications
During 2024, TruScreen was recognised in the following global publications.
 Truscreen study in Saudi Arabia outperforms traditional Pap Smear tests. (See
NZX/ASx announcement 5 August 2024)

 TruScreen selected by UNITAID, an agency of the Worlds Health Organisation
(WHO) and included in its Technology Landscape Report to its member nations.
(see NZX/ASX announcement 03 October 2024)

 TruScreen was selected as one of six global companies, from a cohort of 580
companies, that will have an impact on global women’s health. The evaluation
was conducted by Austrian based StartUs Insights. (See NZX/ASX
announcement 29 October 2024)

 Report published by leading research journal, Germany’s Springer Nature
concluded that TruScreen cervical cancer screening results were comparable and
even better (for patients with type 3 TZ) than conventional LBC (Liquid based
Cytology). (See NZX/ASX announcement 11 November 2024)

Looking Ahead
TruScreen CEO Martin Dillon commented “TruScreen is at the turning point of its
commercialisation phase. Sales have been increasing as markets and medical key opinion
leaders become more aware of the advantages that TruScreen brings to cervical cancer
screening. Recent developments, such as the increased recognition by WHO, NGO’s,
government guidelines, and the invitations to develop public screening programs in Ho Chi
Minh City and Uzbekistan indicate that TruScreen technology is now at a point where
adoption of our unique technology will accelerate, and sales will grow at a higher rate.”

*All population figures are for women aged 15-64 years as detailed in the World Fact Book
: https://www.cia.gov/the-world-factbook/


This announcement has been approved by the Board.
ENDS
For more information, visit www.truscreen.com or contact:
Martin Dillion
Chief Executive Officer
martindillon@truscreen.com
Guy Robertson
Chief Financial Officer
guyrobertson@truscreen.com

About TruScreen:

TruScreen Group Limited (NZX/ASX: TRU) is a medical device company that has developed
and manufactures an AI-enabled device for detecting abnormalities in the cervical tissue in
real-time via measurements of the low level of optical and electrical stimuli.
TruScreen’s cervical screening technology enables cervical screening, negating sampling
and processing of biological tissues, failed samples, missed follow-up, discomfort, and the
need for costly, specialised personnel and supporting laboratory infrastructure.
The TruScreen device, TruScreen Ultra
®
, is registered as a primary screening device for
cervical cancer screening.
The device is CE Marked/EC certified, ISO 13485 compliant and is registered for clinical use
with the TGA (Australia), MHRA (UK), NMPA (China), SFDA (Saudi Arabia), Roszdravnadzor
(Russia), and COFEPRIS (Mexico). It has Ministry of Health approval for use in
Vietnam, Israel, Ukraine, and the Philippines, among others and has distributors in 23
countries. In 2021, TruScreen established a manufacturing facility in China for devices
marketed and sold in China, with the “Made in China” registration.
TruScreen technology has been recognised in CSCCP’s (Chinese Society for Colposcopy
and Cervical Pathology) China Cervical Cancer Screening Management Guideline.
TruScreen has been recognised in a China Blue Paper “Cervical Cancer Three Stage
Standardized Prevent and Treatment” published on 28 April 2023, by COGA (Chinese
Obstetricians and Gynaecologists Association).
In financial year 2023 alone, over 140000
1
examinations have been performed
with TruScreen device. To date, over 200 devices have been installed and used in China,
Vietnam, Mexico, Zimbabwe, Russia, and Saudi Arabia. TruScreen’s vision is “A world
without the cervical cancer”
©
.
To learn more, please visit: www.truscreen.com/.
1
Based on Single Use Sensor sales.

Glossary:
Pap smear (the Papanicolaou smear) test involves gathering a sample of cells from the
cervix, with a special brush. The sample is placed on a glass slide or in a bottle containing a
solution to preserve the cells. Then it is sent to a laboratory for a pathologist to examine under
a microscope. https://www.cancer.net/navigating-cancer-care/diagnosing-cancer/tests-and-
procedures/pap-test
LBC (the liquid-based cytology) test, transfers a thin layer of cells, collected with a brush from
the cervix, onto a slide after removing blood or mucus from the sample. The sample is
preserved so other tests can be done at the same time, such as the human papillomavirus
(HPV) test https://www.cancer.net/cancer-types/cervical-cancer/diagnosis

HPV (human papilloma virus) test is done on a sample of cells removed from the cervix,
the same sample used for the Pap test or LBC. This sample is tested for the strains of HPV
most commonly linked to cervical cancer. HPV testing may be done by itself or combined
with a Pap test and/or LBC. This test may also be done on a sample of cells which a person
can collect on their own.
https://www.cancer.net/cancer-types/cervical-cancer/screening-
and-prevention

Sensitivity and specificity mathematically describe the accuracy of a test which reports the
presence or absence of a condition. If individuals who have the condition are considered
"positive" and those who don't are considered "negative", then sensitivity is a measure of how
well a test can identify true positives and specificity is a measure of how well a test can identify
true negatives:
• Sensitivity (true positive rate) is the probability of a positive test
result, conditioned on the individual truly being positive.
• Specificity (true negative rate) is the probability of a negative test result,
conditioned on the individual truly being negative (Sensitivity and specificity –
Wikipedia).
For more information about the cervical cancer and cervical cancer screening in New Zealand
and Australia, please see useful links:
New Zealand: National Cervical Screening Programme | National Screening Unit
(nsu.govt.nz)
Australia: Cervical cancer | Causes, Symptoms & Treatments | Cancer Council