Key Markets Update and Revenue Guidance
NZX/ASX Announcement
3 March 2025
TruScreen – Key Markets Update and Revenue Guidance
Highlights
• Memorandum of Understanding signed with Hangzhou Dalton Bioscience to
expand its HPV product offerings
• Launch of Ho Chi Minh City Public Health Association confirmed for 12 April
2025
• Indonesian distributor appointed and commercial sales expected to commence
in April 2025
• Uzbekistan product registration due March 2025 which will enable the evaluation
of TruScreen for a national screening program
• Revenue guidance for the financial year ended 31 March 2025
TruScreen Group Limited (NZX/ASX:TRU) is pleased to provide an update of its key
markets and target markets.
Memorandum of Understanding between TruScreen Group Ltd and Hangzhou Dalton
Bioscience (DaltonBio)
TruScreen signed a non-binding MOU with DaltonBio, a leading China based manufacturer
of high-performance HPV DNA tests and laboratory equipment for cervical cancer screening,
for a strategic alliance to expand global commercial opportunities for a suite of DaltonBio’s
HPV related IVD (In Vitro Diagnostic) products to be marketed under the TruScreen brand.
Following due diligence TruScreen would be appointed a global distributor of DaltonBio HPV
related IVD products (excluding U.S.A. and Canada). DaltonBio to explore opportunities to
assist TruScreen’s AI enabled real time cervical screening device within its distribution
network, notably in its selected distributors in China and South America.
Global Markets
China
Number of Women of Screening Age: 476,599,793*
China is TruScreen’s key market accounting for over 75% of global sales.
• Key markets for Growth: TruScreen’s China distributor Beijing Siweixiangtai Tech
Ltd. Co (SWXT) is targeting 6 key provinces for growth in 2025 - Guangxi, Jiangsu,
Hunan, Zhejiang, Shanghai and Guangdong. These provinces have combined
population of 496 million, and an addressable screening market of approximately 124
million women.
• SUS Pull Through: Consumable Single Use Sensor (SUS) pull through per month
per device has peaked at 137 SUS per month per device, an increase of 50 % over
12 months.
• Software Upgrade: China’s NMPA registration variations have been approved and
software upgrade on Chinese devices has commenced. The upgrade will improve user
experience for clinicians and extend the device’s in-use service interval.
• Private Sector Expansion: SWXT targeting of the growing China private health
sector with private clinic and Health Check Centre, saw approvals received in Jiangsu
and Shenzhen.
• Public Health Insurance: In addition to having 11 provinces with approved pricing for
TruScreen, Beijing has renewed public health insurance reimbursement for eligible
patients. Shanghai has approved the final round of evaluation for public health
insurance reimbursement. The administrative processes are yet to be formalised.
Vietnam
Number of Women of Screening Age: 35,887,201*
• Ho Chi Minh City Screening Program to Launch on April 12: As announced in
November 2024, TruScreen signed a Memorandum of Understanding with the Ho Chi
Minh City Public Health Association and Gorton Health Services (GHS, our Vietnam
distributor) to conduct a 5-year program to screen 260,000 women. This will be
launched on April 12, 2025.
• Public Hospital Adoption: Following a January presentation by Professor Michael
Campion at Tu Duc Hospital in Ho Chi Minh City, 6 major Ho Chi Minh City hospitals
have agreed to adopt and install TruScreen.
Mexico
Number of Women of Screening Age: 45,983,174*
• Public Sector Focus: Distributor Sunbird continues to engage with the newly elected
government officials to introduce TruScreen to the public health sector.
• Leveraging the government's focus on AI in medicine. Leveraging this focus,
Sunbird is in advanced discussions with IMSS, (the nation’s largest public health
insurer covering 38% of the population) for TruScreen inclusion in their planned
cervical cancer screening program.
• Mobile checkup units in Mexico City: This program has been delayed following a
restructure of the national health administration system. Discussions are ongoing with
Mexico City health officials.
Uzbekistan
Number of Women of Screening Age: 11,617,411*
• National Screening Program: TruScreen was advised that product registration by the
National Pharmaceutical Safety Committee will be formalised in March. The approval
is a prerequisite for a pilot screening program in Tashkent. TruScreen is dealing
directly with senior Ministry of Health officials. The proposed cervical cancer screening
program will see 14 primary healthcare clinics in Tashkent adopting the TruScreen
technology. The next stage is to extend cervical screening programs to Uzbekistan
nationally.
Indonesia
Number of Women of Screening Age: 95,961,293*
• Distributor Appointed: TruScreen appointed a new Indonesian medical products
distributor PT Mawar Mitra Medika. Commercial sales are expected to commence in
April 2025 in the world’s largest Islamic nation, with a population spread over 14,000
islands. TruScreen offers an ideal solution to providing screening to a geographically
dispersed and diverse population.
• AI presentation by CEO to MOH officials and KOL’s. In December 2024, TruScreen
presented to an AI Health webinar organised by Austrade and the Indonesian Ministry
of Health. TruScreen was one of only two companies invited to present at this webinar,
a recognition of our growing reputation as a leader in AI innovative health technology
with a particular relevance to Low- and Middle-Income Countries (LMIC’s).
Zimbabwe
Number of Women of Screening Age: 5,152,773
• Ministry of Health Re-Validation: Following changes of personnel in the Zimbabwe
Ministry of Health the formal re-validation program for TruScreen was delayed to April
2025. Once the re-validation has commenced the tenders for national screening in
metropolitan and regional Zimbabwe will resume.
Jordan, Palestine and Rwanda
Number of Women of Screening Age: approx. 8,849,008
• Our distributor in Jordan, Palestine and Rwanda, Sadaf Medical, recently featured
TruScreen in seminars and trade shows in these countries. First commercial sales
have commenced to Jordan and Rwanda.
Revenue guidance for the financial year 31 March 2025
The planned screening programs for Zimbabwe and Vietnam have slipped from Q4 FY2025
to Q1/Q2 of FY2026. Delayed product registration for Indonesia and Uzbekistan delayed
commercial activities in those markets. The timing of these revenues from the delayed
commercial activities will be reported in Q1/Q2FY2026.
The Company expects revenue for the financial year 31 March 2025 to be circa $1.7m.
(2024 $2.1m) The increasing SUS sales in the sales mix and rigorous costs management
should see the Company reporting a small lower/improved loss to FY2024 loss of $2m.
Looking Ahead
TruScreen CEO Martin Dillon commented “The collaboration with Dalton Biosciences is a
highly significant opportunity for TruScreen to augment our sales offering to all our current
markets and to increase our distribution strength in China and South America. This will
enable TruScreen to offer both primary screening and triage solutions to cervical cancer
screening programs globally.
Whilst programs in Uzbekistan and Zimbabwe have been delayed, their commencement in
early FY2026, along with the HPHA program in Vietnam for 260,000 women over 5 years,
sees TruScreen well placed for growth in FY2026.”
*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
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.