TRUSCREEN GROUP LIMITED logo

Key Markets Update and Revenue Guidance

Guidance2 March 2025TRUIndustrials

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.