Commercial Opportunities for Western Europe and Middle East

NZX/ASX Announcement
19 December 2025
TruScreen investigates commercial opportunities for Western
Europe and the Middle East

• TruScreen’s India distributor, Renovate Biologicals Pvt Ltd has been authorised to
investigate commercial opportunities in Western Europe and the Middle East
• TruScreen to be launched for Europe and the Middle East at the upcoming World Health
Expo in Dubai in February 2026
• Middle East countries have an estimated screening population of 99.7 million women*
• Western European countries have an estimated screening population of 84.3 million
women*

TruScreen Group Limited (“TruScreen” or “the Company”) advises that it has authorised Renovate
Biologicals Pvt Ltd (Renovate) to investigate commercial and market opportunities in the Middle East
and Western Europe from 1 January 2026.
Middle Eastern commercial activity has been authorised for Bahrain, Kuwait, Oman, Qatar, Saudi Arabia,
UAE, Lebanon, Iraq, Yemen, Iran and Turkey. These countries have an estimated screening population of
99.7 million women*. Renovate will represent Truscreen at the World Health Expo in Dubai from Feb 9 -
12, 2026.
Western European commercial activity has been authorised for Finland, United Kingdom, Netherlands,
Belgium, Denmark, France, Sweden and Germany. These countries have an estimated screening
population of 84.3 million women*.
The TruScreen medical device is CE Mark (Conformité Européenne), certifying that it meets essential EU
health, safety, and environmental standards and allowing it to be sold freely within the European Union.
Renovate is a fast-growing international medical device distributor who was appointed, in April 2025, to
distribute the TruScreen medical device in India. Established in 2015 in Hyderabad, Renovate distributes
gold standard, advanced and innovative technologies which have transformed clinical outcomes in
Diagnostics, Therapeutics, Critical Care, Organ Transplantation, Hematology and Ophthalmology to
global markets.
Renovate’s leadership team has a combined experience of over 50-man years and are supported by a
rapidly expanding sales team and network of sub-distributors, with offices in Hyderabad, Singapore,
Dubai and Amsterdam. The team aims to gain a 70-80% share of the cervical cancer screening device
market by 2030.
TruScreen CEO, Martin Dillon commented:
“It is incredibly exciting to be launching TruScreen’s next phase of global marketing activity with Renovate.
They are well positioned to support our continued global expansion, connecting us with government and
screening initiative leaders.

Western Europe has had a focus on cervical cancer for many years, and Middle Eastern countries have been
increasing their efforts on women’s health. Significant barriers to full population screening remain and
many of these countries are long way off meeting WHO target rates (70% by 2030), so the opportunity for
TruScreen to have an impact on the incidence and mortality from cervical cancer in these regions is real.”

This announcement has been approved by the Board.

* CIA World Factbook (female population aged 15-64yrs)

Ends


For more information, visit www.truscreen.com o r contact:
Martin Dillon
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 29 countries. In 2021, TruScreen established a manufacturing facility in
China for devices marketed and sold in China.
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.
In Dec 2023 TruScreen technology was added to the Vietnam Ministry of Health approved National
Technical List, for use in Vietnam’s public and private healthcare sectors and in 2024 was added to the
Russian guidelines for the screening of cervical cancer.
In financial year 2024 alone, over 200,000* examinations were performed with the 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/.
*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-
andprocedures/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