TruScreen – Commercial Breakthrough in Saudi Arabia

NZX/ASX Announcement

18 September 2023

Commercial breakthrough in Saudi Arabia - commences use of TruScreen
technology

TruScreen Group Limited (NZX/ASX:TRU) is pleased to report that the Dr Sulaiman Al-Habib Medical Group,
has installed the first tranche of four TruScreen devices for commercial use, for the screening of cervical cancer
in Saudi Arabia.
Dr Sulaiman Al-Habib Medical Group (DSAMG) is the largest private hospital network in the Middle East. The
adoption of TruScreen’s screening technology by DSAMG private hospitals will be important reference sites for
further market access in neighbouring Middle Eastern nations.
This installation follows from the previously announced successful completion of the clinical evaluation by
DSAMG network, followed by a successful tender by BettaLife Trading FZC (BettaLife) ( Truescreen’s distributor
in the Middle East).

The excellent clinical results of the evaluation were announced previously: see link

https://www.nzx.com/announcements/408275



TruScreen’s CEO, Dr Beata Edling said:
“I am very pleased that the Dr Sulaiman Al-Habib Medical Group have approved and will use TruScreen
technology to advance the screening for cervical cancer in their hospital network.
We congratulate BettaLife, our partner in Saudi Arabia, on reaching this important milestone which will support
the expansion of the TruScreen operations in the Middle East.”

This announcement has been approved by the Board.

Ends

For more information, visit www.truscreen.com or contact:




Dr Beata Edling
Chief Executive Officer
beataedling@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/EU 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 financial year 2023 alone, over 140000* examinations have been performed
with TruScreen devices. 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 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-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