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Key Markets Update

Operational Update19 May 2024TRUIndustrials

NZX/ASX Announcement

20 May 2024

TruScreen – Key Markets Update


Highlights


• TruScreen installed in major hospital in Jiangsu, China

• Collaboration with PT Mursmedic in Indonesia with product registration in progress

• MOH Uzbekistan evaluating TruScreen for national screening program

• TruScreen partnering with Phillips Pharma for expansion in Kenya, Nigeria, Uganda, Ghana

and Tanzania

• Further progress in Vietnam, Saudi Arabia and Mexico

TruScreen Group Limited (NZX/ASX:TRU) is pleased to provide an update of its key markets and

key target markets. TruScreen continues to make steady progress in its global commercialisation.

China continues to be TruScreen’s key focus, however there are some exciting opportunities in a

number of new markets as outlined below.


China

Number of Women of Screening Age: 476,599,793*

In April, TruScreen’s distributor in China, Beijing Siweixiangtai Tech Ltd. Co (SWXT), commenced a

major initiative in Jiangsu province, located in Eastern China with a population of 85 million people.

TruScreen was installed and key staff trained in the Affiliated Hospital of Nantong University, a major

hospital in North Jiangsu. The hospital’s head of Obstetrics and Gynaecology is a Key Opinion Leader

in this region. SWXT’s local distributor estimates that this hospital will achieve a 1,000 SUS per month

pull through, bringing it into the top 5 TruScreen sites globally.

SWXT reinforced the inclusion of TruScreen in the Chinese Society of Colposcopy and Cervical

Pathology (CSCCP) guidelines by sponsoring their annual conference held in Tianjin on 10 to 12 May

2024. The conference was attended by more than 1,000 gynaecologists from around the country.

The sponsorship is an extension of SWXT’s work with CSCCP to ‘normalise’ the use of TruScreen in

cervical cancer screening.

Sales of our disposable Single Use Sensors (SUS) in China continue to grow, with monthly sales in

April growing 3.6% month on month.

We have also completed our price review in China to reflect our increased cost pressures.

Indonesia

Number of Women of Screening Age: 95,961,293*

TruScreen, with the support of the local Austrade office, is making strides in Indonesia. Indonesia

sees over 36,000 women diagnosed with cervical cancer annually. PT Mursmedic

(https://mursmedic.com/

) has commenced the product registration process for TruScreen in

Indonesia. Based in Jakarta, Mursmedic’s other clients include a suite of major medical device






manufacturers such as Fisher and Paykel Healthcare, Cook, Nanosonics, Stryker

and ThermoFisher Scientific. A key reference site in Jakarta has been identified and installation will

occur as soon as registration is completed.

Uzbekistan

Number of Women of Screening Age: 11,617,411*

The Ministry of Health in Uzbekistan is evaluating TruScreen as a technology to deliver a part of the

Uzbekistan National Screening Solution for Cervical Cancer. This program is a first for Uzbekistan

and being selected would be a transformative opportunity for TruScreen, not just in Uzbekistan but

also to serve as a reference site for other neighbouring Central Asian countries.

Kenya

Number of Women of Screening Age: 17,723,012*

TruScreen is currently in the process of registration in Kenya through our logistics partner, Phillips

Pharma Group ( https://phillipspharma.group/

). Phillips Pharma is one of the most trusted partners in

Sub Saharan Africa supporting many of the major multinational Pharma and Medical Device

companies, as well as Government and NGO clients. Leveraging our proven capability as a screening

solution for women in Zimbabwe, TruScreen will partner with Phillips Pharma first in Kenya, and then

to expand to other countries within their footprint, including Nigeria, Uganda, Ghana and Tanzania.

Mexico

Number of Women of Screening Age: 45,983,174*

TruScreen has recently gained regulatory approval (Cofepris) for TruScreen to be used as a cervical

cancer screening system for public hospitals. Our distributor Sunbird S.A de C.V is leveraging this

approval to gain access to key influencing hospitals in the capital and as a result we have this month

shipped 9 devices to Mexico.

Vietnam

Number of Women of Screening Age: 35,887,201*

Since our inclusion in the Vietnamese Ministry of Health Technical List, significant strides have been

made to streamline the approval process for our medical technology. Our distributor, Gorton Health

Services (GHS), has targeted approval in 64 major public hospitals. GHS is supporting this initiative

to drive the adoption in these targeted hospitals by showcasing TruScreen at the Vietnam National

Gynaecologic Conference on May 24th. Installation into the first key reference sites will commence

mid to late 2024, with a projected peak installation into hospitals in 2025.

Saudi Arabia:

Number of Women of Screening Age: 10,994,061*

Following early success in the private health system, including gaining private health insurance

reimbursement and installation in key reference centres, our distributor Bettalife is working to have

TruScreen accepted into the public healthcare system. Similar to Uzbekistan, TruScreen is being

considered as a component, alongside other technologies, for the National Screening solution for the

7 million women under public health care in Saudi Arabia.







Poland

Number of Women of Screening Age: 13,036,977*

Poland continues to face significant challenges with cervical cancer. TruScreen is working with the

Mother and Child Institute and has identified both private and public hospitals as the first to move from

Liquid Based Cytology to TruScreen. TruScreen is shortly entering the hospital validation phase with

commercial sales following the successful completion of this evaluation.

North Macedonia

Number of Women of Screening Age: 719,627*

TruScreen is currently undergoing evaluation by a local distributor who operates a Medical Clinic in

North Macedonia. When successful, TruScreen will replace Pap Smear in the clinic. This clinic will

serve as a base for demonstration and training for future customers in south eastern Europe. This

potential partnership marks a significant milestone as it would be TruScreen's first partner who is both

a distributor and a key reference centre.

*All population figures are for women aged 15-64 years as detailed in the World Fact Book :

https://www.cia.gov/the-world-factbook/



Martin Dillon, CEO of TruScreen said “I am excited with the opportunities that TruScreen now has.


Many of these markets have taken us many years to gain meaningful access and TruScreen is now

gaining momentum which should deliver much improved results in the year ahead.”



This announcement has been approved by the Board.


ENDS

For more information, visit www.truscreen.com

or contact:

Marty 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 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

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.