TruScreen Stakeholder Newsletter August 2023

My recent trip to Asia and Eastern Europe has confirmed that TruScreen
has an outstanding product and distributors who are dedicated to the
TruScreen technology. We are working tirelessly to grow our existing focus
markets China, and Mexico, while expanding into new promising markets.
The first quarter of the financial year started strongly with good year-on-
year growth. Collaborating closely with distributors, we’re maximizing
efforts for national roll out in Zimbabwe, Saudi Arabia, and Vietnam. In
Saudi Arabia, we are driving sales through the largest network of private
clinics and hospitals. Most importantly, in China, we will commence a
large-scale screening project: the Health Check project, which will screen
10,000 women in the next 3 years, in addition to ongoing growth of
commercial operations in China.
We're pleased to have achieved a significant boost to our growth during
the first quarter of this financial year. TruScreen's technology was
endorsed in the latest edition of CSCCP's China Cervical Cancer Screening
Guideline, published in the July 2023 edition of CSCCP's journal, Chinese
Journal of Clinical Gynaecology and Obstetrics. This endorsement
followed a media announcement during the May 2023 national congress of
CSCCP in Beijing.
This achievement builds upon our earlier success at the beginning of the
financial year when TruScreen was included in the prestigious Blue Book in
China. In this publication, the TruScreen brand is featured in a dedicated
chapter on AI technology, recognized as a named AI technology for
cervical cancer screening. Our commitment to advancing healthcare
through cutting-edge AI technology is now acknowledged and endorsed
by leading medical authorities in the field.
As we continue to strengthen our position, we are paving the way for the
evidence-based adoption of our technology in our targeted growth
markets. Thank you for your ongoing support. We value your feedback and
welcome your thoughts. Please visit our website at www.truscreen.com to
get in touch.
Sincerely,
Beata Edling
Chief Executive Officer
*Chinese Clinical Journal of Obstetrics and Gynaecology, July 2023, Vol. 24, No. 4 Chin J Clin Obstet Gynecol July 2023, Vol.24, No.4
NEWSLETTER
AUGUST 2023
TruScreen Group Limited (NZX/ASX:TRU)
In this
issue:
Strengthening
collaborations
in Vietnam
China Visit
TruScreening
program
continues in
Zimbabwe
Presentation at
Biotech NZ,
Dunedin
Regulatory
Updates
CEO Update
AUGUST 2023 NEWSLETTER
PAGE 01

THE CROSS ROAD
PAGE 02
Drs Edling and Tan also visited several prominent hospitals, including Hung
Vuong Gynaecology Hospital, where they met with Dr. Nghiem, Deputy
Director, and other senior doctors and managers to explore potential
collaborations to create a model of care based on TruScreen’s technology.
This meeting offered a valuable opportunity for the TruScreen delegation to
interact with Vietnamese hospitals and listen to doctors' feedback regarding
TruScreen's screening technology. The feedback received from the doctors of
Hung Vuong Hospital was overwhelmingly positive. They acknowledged the
immense potential of TruScreen's Optical-Electrical technology in Vietnam,
recognising the numerous advantages it brings to both patients and
healthcare professionals. The technology's ability to facilitate rapid
screening and early detection of cervical cancer were well received by the
hospital's medical staff, including the Director of Gynaecological Services.
TruScreen is confident on the potential in Vietnam and that we can make a
significant impact on Vietnam's cervical cancer screening landscape.
We have a committed and professional distributor in GHS, and strong
support from key opinion leaders.
AUGUST 2023 NEWSLETTER
PAGE 02
Strengthening Collaborations in Vietnam
TruScreen’s CEO, Dr Beata Edling, and Lead Commercial Manager for APAC,
Dr. Jerry Tan, recently travelled to Vietnam to support the company's
growing presence in the local market. The trip was to strengthen
relationships, gain firsthand understanding of the market, and set the
platform for accelerating performance and business growth in the coming
year. During their visit, the TruScreen team reviewed detailed market
access plans and growth opportunities with the Gorton Health Services
(GHS), TruScreen’s Distributor in Vietnam. GHS has achieved Ministry of
Health approval in new 2 key public hospitals, with plans for
implementation of TruScreen in four other major hospitals well advanced
and our technology has gained strong support from key opinion leaders.
Meeting with the Board of Directors of Hung Vuong Hospital, Ho Chi Mihn City

China Visit
During their recent visit to Beijing, Dr Edling and Dr Tan met with our
Chinese Distributor, Siweixiangtai Tech Co. Ltd (SWXT). The primary
objective of the visit was to explore collaborative strategies to enhance
sales performance and foster business growth. Through this visit, both
parties sought to identify ways of working together effectively to
achieve mutual success and better serve the healthcare needs of the
Chinese population.
Drs Edling and Tan visited a major referral hospital in Beijing, with over
1,000 beds. The Head of the Gynaecology and Obstetrics, Prof Feng, has
shown strong support for the TruScreen technology and sees the AI
technology as an important path forward in achieving eradication of
cervical cancer in China in line with the World Health Organisation’s
strategy objectives. The Chinese Government actively promotes
healthcare technology advancements, and TruScreen’s devices for
China are Made in China.
TruScreen executives also had the opportunity to meet with Professor
Meng, the vice-head of CSCCP and an early adopter and supporter of
TruScreen’s technology. They discussed the future evolution of cervical
cancer screening
technologies in the coming
decade.
Drs Edling and Tan left
China with a better
appreciation of the
progress achieved by
SWXT, and the very
significant potential of
the Chinese market for
years to come.
AUGUST 2023 NEWSLETTER
PAGE 03

THE CROSS ROAD
PAGE 02
TruScreen’s CEO, Dr Beata Edling, presented our
achievements and future plans at the well-regarded
BiotechNZ event on 20th July in Dunedin, New Zealand.
Alongside several reputable biotech companies, we
introduced our “Mission driven growth” amidst the
challenges of the pandemic. The event, sponsored by ASX,
NZX and major companies, attracted numerous investors.
Our presentation received an enthusiastic reception
leading to further investor interest and potential
collaboration opportunities
AUGUST 2023 NEWSLETTER
PAGE 04
TruScreening Program Continues
in Masvingo Province, Zimbabwe
TruScreen is delighted to share that the Zimbabwe
government’s TruScreening program resumed in June 2023,
with strong screening numbers seen over the first two
months.
The program in Masvingo Province is a collaborative effort
between the Ministry of Health and Child Care, National
AIDS Council, and local health partners. The program
provides screening services to women in remote and
clinically under-served communities, where access to
healthcare can be limited. The screening program, which
began in 2022, has screened over 15,000 women in
Masvingo Province (as at 31 July 2023).
Cervical cancer is a significant health issue in Zimbabwe.
However, many women lack access to adequate screening
and treatment services, which puts them at a greater risk of
developing advanced-stage cancer that can lead to
death. TruScreen's innovative technology addresses this
gap by providing accessible screening services to women in
the region.
Presentation at the BioTech New
Zealand, Dunedin

AUGUST 2023 NEWSLETTER
PAGE 05
MDR readiness
As previously reported, the Medical Device Regulation (MDR) is a new global
regulatory framework that replaced the Medical Device Directive (MDD) for
medical devices being made and/or sold in the European Union after May
2024. The MDR strengthens the safety and efficacy of medical devices,
improves patient safety, and enhances transparency and accountability in
the medical device industry. The MDR introduces more stringent
requirements for manufacturers, including increased clinical evidence
requirements, stricter pre-market controls and post-market surveillance
requirements, and new rules for economic operators, such as importers and
distributors.
TruScreen’s activities in support of the transition to MDR are well underway
and the formal application process for MDR certification has commenced.
TruScreen has secured the necessary audit by the notified body, TUV SUD
Singapore, to seek MDR conformity assessment by May 2024.We are
confident, we meet the criteria for compliancy. While costly and effort-
consuming, achieving the MDR compliance will ensure that TruScreen
technology is competitive and trusted as a leading medical device
NMPA variation application
TruScreen is in the final stages of completing its Chinese regulatory (NMPA)
variation approval submission. This important milestone will grant approval
for the latest TruScreen device updates and recertification to the updated
NMPA standards. Submission is on track to be completed by the end of
August 2023, further strengthening TruScreen’s position in the Chinese
market.
Mexico
In January 2023, TruScreen took a significant step to register our technology
and device with COFEPRIS. This will facilitate the regulatory evaluation
process to obtain updated approval, enabling TruScreen to enter the public
health sector, including government screening programs. Such programs
present promising opportunity to expand TruScreen’s marketing reach in
Mexico. We expect the COFEPRIS decision by December 2023.
Russia-Kazakhstan certification renewal
All documents required for the certification renewal of TruScreen in Russia
and Kazakhstan have been submitted to our distribution partner for
submission to local regulators. We are currently waiting for a response from
these regulators, which is expected within the next 6 to 12 months.
This Newsletter has been approved by The Board.
Regulatory Update

AUGUST 2023 NEWSLETTER
PAGE 06
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 140,000* examinations have been
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.

About TruScreen
For more
information about
the cervical cancer
and cervical cancer
screening in New
Zealand and
Australia, please
see these useful
links:
New Zealand:
National Cervical
Screening
Programme |
National Screening
Unit (nsu.govt.nz)
Australia: Cervical
cancer | Causes,
Symptoms &
Treatments |
Cancer Council