TruScreen Stakeholder Newsletter November 2022

Dear Shareholders,
It is a privilege to be appointed the new CEO for TruScreen Group
Limited. I’m not only inspired by TruScreen’s vision, but I believe
that we have an obligation to bring our world-class technology to
save lives around the world. I stepped into this role after consulting
for TruScreen for two years prior, as the Medical Affairs and Market
Access Lead. This gave me the opportunity to understand our
business, its challenges, its strengths and most importantly, the
people. I want to thank Juliet Hull for looking after TruScreen during
the term of her interim CEO appointment. I had the benefit of
learning from Juliet, while working with her and transitioning into the
CEO role. Juliet has done an outstanding job leading the team
through the turbulence of the Covid pandemic.
Despite the challenges posed by the pandemic, the TruScreen
team held strong and has persistently progressed through the
strategic plan. Over the last year, we have laid many new
foundational inroads in our new and focus markets, while
strengthening our foothold in established markets. Read on for the
update on just some of these projects in China, Zimbabwe and
Vietnam.
It takes a lot of hard work to make something complex appear
simple. This is demonstrated by TruScreen recently having passed
3 quality audits, assessing our Medical Device Reporting (MDR)
readiness and regulatory compliance. I’m proud to say that we have
passed all three with no non-conformance.
I will bring to our TruScreen Team strong and purpose driven
international collaboration, clarity and focus. I believe that the world
is ready for TruScreen technology, and the time is now to make the
most of the WHO strategy and to include TruScreen in the
conversation on making cervical cancer the first ever cancer that
becomes a rare disease. Our financial peformance will be a natural
consequence of our hard work and dedication.
Thank you for reading this newsletter. I look forward to meeting with
all stakeholders in the time ahead. I want to hear from you. I
encourage you to reach out and share your thoughts.

China Market Update
TruScreen has continued to see progress in its core Chinese
market, despite ongoing COVID-19 restrictions. TruScreen’s Made
in China devices have begun to be installed in public hospitals, with
additional tenders ongoing.
TruScreen has been added to the cervical cancer screening routine
in the largest medical check-up centre in China. The health
checkup centre within the People's Liberation Army General
Hospital, approved adding TruScreen to its cervical cancer
screening services with installation expected to follow. TruScreen’s
local distributor, with a government backed association, have been
working towards a health checkup project which will aim to screen
10,000 women across 10 centres in 3-6 months. This project is
expected to commence following installations.
Recently, 8 hospitals in Beijing obtained pricing approval and
another 3 are now in the evaluation process. This process paves
the way for fast-tracked adoption in these hospitals, which include
top-level teaching hospitals that would be expected to generate
high Single Use Sensor (SUS) pull through. Elsewhere in the
region, another 4 major hospitals have awarded TruScreen tenders
in the last 3 months, with 6 more expected to follow.
Despite the ongoing COVID-19 restrictions, TruScreen’s distribution
partner has managed to maintain good momentum throughout the
country. With marketing activities shifting to online seminar to
ensure that projects can continue to move ahead.
Zimbabwe NAC Project Update
The National Aids Council's (NAC)TruScreen Masvingo pilot project
is on track to wrap up in Q1 CY2023. This is the second and final
phase of the government pilot program for the Masvingo province,
one of the most populous regions of Zimbabwe. Since July 16
devices installed at local level clinics and hospitals have screened
over 4,000 women. This project has been seeing strong SUS
usage, averaging ~100 screenings per month per device.
In October NAC further strengthened their commitment to the
project by providing additional resources to increase awareness
and uptake of screening via a community outreach program that will
travel to the 16 sites over the next 3 months.
Dr. Bernard Madzima, CEO of the Zimbabwe National AIDS
Council, recently said of the TruScreen technology, “The
advantage is that the women don't have to incur transport costs if
they go to the clinic to be screened (with TruScreen). The referral
pathway is that when the woman has been screened, they then, if
the result is abnormal, they are then sent to the next level of care
which would be the provincial hospital for colposcopy. We intend to
disseminate the TruScreen method throughout the country, so

for us TruScreen really is a good way of ensuring that services are
available to women at the lowest level.”
Vietnam Hospital approval
TruScreen has continued to see traction in Vietnam over recent
months as the country continues its COVID-19 recovery.
As recently announced, TruScreen obtained Ministry of Health
(MoH) approval for daily clinical use in two top hospitals in South
Vietnam. This approval is expected to accelerate other public
hospitals’ MoH approval, with four hospitals currently in the MoH
evaluation process pending approval. Off the back of these
approvals, a TruScreen seminar will run in HCMC in December
aiming to accelerate the rollout of TruScreen following the new
approvals. The seminar is expected to be attended by potential
users, local key opinion leaders, and hospital directors. TruScreen
is also cooperating to make a member of our Medical Advisory
Committee available for the seminars.
In the private sector, a two-day event in collaboration with private
clinics offered free TruScreen exams for local women. This initiative
is expected to be mirrored in other regions with the goal to
familiarise new clinics with the technology to facilitate adoption.
Local distributor GHS has started working to enter community
medical centres. As they work to introduce TruScreen into the
community medical centres, free TruScreen screenings have been
offered to women and initial training of users has commenced.
District 8 medical center in Ho Chi Mihn City is expected to conduct
a pilot program involving 300 women as the first phase of the
community medical centre.
TUV Audits
During the month of August, TruScreen successfully completed two
regulatory annual surveillance audits with no non-conformance.
The successful completion of all these audits allows TruScreen to
maintain our current EC and ISO certifications.
One audit focused on the TruScreen Manufacturing site in Sydney
and the second one on the legal representative site. Both audits
reviewed and inspected the effectiveness and compliance of our
Quality Management System to the requirements of
ISO13485:2016 and the European Council Directives 93/42/EEC
(MDD) – annex II (w/o 4) including the additional requirements of
MDR Article120 (3); there were no non-conformance found in either
one of these audits.
Subsequently, at the beginning of October, we also had to complete
a mandatory un-announced regulatory audit that focused on the
same compliance areas as the August audits. The un-announced
regulatory audit was also successfully completed, with no non-
conformance identified.

Poland marketing activities
TruScreen’s Poland based distributor, Aspironix, continues
marketing efforts with participation in 2 local conferences in
October. The booth was held at the 2
nd
Autumn Congress of the
Academy of Gynecology and Obstetrics and Rodzinna 2022, a
conference targeting for general practitioners and family doctors.
Participation in such conferences helps to facilitate awareness and
acceptance of novel technologies within the healthcare professional
network.
Upcoming Dates
Half Year Resultsby 30th November 2022
TruScreen Group Limited (NZX/ASX:TRU)
Dr Beata Edling
Chief Executive Officer
beataedling@truscreen.com
Tony Ho
Chairman
tonyho@truscreen.com

Investor Relations
The Capital Network
Julia Maguire
+61 2 8999 3699
julia@thecapitalnetwork.com.au
About us
TruScreen Group Limited (NZX/ASX: TRU) is a New Zealand-
based 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, and it does not incur issues with sampling and
processing of biological tissues, including 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 tool for cervical cancer screening.
The device is 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, Zimbabwe, Israel, Ukraine, and the Philippines, among
others and has active distribution agreements in 23 countries. It is
also National Medical Products Administration approved for sale in
China.  In 2021, TruScreen established a manufacturing facility in
China for devices marketed and sold in China.
To date, over 170000* examinations had been performed
with TruScreen device and 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”.
*Based on Single Disposable Sheath sales.
To learn more please visit our website
Copyright ©TruScreen Group Limited 2022
Level 6, Equitable House, 57 Symonds Street,
AUCKLAND
New Zealand 1010
All rights reserved.

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