TRUSCREEN GROUP LIMITED logo

TruScreen Stakeholder Newsletter

Operational Update6 May 2021TRUIndustrials

May 2021
Executive Update

Welcome to TruScreen’s May 2021 Newsletter. It has been a challenging first quarter stepping

into the Interim CEO role and getting a greater understanding of the day-to-day operations of the

business.

CY2021 Q1 Key Activities:

Dual Listed on the ASX with a NZ$2 million capital raise

Appointment of Juliet Hull as Interim CEO

Appointment of Dr. Dexter Cheung to The Board

FY 31 March 2021 SUS sales volume +120% YOY

China market showing strong recovery

Commenced clinical evaluation in Saudi Arabia

Product registration submitted in 4 new markets in Central and Eastern Europe

ASX welcomes TruScreen Group Ltd as the first ASX debut for 2021. Bottom Right Corner: Non-Executive Director Mr. Chris

Horn, and Non-Exeuctive Chairman Mr. Tony Ho.

The Covid-19 pandemic continues to pose challenges for the global market more than a year after
its discovery, with access to clinics and hospitals reduced in many countries. We are pleased to

see vaccine rollout well underway in our key markets as they continue on their recovery journey.

Despite the challenges faced over the last 12 months, our distribution network has remained

committed to the TruScreen technology and have been taking advantage of this time to train

healthcare practitioners and Key Opinion Leaders (KOL), host educational seminars, and have

continued their work with local government departments and private sector customers to prepare

for the recommencement of clinical and commercial activities in their territories.


We have also seen an increase in publication of data from independent clinical studies,

highlighting the efficacy of the TruScreen device. We are pleased to continue to see such positive

results and to know that women around the world are benefitting from our technology.


COVID has also highlighted the unique capabilities of the TruScreen device. A recently published

paper from China provided invaluable insights into the benefits of TruScreen as a primary

screening tool in a hospital affected by pandemic. Utilising a screening tool that relieves the

pressure on hospital and laboratory facilities, in a time where they are stretched, can mean that

women are still able to receive reliable cervical cancer screening.

In March 2021 we welcomed Dr. Dexter Cheung to The

Board as a Non-Executive Director. Dr. Cheung is a

medical device engineer with extensive experience in

product research and development.

TruScreen also farewelled Mr. Chris Lawrence who

announced his retirement from the board after 4 years.

Despite the global challenges, TruScreen continues to see positive progress in our key markets

and activities. Our Medical Advisory Committee (MAC) has continued to work in close partnership

with our key markets, assisting with seminars, ongoing education programs, and KOL

engagement. As the reach and interest in the TruScreen Device continues to expand around the

world, we are also putting together an International Experts Group and a Central European

Advisory Board.

Following our ASX dual listing in January 2021, we are seeing strong support from both Australia

and New Zealand shareholder and are excited about the future and the opportunities that lie

ahead for us.


Once again, a big thank you to all our shareholders for their continued support as we navigate the

changing dynamics of the world.

Juliet Hull, Interim CEO

FY2021 SUS Volume Sales +120%
April marked the start of our new financial year (FY). Our unaudited results for FY2021 show that

the volume of Single Use Sensor (SUS) sales increased 120% year-on-year (YOY).


Every TruScreen examination requires a SUS. The YOY growth of SUS volumes is a good

indicator that, despite the significant impacts of the global pandemic, we saw a strong increase in

the usage of our cervical cancer screening devices in our markets, notably in China. This trend is

expected to continue as our markets recover and TruScreen’s commercial and clinical projects

resume globally.

China Market Update

China remains TruScreen’s key market, and in the first quarter of the 2021 calendar year we saw

further progress. The installation rate of new TruScreen devices into hospitals over the last 6

months has shown strong recovery, following the impacts of the covid-19 pandemic. Clinical trials

and evaluations have resumed and commercial usage of the TruScreen devices increasing. We

are pleased to have a dedicated distributor who has remained focused and committed to the

TruScreen technology and has delivered outstanding results during the quarter.


China had a record month of SUS usage in March 2021, with well over 8,000 commercial

TruScreen examinations completed. This was the highest monthly SUS usage in our history. We

now have over 80 installed devices for commercial use in China. +165% YOY.


The TruScreen cervical cancer screening technology is continuing to gather attention and interest

throughout China. Over 100 hospitals, have completed clinical evaluations/trials, and are

progressing to approval/procurement stages.


Chinese Obstetricians & Gynecologists Association’s (COGA) TruScreen project is ongoing, with

a total of 74 of the 77 participating hospitals having completed the data collection as of April

2021. While the pandemic has delayed the completion of this trial, completion is now expected by
mid-2021. The results will be reviewed at the COGA Annual Meeting in August 2021. Results

from the pilot study of the project were published in the March edition of the Journal of China

Practical Gynaecology and Obstetrics, a prestigious national medical journal.


Our distributor has also been working closely with The Chinese Society of Colposcopy and

Cervical Pathology (CSCCP), to secure the inclusion of the TruScreen technology in their

screening guidelines, or a consensus recommendation on the use of the technology. The CSCCP

is a national professional organization and a member of International Federation of Cervical

Pathology and Colposcopy (IFCPC), that promotes cervical cancer screening and prevention in

China.

TruScreen's Global Distributors' Conference

An inaugural virtual Distributors’ Conference was successful held on 16 December 2020 with

participants representing over 14 of our markets. The initiative opened a new channel for

information sharing at a time where international travel is not possible. The conference included

presentations from both TruScreen and our distributors, and a lively Q & A session.

Saudi Arabia Evaluation Study

In late January 2021 Dr. Sulaiman Al Habib Medical Group (SHMG), Saudi Arabia's largest private

healthcare provider, commenced its clinical evaluation of the TruScreen device. Three of the six

SHMG hospitals are participating, with over 200 of 600 TruScreen examinations completed by the

end of March 2021.

The study aims to have the TruScreen device receive a recommendation for its use for cervical

cancer screening in all SHMG hospitals. As reference hospitals, we anticipate once the approval

is received it will increase market access throughout the region.

We were delighted and grateful for the presentations from Francisco Camargo, of Sunbird S.A de

C.V, Mexico, and Ms Su Siming, of Beijing Siweixiangtai Tech Co Ltd, China, who shared

experiences in their TruScreen commercialisation pathways. Further Global Distributors’

Conferences will be held in 2021.

Extending our reach in Europe
TruScreen appointed two new distributors, in mid-2020, covering 7 countries in Central & Eastern

Europe (CEE). We are pleased that four markets already have product registrations lodged with

local governing bodies. We expect these countries will commence commercial activities within

the 2021 calendar year.


To support the early development stage of our CEE markets, TruScreen has partnered with our

local distributors and regional Key Opinion Leaders (KOL) to form our new Central European (CE)

Advisory Board. This board will steer the local market access plans, including reimbursement and

cervical screening projects.


An inaugural CE Advisory Board meeting with 4 KOLs, from Poland, Serbia, and Czech Republic,

was held virtually in late March 2021. This meeting was an opportunity for the KOLs to discuss

the value of TruScreen as a primary cervical cancer screening tool and assess individual CE

market needs and opportunities for the technology. TruScreen’s MAC Chairman, A/Prof Michael

Campion, attended the meeting and presented his insights from the clinical research conducted at

the Royal Hospital for Women in Sydney, Australia. The Advisory Board attendees were engaged

in the discussions and saw the potential advantages of the TruScreen technology in a busy clinic

environment. The collaboration on clinical evaluations for the TruScreen device in Central Europe

is ongoing.

Furthering our commitment to Medical Affairs
Dr Beata Edling joined TruScreen in October

2020 as Medical Affairs and Market Access

Lead. Dr. Edling has a MD from Gdansk,

Poland, a PhD in Surgery, and an MBA from

the University of New South Wales, and has

an extensive background in biotechnology,

healthcare management, and strategy.

Dr. Edling will guide TruScreen in scientific

and clinical projects, data generation, and

communication to support our commercial

activities, including reimbursement within our

markets. She is working closely with our

KOLs and distribution network in facilitating

and executing screening evaluations and

programmes.

As a medical device company with a novel technology, TruScreen is focused on and committed to

Medical Affairs and Market Access on a global level. Dr. Edling has led the establishment of

TruScreen’s International Experts Group (IEG) with internationally renowned gynaecology-

oncology experts.


The IEG will collaborate with TruScreen on data generation, communication at global

conferences, research planning and interpretation from the regional perspective, and collaboration

with the international research and screening organisations. We welcome the opportunity for

collaboration toward the implementation of the World Health Organisation’s global strategy to

eliminate cervical cancer.

TruScreen KOL to present at World Congress for Cervical

Pathology and Colposcopy

IFCPC 2021 Eliminating cervical cancer – call for action.

TruScreen MAC Chairman A/Prof. Michael Campion and Prof. Chen Fei, Academy of Medical

Sciences and Peking Union Medical College in China, will each be presenting abstracts on the

TruScreen technology at the 17th International Federation of Cervical Pathology and Colposcopy

(IFCPC) world congress in July 2021.


A/Prof. Campions abstract “Performance evaluation of opto-electronic screening device in

comparison to liquid-based cytology and HPV DNA testing for detection of cervical neoplasia” and

Prof. Chen Fei's abstract “The Performance of Real-time Optoelectronic Device (TruScreen) for

Early Diagnosis of Cervical Cancer and Precancerous Lesions: A Multi-center Evaluation” will

both be presented under the Innovations in Cervical Cancer Screening section of the programme.


The congress was originally scheduled for 2020 but due to the pandemic was postponed and will

now go ahead as the largest conference ever organised on cervical cancer in Asia on July 1st-

5th 2021. The conference’s theme “Eliminating Cervical Cancer – Call for action” is in response

to WHO call for Elimination of Cervical Cancer.

About TruScreen:

TruScreen cervical cancer screening device offers the latest technology in cervical screening, providing

real-time, accurate detection of precancerous and cancerous cervical cells to help improve the health and

well-being of women around the world.

TruScreen’s real-time cervical cancer technology utilises a digital wand which is placed on the surface of

the cervix to measure electrical and optical signals from the surrounding tissues. A sophisticated

proprietary algorithm framework is utilised to detect pre-cancerous change, or cervical intraepithelial

neoplasia (CIN), by optical and electrical measurement of cervical tissue.

TruScreen offers an alternative approach to cervical screening, resolving many of the ongoing issues with

conventional Pap tests, including failed samples, poor patient follow-up, patient discomfort and the need

for supporting laboratory infrastructure. As such, TruScreen’s target market is low and middle-income

countries where no large-scale cervical cancer screening programs and infrastructure are in place, such

as China, Mexico, Africa, Russia, and India. TruScreen’s cervical cancer screening device is CE-marked

and certified for use throughout Europe and NMPA (formerly CFDA) approved for sale in China. The

global market potential for TruScreen is significant.

For more information, visit www.truscreen.com or

contact:

Juliet Hull, CEO

juliethull@truscreen.com

Guy Robertson, CFO

guyrobertson@truscreen.com

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.