TruScreen Stakeholder Newsletter
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
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