TruScreen Stakeholder Newsletter August 2021

August 2021
CEO Update
Click play to watch video in browser
Highlights:
Sales YTD show +36% growth (April-Aug’21 to April-Aug’20,
unaudited)
Completion of COGA evaluation
First sale to new Central European market
Establishment of International Experts Group (IEG)
Rollout for NAC Pilot Project in Zimbabwe
New WHO Cervical Cancer Screening Guideline

China Market Update
The first quarter (Q1) of FY2022 saw a continued uptake of Single Use Sensor
consumption in our key market, China. In April – July 51,000 SUS were consumed, +8%
on the same period last year[1]. This growth reflects the increased commercial user base
and a rise in the number of TruScreen screenings performed in the period.

TruScreen’s large-scale Chinese Obstetricians & Gynaecologists Association (COGA)
evaluation concluded in July. A total of 15,500+ women, from 9 provinces, will be included
in the final results. The COGA panel is expected to meet before the end of 2021 to review
the results and provide their recommendation on TruScreen as a primary screening tool..

TruScreen has been working towards becoming a domestic device in China. The transition
from international to domestic product registration will open new sales channels and widen
TruScreen distribution throughout the country. In May 2021 we completed the initial phase
of production transfer to the new facility in Shenzhen. To date 5 of the planned 20 pilot
devices have been completed. These devices will undergo quality assurance testing
before being rolled out.
Eastern Europe Update
Our new Eastern Europe markets are priorities for the company. Product registration has
been secured in four new countries, with an initial sale to Serbia completed in August[2].
While still feeling the impacts of COVID-19, much of Europe is opening back up and
finding their new normal.

In Poland, we are in the early planning phases for a validation project in the private sector.
Partnering with a highly regarded Key Opinion leader, the project aims to provide firm
support for the adoption of TruScreen as a primary screening tool within the sector.

Dr. Ivan Imre, TruScreen’s Commercial Lead for the region, has extended our distribution
network, with a particular focus on Romania. We are in contract negotiation with a strong
distribution partner in Romania and hope be able to share more soon.

Free Screening Event in Russia
In July, TruScreen’s Russian distributor, IntelMed Systems (IMS), partnered with a
local private clinic to offer women in Saint-Petersburg free TruScreen Screenings.
The event was part of a “Week of Women’s Health” organized by the local Health
Ministry. In total, 242 women screened using TruScreen, with approximately 20%
recording an “abnormal” result. These women received free follow up consultations
with gynaecologists.
IMS is working closely with both the private and public sectors in preparation for a
ramping up of commercial activities as the COVID-19 situation improves.
Establishment of International Experts Group
TruScreen’s International Experts Group (IEG) was formed during Q1 FY2022 and held
their first meeting in May. The IEG is an independent committee that will advise TruScreen
on a wide range of topics relevant to cervical cancer screening and global practises. The
first meeting was centered around steering the global scientific data generation efforts for
TruScreen.

The IEG met again in August to review current clinical trial proposals and consider the
future of the TruScreen technology in the fast-evolving innovation of healthcare.

We will continue to work closely with the IEG and our other advisory bodies to facilitate
accelerated market access and innovations in technology for the company.

Zimbabwe NAC Project Underway
Zimbabwe’s National Aids Council’s (NAC) TruScreen Pilot Project is
underway[3]. This project was initially set to commence in late 2018 but faced
significant delays following the economic crisis in 2019 and the COVID-19 pandemic.

In partnership with our distributor, Southern Skies Medical, NAC restructured the
project plan in July 2021 to enable the launch to commence. The changes include
moving the pilot phase from COVID-impacted Harare to nearby regional towns.

TruScreen facilitated a virtual TruScreen trainer training program in mid-August. 20
new TruScreen operators have now been trained for the pilot and 8 devices have
been rolled out in the region. The initial phase is to screen 500 women by October.

Cervical cancer is the most prevalent and deadly cancer for women in
Zimbabwe[4]. W omen living with HIV have a six-fold increased risk of cervical
cancer compared to women without HIV[5]. W e hope to see continued momentum
and look forward to seeing the outcome of this ground-breaking pilot programme.

WHO Screening Guideline – 2nd Edition
The World Health Organisation (WHO) has released its new cervical cancer screening and
treatment guideline[6]. The guidelines have been updated in the context of WHO’s Global
Strategy to accelerate the elimination of cervical cancer

Importantly for TruScreen, the new guideline acknowledge that “the traditional method to
screen women for cervical cancer has been cytology...this screening approach has
not been successful in low-and middle-income countries”.

WHO’s recommended cervical screening approaches has shifted in the new guideline, with
HPV DNA now the preferred method. Unlike HPV DNA testing and traditional cytology,
TruScreen has minimal impact on healthcare infrastructure, and the patient’s result is
available immediately at the point of screening. The process for obtaining and analysing
cervical samples is similar with cytology and HPV DNA testing. Both methods rely on
qualified specialists and high quality laboratory infrastructure, two things that many women
in LMICs and rural areas do not have access to.

WHO also provided new estimated figures for cervical cancer, showing that global annual
incidence and mortality rates continue to rise;

The new guideline calls for member countries to invest in better technologies, and adhere
to stronger implementation processes, for cervical screening.
Dr Nathalie Broutet, WHO Department of Sexual and Reproductive Health and Research
and HRP, said “What matters most is the coherence of every country’s programme in
ensuring the continuum of care: that all women have access to screening, health care
providers are informed in a timely manner about the results of the screening test and can
in turn share this information with their client.”

TruScreen’s vision and mission statements are reaffirmed by the new guideline in
conjunction with the global strategy. These new guidelines will help guide us and our
commercial strategy as we work towards
A World Without Cervical Cancer.
Key Upcoming Dates:
Virtual Annual Meeting 7th September 2021
Half Year Results by 30th November 2021
References:
[1] 51,300 units April – July 2021 to 47,520 units April – July 2020, unaudited.
[2] As announced 1 July 2021 - https://truscreen.com/news/first-eastern-europe-sale/
[3] First announced to market 14 September 2018, https://truscreen.com/news/truscreen-hiv-african-initiative-update/
[4] Data source: GLOBCAN 2020, International Agency for Research on Cancer 2021
[5] Stelzle D, Tanaka LF, Lee KK, Ibrahim Khalil A, Baussano I, Shah ASV, et al. Estimates of the global burden of cervical
cancer associated with HIV. Lancet Glob Health 2020. doi:S2214-109X(20)30459-9.
[6] . WHO guideline for screening and treatment of cervical pre-cancer lesions for cervical cancer prevention, second edition.
Geneva: World Health Organization; 2021. Licence: CC BY-NC-SA 3.0
IGO. https://www.who.int/publications/i/item/9789240030824
View this newsletter on our website

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

Want to change how you receive these emails?
You can update your preferences or unsubscribe
from this list.