Truscreen July 2020 Stakeholders Newsletter
Executive Update - July 2020
Dear Investors and Partners,
Welcome to the July 2020 Newsletter.
The last few months have been a challenging time for people and businesses around the world. Since the
first COVID-19 outbreak in China, TruScreen has been closely monitoring the situation and assessing it's
potential impacts on the company, supply chain, and customers. TruScreen has continued to be
operational throughout this period, working closely with our suppliers and global distribution network to
navigate this unprecedented time. Ensuring the safety of our employees has been a top priority and in
early May TruScreen activated a business continuity programme, smoothly transitioning the team to
working from home.
COVID-19 has caused delays in some of our rollout projects, particularly in China and Russia, however,
we have been working closely with our local distributors to build the framework for recovery. In China, we
are already starting to see the return to a new post-pandemic normal, with increased usage and continued
device installations over the past 3 months. As a company, we have used this quarter to reset our
business plan, implement changes to our quality management system, reassess our resources, and focus
on supporting our distribution network.
Key early contributor, Professor Ronald Jones, stepped down from the Board and Medical Advisory
Committee (MAC) in April. Prof. Jones has been working with the TruScreen technology since it's
inception and has been a valued member of the Board and MAC since 2017. We would like to thank Prof.
Jones for his dedication as both a Board and MAC member over the year and wish him well in his
retirement.
Significant Events Year-to-Date:
• Successfully completed Capital Raises in May & June totalling $5.24M
• Total Q1 sales show +81.6% year-on-year growth, albeit off a low base
• First commercial sale to Vietnam, following MOH approval
• Enhanced Quality Assurance capabilities
• Nationwide Russian educational program
• Engaged new Eastern EU Consultant, Dr. Ivan Imre
• Hired Chief Technology Officer, Edmond Capcelea, ex Cochlear limited
• Released FY20 Financial Results & Annual Report
In April 2020, we announced a $2m Share Purchase Plan, which closed in May oversubscribed, raising a
total of $3,743,000. In response to the large number of inquiries received from our shareholders and third-
party investors, the Board resolved to undertake a New Same Class Offer to raise a further $1.5 million,
providing both existing NZ shareholders and the wider investor community the opportunity to further
support the company. The New Same Class Offer closed, fully subscribed, in early June 2020.
We would like to thank our shareholders, for their overwhelming support in the recent capital raising
initiatives. The new capital raised will enable the company to implement its business strategy focusing on
growing and increasing our presence in our key markets, as well as providing additional working capital for
the years to come.
We are pleased to advise that our (unaudited) first quarter sales show good growth in comparison to the
same period last year. TruScreen's total sales for FY21 Q1 grew 81.6%, and the total sales volume for
Single Use Sensors (SUS) grew 28% year-on-year (FY21 v FY20).
My first full quarter as CEO has come with some unique challenges in light of the unprecedented COVID-
19 pandemic, but with the guidance of our board and commitment from our team, we have achieved a
successful quarter in spite of the challenges faced. As we move into the second quarter for the financial
year TruScreen remains focussed on the post COVID-19 recovery plan for our key markets, increasing our
support to partners, as well as strengthening our human resources as a company and following through on
our business plan. We remain committed to our vision - A world without Cervical Cancer!
Regards,
Victoria Potarina
Chief Executive Officer
Truscreen Limited
First Commercial Sale to Vietnam
In April 2020 TruScreen received approval from the Vietnam Ministry of Health
(MOH) for commercial rollout. Approval has initially been granted to Hanoi
Obstetrics and Gynaecology Hospital (HOGH), with further rollouts for public &
private hospitals across Vietnam expected to follow.
The approval follows a successful MOH managed clinical trial, held at HOGH,
comparing the performance of TruScreen to traditional Pap Smears. The MOH
approval was a significant milestone for the company, after several years of
engagement in the region, and has materialised into TruScreen's first commercial
sale for the region in June 2020. The initial order, for 6 Devices and 4,320 Single
Use Sensors (SUS) totalling NZD $80,500, will assist in supporting the first
commercial installations in HOGH.
TruScreen is currently working with our Vietnam Distributor to establish the
nationwide roll-out plan, with initial coverage targeting 10 Hospitals throughout
Vietnam, including public & private hospitals.
China Market Update
China remains TruScreen's focus market and is the first of our markets to begin on the road to recovery
post-COVID-19. We have been working closely with our distributor, Beijing Siweixiangtai Tech Co.,
(SWXT), to establish a recovery road map, focusing on commercial roll-outs and the China Obstetrics and
Gynaecology Association (COGA) trial. First-quarter sales to the region totalled approx. NZD $235,700,
meeting forecast for the period. Q1 saw a 16% increase in our Chinese installation base, with the
TruScreen device rolled out in an additional 8 Hospitals including 2 new provinces. The COGA project is
on track to be completed by December 2020, with results to be released early next year for analysis.
Ms Su Siming, managing director and founder of TruScreen's Chinese Distributor SWXT, had this to say
about the Post-pandemic recovery progress; "The coronavirus pandemic has continued to have a big
impact on the development of our hospital sales and other major marketing projects in the last 3
months, but we remained confident and have been doing whatever we can to minimise the impact.
We held numerous online training sessions, academic meetings, and communications with
hospitals/KOLs covering various geographic areas. We’re working to build up a new
sales/marketing model to adapt to the new normal, post-pandemic, and to tackle the long-term
impacts of the pandemic.
In the last quarter, we installed devices in 8 hospitals for commercial daily use. The COGA project
kept moving ahead progressively, 54 participating hospitals have completed data collection to
date, and 15 hospitals are underway. We plan to start another 30 hospitals in the coming months
and are aiming to complete 10,000 patients by the end of the calendar year for data analysis and
paper publication.
We are sponsoring the annual meeting of CSCCP (China Society of Colposcopy and Cervical
Pathology) to be held in July 2020. The CSCCP is an academic society focussing on cervical
cancer screening and diagnosis, this annual meeting brings together hundreds of KOL,
specialists, doctors, and thought leaders in the region. We will have a local Key Opinion Leader
(KOL) presenting TruScreen at the conference.
2020 has become a difficult year due to the Coronavirus pandemic. However, as we enter the
pandemic recovery phase, we are committed in our efforts to overcome the various challenges
until we reach our ultimate goals!"
Chief Technology Officer joins TruScreen
In June, TruScreen welcomed it's new Chief Technology Officer (CTO), Edmond Capcelea.
Edmond is a senior medical device executive with over 20 years of experience in medical
device design & development. He has extensive experience in leading complex research &
development projects from conceptualisation through to development, clinical validation,
manufacturing, and commercialisation stages. He has a Masters in Engineering Physics
and his previous roles include Divisional Director Head of Implants and Design Development
at Cochlear Limited, and Senior Vice President of Research and Development at Saluda
Medical.
As CTO, Edmond will lead the technical department and help steer TruScreen's Research &
Development.
Central & Eastern Europe Commercial Lead
TruScreen engaged Dr. Ivan Imre as Commercial Lead for Central & Eastern Europe. Ivan,
based in Prague, Czech Republic, has over 20 years of experience in the medical device &
pharmaceutical industries in Europe, including Eastern Europe Business unit Director for
Johnson & Johnson.
Central & Eastern Europe (CEE) presents a large market opportunity for TruScreen, with
over 50 million women residing in the region. Women in CEE have a higher cervical cancer
incidence & mortality rate than elsewhere in Europe, partly due to the absence of high
coverage screening. Historically, approximately 40,000 women develop cervical cancer
annually, with 20,000 women dying from the disease each year in the region.
1-3
TruScreen rationalised its distribution in CEE and has commenced negotiations with new
potential distribution partners in the region, to initially cover Czech Republic, Poland,
Hungary, Serbia, Bosnia, Macedonia, and Montenegro.
MAC Chairman
Associate Professor Michael J. Campion, TruScreen Medical Advisory Committee
Chairman, sits down to discuss the science behind TruScreen's Cervical Cancer
Screening Device, it's clinical validation and application in real-world settings.
TruScreen Education Campaign in Russia
TruScreen Education Campaign in Russia
In May 2020 Truscreen's Russian distribution partner, IntelMed Systems (IMS),
completed the first launch of a nationwide education campaign featuring TruScreen
as the preferred screening method. The campaign, titled "Women of a different
age: from onco-denial to onco-phobia. How to prevent cervical cancer", was
developed by Key Opinion Leaders (KOLs) under the leadership of Russia's top
KOL on Cervical Cancer Professor Svetlana Rogovsjaya, President of the Russian
Association on Gynaecological Diseases and Neoplasia and Professor of Russian
Medical Academy.
The educational seminars saw over 2,800 doctors participate in training across 18
cities throughout Russia including; Moscow, Rostov-na-Donu, Tver, Gronzy,
Volgorod, and Novosibirsk.
The outcome of the campaign has seen a high acceptance of TruScreen
technology, with overwhelming support from doctors in the use of Truscreen for
cervical cancer screening.
“Nowadays all hospitals should have TruScreen, because it makes the life of
doctor and patient so much easier – you can see very quickly the clinical
status of the cervix. This method has passed many clinical studies and they
clearly show that Truscreen has high sensitivity and specificity, higher than
of pap smear test and HPV test’. - Prof. Svetlana Rogovsjaya.
TruScreen has used Q1 to focus on increasing our commercial support to our distribution
network. During the quarter there have been several key projects initiated in these areas with the
goal of improving our capabilities to support product roll-out and a higher number of devices active
in the field across the globe.
TruScreen has expanded it's cloud-based Jira system to handle some of our critical business
processes. Jira is an Australian developed software platform from the Atlassian Corporation Plc is
an Australian enterprise software multinational that develops products for software development,
project management, and content management. Its best known for its issue tracking application
Jira, and its team collaboration product Confluence.
TruScreen distributors can now log into the Customer Portal in Jira and provide their feedback in
regards to the TruScreen Device. In addition, our service centres in China, Russia, and Vietnam
can now log in and update service records for work undertaken. An upgraded Product Traceability
module allows TruScreen to follow the whereabouts of devices around the world. TruScreen has
also created a Distributor Portal that houses a suite of commercial, technical, and clinical
knowledge resources via Confluence.
TruScreen's General Manager for Quality & Regulatory Compliance, Paul Curran, says "This is an
important step for the company in bringing our Quality Processes to the next level and ensuring
ongoing compliance to International Standards for our Medical Device."
Cloud-based Customer Support and Product Traceability
Online End User Training
TruScreen has developed an online training platform available to end-users around the world. This
training platform will host our recently developed training video and theory exam and will accompany on-
patient training provided by our distributors. Moving our end-user training to an online format will
significantly reduce the time it takes to train and certify end users, as well as providing TruScreen with
greater visibility of progress for in region training. This tailored online learning platform is a crucial part of
expanding our capabilities, and ensuring we have robust procedures for the future. It will be initially rolled
out in English, Chinese, Russian, and Vietnamese with the availability to expand this further as we see
roll-outs into new regions.
A World Without Cervical Cancer
References:
1. Arbyn M, Raifu AO, Weiderpass E, et al. Trends of cervical cancer mortality in the member states
of the European Union. Eur J Cancer 2009;45:2640-8.
2. Bray F, Lortet-Tieulent J, Znaor A, et al. Patterns and trends in human papillomavirus-related
diseases in Central and Eastern Europe and Central Asia. Vaccine 2013;31S:H32–45.
3. Kesić V, Poljak M, Rogovskaya S. Cervical cancer burden and prevention activities in Europe.
Cancer Epidemiol Biomarkers Prev 2012;21:1423-33.
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