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Truscreen July 2020 Stakeholders Newsletter

Operational Update12 July 2020TRUIndustrials

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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