TruScreen Market Update
NZX/ASX Announcement
22 November 2022
Market Update
• Revenue in line with prior half year ended 30 September, in face of challenging market
conditions
• Further growth potential in China on relaxation of COVID restrictions
• Developments in Vietnam, Saudi Arabia, Mexico, eastern Europe should produce
results in year ahead
• Appointment of CEO, Dr Beata Edling
Cervical cancer screening technology company, TruScreen Group Limited (NZX/ASX: TRU)
(‘TruScreen’ or ‘the Company), is pleased to provide this market update which includes commentary
on its unaudited financial results for the six months to 30 September 2022 (1H FY23).
Revenue was consistent for the six months YOY at $0.74m with COVID Zero lockdowns having a
negative impact in China. The Ukraine war precluded any shipments to Russia and slowed down
TruScreen’s ability to further develop Eastern Europe.
SUS unit sales were in line with the previous year and device sales were up on the previous year with
sales of Made in China devices to China’s new private health check market.
As at 30 September 2022, the Company had cash and cash equivalents of $1.68m.
Operational Update
TruScreen has maintained its revenue base despite disruptive and challenging market conditions.
Market developments
China
TruScreen continues to support ongoing initiatives to expand its reach in China, its most established
market and the world’s largest addressable cervical cancer screening market (circa 404 million
women of screening age).
TruScreen has recently been added to the cervical cancer screening protocol in the largest medical
private check-up centre in China. The private health check-up centre within the PLA 301 General
Hospital, approved the use of TruScreen in its cervical cancer screening services with installation now
having commenced. The private health check-up project aims to screen 10,000 women across 10
centres in 3-6 months.
TruScreen’s China distributor Beijing Siweixiangtai Technology Company Ltd (SWXT) relaunched
distribution of TruScreen cervical cancer screening device to Xinjiang Uygur Autonomous Region,
during the period. The Xinjiang UAR has a population of 26 million spread over an area of 1.7 million
sq km. This vast area has numerous ethnic minority groups in remote locations with the Xinjiang UAR
government providing special funding for cancer screening programmes.
The TruScreen cervical cancer screening device is ideally suited for Xinjiang UAR and has significant
advantages in undertaking cervical cancer screening programmes in this vast area with many remote
locations. The ability to provide a real time result with a robust TruScreen cervical cancer screening
device, without the need for laboratory infrastructure, will support the UAR government’s programme
of improving the lives of women in ethnic minorities.
Latin America
A TruScreen-based cervical cancer screening centre was opened in Ciudad de Mexico (Mexico City),
operated by Mexpharm Medical Clinical, during the period.
Mexpharm Medical Clinical a leader in healthcare in Mexico, specialises in comprehensive medical
care focused on the needs of patients and clinicians. It provides state-of-the-art medical technologies
and doctors specialized in ophthalmology, endoscopy, gynaecology-oncology, internal medicine,
anaesthesiology, and general medicine. It delivers competitively priced, quality short-stay medical
care with high level of professional medical care.
The centre showcases TruScreen’s medical technology, acts as a training centre, and provides
screening services to local population.
Zimbabwe
The National Aids Council's (NAC) TruScreen Masvingo pilot project continues to make good
progress. In FY Q2, 16 devices were installed at local clinics and hospitals, and have screened over
4,000 women, averaging ~100 screenings per month per device. Recently NAC have further
strengthened their commitment to the project by allocating additional funds to increase awareness
and uptake of screening via a community outreach program that will travel to the 16 sites over the
next 3 months.
Vietnam
TruScreen see significant opportunity in Vietnam, despite intermittent COVID lockdown delays.
TruScreen recently received approvals for clinical use of its screening device in two top hospitals in
Southern Vietnam, with a further four evaluations by Ministry of Health (MoH) underway. A roll-out of
TruScreen into community medical centres is scheduled in 2H FY2023.
TruScreen has recently signed a new distributor agreement with its distributor in Vietnam to include
both Vietnam and Cambodia. A national conference is planned in December, building on recent
success in obtaining Ministry of Health approvals for top hospitals in both Hanoi and Ho Chi Minh city.
Medical Symposium
The Company successfully completed delivery of its first global virtual medical symposium to key
opinion leaders from 7 countries, on cervical cancer screening, during 1H FY2023.
The medical symposium was chaired by Professor Neville Hacker, one of the world leaders in
gynaecology-oncology and a Founder of first multidisciplinary Australian Gynaecological Cancer
Centre in Sydney in 1986. The speakers at the medical symposium included Associate Professor
Michael Campion, Head of the Pre-Invasive Clinic at the Gynaecological Cancer Centre of the Royal
Hospital for Women in Sydney, Professor Hextan Ngan from University of Hong Kong, Associate
Professor Fei Chen of Peking Union Medical College Hospital in China, Dr Bernard Madzima, the
CEO of the National AIDS Council in Zimbabwe and Dr Majed Alhudhud, the Director of Gynaecology
Oncology Services at the Aryan Hospital Medical Group, Riyadh, Saudi Arabia.
The medical symposium, titled “Place of advanced technologies in screening for cervical cancer” had
132 registrations from Key Opinion Leaders from China, Mexico, Russia, Poland, Vietnam, Zimbabwe
and Saudi Arabia. The medical symposium enabled professional discussions on TruScreen and its
current clinical data and presented the success in cervical cancer screening programs in several
countries.
Professor Fei Chan presented her report on the excellent results from the 3 years COGA (Chinese
Obstetricians & Gynaecologists Association) trial where 15,661 women were screened across 64
hospitals.
Regulatory Compliance
TruScreen is currently investing and transitioning its documentation and regulatory processes to
comply with the new Medical Device Regulation (MDR) which is mandatory in May 2024. During the
half year the Company was subjected to three external audits necessary to maintain compliance with
EC and ISO requirements and to determine MDR readiness. No non-conformances were identified.
Appointment of Chief Executive Officer
In recognition of the waning of the COVID 19 pandemic and the need for the Company to prepare
itself for the post-pandemic economic environment, the Company moved to appoint a permanent
Chief Executive Officer to provide leadership to the Company. Dr Beata Edling was appointed Chief
Executive Officer in early October 2022 having previously worked with TruScreen’s as the Medical
Affairs and Market Access Lead.
Dr. Edling, who joined TruScreen in October 2020, is an experienced executive who previously led
large and small Medical Affairs Teams and commercialised numerous medical products with global
pharmaceutical companies, Sanofi-Aventis, Shire, Eli Lily and Amgen for Australia and New Zealand.
Dr Edling was previously a Non-Executive Director of ASX listed Noxopharm Limited. Dr. Edling is
multi-lingual and speaks several European languages. In addition to her medical degrees and training,
Dr. Edling holds an MBA from Australian Graduate School of Management.
Outlook
TruScreen has managed to maintain its financial performance despite the disruptive and challenging
global market conditions. We have continued to support our distributors and invest in developing our
emerging new markets. We have invested heavily in transitioning our regulatory systems and
processes to the new MDR framework. Our Made In China devices for China has opened up new
market opportunities in China. We will continue to focus on manufacturing cost reductions to enhance
gross margin. As we come out on the other side of the COVID 19 pandemic, we expect that the many
initiatives of the past years will bear fruit in the years to come.
For more information, visit www.truscreen.com or contact:
Dr Beata Edling
Chief Executive Officer
beataedling@truscreen.com
Guy Robertson
Chief Financial Officer
guyrobertson@truscreen.com
Julia Maguire
Investor Relations
julia@thecapitalnetwork.com.au
About TruScreen:
TruScreen Group Limited (NZX/ASX: TRU) is a New Zealand-based medical device company that
has developed an AI-enabled device that can detect precancerous and cancerous cervical changes
in real-time via optical and electrical measurements of cervical tissue. Unlike many cervical screening
technologies that have only triage/adjunct functionality, the TruScreen device is registered as a
primary screening tool.
TruScreen’s cervical screening technology effectively resolves many of the ongoing issues with
conventional cytology, including failed samples, poor patient follow-up, patient discomfort, and the
need for supporting laboratory infrastructure.
The device is CE-marked, meaning it meets EU safety, health and environmental protection standards
required for sale and use throughout Europe. It is also National Medical Products Administration
approved for sale in China. In 2021, TruScreen established a manufacturing facility in China for
devices marketed and sold in China.
TruScreen is currently targeting product sales to a range of low and middle-income countries,
including China, Mexico, Vietnam, Russia, Zimbabwe and Saudi Arabia, where no large-scale cervical
cancer screening programmes and infrastructure are currently in place. By doing so, the Company
hopes to help improve the health and wellbeing of women worldwide.
To learn more, please visit: www.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.