TruScreen Manufacturing and Supply Chain Update
NZX Announcement
11 January 2020
TruScreen Manufacturing and Supply Chain Update
Highlights
• China manufacturing approvals expected to provide TruScreen greater market access
• Local manufacturing contracts in China under negotiation with expected reduction in
component costs
• Novel Coronavirus may slow TruScreen device rollout in China in short term
TruScreen Limited (NZX:TRU) (TruScreen or Company) provides a market update on its
manufacturing and supply chain status.
Regulatory approvals allow local manufacturing in China
The distributor of Truscreen’s cervical cancer screening device in China, Beijing Siweixiangtai
Tech Co Ltd (SWXT) (through 100% owned subsidiary Osler Intelligent Technology Co. Ltd) has
recently received CFDA (China Food and Drug Administration) domestic product registration and
a manufacturing permit for its Shenzhen manufacturing facility.
The approvals allow TruScreen to sub-contract its screening device assembly to SWXT enabling it
to participate in tenders for government programs that have a bias for locally manufactured
products.
The contract between TruScreen and SWXT to enable manufacture in China is under negotiation.
The contract should enable TruScreen to reduce the cost of manufacture of its TruScreen device
and give the TruScreen product a much broader exposure to public health business in China.
In addition, the Company is negotiating an agreement with the supplier of its Single User Sheath
(SUS) in China which will significantly reduce the cost of these units based on a minimum annual
order.
Novel Coronavirus may disrupt supply chain in short term
Following the declaration of an International Emergency by the World Health Organisation from
the recent unfortunate outbreak of the novel coronavirus (the virus) in China there is a potential
risk of disruption to the supply chain of key production inputs to the Company’s manufacturing
and sales.
China’s Centre of Disease Control (CDC) and provincial authorities have taken steps to contain
the spread of the virus, including the extended closure of manufacturing facilities and shipping
services. If these containment steps are further extended, it has the potential to disrupt the
availability of electronic components and the Company’s Single Use Sheath (SUS) which are
sourced from China.
Our distributor in China, SWXT, maintains inventory of both Truscreen T2 cervical cancer devices
and SUS. However, sales and distribution activities are presently suspended until such time that
the CDC and provincial authorities lift the current closure directives.
China’s Central Government has now allowed businesses (excepting those in Hubei province) to
reopen. However, local governments retain the ability to restrict movement. For example,
workers returning to Beijing from elsewhere in the country are required to self-isolate for 14
days.
These restrictions will have some impact on the TruScreen’s ability to sell and distribute in the
short term. The Company will continue to assess the situation closely and keep the market
informed.
- ENDS -
For more information, visit www.truscreen.com or contact:
TruScreen
Tony Ho
Chairman
tonyho@truscreen.com
TruScreen
Guy Robertson
CFO
guyrobertson@truscreen.com
Investors
Investor Relations
Phone: +61 2 9237 2801
TruScreen@we-
worldwide.com
About TruScreen:
TruScreen is a Cervical Cancer Screening Device which offers
the latest technology in cervical screening, providing real-
time, accurate detection of pre-cancerous 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 intra-epithelial 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 Pap tests, including failed samples, poor patient follow-up,
patient discomfort and the need for supporting laboratory infrastructures. 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 CFDA-approved for
sale in China. The global market potential for TruScreen is significant.
For more information, visit our website at www.truscreen.com
Watch our video on TruScreen: http://truscreen.com/truscreen-the-company/truscreen- ultra-video/
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