Saturday, 23 February 2019



14 Dec 2017 08:30NZX
NZX and Media Release
14 December 2017


Cervical cancer technology company, TruScreen Limited (NZAX:TRU) has released
its 2018 interim results for the six months to 30 September 2017.

The company has continued to build its global footprint with a number of new
distribution agreements signed in the first half of the year and positive
progress being made in discussions to utilise TruScreen2 in public screening

Commercial performance was hampered in the first half due to delays in
gaining CFDA approval for the TruScreen2 device in China. This has now been
received and benefits are expected in the final quarter of FY18 and onwards
as initial orders for the TruScreen2 device are exported to China and
commercialisation moves ahead in other new markets. A corresponding increase
in sales of the Single Use Sensors is expected as more devices enter the

Total revenue was $572,101 made up of sales of $225,896 (HY17: $361,443) and
other income of $346,205, primarily from grants for Research & Development.
Sales were down on the previous first half year (although in line with the
second half of FY17) due to ongoing product improvements and validation
thereof and the delays in obtaining Chinese CFDA approval. In line with this,
net operating cashflow decreased slightly to $(1.77) million (HY17:

Inventory costs rose as expected, due to increased production of TruScreen2
in advance of receiving CFDA approval and in anticipation of growing demand
from new markets.

In May 2017 the company successfully completed an $897,000 Share Purchase
Plan as part of a larger capital raising which included a private placement
of $4.09m in March 2018.  This contributed to cash and cash equivalents of
$2.63 million as at 30 September 2017, and was the primary driver for the
increased foreign exchange impact, following translation from New Zealand
into Australian dollars.

TruScreen reported a Net Loss of $1.76 million for the six months, slightly
up on the previous first half year of $1.68 million.

Operational Review

In the past two years, TruScreen has made significant progress with a number
of major achievements including an expanded global market presence,
development and CE mark certification of the new TruScreen2 device and, most
recently, CFDA approval for TruScreen2 in China.

TruScreen has signed distribution agreements covering 24 countries, with a
combined screening population of approximately 1 billion women and is
continuing to negotiate new agreements. The focus remains firmly on the
larger of these markets - China, India, Russia and Mexico - and capitalising
on the work done over the past two years to gain acceptance of TruScreen in
these countries.

Acceptance and adoption can take time and is often dependent on the decisions
and speed of progress of third parties, such as regulatory bodies or
government departments, and this timing can be hard to predict. In
particular, evaluations of the TruScreen product for use in public screening
programmes can take many years and involve multiple in-market trials,
however, each could produce significant revenue in the future.

China remains the primary opportunity for the company and the current focus
is on encouraging the selection of TruScreen technology for large screening
programs, as well as increasing adoption in large provincial hospitals.

A major new sub-distribution agreement was signed in the first half to manage
government sales channels in China. The goal is to have TruScreen recommended
for use in major central government screening programs and to be included in
the list of basic medical equipment for the over 30,000 community healthcare
centres throughout rural China.

After China, India is potentially the world''s largest screening market with
close to 300 million women of screening age and the Indian government is
looking to set up public screening programmes. TruScreen is currently going
through the validation process for inclusion in these programmes.

In Mexico, the evaluation of TruScreen by the Ministry of Health as a
screening protocol has commenced and subsequent approval will allow
government hospital purchases. In addition, the company is tendering for a
major national health secretariat program to supply primary screening to the
Central Government in Mexico and has also commenced sales to hospitals
controlled by the largest public health insurer in Mexico, ISSSTE.

TruScreen has been approved for reimbursement by a major health insurer in
Jordan.  Whilst Jordan is not a major market, the attaining of this insurance
rebate is noteworthy in that it is the first of its kind globally for
TruScreen.   This is an important step in breaking down the pricing barriers
that traditional cytology tests enjoy in larger markets.

The clinical performance evaluation of TruScreen2 at the Royal Hospital for
Women in Sydney is progressing well. Initial results have confirmed
TruScreen''s advantages over the Pap smear in developing countries and
indicate that TruScreen2 will be a substantially more accurate screening
method than cytology in those target markets.

The Board was refreshed during the half year period, with world renowned
Professor Ron Jones replacing director Tim Preston as an independent


There is growing awareness and demand from low resource countries for
screening programmes and the global market for cervical cancer screening is
forecast to exceed US$22 billion per year in the next three years .

The opportunities for TruScreen look promising and the company is well
positioned to continue to advance the commercial agenda for its product.

With the outlook of increasing sales following the receipt of the CFDA
approval the company is looking to increase its manufacturing capabilities
both locally and overseas in certain key markets.


For more information visit or contact Martin Dillon,
TruScreen Chief Executive Officer, eMail:

About TruScreen:

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 tissue. A sophisticated proprietary
algorithm framework distinguishes between normal and abnormal (cancerous and
precancerous) tissue to identify precancerous change, or cervical
intraepithelial neoplasia (CIN).  A Single Use Sensor (SUS) is used for each
patient to protect against cross-infection.
End CA:00311907 For:TRU    Type:HALFYR     Time:2017-12-14 08:30:46
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