TruScreen has recently released their Annual Report 2017. Below is a summary of the CEO and Chairman’s Report from this release. For the full Annual Report 2017 please refer to our Reports and Presentations page.
CHAIRMAN AND CEO REPORT
Our strategy remains to focus on those developing countries where there are no large scale cervical cancer screening programmes and infrastructure in place. Every year, we set goals for our company and we were pleased to achieve or make progress on all of these in the 2017 financial year.
China remains an important commercial opportunity for TruScreen, with the largest screening population in the world and an estimated potential market value of around US$800 million annually.
In partnership with our highly regarded in-country subdistributor in Beijing, we are targeting large provincial hospitals, as well as screening programmes and more recently military hospitals. We continue to make good progress and more than 100 hospitals, including large military hospitals, are now in commercial use or trialling our TruScreen technology. We are also involved in three large screening programmes, with over 41,500 women screened so far out of a potential 390,000 women.
All medical devices in China must have CFDA registration and approval before they can be procured. We already have this for our TruScreen1 device and are awaiting model upgrade approval for our TruScreen² device. This is a lengthy process and has taken longer than anticipated, with many companies continuing to report long waits. However, we anticipate receiving approval in Q3 of 2017 and will then quickly move to commercialise TruScreen² in the eight provinces in China where we already have pricing approval. This will also allow us to pick up the pace on our existing screening programmes.
There is strong interest in our second generation device in China and, with our expertise and specialist country knowledge, we expect increasing traction over the medium term.
While China remains an important opportunity for us, we are also focused on building sales in other targeted markets in Latin America, Central Asia, Europe and the Middle East.
We have grown our international footprint significantly in the past year, with the signing of a number of new distribution agreements including the European Union, the Middle East and Central Asia.
It takes time to build awareness and acceptance of our product and in each new market we enter, we roll out a programme that includes government lobbying, clinical trials, key opinion leader (KOL) engagement and major in-market conferences and regulatory applications.
We are targeting public and private health providers in these countries and are also engaging with health officials who are evaluating our product for use in public screening programmes, including in Mexico and India. While these evaluations can take many months, and involve multiple ‘in-field’ trials, each could produce significant revenue in the future.
These clinical and familiarisation trials are an essential part of our technology being adopted. As we widen the markets and opportunities we are targeting, we expect to see our investment into this area increase.
After China, India is the world’s largest screening market (close to 300 million women of screening age) and we have recently appointed an Indian distribution partner. In addition to sales to the private sector which are expected to commence this year, we have commenced the process of engaging with the Indian Government in regard to a longer term, large scale government screening opportunity.
In Mexico, the evaluation of TruScreen by the Ministry of Health as a screening protocol has commenced and government hospital purchases are expected in Q3 of calendar year 2017.
To support our growth strategy, we undertook a capital raising in 2017, raising $4.09 million in a private placement in March 2017, and an additional $897,500 through a Share Purchase Plan post financial year end, delivering a total of $4.99m of funds raised. These funds will be used to strengthen our balance sheet, fund sales and marketing initiatives, expand manufacturing capabilities and continue to improve the performance of our technology.
The use of leading edge technology is a core part of our offer and one that makes us stand out ahead of the crowd. Our hand held device has a microcomputer that utilises a sophisticated algorithm framework to distinguish between normal and abnormal tissue and provide immediate, high quality results in the field, without the need for specialist clinicians or laboratories. The Algorithm and Software Improvement Programme has been a large investment and focus for us in FY17 and we believe this will be a game changer for our company and the industry when released.
Internet browser capability, Wi-Fi connectivity and a massively increased processing capacity on the second generation device also adds to the technological benefits offered by TruScreen².