TruScreen Interim Report 2017

Published: 01 February 2017

TruScreen has recently released their Interim Report 2017. Below is a summary of the CEO and Chairman’s Report from this release. For the full Interim Report 2017 please refer to our Reports and Presentations page.

CHAIRMAN AND CEO REPORT

In the six months to September 30, 2016, TruScreen focused on four key pillars of activity.

  • Further development of the company’s innovative technology, TruScreen²
    and Algorithm².
  • Clinical validation, certification and registration of TruScreen².
  • Review and improve our manufacturing costs and capacity.
  • Further enhance our distribution network and servicing capacity.

TruScreen² is in the early stages of commercialisation.  Convincing governments and large private institutions to adopt an innovative medical technology is neither simple nor instant and regulatory approval processes take time.

As previously advised to the market, initial stocks of the original TruScreen1 device sold out quickly in 2015 and the company chose to discontinue with the sale and supply of the original device and instead focus on further development and product improvements to our second-generation device known as TruScreen². This has involved significant R & D cost to refine the device and Single Use Sensors (SUS) together with associated clinical trials and regulatory certifications.

The company continued to refine its diagnostic capacity through its Algorithm Improvement Programme with a significant improvement in accuracy expected. Algorithm² has been released for clinical evaluation at a number of leading hospitals in Australia, Mexico and China. The company has also made significant product improvements to improve the device in both clinical and practical use.

TruScreen received European certification (CE Mark) and commenced production of the TruScreen² device in April 2016, with several other country-specific regulatory approvals received in subsequent months. Our application for Chinese Certification of TruScreen² (CFDA) is progressing to plan and is expected to be finalised mid-2017.

The company has initiated small sales of TruScreen² to new markets including Mexico, Hong Kong, Vietnam, Turkey, Kazakhstan and Poland during the six-month period, with subsequent sales to Jordan, Philippines and Russia since September. We have also progressed our plans to enter the European market and have identified several suitable and interested distributors in various countries including the European Union, Middle East and Latin America.

The company’s strategy is to gain early adoption in all markets and then after a period of evaluation, gain key opinion leader endorsement which is essential for adoption for recurring sales in both the private and government sectors. TruScreen is still the world’s only real time, certified primary screening device for cervical cancer and is an innovative technology which takes time for adoption by governments and major medical institutions.

China remains an important long term opportunity for the company and the current focus is on building a customer and reference base, and in particular, encouraging the selection of TruScreen technology for large screening programs, as well as increasing adoption in large provincial hospitals. The CFDA model upgrade approval process for TruScreen2 is progressing to plan and, the company is continuing to promote TruScreen1 device which are being used in several large-scale screening programs in China. Over 40,000 women have been screened so far in the three main programs underway conducted by the All-China Federation of Trade Unions, the China Doctors Association and the Shengli Oilfields programs. Continuation of all three of these programs has been confirmed for 2017 where the speed of women being screened is expected to increase once TruScreen² is introduced. In total, 86 hospitals in China are in the process of procuring TruScreen devices and another 57 hospitals have TruScreen installed either for trial or acting as reference centres. Twenty-four hospitals are now commercially using TruScreen’s technology.

In Mexico, we continue to gain momentum. TruScreen² has been undergoing evaluation for inclusion by the Federal Health Secretariat in the National Standard for the Primary Screening of Cervical Cancer.  The initial pilot evaluation at the National Cancer Institute (INCAN) in Mexico City has been completed and TruScreen2 is now undergoing a 300 patient evaluation at the same centre of excellence. TruScreen2 has also started the official evaluation process for acceptance as a replacement for HPV DNA testing for the primary screening of women for cervical cancer by the Ministry of Health in the State of Nuevo Leon in Mexico, and commenced preparatory steps for similar state Ministry of Health adoption in other states – Jalisco, Guanajuato and Queretaro.

In the Philippines, TruScreen² has recently been selected for inclusion in a screening program in the province of Pampanga, which started in December 2016. This pilot project is designed to evaluate TruScreen for use in government funded screening programs with the aim that, if successful, TruScreen will be gradually adopted as the preferred device for additional Provincial Government screening programs in the Philippines.

India represents perhaps the largest government program opportunity for TruScreen² with a population of 1.3 billion and approximately 300 million women of screening age. With a shortage of expert colposcopists and cytologists, the Indian government has identified a need for innovative technology including an economical real time solution for adoption in their country. TruScreen’s technology potentially meets India’s requirements and we have started liaising with the Indian government on this opportunity.

Outlook

TruScreen has made significant progress in the further development of its products and market opportunities during 2017 and we look forward to experiencing the commercial benefits of these in the near term.

We wish to thank shareholders for their patience and continued support.