TruScreen Group Limited — Capital/Financing Update 2021

Dec 15, 2021

NZX/ASX Announcement

15 December 2021

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TruScreen continues to make progress in key markets worldwide

Positive developments in Vietnam, Russia, China and Mexico

Key Highlights

• Milestone achieved in Vietnam. TruScreen to be the primary screening method in leading hospital in Hanoi, Vietnam, replacing traditional cytology

• TruScreen’s Russian distributor continues to raise awareness of the TruScreen technology throughout the Russian Federation, paving the way for market entry

• A new study published in the Chinese Journal of Eugenics and Genetics further reiterates TruScreen’s role in cervical cancer screening in China

• TruScreen’s Mexico distributor to partner with a local medical device financing company to bring the TruScreen cervical cancer screening device to its 3,000 strong client base of private and public hospitals

TruScreen Group Limited (NZX/ASX: TRU) (‘TruScreen’ or ‘the Company’) is pleased to provide a market update, outlining the Company’s progress in several of its key target markets.

TruScreen achieves major milestone, set to replace cytology at leading Hospital in Hanoi, Vietnam

In Vietnam, the TruScreen cervical cancer screening technology is set to replace the more traditional Liquid Based Cytology as the primary cervical cancer screening method at one of the largest and most prestigious gynaecologic hospitals, Hanoi Obstetric and Gynaecologic Hospital (HOGH). In early December, the Company’s local distributor upgraded the four TruScreen devices in the hospital to the newest software, enabling the replacement screening program to commence. Once the current COVID-19 outbreak eases, the Company expects to see a significant increase in TruScreen usage in Vietnam.

Russian marketing initiatives continue

TruScreen’s Russian distributor, IntelMed Systems (IMS), has been focussed on raising awareness of the TruScreen technology throughout the Russian Federation. In September, IMS participated in the 15[th] annual ‘Wave of Health’ hospital ship, with TruScreen included in the initiative. The annual all-Russian campaign health ship, with teams of doctors and innovative technologies, travel on the waterways visiting nine cities in the Russian Federation (See figure 1). The annual campaign is to introduce innovative technologies, and providing targeted health care, throughout the regions.

TruScreen’s portability is well suited for the ‘Wave of Health’ campaign as TruScreen’s technology is not dependant on pre-established laboratories. TruScreen also conducted master classes led by local key opinion leader, Professor Apolikhina, that were held in each of the cities, with local specialists participating in TruScreen Device demonstrations and patient examinations. Professor Apolikhina is from the Russia Federal State Budgetary Institution and the National Medical Research Centre of Obstetrics, Gynaecology, and Perinatology.

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Figure 1. “Wave of Health” ship.

The campaign was conducted during the ongoing COVID-19 outbreaks. IMS’s marketing initiatives have increased the acceptance of the TruScreen technology throughout Russia.

Newly published paper[1] confirms TruScreen’s role in cervical cancer screening in China

One of TruScreen’s major users in China, the 2[nd] Affiliated Hospital of Harbin Medical University in Harbin, a leading hospital in the Northeast, conducted a review of TruScreen’s performance compared to liquid-based cytology (LBC) at the hospital. The results showed TruScreen’s sensitivity* and specificity** were 88.24% and 78.85% respectively (LBC: 66.27% and 97.37%).

The published paper further confirms TruScreen’s role in cervical cancer screening in China, especially in low resource areas, with the authors concluding, “TruScreen can make timely and efficient diagnosis of cervical lesions and can make up for the shortcomings of limited application of LBC examination at the basic level. It is of great significance for the screening of cervical cancer and precancerous lesions and has high clinical application value.”

1 Zhao Dongxu, Li Anfeng, Gao Jiayin, Qiu Xiaohong: The effect analysis of TruScreen in cervical screening. Chinese Journal of Eugenics and Genetics , Volume 29, Issue 4, 2021 (中国优生与遗传杂志 2021 年第 29 卷 第 4 期). DOI:10.13404/j.cnki.cjbhh.20210812.001

• Sensitivity: a high sensitivity point means fewer false negatives.

** Specificity: a high specificity results in fewer false positives in the screening process.

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In November, strong results from stage 1 of an ongoing multicentre clinical trial in Hunan province were presented at the 34[th] international Papillomavirus Conference (IPVC 2021). The clinical trial compared the TruScreen cervical cancer screening to LBC and high-risk HPV DNA testing (hrHPV). Stage 1 of the trial of 1,162 women, in 6 hospitals across Hunan province. TruScreen’s reported sensitivity* for detection of CIN2/3 was 83.3% (LBC 81.3%, hrHPV 91.7%) and specificity** was 44.4% (LBC 69.9%, hrHPV 27%). The results were presented at IPVC by the lead investigator for the trial, a top key opinion leader in the province.

These results are particularly important because TruScreen’s results are available immediately in areas where the infrastructure to support LBC and hrHPV testing are either unavailable or require lengthy turnaround times between conducting the test and receiving the results with the unfortunate potential for loss of patient contact.

Mexico distributor to partner with medical device financing company

TruScreen’s Mexico distributor has partnered with a local medical device financing company to bring the TruScreen cervical cancer screening device to its 3,000-strong client base of private and public hospitals. The financing company will market financing packages of TruScreen Devices and Single Use Sensors (SUS). The TruScreen product introduction meeting is scheduled for January 2022, with 100 doctors and specialists to attend. This partnership opens innovative sales channels for the Company and extend the TruScreen commercial user base in Mexico.

TruScreen CEO Juliet Hull said: “As we come to the close of CY2021, we are pleased to continue to see successes throughout our markets, despite the challenges faced due to the pandemic. Our strong distribution network and their innovative market access has continued to lay solid foundations throughout the year, and we look forward to seeing their hard work payoff in the new year. We have many exciting opportunities ahead as we continue to work towards a world without cervical cancer.”

This announcement has been approved by the Board.

-ENDS-

For more information, visit www.truscreen.com or contact:

or more information, visit w	ww.truscreen.com or contact:
Juliet Hull	Guy Robertson	Julia Maguire
Chief Executive Officer	Chief Financial Officer	Investor Relations
juliethull@truscreen.com	guyrobertson@truscreen.com	julia@thecapitalnetowrk.com.au
		+61 2 8999 3699

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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.

TruScreen is currently targeting product sales to a range of low and middle-income countries, including China, Mexico, Vietnam, Russia, and Saudi Arabia, where no large-scale cervical cancer screening programs 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/