Sales YTD show +36% growth (April-Aug'20 to April-Aug'21, unaudited)
Completion of COGA evaluation
First sale to new Central European market
Establishment of International Experts Group (IEG)
Rollout for NAC Pilot Project in Zimbabwe
WHO Cervical Cancer Screening Guidelines
China Market Update
The first quarter (Q1) of FY2022 saw a continued uptake of Single Use Sensor consumption in our key market, China, with 51,000+ SUS consumed in April - July, +8% on the same period last year. This growth reflects the increase commercial user base and a rise in the number of TruScreen screenings performed in the period.
TruScreen's large-scale Chinese Obstetricians & Gynaecologists Association (COGA) evaluation project reached completion in July. Screening 15,500+ women, in 9 provinces.
The evaluation aims for TruScreen to receive a COGA recommendation as a primary screening tool. The COGA panel are expected to meet in before the end of 2021 to review the results and provide their consensus.
TruScreen has been working towards becoming a domestic device in China. The transition from international to domestic product registration will open new sales channels and help to establish new pipelines throughout the country. Working with our local partners in May 2021 we completed the initial phase of production transfer. With the new production facility established in Shenzhen, Guangdong Province, we are aiming to complete a pilot run of 20 locally manufactured devices, with 5 completed to date. These devices will undergo quality assurance testing before being rolled out.
Eastern European Market Update
Eastern Europe remains a focus for the company. Product registration secured in four new markets and initial sale to Serbia completed in August. While still feeling the impacts of COVID-19, much of Europe is opening back up and finding their new normal.
In Poland, we are in the early planning phases for a validation project in the private sector. Partnering with a highly regarding Key Opinion leader, the project aims to provide firm support for the adoption of TruScreen as a primary screening tool within the sector.
Dr. Ivan Imre, TruScreen's commercial lead for the region, has been working on extending our distribution network, with a particular focus on Romania. TruScreen is in contract negotiation with a viable and profitable distribution partner in Romania and hope be able to share more soon.
Free Screening Event in Russia
In July, TruScreen's Russian distributor, IntelMed Systems (IMS), partnered with a local private clinic to offer women in Saint-Petersburg free TruScreen Screenings.
The initiative was part of a 'Week of Women's Health' organized by the local Health Ministry. In total, 242 women screened using TruScreen, with about 19% recording an 'abnormal' result. These women received free follow up consultations with gynaecologists.
IMS are been working closely with both the private and public sectors in preparation for a ramping up of commercial activities as the covid situation improves in the coming months.
Establishment of International Experts Group
TruScreen's International Experts Group (IEG) was formed and held their first meeting in May. The IEG is an independent committee that will advise TruScreen on a wide range of topics. The first meeting was centered around steering the global scientific data generation efforts for TruScreen.
The IEG met again in August to review current clinical trial proposals and consider the future of the TruScreen technology in the fast-evolving innovation of healthcare.
We will continue to work closely with the IEG and our other advisory bodies to facilitate accelerated market access and innovations in technology for the company.
Zimbabwe NAC Project Underway
Zimbabwe's National Aids Council's (NAC) TruScreen Pilot Project is underway. This project was initially set to commence in late 2018 but faced significant delays following the economic crisis in 2019 and the COVID-19 pandemic.
In partnership with our local distributor, Southern Skies Medical, NAC restructured the project plan in July 2021 to enable the launch to commence.
The changes include moving the pilot phase from COVID-impacted Harare to Masvingo City.
TruScreen facilitated a vigorous virtual Trainer training program in mid-August. 20 new TruScreen operators were trained in the last week of August. 8 devices have been rolled out in the region, with an aim to screen 500 women by October.
Cervical cancer is the most prevalent and deadly cancer for women in Zimbabwe. Women living with HIV have a six-fold increased risk of cervical cancer compared to women without HIV.
We hope to see continued momentum and look forward to the outcome of this ground-breaking trial.
WHO Screening Guidelines - 2nd Edition
The World Health Organisation (WHO) has released its new cervical cancer screening and treatment guidelines. The guidelines have been updated in the context of WHO's Global Strategy to accelerate the elimination of cervical cancer, calling on member countries to invest in better technologies, and adhere to strong implementation processed for cervical screening.
Importantly for TruScreen, the new guidelines acknowledge that 'the traditional method to screen women for cervical cancer has been cytology…this screening approach has not been successful in low-and middle-income countries (LMICs)'.
WHO's recommended cervical screening approaches has shifted in the new guidelines, with HPV DNA now the preferred method. Unlike HPV DNA testing and traditional cytology, TruScreen has minimal impact on healthcare infrastructure, and the patient's result is available immediately at the point of screening. The process for obtaining and analysing samples is similar with cytology and HPV DNA testing. Both methods rely on qualified specialists and high quality laboratory infrastructure, two things that many women in LMICs and rural areas do not have access to.
WHO also provided new estimated figures for cervical cancer, showing that global annual incidence and mortality rates continue to rise.
600,000+ new cases in 2020
340,000+ deaths in 2020
Dr Nathalie Broutet, WHO Department of Sexual and Reproductive Health and Research and HRP, said 'What matters most is the coherence of every country's programme in ensuring the continuum of care: that all women have access to screening, health care providers are informed in a timely manner about the results of the screening test and can in turn share this information with their client.'
Our company vision and mission statements are reaffirmed by the new guideline in conjunction with the global strategy. These new guidelines will help guide us and our commercial strategy as we work towards
A World Without Cervical Cancer.
 51,300 units April - July 2021 to 47,520 units April - July 2020, unaudited.
 As announced 1 July 2021 - https://truscreen.com/news/first-eastern-europe-sale/
 First announced to market 14 September 2018, https://truscreen.com/news/truscreen-hiv-african-initiative-update/
 Data source: GLOBCAN 2020, International Agency for Research on Cancer 2021
 Stelzle D, Tanaka LF, Lee KK, Ibrahim Khalil A, Baussano I, Shah ASV, et al. Estimates of the global burden of cervical cancer associated with HIV. Lancet Glob Health 2020. doi:S2214-109X(20)30459-9.
 . WHO guideline for screening and treatment of cervical pre-cancer lesions for cervical cancer prevention, second edition. Geneva: World Health Organization; 2021. Licence: CC BY-NC-SA 3.0 IGO. https://www.who.int/publications/i/item/9789240030824