Certification for TruScreen 2nd Generation Device

Published: 15 April 2016

TruScreen is pleased to announce that its second generation cervical cancer screening device, known as TruScreen Ultra, is now ready for commercial launch in select markets following receipt of CE Mark certification.

TruScreen cervical screening

Cancer technology company, TruScreen Limited (NZAX:TRU) advises that its second generation cervical cancer screening device, known as “TruScreen Ultra”, is now ready for commercial launch in select markets following receipt of CE Mark certification. This will enable the company to distribute and sell its TruScreen Ultra device in the European Union and many other markets that view the CE Mark as an endorsement of compliance, quality & design of the device’s technology & efficacy.

CEO of TruScreen, Mr Martin Dillon, said: “This is a significant step forward in our commercial plans, allowing us to immediately commence manufacture of our new device and fill the inventory gap caused last year when all stocks of the original TruScreen device were sold out.”

The TruScreen Ultra device is the culmination of over 2 years of intensive product development that encapsulates world class medical technology containing many new & unique features including:

  • Massively increased processing capacity and faster processing
  • Significantly improved performance
  • Wireless handpiece with significantly increased portability
  • Rechargeable battery freeing the device from reliance upon continuous connection to mains power
  • Wi-Fi connectivity to PC’s, Laptops and Smart Devices
  • Internet Browser compatibility
  • Graphic User Interface with LCD touch screen.

Recent research reports  have estimated the annual global cervical cancer screening market to be USD $15 billion, and has forecast it to grow to USD $22 billion by 2020[i]. The granting of the CE mark to TruScreen’s new Ultra device enables the company to immediately target the European Union, India and other select western markets where TruScreen will be working closely with both private and public health systems. TruScreen’s estimates the potential annual screening market of the European Union & India to be over USD $329 million and USD $681 million respectively.

The granting of the CE mark of the new device also enables the company to pursue model upgrade registration with the CFDA in China where the majority of its commercial activity to date has been centred. The Chinese market is estimated to have an annual screening value of USD $800 million

TruScreen is the only device in the world that is a CE certified, stand-alone real time primary screening tool for Cervical Cancer. TruScreen has successfully combined the use of both optical and electrical tissue differentiation to create a clinically acceptable level of performance in the primary screening of cervical cancer.

[i] http://www.marketsandmarkets.com/PressReleases/cervical-cancer-screening.asp