Nanoveu Limited (ASX:NVU) has applied for registration of its Nanoshield Film line as a Class I medical device with the UK-based Medicines and Healthcare products Regulatory Agency (MHRA) for the UKCA (UK Conformity Assessed) Mark.
The Nanoshield product, which is a protective film employing a transparent resin with activated copper exhibiting antimicrobial and antiviral properties, will now be able to be marketed for a range of medical and non-medical applications in the United Kingdom.
Nanoveu continues to support its Nanoshield product in a range of international markets and is exceptionally pleased that it has been filed for registration as a Class I medical device in the UK,” Nanoveu’s Managing Director and CEO, Alfred Chong, said.
“This is important as it enhances the reach of our products, but also builds confidence amongst end users that Nanoshield is accepted in major markets such as the UK. The registration quickly follows similarly positive regulatory news with the product receiving EPA Approval in the USA.
“By any measure, the UK is one of the largest healthcare markets, with the UK’s National Health Service being one of the world’s largest employers, and the nation is also home to a number of other major health organisations.
“Given its global significance, the UK is an important target for Nanoveu.
“Nanoveu will continue to make regulatory submissions to key medical markets across the globe and will endeavour to keep shareholders updated as further progress is made.”
Nanoshield is intended to be applied to high touch surfaces of medical devices including, but not limited to, display screens of defibrillators and imaging devices to provide long lasting, continuous disinfection, reducing user-to-user touch cross-contamination thus assisting in prevention of disease. The applications within the medical context can also include touch screens, handrails, trolleys, wheelchair handles and just about any high touch point.
Mr Chong, said Nanoveu is well placed to enhance sales under the UKCA Mark, with the Company having executed an exclusive distribution agreement within the region with CuVira Limited in 2021. CuVira is a recently established venture with strong links throughout the UK, particularly in the commercial and construction sectors.
Mr Chong said that as the UK economy opens, Nanoshield is well poised to provide a passive way of defending consumers against the virus. Nanoveu’s antiviral technology has been independently demonstrated to be a highly effective agent for the inactivation of viruses and bacteria.
The technology has been proven to eliminate 99.99% of SARS-CoV-2 (COVID-19) and HCoV-299E, OC43, another coronavirus affecting humans in 30 minutes.
In addition to SARS-CoV-2 (COVID-19) and HCoV-299E, Nanoveu’s antiviral technology has been independently demonstrated to be a highly effective agent for the inactivation of other viruses. The technology has been proven to eliminate 99.99%4 of OC43, another coronavirus affecting humans in 30 minutes.
The antiviral protection has also been validated against other bacteria and viruses including E. coli, Influenza A (subtype H3N2), and coronavirus MHV-A595 . Additionally, testing simulating 12 months outdoor weather exposure has found Nanoveu’s film products retain their effectiveness against MS2 Bacteriophage, a single-strand RNA virus.