eHealth SaaS Company Respiri Limited’s (ASX:RSH) wheezo health management systemis now registered and approved for sale in the UK market following its registration with the UK Competent Authority, the Medicines and Healthcare Products Regulatory Agency (MHRA).
CEO, Marjan Mikel, noted that as per MHRA requirements, the company appointed European Device Solutions (UK) Ltd as the UK Responsible Person (UK-RP) and has demonstrated that wheezowill perform safely and achieve the stated performance claims for its intended use. As a result, the Company can now apply the new UK Conformity Assessed (UKCA) mark on wheezo.
UKCA marking is a new UK product marking that is used for goods being placed on the market in Great Britain (England, Scotland and Wales). It is a prerequisite for the approval of products following Brexit and indicates conformity with applicable regulatory requirements.
UKCA replaces CE marking, which can still be used in the UK until December 31, 2021 for products that are currently being sold in the UK but CE cannot be used for any products that have not been sold in the UK market after January 1, 2021. Accordingly, this process fulfils a commercial requirement for wheezo, which is due to be launched in the UK in Q4 CY 2021.
Respiri has been in ongoing planning discussions and negotiations with potential commercial and distribution partners in the UK as it readies for the planned launch in Q4 CY2021. The UKCA marking for wheezois another accomplishment for Respiri; the final regulatory requirement that now permits Respiri to commence commercialising wheezo®in the UK in Q4 CY2021, as planned” Mr Mikel said.
“It is important to note that asthma exacerbation is the 3rdmajor cause of hospitalisations in the UK and the most common reason for re-hospitalisation, resulting from poorly controlled and managed asthma.
“Given the high incidence of hospitalisation resulting from poorly controlled, asthma we are pleased that wheezo®has been chosen as a technology of choice by a number of prominent UK Universities to study its impact on improving patient asthma management and we will keep the market informed of these developments.”
Asthma represents a significant disease burden in the UK with 5.4 million people currently receiving treatment for their condition, and the NHS spending around £1 Billion GBP per annum, treating and caring for people with asthma.
Asthma UK believe that digital health technology has a significant role to play in helping people better manage their condition2and in 2016 published the Connected Asthma Report, highlighting how asthma is ideally placed to be transformed by technology3”.