11 Jun PainChek Submits For Canadian Regulatory Clearance
Listed Australian company PainChek Ltd (ASX:PCK) continues positive progress towards expanding global regulatory clearances and market presence for the PainChek adult medical app.
PainChek Ltd has submitted for regulatory clearance with Canada Health under the Canadian regulatory “Software as a Medical Device” (SaMD) category. The Company has applied for a Class 1 medical device clearance which is based on the PainChek App risk classification and in line with the existing CE Mark and TGA clearances.
Canada Health has estimated a 120-day review timeframe for PainChek’s application which, based on this timeline, would allow PainChek to enter the Canadian market as a cleared regulatory medical device as early as Q4 Calendar 2020.
Obtaining Canadian regulatory clearance is part of the Company’s global market entry strategy building on the existing presence in Australia, the UK, New Zealand, and Singapore. It will also provide a geographical base for PainChek’s early entry into the North American market prior to our projected FDA clearance in the USA.
“Our goal is to establish a business presence in North America in line with regulatory clearance. The Canadian market is an attractive market and has a strong commonality with the Australian market in terms of care provision and the importance of pain assessment within aged care. There are more than 250,000(1) aged care beds across the country and a strong government-funded home care market for those who want to receive their care in the home environment” commented Philip Daffas CEO, PainChek Ltd.
PainChek Ltd has an existing integration commercial agreement in place with the Canadian based company AlayaCare/Procura(2) for the Australian aged care market. “We are in discussions to extend this collaboration into the Canadian market, where AlayaCare also has a strong Home Care market presence, during 2020. This is consistent with our strategy of working with our integration partners in multiple markets to provide a fully automated and high quality of care service for our collective clients” added Daffas.
This ASX announcement has been approved for release by Philip Daffas, Managing Director.
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