Shares in junior healthcare technology company PainChek Ltd (ASX: PCK) have reached a 12-month high, up more than 30%, following the company's clearance of a key regulatory hurdle in the US.
PainChek informed the ASX in a statement on Wednesday morning that the US Food and Drug Administration (FDA) had granted its smart device-based pain assessment and monitoring application a De Novo classification, a regulatory pathway to market for novel medical devices.
As the company explained:
This is a major milestone as (the) PainChek Adult App becomes the first and only regulated medical device available to assess pain (for) people who cannot reliably verbalise within the US nursing home and long-term care market. With its FDA De Novo grant, PainChek is recognised as a unique medical device, with no regulated competitive product, addressing critical unmet needs in pain management, especially within the substantial US aged care market.
PainChek said the initial addressable market in US aged care comprised more than three million long-term care beds and represented a commercial opportunity worth more than US$100 million ($152 million).
Other markets to open up
The company said the development also streamlined the pathway for rapid regulatory clearances in additional market segments, including home care and hospitals, "which are estimated to take the total US aged care market opportunity to $582 million".
PainChek is strongly positioned for immediate commercial rollout in the US, bolstered by strategic partnerships with leading healthcare software providers PointClickCare and Eldermark. Additionally, a reseller agreement with Eldermark is in place to accelerate market entry and sales growth.
The company said it was already active in business development in the US market via relationships with resellers and through direct channels, "and this will be accelerated following the FDA De Novo clearance''.
The company will also be presenting at aged care conferences in Las Vegas and Boston in the coming months.
PainChek Chief Executive Officer Philip Daffas said the De Novo clearance was a "transformative achievement'' for the company.
It validates our innovative technology and provides the foundation for accelerated US market growth, building off our established success in Australia and the momentum we've recently achieved in the UK.
The clearance was based on data from a two-year clinical trial in the US, and the company said it had patent protection across the world's major markets, including the US, the European Union, and China.
PainChek shares traded as high as 10.5 cents in early trade on Wednesday, up 31.2% on the previous day's close, before settling back to be just 1.3% higher at 8.1 cents.
Shareholders are sitting on healthy gains over the past 12 months, with the stock trading as low as 2.4 cents during that period.
PainChek was valued at $165.1 million at the close of trade on Tuesday.
