PainChek's Quarterly Update: US FDA Study Completion and Global Expansion
PCK (PCK) Share Update July 2024 Monday 29th
PainChek Completes US FDA Clinical Study and Expands Global Reach
PainChek Limited (ASX: PCK), the developer of the world's first smart device-based pain assessment and monitoring application, has announced significant progress in its quarterly update for the period ending 30 June 2024.
Instant Summary:
- 95,000 contracted licenses globally, with an ARR of $4.6M once fully implemented.
- Completion of US FDA de Novo clinical study data collection.
- Launch of PainChek Infant Early Access Program in Australia.
- Cumulative pain assessments reach 6,000,000, a 103% increase over the previous year.
- UK market penetration reaches 36,000 licenses, an 8% market share.
Global License Expansion
PainChek Limited has achieved a total of 95,000 contracted licenses globally, representing a 6% increase from the previous quarter and a 36% increase year-over-year. The annual recurring revenue (ARR) from these licenses is expected to reach $4.6 million once fully implemented. In the UK, the company has secured 36,000 licenses, achieving an 8% market penetration, which marks a 19% increase from the previous quarter and a 93% increase from the previous year.
US FDA Clinical Study
The company has successfully completed data collection for its US FDA de Novo clinical study. The Clinical Investigation Report is scheduled for completion in Q3 CY24, with the FDA de novo application submission to follow in the same quarter. This is a significant step towards entering the North American market, which comprises 2,000,000 residential aged care beds and represents a $100 million annual market opportunity.
PainChek Infant Early Access Program
PainChek is set to launch its PainChek Infant Early Access Program in Australia in Q3 CY24. This program will allow parents of infants aged 1-12 months to register and participate in a closed group initiative to provide feedback before the product's broader commercial launch. The PainChek Infant app is the world's first AI-enabled mobile application for instant pain assessment in infants.
Financial Performance
PainChek reported customer receipts of $720,000 for the quarter and received a $1,206,000 R&D tax incentive refund for FY23. The company maintains a strong sales pipeline and continues to focus on client retention rates, which stood at 85% for the quarter.
Market Penetration and Partnerships
In Australia and New Zealand (ANZ), PainChek has approximately 59,000 contracted licenses, covering around 30% of the aged care market. The company has also signed a reseller agreement with Best Health Solutions Pty Ltd (BestMed), a leading medication management solution provider in Australia. This partnership is expected to drive further growth in the ANZ market.
In the UK, PainChek's market penetration continues to grow, with significant contracts secured with large clients such as NHS Bedford, Luton and Milton Keynes ICB, Exemplar Healthcare, and We Care Group. The company is also exploring market opportunities in mainland Europe and Japan.
The completion of the US FDA clinical study and the upcoming submission for FDA de novo clearance are significant milestones for PainChek. These developments are likely to positively impact the company's stock as they pave the way for entry into the lucrative North American market. The expansion of global licenses and the launch of the PainChek Infant app further strengthen the company's market position and growth potential.
Investor Reaction:
Analysts are expected to react positively to PainChek's progress in the US FDA approval process and its expanding global footprint. The company's strong financial performance and strategic partnerships are likely to boost investor confidence.
Conclusion:
Investors should closely monitor PainChek's upcoming FDA de novo application submission and the launch of the PainChek Infant Early Access Program. These milestones, along with the company's continued market expansion, present significant growth opportunities. Staying informed on PainChek's developments will be crucial for making informed investment decisions.