PainChek Ltd Names Interim CEO as US Market Push Follows FDA Clearance
PainChek Ltd (ASX: PCK) has advised that Philip Daffas will cease to serve as Chief Executive Officer and Managing Director, effective immediately, as of 6 July 2026. The company described the move as a planned transition to support its Financial Year 2027 (FY2027) strategy following FDA De Novo clearance.
Current Chief Operating Officer (COO) Andy Hoggan steps in as Interim CEO during the transition period.
The Board framed the change as a forward-looking decision designed to accelerate PainChek’s development of the US market. The timing aligns with the company’s recent US regulatory milestone and its development of the US market.
A planned handover to accelerate the US opportunity
According to the announcement, the Board and Mr Daffas agreed that “now is the right time for a change in leadership to accelerate PainChek’s development of the US market.”
The transition is explicitly tied to the FY2027 strategy and the recent FDA clearance. Having achieved regulatory validation in the United States, the company aims to accelerate development of the US market following FDA clearance.
The CEO transition is the second significant leadership change in under two months, following the appointment of Lil Bianchi as Non-Executive Chair in May 2026 to spearhead PainChek’s US market push, a role she took having previously guided 4DMedical from IPO to a $2 billion-plus market capitalisation.
The Board advised that the process to appoint a new CEO is progressing, with a new CEO expected to be announced in due course. It confirmed it will keep the market informed in accordance with its continuous disclosure obligations.
Board Acknowledgement
The Board thanked Philip Daffas for his ten years of leadership as PainChek evolved from Australian research into the world’s first AI-powered clinically validated pain assessment platform, and wished him well in his next endeavours.
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Daffas’s decade of leadership: from research to a world-first platform
Over his tenure, Daffas led PainChek’s evolution from an Australian research initiative into a globally cleared medical device platform with operations spanning multiple continents.
Key milestones during his 10 years of leadership include:
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Over 20 million clinical pain assessments completed
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Over 2,000 aged care facilities secured
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FDA De Novo clearance achieved in the United States
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Operations established across Australia, UK, NZ and North America
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Development of the world’s first AI-powered clinically validated pain assessment platform
Andy Hoggan takes the interim reins
Andy Hoggan, currently COO, will act as Interim CEO during the transition period. He has served as a senior PainChek executive for six years and, according to the company, has the full support of the Board.
The appointment provides operational continuity while the Board conducts its search for a permanent CEO.
| Detail | Outgoing / Incoming |
|---|---|
| Outgoing CEO & MD | Philip Daffas |
| Interim CEO | Andy Hoggan (current COO) |
| Tenure at PainChek (Hoggan) | 6 years |
| Effective date | 6 July 2026 |
| Permanent CEO | Search progressing |
What is FDA De Novo clearance and why it matters
For PainChek, the clearance opens access to the United States healthcare market. It is the catalyst behind the leadership transition and the company’s FY2027 strategy.
The company has not disclosed US revenue projections or market-size figures.
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What comes next for PainChek investors
The immediate priority is the appointment of a permanent CEO, which the Board expects to announce in due course while maintaining its continuous disclosure commitments. The FY2027 strategy and US market development remain the near-term focus for the new leadership.
The commercial groundwork for that US push was laid earlier in 2026, when PainChek secured the Sabra Health Care REIT agreement to deploy its AI pain technology across up to 20,000 beds in 329 North American facilities, establishing the REIT-funded partnership model as a scalable blueprint for institutional adoption.
PainChek® has attained regulatory clearance as a medical device across several jurisdictions:
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Australia (TGA)
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United States (FDA De Novo)
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United Kingdom
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European Union
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Canada
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New Zealand
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Singapore
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Malaysia
This multi-jurisdiction regulatory footprint underpins the global commercialisation runway that the incoming leadership will execute against, with the US market positioned as the central opportunity for the period ahead.
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