Playphysio's activities during 2024-2025 have been necessarily constrained by the legal re-quirement for regulatory approval before our medical devices can be made available for wid-er clinical use. As a medical device company operating under the Medical Device Regulation (MDR), we cannot proceed with commercial activities or broader patient access until we have completed the regulatory approval process. During this period, the company has been mak-ing comprehensive preparations for the final research outcomes from the ongoing Alder Hey Children's Hospital research project, ensuring we are positioned to move swiftly through the regulatory pathway once the clinical evidence is complete. To achieve meaningful community impact with our respiratory physiotherapy devices, Play-physio recognises the critical importance of engaging with the UK NHS ecosystem. Our ac-tivities have therefore focused on building relationships and understanding requirements across multiple levels of the healthcare system, including clinical staff, procurement teams, commissioning bodies, and healthcare technology assessment organisations. This engage-ment is essential to ensure our devices can be effectively integrated into NHS pathways and made accessible to the patients who need them most, while meeting the complex require-ments of NHS procurement and commissioning processes. Additionally, Playphysio has invested significant time in securing advice and guidance from a range of experienced mentors with extensive ‘medtech’ experience across devices, sales, funding, and growth strategies. These activities have been essential in preparing the com-pany for the transition from research phase to commercial readiness, ensuring we have the expertise and strategic guidance necessary for successful direct marketing to organisations, clinicians and patients with our medical devices. Throughout this period, we have benefitted from continued support and engagement with key organisations including Innovate UK, AMR (A Million Realities – Packard Foundation), NICE (National Institute for Health and Care Excellence), NHS England PPI team, University of Liverpool, and Alder Hey Children's Hospital Respiratory teams. These partnerships have provided invaluable guidance on regulatory pathways, clinical evidence requirements, and healthcare system integration, ensuring our development activities remain aligned with na-tional healthcare priorities and patient needs. Notably, Will Jackson was one of the first 8 pa-tients to be awarded a place on the full NHS Clinical Entrepreneur Program as a 'Pa-tient/Carer', further strengthening our connection to NHS innovation pathways and patient-centred healthcare development. Unfortunately this year we encountered the need to engage with additional statistical consul-tation to ensure the robustness and accuracy of our research findings. Resulting in una-voidable delays to the publication of our results. While these delays have impacted our time-line, this thorough approach to statistical analysis ensures that our published outcomes will meet the highest standards of clinical evidence required for regulatory approval and patient safety.

Playphysio has continued to provide full treatment monitoring services to all participants in the clinical research trial, even after the research has been concluded. This ongoing com-mitment ensures that families who participated in the study continue to benefit from our (24 hour 365 day availability) respiratory physiotherapy monitoring and gamification technology, maintaining continuity of care and demonstrating our dedication and robust commitment to the wellbeing of our patient community beyond the formal research period. Through Will Jackson's participation in the NHS Clinical Entrepreneur Programme (CEP), Playphysio has been able to engage with many stakeholders within the UK NHS. The CEP is the world's largest entrepreneurial development programme, providing access to a network of over 1,200 frontline NHS staff, clinical mentors, healthcare experts, and patient advocates. This programme has enabled us to consult with diverse stakeholders including clinical and non-clinical NHS professionals, procurement specialists, commissioners, and patient repre-sentatives from across different NHS trusts and regions, ensuring our development activities remain aligned with real-world NHS needs and patient priorities.

No remuneration was received

No transfer of assets other than for full consideration