IAA - Smartwound - Development

Original Purpose: Smartwound-Development An infection diagnostic dressing has been developed by the Jenkins group at the University of Bath, following an initial discovery of bacterial responsive lipid vesicles in 2008, on an EC-EP7 funded grant, Bacteriosafe. The fundamental health economic, clinical and social impact of this technology will be to reduce unnecessary prescription of antibiotics (decreasing impact of bacterial resistance); shorten hospital lengths of stay; improve healing and patient outcomes – all of which will save costs for both patients and the NHS. The current diagnostic dressing project is reaching a critical stage: within 4 years, first human-use in a clinical trial is planned; by autumn 2019 the infection diagnosis algorithm will be published and disseminated in the UK via publication in the British Medical Journal and through the British Burns Association. The IAA will directly fund the development of the infection diagnosis algorithm which will deliver significant impact to UK, European and Worldwide burn-care through the standardisation of, and consensus in, diagnosing wound infection. The first human trial of the diagnostic dressing requires preliminary work, including stakeholder engagement, optimised hydrogel, a manufacturing plan and patient-public engagement plan (PPI).

Updated Purpose (from April 2019): SPaCE Pilot The IAA funded Smartwound Development project ran for just over 6 months and successfully met its milestones. However, as a result of management changes within the partner organisation Paul Hartmann AG (at CEO / Board level) there was uncertainty with regard to their funding of the next critical stage of the work: GMP compliant manufacture of the wound dressing. This is essential for on-patient clinical study of the Smartwound dressing itself. This situation provided an unforeseen opportunity: we realised we can test the active vesicles (the active component of the

Smartwound dressing) in a Near to patient (NtP) sensor which will be of great potential clinical and commercial utility in itself and also will provide information about the likely on-patient efficacy of the Smartwound dressing itself. The Smartwound Development project paused for 3 months from January to March 2019 so the RA could focus on a 3-month ICURe project to improve understanding of the potential markets. It recommenced from 1 April 2019 and continued until 31 December 2019. In this time, the PI explored various alternative avenues for commercialisation with Phil Brown, Research Commercialisation Manager in RIS, and applied to the IAG for a change of scope for the SPaCE Pilot and was extended to 31 December 2019. The change of scope to the SPaCE project was approved by the IAG. The new scope would focus on developing the SPaCE system as a commercial entity as well as carrying out research into market need. Thet has manufactured ca. 60 SPaCE test kits ready for use prior to starting his secondment. The £14,595 previously assigned to fund research nurses at the Royal Bristol Hospital for Children would be used to kickstart the SPaCE-Pilot clinical study, rather than the original workplan. They worked on the protocol, PPI, ethics and HRA application as well as training of clinical staff in use of the SPaCE NtP sensor. Results from the SPaCE Pilot would underpin a much larger application to Wellcome in late summer 2019 for a larger clinical study of SPaCE and hopefully development of Smartwound dressing (with Paul Hartmann).