Public Funding for Plexaa Ltd

The NHS conducts \>10 million operations every year (HES, 2022). Approximately 20% of patients suffer significant postoperative complications (Ludbrook, 2022). Breast surgery represents one such example with a relatively high volume of procedures (102,000 per year in the NHS, England - GIRFT, 2021) and complication rates of up to 30% (Bennett 2018). This challenge is not exclusive to the UK but is shared globally among all healthcare systems. Wound healing complications in this area specifically can cost the NHS between £3000-6000 in extra theatre time, delayed discharge and delays to life-saving adjuvant chemo-radiotherapy. Therefore, there is a need for tailored techniques that can improve surgical outcomes in this group of patients. Plexaa are addressing this need by developing a portable patent-protected wearable device to precondition the breast before surgery to reduce the risk of postoperative wound healing complications. During patient interviews to assess user requirements for our hardware, several patients expressed a desire for a digital surgical preparation app to accompany the hardware. Preparation for surgery, or "prehabilitation", was first introduced as a recognised concept to improve outcomes by the Royal College of Surgeons and Anaesthetists in 2019 (Grocott 2019) and it is widely accepted that well-prepared patients have better outcomes (Durrand 2019, Valkenet 2011). Prehabilitation is becoming more widely adopted across all healthcare systems as a cost-effective means of improving surgical outcomes and reducing costs (Rombey 2023). Digital app-based solutions offer a unique opportunity to deliver prehabilitation regimes. However, upon review of current apps, there appeared to be a heavy focus on orthopaedic surgery and nothing that caters to the specific needs of breast surgery and indeed women. Therefore, Plexaa seeks funding to develop a bespoke breast surgery app to accompany our hardware to help women in their preparation for surgery. This will provide a holistic and multifaceted approach to tackling and reducing surgical complications, including those that extend beyond wound healing. The aim of this project is to assess the feasibility of such an app, evaluate its potential impact and exploit our findings to develop a commercialisation model for widescale adoption in the future. The combination of our hardware and this app represents a major innovation in women's health as it has the potential to improve outcomes, reduce breast cancer waiting lists and lower the burden of complications on the NHS in terms of human resource and costs.

The NHS conducts \>10m operations p.a (Hospital\_Episodes\_statistics). From these, roughly 20% of patients suffer significant postoperative complications (Nepogodiev-2019; International\_Surgical\_Outcomes Study Group-2016). As well as being potentially avoidable, stressful events, these complications extend hospital stays, clog up NHS beds and push up treatment costs. The challenge and cost of managing postoperative complications to the NHS is predicted to increase by 10% p.a. as our population ages (Ludbrook-2019). Currently unhealed surgical wounds account for 11% (\>250,000 patients) of all wounds the NHS manages, with an attributable management cost of £982.9m p.a. (Guest\_2017). This creates a significant healthcare need and commercial opportunity which is common globally. Plexaa has developed technology which delivers preconditioning therapy, where the surgical site is heated to a "supraphysiological" level, 43°C, 12-hours before surgery. This improves the blood flow to the skin this enhancing the patient's ability to heal and preventing wound healing complications. This is a non-invasive, pre-operative intervention that focusses on preventing surgical complications before they happen. Our previous NIHR-funded clinical research (preHEAT RCT-2019) proved this technique to be extremely effective at improving healing rates and preventing surgical wound complications. It also reduces the need for corrective surgery by 50%, outpatient visits by 70%, and hospital stays by 3-4 days per person -- all of which offer significant cost savings to the healthcare provider, estimated at £1,900-£2,300 per patient. While applicable to a very broad range of surgeries, we are targeting breast surgery as an initial specialisation. In part this is due to high surgical complication rates: ~30% of 102,000 p.a with 20% (\>20,000) needing reoperations. We can halve this number, improving physical, social and economic outcomes for patients, hospitals and the UK and offering potential savings of close to £100m per year. The proposed Plexaa device safely delivers the preconditioning in an accurate and consistent way suitable for home-use. The product represents our first device and will spearhead a new range of pre-conditioning products for surgery, tackling the twin social and economic issues of hospital occupancy and surgical wound complications.