Paxman Coolers Limited Public Funding

This project will utilise state-of-the-art technological advances to develop a wearable medical cooling device for the prevention of Chemotherapy-induced peripheral neuropathy (CIPN). CIPN is a common side-effect experienced by 30%-40% chemotherapy patients. CIPN causes progressive often irreversible pain/sensitivity in hands and feet, causing long-term suffering for patients and significantly increasing healthcare costs. Severe CIPN affects cancer survival rates as it can cause delays and discontinuation of chemotherapy treatment. Without preventative-treatment, 31,500 UK-patients, and 1.5M worldwide, are at risk of developing CIPN annually. CIPN is currently an unmet, and increasing, clinical need. Limb-cooling during chemotherapy has demonstrated a CIPN neuroprotective effect. With cancer incidence rates rapidly rising (55% increase projected between 2020-2040) the need for effective CIPN-preventative treatment is escalating. SME, Paxman, are global leaders in scalp-cooling, for the prevention of chemotherapy-induced alopecia (CIA). CIA is a chemotherapy side-effect, occurring alongside CIPN. Paxman are active in \>63 countries, dominating the market with an 80% share. Building on previous highly successful collaborations, between **Paxman Coolers Ltd**. and the **University of Huddersfield**; this project integrates expertise from **University of Leeds;** extending the collaboration network and strengthening Paxman's developing R&D team. Paxman's regulatory and medical-cooling expertise; established distribution-network and route-to-market, provide an optimal position for leading this development. Paxman is a profitable/growing business, profits are currently focused on re-investment to meet agreed growth objectives, providing a secure business foundation for this additional development and CIPN-divergence. A **Human-Centred-Design** approach will underpin the project, **placing the patient at the heart of the design process**, leading to new patient-friendly solutions which maximise useability and self-administration, whilst minimizing impact on hospital resources, thus dramatically increasing patient access to this much-needed treatment. Addressing this accelerating unmet-clinical-need will enhance patient Quality-of-Life, patient work loss will be reduced through accelerated return to work, and CIPN-associated increasing economic/healthcare burden will be alleviated.

Chemotherapy-induced alopecia (CIA)/hair-loss is widely recognised as one of the most traumatic side-effect of chemotherapy treatment. Without treatment CIA affects 3.5 million patients worldwide and over 67,000 in the UK annually. Scalp cooling is recognised as the only effective treatment for CIA prevention. SME, Paxman Coolers Ltd., are the global leaders in scalp cooling, active in \>63 countries they dominate the market with an 80% share. The demand for machine-based scalp cooling has exponentially increased year-on-year since 2017, when the Paxman Scalp Cooling System (PSCS) achieved FDA approval. Recent international clinical recommendation drives increased demand for machine-based scalp cooling, with Clinical Practice Guidelines revised to include scalp cooling for cancer care in the USA (NCCN 2019/2020), Europe (ESMO 2020) and Australia (CancerAustralia2020). In the USA, following recent publication of 2 x CPT codes (AMA:2021) broader insurance coverage/payment is expected within 2-years which will further increase US-demand as treatment becomes financially viable for more patients. Building on previous successful collaborations, this project will bring together, **Paxman Coolers Ltd**, and the medical-design expertise of the **University of Huddersfield**'s award-winning product design team and technical material research. Through innovative, advanced design and development, this project will dramatically increase patient and clinical access to effective scalp cooling treatment internationally and enable Paxman to take a monumental step towards their long-term goal of 'scalp cooling being offered to all chemotherapy patients worldwide, with Paxman as the natural choice'. The efficacy of scalp cooling treatment will be maximised through single-patient caps, promoting optimised cap fit and increasing treatment success. Single-patient caps will also promote enhanced infection-control, a factor of paramount importance due to chemotherapy-induced immune suppression, and particularly emphasised by the Coronavirus pandemic. Crucially, this project will also address the environmental impact associated with increased demand of this single-patient medical device. The focus on eco-design will promote the circular economy and minimise this products end-of-life impact.

Awaiting Public Project Summary

To design and develop a novel single use cooling cap system supported by 3D printed tooling technologies to facilitate mass manufacture and global market entry.

To develop improved scalp cooling medical devices to minimise hair loss during chemotherapeutic treatments and embed a biologically and physiologically informed evidence-based product development strategy.

Aside from the trauma of coping with the disease itself, hair-loss induced by chemotherapy remains the most distressing psychological impact that cancer patients will endure. Hair loss is a constant reminder of the disease and is often perceived as a source of shame and stigma. Chemotherapy-induced-alopecia occurs because chemotherapy drugs are designed to target rapidly dividing cells. Unfortunately, at any given time, 90% of hair follicles are also in the division phase. Hair loss occurs due to the partial or total atrophy of the hair root bulb causing constriction of the hair shaft which may then break off easily. Paxman Coolers manufactures specialist scalp cooling equipment that is designed to prevent such hair loss. This system operates by circulating a cooled liquid to a specially designed flexible silicone cap via flexible cooling lines: this cap reduces scalp temperature. This temperature reduction creates a restriction in the amount of blood reaching the hair follicles thereby protecting them from the effects of the concentrated chemotherapy drugs in the blood stream. Comprehensive clinical and academic studies have shown that this therapy has had a significant impact on the prevention of hair loss in patients: showed rates in the range 70% to 90% reporting hair loss to such low extent that no wig or head cover was required following treatment. However, these studies also show that the performance of the system is strongly dependent upon the regime of chemotherapy being employed (as low as 8%) and the ethnicity of the patient. This significantly restricts the total capability and market size of the system. This project proposes to develop a prototype of a smart cooling system capable of achieving 90% success across all ethnicities and chemotherapy regimes. It will achieve this by applying fundamental research at the cellular level to develop scalp cooling models and regimes tailored to the patient being treated and the chemo regime being used.