Scalp cooling for the prevention of chemotherapy-induced alopecia: increasing patient access through eco-design and innovative manufacturing.

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.