Huddersfield’s Paxman Coolers has gained US regulatory approval for its Scalp Cooling System to stymie hair loss during chemotherapy.
The concept behind the pioneering system came when mother of four Sue Paxman experienced first-hand the trauma of chemotherapy induced hair loss.
“Hair loss is consistently ranked in the top five most distressing cancer chemotherapy side effects,” said CEO Richard Paxman.
He added: “Like my mum, many people find hair loss to be extremely traumatic. It is estimated that 8% of patients actually refuse chemotherapy because they do not want to lose their hair.
“After experiencing this first hand, we have been determined to change this, and help minimize hair loss in women who are undergoing chemotherapy for breast cancer.”
As part of the US Food and Drug Administration (FDA) clearance process, the scalp cooler was used in the first-ever randomised clinical trial to evaluate modern scalp cooling.
The multi-centre prospective study – which involved 186 women across New Jersey, New York, Texas and Ohio – revealed that the cold cap preserved hair in more than 50% of the women who used it.
Dr Julie Nangia, MD, Assistant Professor of Medicine at Baylor College of Medicine, Houston, Texas, said: “Hopefully in five years from now, we will consider scalp cooling part of routine practice, the same way that we can see an IV-pump with an IV-pole as part of the regular equipment you would expect in an infusion suite.
“It’s important that people undergoing chemotherapy understand what scalp cooling is and that it is an option available to them if they want to prevent hair loss.”
Over the next 12 months, Paxman plans to install 250 systems across the US and will be working with a large number of cancer centres and large community oncology groups to roll out their scalp cooling systems.
The Company aims to revolutionise the current landscape of scalp cooling by ensuring that affordability is at the centre of the treatment giving more patient choice.
This involves launching a single patient use personal cap model, which will be loaded with scalp cooling credits depending on the number of chemotherapy infusions they are having.
Mr Paxman: “The USA is the largest healthcare market in the world with over 1.6 million diagnoses of cancer each year. We have spent six years conducting a comprehensive multi-centre randomised clinical trial to ensure our data is as robust as possible.
“This has been a significant investment for us, but we are incredibly excited to be able to offer scalp cooling to US patients giving them a choice to maintain some control during treatment as we see in the UK and other parts of the world.”