FDA clearance for Yorkshire medical firm’s scalp cooler to reduce hair loss during chemotherapy
The US Food and Drug Administration (FDA) has cleared Huddersfield-based medical firm Paxman Coolers to market its Paxman Scalp Cooling System, which reduces hair loss in breast cancer patients undergoing chemotherapy.
The concept behind the pioneering Paxman Scalp Cooling 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,” says Richard Paxman, CEO at Paxman.
“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 minimise hair loss in women who are undergoing chemotherapy for breast cancer, positively contributing to their overall health and recovery.”
As part of the FDA clearance process, the Paxman scalp cooler was used in the first-ever randomised clinical trial to evaluate modern scalp cooling, which took place at a number of sites in the US.
The 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.
Lead researcher Dr. Julie Nangia, MD, assistant professor of Medicine at Baylor College of Medicine, Houston, Texas, USA added: “The Paxman Hair Loss Prevention System is a safe and effective method for reducing hair loss in women being treated with chemotherapy for breast cancer, especially for those on taxane-based regimens.”
“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 its scalp cooling systems.
Paxman added: “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 randomized 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.”
