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Expanded FDA Clearance For Chemo Hair Loss Prevention System

In April 2017 the Paxman Orbis Scalp Cooling System device was cleared by America’s Food and Drug Administration (FDA) for use by breast cancer patients undergoing chemotherapy to help prevent hair loss.

Also known as a ‘cold cap’ or scalp cooling system, British firm Paxman has now received an expanded clearance from the FDA, following its 510k application. This means its device can now be used on cancer patients receiving chemo for all solid tumours.

Paxman Scap Cooling Cold Cap Hair Loss Prevention SystemReduce likelihood of chemotherapy-induced hair loss

In an 11th June 2018 press release issued by Paxman, a family company who developed scalp cooling technology from beer cooler refrigeration apparatus, it was stated that the FDA clearance for expanded indication means that the Paxman Scalp Cooler is also now  ‘indicated to reduce the likelihood of chemotherapy-induced alopecia (CIA) in cancer patients with solid tumours’.

Under the previous authorisation the company estimated that 250,000 breast cancer patients per year were able to use the hair loss prevention device. Now, Paxman expects the number to increase to more than 1 million cancer patients.

The company’s ultimate goal, according to CEO, Richard Paxman, is to eventually prevent hairloss from chemotherapy completely.

This pattern of FDA clearance starting with breast cancer patients and then being broadened out to include all solid tumours, was previously demonstrated with the DigniCap System. This received these clearances in 2015 and 2017, respectively.

Currently the Paxman Hair Loss Cooling System and the DigniCap System are the only two cold cap devices with FDA clearance for use by chemotherapy patients with breast cancer and solid tumour cancers to prevent hair loss.

Paxman Scalp Cooling System Chemotherapy Hair Loss Prevention Cold Caps

How scalp cooling systems work

When chemotherapy drugs enter a patient’s system the aim is for them to destroy cancerous cells, however they have something of a non-discriminatory approach. When the drugs attack the hair follicles, anagen effluvium – the type of hair loss seen in cancer patients – can occur.

What scalp cooling systems do is use a cap-like device – a cold cap – to chill the area to extremely low temperatures whilst the chemo is taking place. This discourages the drugs from heading towards the hair follicles, allowing a better chance of hair retention. Though some hair loss may still occur, it is likely to be less than without scalp cooling.

Findings from a 2017 retrospective review of the Paxman Scalp Cooling System’s efficacy for 86 primary breast cancer patients showed the device had a 64% success rate in terms of hair preservation. The results taken three weeks after chemotherapy had been completed showed that 40.7% of study participants completely retained their hair whilst 23.3% retained it in part.

It was further noted that a pattern of improved efficacy was identified relating to the type or order of chemotherapy treatments patients underwent. Those who used a taxane drug, or a taxane followed by an anthracycline, had a better chance of preventing hair loss, with success rates of 80% and 73.9% respectively. Those starting chemotherapy with an anthracycline drug which was then followed by a taxane had a success rate of 47.4%.

Those men and women who do still experience hair fall should find their hair regrows within 12 months of their final chemo session. However, they may notice changes to the texture or colour of their hair regrowth. This is entirely normal and usually rights itself within a couple of hair growth cycles.


The Belgravia CentreThe Belgravia Centre

The Belgravia Centre is the leader in hair loss treatment in the UK, with two clinics based in Central London. If you are worried about hair loss you can arrange a free consultation with a hair loss expert or complete our Online Consultation Form from anywhere in the UK or the rest of the world. View our Hair Loss Success Stories, which are the largest collection of such success stories in the world and demonstrate the levels of success that so many of Belgravia’s patients achieve. You can also phone 020 7730 6666 any time for our hair loss helpline or to arrange a free consultation.


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