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Paxman Scalp Cooling for cancer patients gains FDA clearance in the US

Medilink member Paxman recently announced clearance from the U.S. Food and Drug Administration (FDA) to market their Paxman Scalp Cooling System - a scalp cooling technology that was developed by a British family to reduce hair loss in breast cancer patients undergoing chemotherapy.

The concept behind the pioneering Paxman Scalp Cooling System came when the 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,” explains 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.”

As part of the FDA clearance process, the Paxman scalp cooler was used in the first-ever randomized clinical trial to evaluate modern scalp cooling.

The multi-center 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.

Over the next 12 months, Paxman plans to install 250 systems across the U.S. and will be working with a large number of cancer centers 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.

How Scalp Cooling Works 

Chemotherapy works by targeting all rapidly dividing cells in the body. Hair is the second fastest dividing cell, and this is the reason why many chemotherapy drugs cause alopecia. The hair follicles in the growth phase are attacked, resulting in hair loss approximately two weeks after the commencement of the chemotherapy treatment.

The damage that chemotherapy causes to the hair follicle can be alleviated by using scalp cooling, also known as the 'cold cap.'Scalp cooling works by reducing the temperature of the scalp by a few degrees immediately before, during and after the administration of chemotherapy.

Paxman Scalp Cooling technology, with over 2500 systems in hospitals, clinics, and treatment centers around the world, is made from lightweight, biocompatible silicone. The liquid coolant passes through the cap, extracting heat from the patient's scalp, ensuring an even, constant temperature is maintained to minimize hair loss.

The prevention of hair loss represents an important challenge in oncology, which affects over four million patients annually. By 2030 it is estimated it will affect over 6.7 million patients every year.

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