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FDA clears marketing of scalp-cooling system to reduce chemotherapy-associated hair loss
The FDA cleared Paxman Coolers Limited to market the Paxman Scalp Cooling System, designed to reduce hair loss among patients with breast cancer who undergo chemotherapy.
The Paxman Hair Loss Prevention System reduces the temperature of the scalp by a few degrees immediately before, during and after the administration of chemotherapy.
The device is intended to reduce the amount of chemotherapy that reaches the hair follicles, reduce drug diffusion through the cell membrane, decrease cell division, reduce active transport mechanisms and generally reduce metabolic activity.
“Hair loss is consistently ranked in the top five most distressing cancer chemotherapy side effects,” Richard Paxman, CEO of Paxman, said in a company-issued press release. “It is estimated that 8% of patients actually refuse chemotherapy because they do not want to lose their hair. ... We have been determined to change this and help minimize hair loss in women who are undergoing chemotherapy for breast cancer, positively contributing to their overall health and recovery.”
A multicenter, randomized, prospective study designed to evaluate the scalp-cooling technology in 186 women with breast cancer undergoing chemotherapy showed the system helped preserve hair in more than half of the women who used it.
“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,” researcher Julie Nangia, MD, assistant professor of medicine at Baylor College of Medicine, said in the press release.
Paxman plans to install 250 systems across the United States within the next year.
“Hopefully in 5 years ... 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,” Nangia said. “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.”