FDA Clears Second Scalp Cooling System for Hair Loss in Patients With Breast Cancer

The Food and Drug Administration (FDA) has cleared for marketing the nation’s second cooling cap — Paxman Scalp Cooling System — to reduce hair loss in patients with breast cancer undergoing chemotherapy.
BY KATIE KOSKO @Katie_Kosko
PUBLISHED: APRIL 19, 2017
Photo credit: Paxman Coolers Limited
Photo credit: Paxman Coolers Limited
The Food and Drug Administration (FDA) has cleared for marketing the nation’s second cooling cap — Paxman Scalp Cooling System — to reduce hair loss in patients with breast cancer undergoing chemotherapy.

The United Kingdom-based company plans to install 250 systems across the U.S. over the next year, working with many cancer centers and large community oncology groups.

“The clearance of our Paxman Scalp Cooling System has a huge impact,” Richard Paxman, CEO, told CURE in an interview. “We now have the opportunity to offer scalp cooling to patients with breast cancer in the USA. We are excited to now be in a position to roll out equipment throughout the U.S.”

The development of the scalp cooling system has been a personal mission for Paxman and his family after they saw the effects of chemotherapy firsthand through their mother, Sue Paxman. To ensure her legacy lived on, the company created the cooling caps to better the quality of life of other women around the world battling cancer.

A multi-center prospective study of 186 women found that the cold cap preserved hair in more than 50 percent of women who used it, compared with zero percent in the control group.

Researchers examined the system in women being treated with neoadjuvant or adjuvant taxane and/or anthracycline–based chemotherapy for their stage 1/2 breast cancer. The multicenter trial was conducted at seven sites across the United States, from December 2013 to September 2016.

“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,” Julie Nangia, M.D., assistant professor of medicine at Baylor College of Medicine, Houston, said in a statement. “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.”



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