Paxman seeks FDA clearance for scalp cooling technology

Medical device company, Paxman, has announced that it has filed an application with the FDA to market an advanced scalp cooling technology for the prevention of hair loss in women undergoing certain forms of chemotherapy for breast cancer.

The Paxman Scalp Cooling System device has been shown to preserve hair in over 50% of women, according to clinical trials. Data from the trials was submitted to the FDA as part of the premarket notification at the San Antonio Breast Cancer Symposium (SABCS) in 2016. 

Researchers concluded that the Paxman system is safe and effective in reducing hair loss in women being treated with chemotherapy for breast cancer, especially for those on taxane-based regimens.

The Paxman scalp cooling technology is used in more than 2,000 hospitals clinics and treatment centres around the world. It used a form-fitting silicon cap in which a coolant is circulated to reduce the temperature of the scalp. Cooling the scalp is thought to reduce the amount of chemotherapeutic agent that reaches the hair follicles and causes hair loss.

“With society’s emphasis on a woman’s appearance and the cultural significance of a woman’s hair, it is no wonder that women find the prospect of losing their hair as one of the most distressing aspects of the disease and its treatment,” said Richard Paxman, CEO at Paxman.

“It is such an honour that our clinical trial findings used in the FDA submission were chosen to be presented as a late-breaking abstract at SABCS. This is a real privilege for not only the researchers involved but for all the patients that took part in the trials.” 

Clinical trials involving 186 women were conducted at a number of US sites, including the Lester and Sue Smith Breast Centre at Baylor.