The Paxman Scalp Cooling System has been submitted to the U.S. FDA for 510(k) clearance. The news comes hot on the heels of favourable clinical trial results, covered on our pages a few days ago.
UK company, Paxman has lodged an application with U.S. FDA to market its advanced scalp cooling technology for the prevention of hair loss in women undergoing certain forms of chemotherapy for breast cancer.
The pioneering Paxman Scalp Cooling System device, developed in the UK, has been shown in clinical trials to preserve hair in more than 50% of the women who used it.
The system, which is used in more than 2,000 hospitals, clinics and treatment centers around the world, involves a form-fitting silicon cap in which a coolant is circulated to reduce the temperature of the scalp. It is believed that cooling the scalp reduces the amount of chemotherapeutic agent that reaches the hair follicles and causes hair loss. The cap is worn before, during and after chemotherapy sessions.
The ground breaking data submitted as part of the FDA premarket notification was presented as a late breaking abstract at the recent San Antonio Breast Cancer Symposium (SABCS) in 2016.
Researchers described the data as the first-ever randomized clinical trial to evaluate modern scalp cooling. The 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 (women enrolled in the trial were treated with anthracycline or taxane-based chemotherapy for at least 4 cycles).
It revealed that 50.5% of women in the scalp cooling group had hair preservation, while none of the women in the no cooling group preserved hair. The success rate allowed the researchers to halt the study and release the findings.
Paxman said it expects the FDA to respond to the application in 2017.
“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.”