Paxman Seeks FDA Clearance For Advanced Scalp Cooling Technology

scalp-cooler3Medilink member Paxman has announced that it has filed a 510(k) application with the Food and Drug Administration to market an 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 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.

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, a family-owned medical device company, are pioneers in scalp cooling technology for the prevention of hair loss during chemotherapy, helping over 100,000 patients in 25+ countries to retain their hair during chemotherapy.

Supported by leading oncologists from around the world, the system is used in hospitals and specialist cancer treatment centres globally.

Richard Paxman, CEO at Paxman, said: “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.”

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