FDA Gives Clearance to Second Scalp Cooling System for Chemo-Induced Hair Loss

The US Food and Drug Administration gave its approval for the second cooling cap system capable of reducing or preventing hair loss caused by chemotherapy in breast cancer patients.

The clearance given by the FDA came just a few months after a study showed that the Paxman Scalp Cooling System was able to prevent chemotherapy-induced hair loss in more than 50 percent who used it.

"It is estimated that 8 percent of patients actually refuse chemotherapy because they do not want to lose their hair," explains Richard Paxman, CEO at Paxman Coolers Limited, in an e-mail to Nature World News. "After experiencing this first hand, 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."

Paxman Coolers Limited plans to install 250 Paxman Scalp Cooling System across the United States within the next 12 months. The company also plans to work with a large number of cancer centers and oncology community groups to roll out their scalp cooling system.

This is not the first cooling cap system for chemotherapy-induced hair loss that was cleared by the FDA. In 2015, the FDA gave its approval to Digitana Inc's DigniCap Cooling System.

Chemotherapy drugs target all cells in the body that divides rapidly. Because hair is the second fastest dividing cell in the body, many chemotherapy drugs cause alopecia. These drugs attack the hair follicles in the growth phase, resulting in hair loss approximately two weeks after the chemotherapy treatment.

Scalp cooling system works by reducing the temperature of the scalp before, during and after chemotherapy. By cooling the scalp, the amount of chemotherapy drugs that reaches the scalp is reduced due to vasoconstriction. This results to educed drug diffusion through the cell membrane, decreased cell division, reduced active transport mechanisms, and a general reduction in metabolic activity.