FDA Clearance Expands Scalp Cooler Indication

The Paxman Scalp Cooling System has now been cleared by the US FDA for use during treatment of patients with solid tumours.


The Paxman Scalp Cooling System has been developed by the Paxman family to reduce hair loss in cancer patients undergoing chemotherapy. The concept behind the technology came when mother of four, Sue Paxman, experienced first-hand the trauma of chemotherapy induced hair loss. The company has since been on a personal journey to ensure Sue’s legacy lives on by helping people around the globe minimize chemotherapy-induced hair loss and contribute to their quality of life.

With more than 3,000 systems delivered to hospitals, clinics and treatment centres around the world, Paxman is the leading supplier of Scalp Cooling technology. Since its original FDA clearance in April 2017, the company has installed around 225 scalp cooling systems in the US with a further 65 awaiting delivery and installation.

The system is now indicated to reduce the likelihood of chemotherapy-induced alopecia (CIA) in cancer patients with solid tumours such as: ovarian, breast, colorectal, bowel and prostate cancer. The expanded FDA clearance substantially increases the potential number of new cancer patients per year that the system can be marketed to in the USA – from an estimated 250,000 breast cancer patients to over one million.

The clearance paves the way for more people to use Paxman Scalp Cooling and will undoubtedly have a positive impact on the number of patient enrolments for systems already installed. It also increases the likelihood of existing locations ordering additional systems in the future. It is the only scalp cooler in the world to offer a single patient use cooling cap to each user.

Clinician comments

Professor Debu Tripathy of The University of Texas MD Anderson Cancer Center, said: “This is another step forward in making cancer therapy more personalized and putting the patients in the driver’s seat as we create more options and pathways our patients.”

Steven Isakoff of Massachusetts General Hospital, added: “Scalp cooling has been a real game changer for so many of our patients with breast cancer, minimizing the risk of one of the most dreaded side effects of chemotherapy.  Thanks to the recent expanded FDA indication for the Paxman Scalp Cooling system, so many more patients with solid tumors in the US can now consider this option as a safe and effective way to keep their hair during chemotherapy.  We are already working on plans to make this available to all of our patients with solid tumors.”

Source: Paxman


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