FDA clearance announced for expanded indication of scalp cooling system in the US

Huddersfield-based Paxman's advanced scalp cooling system has now been cleared by the US Food and Drug Administration (FDA) for use during treatment of patients with solid tumours.

The Paxman Scalp Cooling System has been 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 breast cancer and solid tumour cancer patients.

Paxman's 510k application for expanded use of its scalp cooling system was submitted to the US FDA in October 2017 and was supplemented in early May in response to a request for additional information and analysis.

Since its original FDA clearance in April 2017, the company has installed around 225 scalp cooling systems in the US with a further 65 systems awaiting delivery and installation. 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 Paxman locations ordering additional systems in the future. According to the company, it is the only scalp cooler in the world to offer a single patient use cooling cap to each user.

Leading US clinicians welcomed the news. 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 Jay Isakoff, MD, PhD, medical oncologist of Massachusetts General Hospital, added: “Scalp cooling has been a real game changer for so many of our patients with breast cancer, minimising 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 tumours.”

Hair loss is a well-known side effect of many chemotherapy regimens, with many men and women reporting it to be the most traumatic aspect of their treatment. Scalp cooling provides a proven alternative to hair loss, resulting in a high level of retention or even complete hair preservation, improving patients’ self-confidence and creating positive attitudes towards treatment. 
The Paxman Cooling System (also known as the 'cold cap') alleviates the damage caused to the hair follicles by chemotherapy. It works by reducing the temperature of the scalp by a few degrees immediately before, during and after the administration of chemotherapy. Liquid coolant passes through the cap extracting heat from the patient's scalp, ensuring the scalp remains at an even, constant temperature to minimise hair loss.

The 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 minimise chemotherapy-induced hair loss and contribute to their quality of life.

Nancy from The Rapunzel Project, an non-profit organization dedicated to helping chemotherapy patients keep their hair during treatment said they were thrilled.
She said: “Now all solid tumor patients will have the opportunity to choose this revolutionary technology to save their hair during chemotherapy. Reducing the likelihood of hair loss, a dreaded side effect of chemo, as well as protecting one’s identity and privacy while being treated for cancer, are game changing benefits for patients!”

Bethany Hornthal, founder of HairToStay, added: “HairToStay has had the privilege of subsidizing a growing number of Paxman scalp cooling users for nearly a year now. This expanded clearance, will increase this wonderful option for patients and we expect to see a significant increase in demand for scalp cooling and subsidies. Richard and his team understand the need to make scalp cooling as affordable as possible, and they have worked closely with us to create partnerships with medical facilities using the Paxman scalp cooling system. We look forward to even more partnerships, which in return will result in even greater access for patients undergoing chemotherapy treatment for cancer."


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