Paxman, the leading global expert and supplier in scalp cooling for cancer chemotherapy patients, has been granted Investigational Device Exemption (IDE) Approval by the U.S. Food and Drug Administration FDA ahead of a multi-centre, randomized trial of the patented Paxman scalp cooling system for the prevention of chemotherapy induced alopecia.
The trial, which was recently approved by the FDA, is the final phase of approval in the United States and paves the way for FDA market approval of the Paxman scalp cooler device, which is already widely used around the world.
The study will be conducted with 235 patients in a number of medical centres across the US. Dr Julie Nangia, assistant professor of the Lester and Sue Smith Breast Center at Baylor College of Medicine, and principal investigator of the lead study site commented: "Outside of the United States, scalp cooling devices have shown promise as an effective and safe way to prevent hair loss in breast cancer patients undergoing chemotherapy treatment. We are very excited to conduct clinical research here with the Paxman Device to get proof that the device is safe and effective also for US patients. We hope that this device will be approved in the United States for all breast cancer patients undergoing chemotherapy."
As a family business borne out of the hair loss of their Founder and Chairman's wife whilst receiving chemotherapy treatment for breast cancer, Paxman know first-hand that this is often devastating for patients and their families. The fear of hair loss has even been known to cause refusal of treatment. Patient care is among the Company's core values with the overriding objective being that cancer patients, no matter where they are based in the world, have information about and access to scalp cooling treatment.
In the 15 years since Paxman was formed thousands of patients have been treated worldwide - 1800 systems in 32 countries - with their innovative technology. It is a system that works, is user friendly and is cost effective. It has been accepted by doctors, nursing staff and patients alike. Previous problems associated with cold therapy treatments have been eliminated.
Richard Paxman, Managing Director commented "This is a monumental step for the business in line with our global export strategy and our mission to increase the awareness of scalp cooling worldwide to establish it as a common treatment practice for all patients undergoing chemotherapy. We will continue to work in partnership with medical professionals, research centres, cancer! support groups, charities and patients to continually advance scalp cooling in order to attain the best results possible and work on an improvement programme to gain further knowledge and understanding of hair loss prevention for cancer patients receiving chemotherapy."