FDA clearance for Paxman Scalp Cooler
Paxman Scalp Cooler, a system developed to reduce the risk for hair loss in cancer patients undergoing chemotherapy, has now been cleared by the US Food and Drug Administration (FDA).
As part of the FDA clearance process, the Paxman scalp cooler was used in the first-ever randomized clinical trial to evaluate modern scalp cooling, and took place at a number of sites including Baylor College of Medicine, Memorial Sloane Kettering, the U.S. Oncology Network and Cleveland Clinic & Summit Medical Group. The multi-centre prospective study, which involved 186 women across New Jersey, New York, Texas and Ohio, revealed that the cold cap preserved hair in more than 50 % of the women who used it.
Over the next twelve months, Paxman plans to install over 250 systems across the U.S. and will be working with a large number of cancer centres and large community oncology groups to roll out its scalp cooling systems.
“Hair loss is ranked among the top five most distressing cancer chemotherapy side effects”, explains Richard Paxman, C.E.O. at Paxman AB (publ). “It is estimated that 8 % of all patients actually refuse chemotherapy because they do not want to lose their hair. After experiencing this first hand, we have been determined to change this”.
For further information, contact:
Richard Paxman, C.E.O.
Tel: +44 7968 020641
This information is information that Paxman AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 8.30 C.E.T. on 19 April 2017.
The Paxman Scalp Cooling System has been developed by the Paxman family to reduce hair loss in breast cancer patients undergoing chemotherapy. The concept behind the pioneering system came when the 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 women around the globe minimize chemotherapy-induced hair loss and contribute to their quality of life. The Paxman Scalp Cooling technology, with over 2,500 systems installed in hospitals, clinics and treatment centres around the world, is made from lightweight, biocompatible silicone. The scalp-cooling cap is soft and flexible, providing a snug yet comfortable fit during treatment.
Paxman AB (publ) has applied for a listing on Nasdaq First North in early June. Erik Penser Bank is the company’s Certified Adviser.