PAXMAN supplements application for expanded FDA clearance in the USA
PAXMAN AB (publ) has supplemented the company’s premarket notification application to the US FDA for an expanded indication by responding to a request for additional information. The application seeks to expand use of the company’s scalp cooling to reduce the likelihood of chemotherapy-induced alopecia (CIA) in cancer patients with solid tumors.
The additional information, that has been submitted to and received by the FDA, consists of an in-depth analysis of the clinical results provided as the basis for the expanded indication.
“The clinical results for our expanded FDA application demanded a more thorough analysis for optimal overview than we expected. This has led to a longer regulatory process in this case, but it also creates potential to speed up upcoming applications in other regions,” says PAXMAN’s CEO Richard Paxman.
PAXMAN expects the FDA to be able to complete the application process without the need for additional amendments.
For further information, please contact:
Richard Paxman, CEO
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 10.35 CET on 8th May 2018.
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 system came when the mother of four, Sue Paxman, experienced first-hand the trauma of chemotherapy-induced hair loss. With close to 3,000 systems delivered in to hospitals, clinics and treatment centres around the world, PAXMAN is the leading supplier of Scalp Cooling technology. PAXMAN’s scalp-cooling cap is made from lightweight, biocompatible silicone that is soft and flexible, providing a snug yet comfortable fit during treatment. PAXMAN AB (publ) has its headquarters in Karlshamn (Sweden), with subsidiaries in Huddersfield (UK) and Houston, Texas (US)
The PAXMAN share is listed on Nasdaq First North. FNCA Sweden AB is the company’s Certified Adviser.