Paxman today announced a series of significant regulatory milestones that strengthen its global quality management framework, supporting the forthcoming commercialisation of its expanded cryotherapy device portfolio to manage chemotherapy-induced side effects.
Paxman has successfully extended the scope of its UK Conformity Assessed (UKCA), European Conformity (CE), International Organization for Standardization (ISO) 13485 and Medical Device Single Audit Program (MDSAP) certifications to include its new cryocompression technology for the management of chemotherapy-induced peripheral neuropathy (CIPN).
The extended scope fulfils certification requirements in the UK and the EU and represent a key milestone toward approvals in Australia, Brazil, Canada, Japan and the United States for Paxman’s next-generation cryotherapy devices for managing chemotherapy-induced peripheral neuropathy (CIPN) and chemotherapy-induced alopecia (CIA).
These certifications strengthen the Company’s global regulatory position, and mark a critical step in Paxman’s strategy to expand access to innovative cooling technologies designed to mitigate the side effects of chemotherapy, supporting patients globally. Paxman’s solution for preventing CIPN delivers both controlled cooling and compression to the hands and feet before, during, and after chemotherapy infusion, making it a unique and differentiated product in the market.
“Expanding our regulatory certifications helps us bring innovative solutions to more patients worldwide. There is a clear and unmet need for clinical intervention that reduces the risk of CIPN, and we remain committed to improving access to our technology, helping patients better tolerate treatment, reduce side effects, and maintain quality of life throughout their cancer journey.” said Richard Paxman OBE, Chief Executive Officer of Paxman.