Paxman Expands Global Regulatory Certifications for Cryocompression Device for Prevention of Chemotherapy-induced Peripheral Neuropathy (CIPN)
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.
Contacts
Richard Paxman, CEO
Tel: +44 7968 020641
Email: richard@paxmanscalpcooling.com
www.paxman.se
About Us
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. In 2025, PAXMAN AB acquired Dignitana, merging to form a stronger united company.
Today, PAXMAN’s portfolio includes both the Paxman and DigniCap systems with several thousand installations in hospitals, clinics and treatment centres worldwide, reaffirming PAXMAN as the leading global supplier of Scalp Cooling technology.
PAXMAN AB (publ) has its headquarters in Karlshamn (Sweden). Subsidiaries of the PAXMAN Group are Paxman Coolers Limited (Huddersfield UK), Paxman Inc. (Houston, Texas US), Paxman Canada (Toronto, Ontario CA), Dignitana AB (Lund, Sweden), Dignitana Inc. (Dallas, TX US), and Dignitana S.r.l. (Milan, IT).
The PAXMAN share is listed on Nasdaq First North Growth Market.
FNCA Sweden AB is the company’s Certified Adviser.