Market Clearance Granted for Paxman Scalp Cooling in South Korea

Paxman today announces that the first step in product registration for market clearance for the Paxman Scalp Cooling System has been granted in South Korea.

TPC Korea (Nokwon) has been Paxman’s distribution partner in the region since 2020 and is now working on the next steps to navigate insurance reimbursement for scalp cooling treatment, with the final approval for commercialisation expected to be granted around May 2024.
With a population of 51.74 million cancer is the leading cause of death in South Korea with breast cancer featuring in the top 5 most common cancers in the country. In 2022, the National Library of Medicine forecasts nearly 275,000 new cancer cases per annum.

Scalp cooling treatment is a new concept in Korea with a number of regulatory requirements to overcome prior to full commercialisation. These involve the verification of scalp cooling as an existing / new medical technology by Health Insurance Review and Assessment Service (HIRA). This step is expected to be completed by March 2023. In Korea there are 3 pathways for reimbursement registration: Reimbursement, Screening Selective Reimbursement and Non-Reimbursement. The evaluation of the new medical technology and reimbursement registration is the second process for completion which is anticipated to be completed by May 2024.

A clinical study in collaboration with Paxman on the effectiveness of the Paxman Scalp Cooling System in reducing chemotherapy-induced alopecia in women with breast cancer, is nearing completion. The study data collection is finalised, led by Professor Jin Seok Ahn, MD at Samsung Medical Center, Seoul, and is now awaiting analysis.

TPC Korea are now ready to move forward with their pre-marketing plans for 2023 to raise awareness of the patient benefits of scalp cooling and plan to attend sector-specific conferences in the year ahead.

Datum 2022-11-21, kl 08:00
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