SinoShoor Lutronic Secures Regulatory Approvals for XERF in Four Countries

SinoShoor Lutronic announced on the 20th that its monopolar radiofrequency (RF) medical device, XERF, has recently obtained medical device approvals in key countries across the Asia-Pacific (APAC) and Middle Eastern regions, significantly bolstering its global market expansion strategy.

Most notably, the company has received final approval for XERF from the Emirates Authority for Health Services (EDE) in the United Arab Emirates (UAE), marking another key regulatory milestone after gaining certification in Saudi Arabia (KSA) in January. This sequence of approvals positions SinoShoor Lutronic for a substantial push into the Middle Eastern medical aesthetic market.

Moreover, XERF had previously established its foothold in the Oceania market after receiving approval from the Australian Therapeutic Goods Administration (TGA) in October of last year. Additionally, the recent approvals in Indonesia and Myanmar further solidify the brand's presence within the APAC region.

XERF has been recognized by regulatory authorities in three APAC countries (Australia, Indonesia, Myanmar) and the UAE as a non-invasive cosmetic RF device, with approved indications including facial contouring and wrinkle treatment, eyebrow lifting, and improving facial and neck laxity. This diverse indication allows for a wider market appeal and caters to various consumer needs.

The device, which is the first product launched following the merger of SinoShoor and Lutronic, features a dual monopolar approach by incorporating an additional 2 MHz frequency alongside the traditional 6.78 MHz. This innovation enables customizable treatment depths across three levels, ensuring tailored procedures for diverse needs. Additionally, the patented 'Spider Pattern' technology integrated into the XERF Effector allows for effective energy delivery over a maximum area of 20×30 mm per shot, enhancing treatment efficiency.

With these four recent approvals, XERF has now secured authorization in 13 countries including the United States, Canada, Brazil, Japan, and South Korea. As the approved markets expand, there is an expected rise in demand for XERF's consumables, particularly the XERF Effector, which is anticipated to contribute to a stable revenue structure beyond equipment sales.

A representative from SinoShoor Lutronic stated, "XERF has garnered significant interest from global medical professionals since its launch, driven by our non-invasive RF technology. With the recent regulatory approvals in the APAC and Middle Eastern regions, we aim to solidify our leadership position in the global RF market."