Sofwave Gains Chinese Market Approval for Non-Invasive Aesthetic Treatments

Sofwave has secured marketing approval in mainland China for its Sofwave system, a significant step into a market estimated at over $20 billion for non-invasive aesthetic procedures. The approval was granted by China's National Medical Products Administration (NMPA) following a successful clinical trial.

The company's Chinese distributor, HTDK, announced the clearance, which permits Sofwave to market its SUPERB technology for wrinkle treatment in the mid-face, cheeks, and jawline for individuals aged 22 and older. Sofwave plans to commence shipments to China shortly, transitioning from a multi-year regulatory process to commercial operations.

The Chinese market for aesthetic procedures was valued at approximately 146 billion yuan ($20.6 billion) in 2023. While specific revenue projections for Sofwave in China were not disclosed, the company views this as a major expansion of its global commercial activities. The partnership with HTDK, established in 2022, will see the distributor lead marketing, distribution, and sales efforts.

Sofwave CEO Louis Scafuri described the NMPA approval as a key milestone in the company's international growth strategy, emphasizing China's importance in the non-invasive aesthetic treatments sector. He stated the company is now focused on a meticulous commercial launch and long-term market development.

The approval followed a prospective, multi-center, randomized, controlled clinical trial in China involving 200 participants aged 22-65. The trial demonstrated statistically significant improvements, with 95.1% of treated patients showing improvement on the GAIS scale compared to 23.4% in the control group, and 81.3% showing improvement on the FWCS scale versus 17% in the control group. Most observed side effects were mild.

Dr. Shimon Eckhouse, Sofwave's Chairman and Co-Founder, highlighted that the approval substantially broadens the company's potential market. Sofwave, founded in 2015 and publicly traded on the Tel Aviv Stock Exchange since 2021, develops non-invasive ultrasound-based medical aesthetic devices. Its SUPERB system also holds FDA clearance for various aesthetic uses in the U.S., including wrinkle improvement, brow lifting, and acne scar treatment.