{"id":85671,"date":"2026-09-24T12:07:00","date_gmt":"2026-09-24T12:07:00","guid":{"rendered":"https:\/\/english.saigonbiz.com\/vn\/?p=85671"},"modified":"2026-09-25T01:26:22","modified_gmt":"2026-09-25T01:26:22","slug":"sofwave-receives-nmpa-approval-in-mainland-china","status":"publish","type":"post","link":"https:\/\/english.saigonbiz.com\/vn\/sofwave-receives-nmpa-approval-in-mainland-china\/","title":{"rendered":"Sofwave Receives NMPA Approval in Mainland China"},"content":{"rendered":"

NMPA approval supported by a 200-subject, randomized, controlled study in China demonstrating statistically significant improvement in mid-to-lower facial wrinkles and a favorable safety profile<\/em><\/p>\n

China represents a growing medical aesthetic market, with the market for non-invasive\/minimally invasive procedures valued at RMB 146.0 billion (approximately US$20.6 billion) in 2023<\/em>1<\/em><\/sup><\/p>\n

SAN CLEMENTE, Calif., Sept. 24, 2026 (GLOBE NEWSWIRE) — Sofwave Medical Ltd. (TASE: SOFW), a global regenerative aesthetics company advancing non-invasive technologies for skin and body, today announced that it has received approval from China\u2019s National Medical Products Administration (NMPA) to market the Sofwave™ System in mainland China. The approval clears Sofwave\u2019s proprietary SUPERB™ (Synchronous Ultrasound Parallel Beam) technology for use in mainland China to improve wrinkles in the mid-to-lower face for individuals aged 22 and older.<\/p>\n

Sofwave\u2019s proprietary SUPERB™ (Synchronous Ultrasound Parallel Beam) technology is supported by a growing body of clinical evidence and is used by physicians worldwide to deliver non-invasive aesthetic treatments. The approval follows Sofwave\u2019s 2022 collaboration and distribution agreement with HTDK Group, a leading healthcare commercialization solutions provider, under which HTDK supported Sofwave\u2019s regulatory submission and will lead product marketing, distribution, and sales in the region. Sofwave plans to begin shipments in the near term.<\/p>\n

\u201cReceiving NMPA approval is an important milestone in our international growth strategy. China represents a significant market for non-invasive aesthetic treatments, and this approval expands access to Sofwave\u2019s clinically supported technology. HTDK has been an important partner throughout the regulatory process. We are now focused on executing a disciplined commercial launch and building the market over time,\u201d said Louis Scafuri, Chief Executive Officer of Sofwave Medical.<\/p>\n

Dr. Shimon Eckhouse, Chairman of the Board, added, \u201cThe approval of our SUPERB™ technology in China significantly expands Sofwave\u2019s addressable market. China is becoming a global leader in aesthetic medicine, with non-invasive regenerative skin treatments representing one of the sector\u2019s fastest growing segments.\u00a0Our investment in SUPERB™ technology and clinical development plays a significant role in our commercial success, and we believe it will continue to deliver results as Sofwave grows. The rigorous clinical trial conducted in China that led to this important approval reflects our longstanding strategy of investing in the science of regenerative aesthetic medicine.\u201d<\/p>\n

\u201cWe are delighted to partner with Sofwave and excited by the opportunity to bring SUPERB to market in China,\u201d said Teresa Chen, Chief Executive Officer of HTDK. \u201cThis approval was supported by a rigorous, multi-site clinical study that reinforces the strength of the SUPERB technology platform by demonstrating statistically significant superiority over control, meaningful improvement rates, and a favorable safety profile with no serious device-related adverse events. Sofwave\u2019s growing utilization and recognition around the world reflects the confidence physicians and patients have in the technology. We look forward to the commercial launch of SUPERB in China with shipments beginning in the near term.\u201d<\/p>\n

The NMPA approval was supported by a prospective, randomized, blank controlled superiority study conducted at five clinical sites across China. The study enrolled 200 subjects aged 22 to 65 seeking improvement of mid-to-lower facial skin wrinkles. The study evaluated efficacy using two primary endpoints assessed by independent evaluators three months after treatment completion: improvement rate on the Global Aesthetic Improvement Scale (GAIS) and improvement rate on the Fitzpatrick Wrinkle Classification System (FWCS).<\/p>\n

Key findings included:<\/strong><\/p>\n