Sofwave Receives NMPA Approval in Mainland China

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

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 2023¹

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’s National Medical Products Administration (NMPA) to market the Sofwave™ System in mainland China. The approval clears Sofwave’s 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.

Sofwave’s 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’s 2022 collaboration and distribution agreement with HTDK Group, a leading healthcare commercialization solutions provider, under which HTDK supported Sofwave’s regulatory submission and will lead product marketing, distribution, and sales in the region. Sofwave plans to begin shipments in the near term.

“Receiving 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’s 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,” said Louis Scafuri, Chief Executive Officer of Sofwave Medical.

Dr. Shimon Eckhouse, Chairman of the Board, added, “The approval of our SUPERB™ technology in China significantly expands Sofwave’s addressable market. China is becoming a global leader in aesthetic medicine, with non-invasive regenerative skin treatments representing one of the sector’s fastest growing segments. Our 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.”

“We are delighted to partner with Sofwave and excited by the opportunity to bring SUPERB to market in China,” said Teresa Chen, Chief Executive Officer of HTDK. “This 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’s 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.”

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).

Key findings included:

• GAIS improvement rate: 95.1% in the treatment group versus 23.4% in the control group, a between-group difference of 71.7% (95% CI: 59.1% – 84.3%)
• FWCS improvement rate: 81.3% in the treatment group versus 17.0% in the control group, a between-group difference of 64.2% (95% CI: 51.7% – 76.7%)
• In the subset of subjects with a Fitzpatrick Wrinkle Classification System (FWCS) score of 3–6 points (FWCS score 3 – 6) who completed the primary efficacy evaluation, GAIS improvement reached 98.4% in the treatment group versus 25.0% in the control group, and FWCS improvement reached 83.7% in the treatment group versus 18.2% in the control group
• In both datasets, the lower bound of the 95% confidence interval exceeded the pre-specified 15% superiority margin (all P < 0.001), demonstrating statistically significant superiority over the blank control
• No serious device-related adverse events were reported; observed adverse events were predominantly mild (erythema and pain at the treatment site), consistent with the device’s expected safety profile

About Sofwave Medical Ltd.
Sofwave Medical Ltd. (TASE: SOFW) is a global regenerative aesthetics company advancing non-invasive technologies for skin and body. Its proprietary SUPERB™ (Synchronous Ultrasound Parallel Beam) technology delivers controlled ultrasound energy to the mid-dermis to stimulate the body’s natural regenerative response and is FDA-cleared in the United States for the treatment of facial lines and wrinkles, lifting the eyebrow and lax submental and neck tissue, improving the appearance of skin laxity on the upper arms, short-term improvement in the appearance of cellulite, and treatment of acne scars.

Sofwave’s global portfolio also includes Pure Impact™, which utilizes electrical muscle stimulation (EMS) technology for muscle strengthening, toning and firming. Together, Sofwave’s technologies provide physicians with clinically supported, non-invasive solutions for the evolving needs of aesthetic patients worldwide.

¹ The Chinese Pulse. 2024. “Light Medical Beauty in China: The Future of Skincare? 2024.” https://thechinesepulse.com/studies/light-medical-beauty-in-china-the-future-of-skincare/.

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Media Contact:
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CMB Media
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Investor Contact:
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LifeSci Advisors LLC
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