Solta Secures NMPA Approval for New RF Device; Weisi Medical Forecasts 2023 Net Profit of at Least RMB 131 Million; Harbin Regulators Crack Down on Unlicensed Aesthetic Practices

Jan 18, 2024 17:23 CST Updated 17:23

VISHEE

Developer, Manufacturer, and Distributor of Rehabilitation Medical Devices

Industry Trends

丨Solta's Another "RF Therapy Device" Approved for Marketing by NMPA

On January 17, the "Radiofrequency Therapy Device" and "Single-Use Neutral Electrode" submitted by Solta Medical, Inc. (hereinafter referred to as "Solta," represented by Solta (Shanghai) Health Management Co., Ltd.) were successfully approved for marketing by the NMPA. The registration certificate numbers are: China Medical Device Registration No. 20243090033 and China Medical Device Registration No. 20243090034, respectively.

Public information shows that Solta is a globally renowned medical aesthetics device manufacturer, primarily producing devices for skin tightening, whitening, and body sculpting. It owns four major brands: Thermage (known as "Ulthera" in China), Clear+Brilliant, Fraxel, and VASER.

Among them, the dual-wavelength fractional semiconductor laser device CLEAR + BRILLIANT (used for reducing superficial fine wrinkles), the radiofrequency device Thermage CPT (used for non-invasive treatment of wrinkles on the body, face, and around the eyes), and the dual-wavelength laser system Fraxel DUAL 1550/1927 (1550nm: used for treating freckles, solar lentigines, actinic keratosis, acne scars, surgical scars, melasma, and reducing periorbital wrinkles. 1927nm: used for treating actinic keratosis) have successfully received NMPA approval for marketing.

丨 VISHEE Medical Predicts Net Profit for 2023At least 131 million yuan

On January 17, VISHEE issued a performance forecast, expecting to achieve a parent company net profit of 131 million yuan to 141 million yuan in 2023, representing a year-on-year increase of 40% to 50%. The company expects that the parent company net profit for 2023, after excluding the impact of share-based payment expenses, will be between 146 million yuan and 155 million yuan, reflecting a year-on-year increase of 56% to 66%.

The main reason for the change in performance is that during the reporting period, the company adhered to innovation-driven R&D, continuously expanded its product pipeline, achieved steady growth in operating scale, and gradually optimized and improved its business structure. Among these, the next-generation pelvic floor functional magnetic stimulators, transcranial magnetic stimulators, and group biofeedback devices were iteratively upgraded and launched into the market, significantly enhancing market competitiveness. Since their launch, the business scale and market share of core products represented by magnetic stimulation have grown rapidly, receiving positive feedback from end users in the market.

Industry Regulation

丨 H City Market Supervision Department Inspects Medical Beauty Institutions in Xiangfang District

Recently, the municipal and district-level market supervision departments conducted a joint inspection of medical beauty institutions in Xiangfang District.

This inspection focuses on categories such as injectable sodium hyaluronate gel, radiofrequency skin treatment devices, pulsed light therapy devices, and implant fillers. The key focus is to check whether medical aesthetic institutions are using unregistered medical devices and whether they have established and implemented an incoming goods inspection system. Two medical aesthetic institutions that failed to comply with the incoming goods inspection record system as stipulated in the Regulations on the Supervision and Administration of Medical Devices were investigated.

Next, the Xiangfang District Market Supervision Bureau will increase the publicity and dissemination of medical aesthetics policies and regulations during routine supervision, and severely crack down on...Crack down on related illegal and irregular behaviors, standardize the market order of the medical aesthetics industry, and effectively safeguard the health and safety of the people.

丨XuzhouHao MoumouIn a certain smallFined 50,000 for Injecting Hyaluronic Acid Within the Area

Hao Moumou in Xuzhou injected hyaluronic acid for customers in a residential community. After investigation and verification by the Yunlong District Health Supervision Institute, it was confirmed that Hao Moumou had not obtained the "Physician Qualification Certificate" and the "Physician Practice Certificate" but still provided medical cosmetic services. According to the provisions of the "Physicians Law," Hao Moumou was given an administrative punishment of confiscating illegal earnings of 1,300 yuan, confiscating hyaluronic acid and other medicines and devices, and imposing a fine of 50,000 yuan.