Nanjing Sigma Medicine
Recently, Allergan's botulinum toxin Botox has been approved by the NMPA for a new indication, which can be used to temporarily improve significant or very significant masseter muscle protrusion (hypertrophy) in adults.
Botox was first approved by the FDA in 1989 for the treatment of blepharospasm and strabismus in adults, two eye muscle diseases, and was the world's first approved botulinum toxin type A product, and was approved for the treatment of glabellar lines in 2002.
In 2023, the world's first Phase III clinical study data of Botox for the treatment of masseter muscle hypertrophy/protrusion was officially released, providing observational data on the safety and efficacy of this clinical application from the perspective of evidence-based medicine. The clinical study was conducted in multiple centers around the world, and 87.3% of the subjects were Asian aesthetic needs, which is of great breakthrough significance. The results of the Phase 3 clinical trial not only showed that a single treatment with Botox was effective in improving the severity of masseter muscle protrusion (hypertrophy) and improving the lower facial morphology for up to 6-9 months, but also fully observed the efficacy and safety in the Phase 3 clinical study of up to 540 days. China is also the first country in the world to disclose the results of this clinical study.
Nanjing Sigma Medical adheres to the original intention of "making no difficult devices in the world", continuously deepens the customer-centric service concept, promotes more professional and efficient clinical trials, continuously upgrades digital management technology, makes full use of its own platform resource advantages, better empowers customers, promotes the listing of more medical devices with clinical value, helps the innovation and development of the medical device industry, and seeks the well-being of more patients.
The one-stop service model of early start and fast delivery
Nanjing Sigma Medicine, headquartered in Nanjing, radiates the whole country. Sigma Med is an innovative CRO specializing in clinical research of medical devices, stock code: 873450, which is committed to providing clinical trial special services, clinical research, protocol writing, statistical analysis, data management, monitoring, device SMO, subject recruitment, third-party audit and registration declaration of overall solutions for medical devices. Since its establishment in 2009, it has been rated as a high-tech enterprise for many years, a member of Jiangsu Medical Device Association, passed the ISO9001 quality system and on-site certification of a number of domestic and foreign enterprises, and established a joint workstation with Suzhou University, Southeast University and Nanjing Medical University. It has successfully provided professional and technical services for nearly 100 customers at home and abroad, successfully completed medical program design and writing, statistics, audit, clinical trials, registration declaration, etc., and established long-term and stable cooperative relations. Involving more than 20 major therapeutic areas, orthopedics, ophthalmology, nephrology, nursing, plastic surgery, IVD, cardiology, cardiac CDMECMDE surgery, dermatology, etc., it has cooperated with nearly 1,000 hospitals in 25 provinces across the country, and set up one-stop services in major provinces and cities in China, and has worked closely with 80% of the country's clinical trial institutions, with a professional team that is stable and operates in accordance with international standards (ICH-GCP) at the middle and high levels, and has complete and detailed standard operating procedures (SOP). Provide clinical trials and clinical evaluation reports that meet the requirements of NMPA, FDA, EU MDR, and successfully complete more than 1,000 clinical trials of NMPA medical device class III products. The project has passed the national bureau, provincial bureau and external audit and audit for many times. In order to better serve and facilitate customers, we have specially opened Shanghai Nange Branch and many offices.