The board of directors of Venus Medtech (Hangzhou) Inc. announced that on March 3, 2023, the Liwen RF ablation system developed by the Company for treatment of obstructive hypertrophic cardiomyopathy (HOCM) has successfully enrolled one patient at West China Hospital, Sichuan University, thus completing the enrollment of patients for confirmatory clinical trial in China. The Liwen RF ablation system is independently developed by Hangzhou Nuocheng Medical Technology Co. Ltd., a wholly-owned subsidiary of the Company, and completed an exploratory clinical trial enrolled 144 patients and entered the multi-center confirmatory clinical trial in China in January 2021.

The clinical trial was led by Professor Liwen Liu of The First Affiliated Hospital of Air Force Medical University as the principal investigator (PI), with academicians Junbo Ge of Zhongshan Hospital, Fudan University and Yun Zhang of Qilu Hospital of Shandong University as co-PIs, and completed enrollment of 128 patients in 20 centers, including The First Affiliated Hospital of Air Force Medical University, Zhongshan Hospital, Fudan University, Qilu Hospital of Shandong University, the Second Affiliated Hospital, Zhejiang University School of Medicine, West China Hospital Sichuan University, Guangdong Provincial People's Hospital, Xiamen Cardiovascular Hospital Xiamen University, University of Health and Rehabilitation Sciences Qingdao Hospital, Qingdao Municipal Hospital, the 7th People's Hospital of Zhengzhou, The First Affiliated Hospital of Dalian Medical University and Shanxi Cardiovascular Hospital. Exploratory clinical results showed that compared with the traditional gold standard surgical procedure, the Liwen RF ablation system had an 88% success rate, no death case after operation one year, and significant improvements in patients' clinical performance, cardiac function and quality of life, and was significantly better than septal myectomy surgery and alcohol septal ablation, providing strong evidence of its safety and efficacy and superior performance. In addition, a recent study was published by Professor Liwen Liu's team in the JAMA Cardiology in March 2022.

The medium to long-term follow-up of 200 HCM patients treated with the Liwen procedure showed that the Liwen procedure is effective in reducing complications and mortality, and required no permanent pacemaker implantation, reaffirming the long-term safety and efficacy of the product. With its technical advantages of minimal trauma, precise positioning, unrestricted by target blood vessels, significant reduction in septal ventricular thickness and reduced complications such as conduction system damage, the Liwen RF system offers a safe, effective, precise, minimally invasive and innovative treatment option for HOCM patients. In August 2022, the product was approved for special review through the special examination and approval of the National Medical Products Administration for innovative medical devices.

The Board believed that the completion of the full patient enrollment for confirmatory clinical trial of Liwen RF in China is a major milestone in its commercialisation process and a significant advancement in innovative therapies for hypertrophic cardiomyopathy worldwide. With the Company's well-established strengths in research, development, manufacturing and commercialisation in the field of structural heart disease, the company hope that the Liwen RF ablation system will soon be available for the benefit of patients.