Confirmatory clinical trial of Liwen RF™ ablation system in China concluded

HANGZHOU,China,March 6,2023 -- On March 3,Venus Medtech (Hangzhou) Inc. (Venus Medtech,2500.HK),trailblazer in structural heart therapies worldwide,announced that the Liwen RF™ ablation system developed by the Company has successfully enrolled one patient at West China Hospital,Sichuan University,thus completing the enrollment of patients for confirmatory clinical trial in China. This marks a significant milestone of Liwen RF™ablation system for treatment of hypertrophic cardiomyopathy (HCM) and another stride towards commercialization.

Liwen RF™ ablation system,an innovative device for the treatment of HCM,was developed in-house by Hangzhou Nuocheng Medical Technology Co.,Ltd.,a wholly-owned subsidiary of Venus Medtech. 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. Since the first clinical enrollment in January 2021,128 patients have been enrolled in 20 hospitals,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.

Liwen RF™ ablation system offers technical advantages such as less trauma,precise localization,no target vessel restriction,significant reduction of septal thickness,and reduced risks of conduction system damage and other complications. It provides an innovative therapy for HCM that is safe,efficient,precise,and less invasive. In August 2022,the product was qualified for the Special Approval Procedures of Innovative Medical Devices promulgated by the National Medical Products Administration (NMPA).

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 January 2023,Liwen Procedure,as an innovative technique associated with the product,was selected as 2022 Level I Class A project in the category of new clinical techniques and therapies by Air Force Medical University.

In addition to 144 cases in earlier exploratory clinical trials,medium to long-term follow-up data of 200 HCM patients treated with the Liwen procedure showed an effective decrease in complications and mortality,as revealed in a recent study by Professor Liwen Liu and her team published in JAMA Cardiology in March 2022. Moreover,no permanent pacemaker was required from any patients. The results once again corroborated the long-term safety and efficacy of the product. Furthermore,Liwen Procedure received the Outstanding Innovation Award at CSI and First Prize of Scientific and Technological Progress Award of Shaanxi Province. It was also included in the 2023 Guideline for Diagnosis and Treatment of Patients with Hypertrophic Cardiomyopathy.

Professor Liwen Liu said,"It's such an exciting moment to witness the conclusion of patient enrollment for Liwen RF™. Venus Medtech has been a huge proponent throughout the journey to facilitate clinical trials and promotion. As an ultrasound specialist,I owe a debt of gratitude to cardiology and cardiac surgery departments for their valuable collaboration,support and recognition. The population of HCM patients has been greatly underestimated due to limited screening methods. As Liwen Procedure reaches broader communities,I'm confident it will benefit more patients."

Professor Mao Chen said "We appreciate Prof. Liu's personal presence. It is an important recognition of our technical capabilities that West China Hospital enrolled the last patient for the trial. We are also thankful to Venus Medtech. Although our hospital was a latecomer to the clinical trial,we will strive for a leading role in promoting the procedure,thus bringing hopes to more HCM patients."

Eric Zi,Founder,Executive Director and General Manager of Venus Medtech also felt a surge of emotions: "Liwen RF™ pioneers the use of ultrasound-guided percutaneous intramyocardial septal radiofrequency ablation. European experts have taken notice of the procedure and emphasized its importance as part of the larger family of structural heart solutions. Embedded in our mission is a commitment to addressing patient concerns. Therefore,we are actively exploring additional indications for the product to create greater synergy with our existing product line. We will also leverage our progress in China to advance clinical trials and registration overseas."

About HCM and its main therapies

Hypertrophic cardiomyopathy (HCM) is a common hereditary cardiovascular disease worldwide and the leading cause of sudden cardiac death (SCD) in adolescents and athletes,with epidemiological studies in the United States,Japan and Europe indicating a prevalence rate of 0.17%-0.23% and an estimated 20 million cases worldwide. The prevalence in China is approximately 0.18%,on which basis it is estimated that there are over 2 million cases in China. Approximately 40%-60% patients are caused by gene mutations in the myocardial sarcomere. In other words,it is difficult to significantly reduce morbidity in the future through treatment of the existing patient population. In addition,the cases of HCM are significantly underestimated with a clinical diagnosis rate of only 10% due to the lack of a standardized genetic screening system and limited application of imaging technology,which is an important reason for the high number of SCD in China.

There are no well-established therapies for HCM worldwide,while existing mainstream therapies focus on controlling complications and preventing disease progression by managing symptoms and improving cardiac function. Mavacamten has received the most attention in the HCM therapeutic area in recent years. In October 2020,Bristol-Myers Squibb (BMS) announced that it would acquire MyoKardia for US$13.1 billion in cash at a premium of 60%,in order to obtain its new drug candidate,mavacamten,an allosteric inhibitor of myocardial myosin,which can be used for the treatment of HOCM. The clinical results showed that although mavacamten can relieve obstruction,reached the primary and secondary clinical endpoints,it fails to reduce the ventricular septal thickness and has limited effect in patients with severe HOCM.

Septal myectomy surgery requires an open-chest procedure,which is traumatic,risky,prone to damage the conduction bundle,thus causing conduction block and eventually heart failure,thus having higher requirements on the operator. Alcohol septal ablation does not completely relieve left ventricular outflow tract obstruction in patients with a mismatch between the first septal branch and the site of obstruction; and implantable cardioverter-defibrillator (ICD) is currently the only effective treatment to prevent SCD in patients with HCM,but the ICD affects the quality of life of patients due to electric shock,has a high rate of complications and fails to reduce septal thickness. The advent of the Liwen procedure offers the possibility of safe and effective treatment of HOCM.