Pulnovo Medical Completes Global First-in-Class RCT Enrollment for Pulmonary Arterial Hypertension Therapy, Ushering in a New Era for PH Treatment

Recently, Pulnovo Medical’s PADN-CFDA clinical trial has completed full patient enrollment. The company will continue to assist participating centers in conducting follow-up visits for enrolled patients, retrieving data, and performing data cleaning, while also supporting the National Clinical Research Center in subsequent tasks. According to reports, the PADN device is designed for pulmonary hypertension; when used in conjunction with percutaneous pulmonary artery denervation, it provides a treatment option for patients with pulmonary hypertension.

Pulmonary hypertension refers to a clinical and pathophysiological syndrome characterized by structural or functional changes in the pulmonary vasculature caused by various heterogeneous diseases (etiologies) and different pathogenic mechanisms, leading to increased pulmonary vascular resistance and elevated pulmonary arterial pressure, which subsequently progresses to right heart failure and even death. As a condition with extremely high incidence and mortality rates, often described as “the cancer of cardiovascular diseases,” pulmonary hypertension affects nearly 100 million patients worldwide. However, to date, it remains one of the lesser-known malignant diseases.

Previously, the available treatment options for patients with pulmonary hypertension mainly relied on targeted drugs and lung transplantation. According to the article published in Lancet Respiratory Medicine in 2018 titled “Pulmonary hypertension: the unaddressed global health burden》One Article US-Canada TeamStatistical data indicate that the annual cost of pharmacological treatment for patients with pulmonary hypertension is approximately $80,000, a sum that is unaffordable for the vast majority of patients. As for lung transplantation, the procedure is extremely challenging due to the severe scarcity of donor organs, as well as the high risk of postoperative complications such as infections and rejection. Furthermore, patients must take immunosuppressive medications long-term after surgery. In addition to these challenges, the prohibitive cost of the surgery itself deters many patients from pursuing this option.

Fortunately, Pulnovo Medical has introduced a novel therapeutic approach for patients with pulmonary arterial hypertension, which is easy to administer and reasonably priced. In 2021,Pulnovo Medical’s independently developed radiofrequency ablation product secured U.S. FDA Breakthrough Device designation in a record-breaking 16 days, marking the first such achievement for any company in the field of pulmonary hypertension.

Pulnovo Medical, established in 2013, specializes in the field of pulmonary hypertension. Its two core product categories—high-frequency ablation devices and intravascular catheters—are both international firsts, and the company holds more than 40 invention patents worldwide. Currently, Pulnovo Medical has built Class 10,000 cleanrooms, active production workshops, and warehouses in compliance with GMP and ISO 13485 requirements. It features comprehensive water for injection and purified water systems, as well as independent physical, chemical, and microbiological laboratories, equipped with various professional testing instruments and production facilities.

Data shows that Professor Chen Shaoliang, the inventor of the PADN procedure, is a top cardiovascular expert in China. He has received more than 40 awards for scientific and technological achievements and has been listed among China’s Most Cited Chinese Researchers in the “Medicine” category for seven consecutive years.Most-cited single paper exceeds 1,574 citations, ranking first among cardiovascular scholars in China。ZengHe has organized more than 10 international, prospective, multicenter clinical studies and obtained 15 invention and utility model patents. In 2012, Professor Chen Shaoliang pioneered percutaneous pulmonary artery denervation (PADN) and collaborated with engineers to develop high-frequency ablation devices and intravascular catheters specifically designed for use in PADN procedures.

As the inventor of percutaneous pulmonary artery denervation, Professor Chen Shaoliang has repeatedly presented relevant clinical research findings at the Transcatheter Cardiovascular Therapeutics (TCT) conference in the United States, confirming its exceptional safety and efficacy. To date, Professor Chen has traveled extensively to Europe, the United States, and Asia for theoretical instruction and surgical demonstrations, provided live on-site surgical guidance abroad on numerous occasions, and delivered more than 20 invited international academic lectures, garnering significant attention worldwide.

Currently, enterprises, medical institutions, research organizations, and scientists worldwide who are focused on pulmonary hypertension are eagerly awaiting the publication of PADN research findings, looking to Pulnovo Medical forNew TherapiesProvide reliable scientific evidence.