SHANGHAI, Sept. 8, 2022 /PRNewswire/ — Pulnovo Medical Limited, a globally recognized OTM innovative platform, today announced that it has successfully concluded the first Steering Committee meeting for PADN Global Clinical Trial.
As members of the Steering Committee, the world’s leading cardiopulmonary experts presented and discussed about the future clinical workflow and the latest clinical trial results of PADN-CFDA. The success of this meeting will lay a solid clinical foundation for the development of the PADN (pulmonary artery denervation) Global Clinical Trial and will facilitate the announcement of the PADN-CFDA study results at the upcoming TCT2022 (Transcatheter Cardiovascular Therapeutics 2022) LBCT session （Late Breaking Trial) on 18th September .
Dr. Shaoliang Chen, Chair of Pulnovo Medical’s Scientific Advisory Board and pioneer of the PADN technology, attended the meeting and presented the technical principles of PADN in detail, further dissected the results of the PADN series of clinical studies and the series of safety and efficacy validation data, and explained the clinical indicators and functional improvement of patients with pulmonary hypertension (PH) after receiving the PADN procedure.
Dr. Gregg W. Stone, Chair of the PADN Global Trial’s Steering Committee and member of the company’s Scientific Advisory Board, introduced the members of the Steering Committee as the opening and described the upcoming PADN Global Clinical Trial, and provided a detailed introduction to the proposed the PADN protocol for conducting a global multi-center trial around time planning and patients enrollment.
The proposed protocol for PADN Global Clinical Trial is expected to be highly similar to that of the PADN-CFDA (China FDA) registered randomized clinical trial, which was successfully completed at the end of 2021 and met the primary efficacy endpoint. Patients enrolled in the PADN-CFDA study experienced significant improvements in all study endpoints, hemodynamic standard and physical functioning capacity with no device–related adverse events.
Cynthia Chen, Pulnovo Medical’s Chairwoman, said: “It was a great honor to have the support of a number of global experts in the cardiopulmonary field, all of whom showed great interest in participating in the PADN Global Clinical Trial. The success of the Steering Committee meeting has boosted our confidence in the successful announcement of the clinical results at TCT2022 on 18 September, which will greatly facilitate the promotion of the PADN global multi-center clinical trial in the international arena and accelerate the pace of PADN’s international clinical progress. We have reason to believe that the road to international clinical studies of PADN will advance with the guidance from top experts, and we look forward to the continuous development of PADN’s technology and R&D pipeline layout under the leadership of the experts, to jointly promote the incubation of innovative technologies and the internationalization of products.”
Jessie Lian, Pulnovo Medical’s CEO, said: “Recently, PADN was included in the latest edition of the European Guidelines for the Management of PH, which presents the improvement of clinical outcomes for PH patients after PADN. This guideline was published by the European Society of Cardiology (ESC) in collaboration with the European Respiratory Society (ERS), and will have a significant impact on the choice of clinical management of PH worldwide. This will greatly benefit PADN to gain great reputation and trust worldwide and help PADN to bring innovative devices to the global market. In this important milestone of PADN’s international marketing, the successful convening of PADN’s first Steering Committee for PADN Global Clinical Trial will not only increase PADN’s global clinical experience in multi-center clinical practice, but also greatly broaden PADN’s influence in the international arena.”
About PADN Device
PADN is a potential global first-in-class, best-in-class innovative radiofrequency ablation device for treating pulmonary arterial hypertension (PAH). It received the Breakthrough Device Designation from the FDA in 2021. PADN is a vascular interventional ablation technology that uses radiofrequency ablation to block pulmonary intima sympathetic nerves and reduce pulmonary artery pressure to delay disease progression. In August 2022, PADN was included in the international ESC guidelines for the first time, which affirmed the improvement of clinical outcomes of PH patients after PADN.
About Pulnovo Medical Limited
Pulnovo Medical Limited, a Global OTM Innovative Platform, is a globally recognized device pioneer in the treatment for cardiopulmonary diseases. Established in 2013 and rooted in innovation, Pulnovo Medical upholds evidenced-based research and translational medicine, and starts our research and development efforts alongside physicians at the operating table with the goal to market our innovative therapeutic solutions and benefit patients around the world.