Pulnovo Medical Limited, a globally recognized device pioneer in the treatment for cardiopulmonary diseases, today announced that it has successfully concluded the first Pre-Sub meeting with the U.S. Food and Drug Administration (“FDA”) for its Pulmonary Artery Denervation (PADN) Global Trial.
Dr. Shaoliang Chen, Chair of Pulnovo Medical’s Scientific Advisory Board and pioneer of the PADN technology, attended the meeting and presented the company’s technology and background studies, pulmonary hypertension patients’ clinical needs for PADN products, a series of investigator-initiatedPADN studies ranging from animal studies to long-term efficacy studiesthat encompassed over 400 human cases with a wealth of convincing safety and efficacy data, and the PADN-CFDA registered randomized clinical trial along with the trial data.
Dr. Gregg W. Stone, Chair of the PADN Global Trial’s Steering Committee and member of the company’s Scientific Advisory Board, provided a detailed introduction to the proposed IDE protocol, and discussed the study design and objectives, trial endpoints for the evaluation of safety and effectiveness, patients selection, biocompatibility, and statistical analysis plan.
The proposed protocol for the U.S. pivotal 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: “We are leveraging an accelerated regulatory pathway that is enabled by our FDA Breakthrough Device Designation. This first Pre-Sub meeting with the FDA allowed us to showcase our technological and clinical strengths and helped us gain insights into the IDE process for an innovative device. Having laid the groundwork over more than a decade, we consider this meeting one of the last few steps we needed to take before we formally file our application seeking the FDA’s approval for us to begin the PADN Global Clinical Trial. Numerous key opinion leaders, including well-respected cardiologists and pulmonary hypertension physicians across the United States and Europe, have expressed strong interest in participating in the PADN Global Clinical Trial and serving on the trial’s Steering Committee.”
Jessie Lian, Pulnovo Medical’s CEO, said: “Over a decade of clinical evidence provides to FDA an excellent roadmap for what we hope will be a successful pivotal trial and we look forward to filing our IDE application and working with the FDA to obtain IDE approval to begin patient enrollment. We will provide periodic updates regarding Pre-Sub meetings, site selection, IDE approval, and other important milestones related to the proposed global trial as Pulnovo progresses through the IDE approval process.”
PADN device 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.
Other FDA news of interest can be found here.