Pulnovo Medical Successfully Holds First FDA Pre-Submission Meeting for Global Multicenter PADN Clinical Trial
Recently, PAM Medical announced that it has successfully held a Pre-Submission meeting with the U.S. Food and Drug Administration (hereinafter referred to as the “FDA”) for the global multicenter clinical trial of PADN, officially entering the FDA Premarket Approval (PMA) process. As the first domestic medical device innovator to apply for PMA review after obtaining the FDA Breakthrough Device designation, this milestone signifies that PADN technology and products will undergo the most rigorous clinical, regulatory, and product evaluations within the international medical regulatory system. This includes more in-depth and comprehensive product testing, such as system testing, animal studies, and human clinical trials, to ensure that the product provides a safer and more effective clinical treatment solution for pulmonary arterial hypertension. This achievement will greatly enhance PADN’s global reputation and trust, helping PAM Medical bring its original Chinese medical devices to the world market to address more unmet clinical needs.
The Pre-Submission (Pre-Sub) program, formerly known as the Pre-IDE program, was established in 1995 to provide sponsors with a mechanism for communicating with the FDA, enabling them to obtain timely and rapid feedback prior to submitting future Investigational Device Exemption (IDE) applications. Currently, Pre-Submissions cover a range of premarket applications, including IDEs for clinical study devices, Premarket Approval (PMA) applications, Humanitarian Device Exemption (HDE) applications, De Novo classification requests, 510(k) premarket notifications, Dual 510(k) submissions, Biologics License Applications (BLAs), Investigational New Drug (IND) applications, accessory classification requests, and Clinical Laboratory Improvement Amendments (CLIA) waiver applications. To further improve application efficiency, and with the support of the U.S. Congress, the U.S. Department of Health and Human Services established the “Pre-Submission (Pre-Sub)” mechanism within the existing FDA structured process in 2012. This initiative has significantly enhanced sponsors’ ability to ensure the accuracy and standardization of IDE submission materials, thereby accelerating the overall application process.
The team attending the Pre-Sub meeting for the global multicenter clinical trial of PADN this time consists ofLed by the FDA’s Chief Reviewer, Comprising Department Heads with MD/PhD Backgrounds, the team will becomePADN Global Multicenter Clinical FDA PMA Review Panel。
The Parmed Medical conference delegation consists of:Professor Shaoliang Chen, Chair of the Scientific Advisory Board (SAB) and founder of PADN technology; Professor Gregg W. Stone, Chair of the Steering Committee for the global multicenter clinical trials of PADN and member of the SAB; Dr. Krishna Sudhir, member of the SAB; Cynthia Chen, Chairwoman of Pulmonx Medical; Jia Lian, CEO; Wen Gu, Senior Vice President of Clinical Affairs; and the North American advisory team of Pulmonx Medical.
During the one-hour discussion, Professor Chen ShaoliangA detailed interpretation was provided on PADN technology and background research, the clinical needs of patients with pulmonary hypertension (PH) for PADN products, the results of a series of clinical studies on PADN, as well as comprehensive data validating the product’s safety and efficacy.
Professor Gregg W. StoneProvides a detailed overview of the proposed Investigational Device Exemption (IDE) clinical protocol, covering topics such as study objectives and design, endpoint discussions, safety and efficacy evaluations, patient inclusion criteria, biocompatibility, and the statistical analysis plan.
The preliminary protocol for PAM Medical’s global multicenter clinical study on PADN is highly similar to the clinical registration study protocol for PADN-CFDA, with enrollment sites spanning major centers across Europe and the United States. The PADN-CFDA study successfully completed patient enrollment, follow-up, and data analysis by the end of 2021. According to the research results currently published by Professor Chen Shaoliang, patients in the PADN group demonstrated significant improvements in all study endpoints, hemodynamic parameters, and physical function, with no device-related adverse events reported.
Cynthia Chen, Chairman of Pamu Medical, stated:In light of Pama Medical’s successful attainment of the FDA Breakthrough Device designation, we were able to gain deeper insights into the Investigational Device Exemption (IDE) clinical study process during our initial Pre-Submission meeting with the FDA. This has laid a solid regulatory foundation for the smooth launch of the PADN global multicenter clinical trial and will significantly accelerate the pace of PADN’s international clinical development. Leading cardiovascular and pulmonary hypertension experts from Europe, the United States, and other countries have expressed strong interest in participating in the upcoming PADN global clinical trial and have actively joined the PADN Global Multicenter Clinical Trial Steering Committee led by Professor Gregg Stone. We are confident that the international clinical research program for PADN will proceed smoothly under FDA endorsement and the guidance of these top-tier experts.
Lian Jia, CEO of Pamu Medical, stated:Over a decade of accumulated clinical data on PADN has effectively demonstrated to the FDA Pamo Medical’s unwavering commitment to continuous exploration. We sincerely hope that PADN will provide better and superior solutions for patients with pulmonary hypertension whose treatment needs remain unmet worldwide. Concurrently, we are expediting the submission of our Investigational Device Exemption (IDE) application and look forward to further collaboration with the FDA, with the aim of initiating patient enrollment as soon as IDE approval is obtained. Pamo Medical will continue to provide updates on progress throughout the IDE review process, including preparations for and approval of Pre-Submission meetings, as well as other key milestones related to international clinical trials of PADN. Let us jointly anticipate the successful launch of the international clinical trials for PADN, thereby adding robust and significant evidence to the existing body of data supporting PADN research.
PamMed’s original PADN multipolar pulmonary artery radiofrequency ablation catheter has ushered in a new era of interventional device therapy for pulmonary hypertension (PH). It has successfully secured over 50 invention patents and methodological protections both domestically and internationally, entered the China Food and Drug Administration (CFDA) Green Channel for Innovative Medical Devices, and obtained CE quality system certification. In February 2021, the PADN radiofrequency ablation catheter rapidly received FDA Breakthrough Device Designation within just 16 days, making PamMed the first company in China to achieve this distinction in the field.
Pamu Medical, founded in 2013 with a focus on the cardiopulmonary field, is committed to addressing more unmet clinical needs. The company has long been dedicated to scientific exploration of breakthrough technologies and commercial expansion with a global perspective, striving to build an OTM (From Operating Table to Market) innovation platform driven by clinical value, acting to enhance patients’ resilience for life recovery.
Guided by a commitment to innovation and the craftsmanship of enhancing patients’ health resilience, Pumu Medical has remained dedicated from the operating room to the marketplace to delivering breakthrough therapies driven by clinical value. Emerging as a dark horse, it has rapidly taken the lead in interventional therapies for pulmonary hypertension and will continue to uphold its foundational principles, leveraging relentless R&D strength to join hands with patients in stepping into a new era.