Pulnovo Medical Files for IPO: Pioneering Global Pulmonary Hypertension Intervention with PADN Technology Led by TCT Chair Gregg W. Stone

2021Year11Month4June 6, the Transcatheter Cardiovascular Therapeutics (TCT) Conference in the United States (TCT2021）Officially convened in Orlando, USA, this conference adoptedOffline and Onlinelaunching a global live broadcast through an integrated approach。

Data shows that,The TCT Conference isByThe world’s largest and most important educational conference focused on cardiovascular interventional medicine, hosted by the Cardiovascular Research Foundation (CRF) in the United States, attracting over 10,000 cardiovascular interventional specialists from more than 90 countries worldwide each year, including cardiac imaging experts, cardiac and vascular surgeons, clinical cardiologists, vascular medicine specialists, and nurses.

For 30 years, the TCT Conference has been characterized by major breakthroughs in medical research, enhancing the clinical practice capabilities of physicians worldwide by providing cutting-edge educational content and showcasing the latest advances in current treatments and clinical research.Currently, the TCT Conference has become the bellwether for the global cardiovascular intervention field.

According to the introduction, this year’s TCT conference will feature 25 complete case studies on new technologies and transcatheter therapies, clinical applications of emerging technologies, the latest clinical trial data and interpretations of new technologies, demonstrations and sharing of innovative technology application cases, as well as educational forums and learning workshops.

For the Chinese medical community, this year's TCT ConferenceFull of uniqueSignificance.In the past, Chinese attendees primarily went to witness, learn about, and understand overseas innovative technologies. This year, however, Pulnovo Medical made a prominent debut at TCT 2021 with its independently developed Chinese innovation, Pulmonary Artery Denervation (PADN), helping propel Chinese technology onto the global stage and showcasing the strength of China’s self-driven innovation.

Just as Armstrong’s small step was a giant leap for mankind, Pulnovo Medical in the field of high-end medical devicesofBreakthrough innovations alsoLeadChina's Medical DevicesTechnological RealizationThe Leap from Imitation to Originality.

At the Pulmonary Hypertension Special Session of the TCT Conference, TCT Conference Chair and world-renowned cardiovascular expert Gregg W. Stone officially announcedFranchisePulnovo Medical, as the Global PIRateNumerous European and American Experts in Pulmonary Hypertension and Cardiovascular Diseases Launch Global Clinical Trials for Pulmonary Hypertension.Gregg W. Stone stated on-site: The global multicenter clinical trial on PADN will become a milestone study in this field,is expected toBy the end of 2022, complete the enrollment of the first patient in the global multicenter clinical trial for PADN.All Preparatory Work。

Data shows that Professor Gregg W. Stone is from the Transcatheter Cardiovascular Therapeutics (TCT) annual meeting in the United States (TCT) Chair, Interventional Cardiologist and Director of Academic Affairs at the Mount Sinai Heart Health System in the United States, Professor of Medicine (Cardiology) and Population Health Science and Policy, Cardiovascular Research Foundation USA (CRF) Medical Research andEducationCo-Director of the Department. Renowned in the field of interventional cardiology. He has served as the principal investigator for approximately 100 national and international multicenter randomized trials, delivered thousands of lectures worldwide, and authored numerous highly influential papers and monographs.

Gregg W.Prof. StoneConsider“Pulmonary hypertension remains a disease with significant academic barriers in the global medical field to date. The complexity of its pathogenesis and the limitations of available treatments have greatly hindered the progress and development of medical technology. As healthcare professionals, our shared aspiration across the global medical community is the restoration of patients’ health. As a pioneer in advancing therapies for pulmonary hypertension, Pulnovo Medical has innovatively developed pulmonary artery denervation, a technique supported by efficacy and safety data from multiple randomized controlled trials. The opportunity to stand at the forefront of this emerging technological frontier serves not only as a driving force for medical exploration but also as a beacon of hope for patients. This global multicenter clinical trial will implement targeted clinical strategies tailored to the specific epidemiological characteristics of pulmonary hypertension in various countries. We look forward to achieving results promptly, thereby benefiting patients with pulmonary hypertension worldwide at the earliest possible time.”

On-site Report: As a pioneering innovator in China’s high-end medical device sector, Pulnovo Medical has made its official debut on the international stage. The strong endorsement by numerous renowned scholars for the pulmonary hypertension session, “Pulmonary Artery Denervation for Pulmonary Hypertension,” not only highlights Pulnovo Medical’s breakthrough achievements but also represents the continuation of China’s original innovation aspirations.

Pulmonary Artery Denervation for Pulmonary HypertensionSchedule

Cynthia Chen, Executive President of Pulnovo Medical, stated, “For a long time, pulmonary hypertension—a complex and refractory condition characterized by an extremely low cure rate, low public awareness, and high prevalence—has been largely overlooked. As the Transcatheter Cardiovascular Therapeutics (TCT) conference is a highly anticipated global cardiovascular specialty meeting, we hope that our participation will draw greater attention to pulmonary hypertension, enhance understanding of the disease, and facilitate learning about its latest advancements. Furthermore, we aim to showcase the expansion of Chinese original technologies in the field of innovation, as well as the efforts and breakthrough achievements made by Pulnovo Medical in recent years.”

For Pulnovo Medical, thisExclusive Debut at the TCT Conference,is another major milestone. This not onlyRepresentativePulnovo MedicalGo upInternationalThe Platform's Firm Stance, presenting China's innovative achievements to global scholars at the TCT conference; furthermoreRepresentativePulnovo Medical Self-DevelopedofThe innovation and significant medical value of the PADN procedure have been recognized by top global cardiovascular intervention conferences.。

For a long time, Chinese medical devices and pharmaceuticals have been labeled with terms such as “imitation,” “bandwagoning,” and “Me-Too.” Meanwhile, the high-end medical device sectors, including endoscopy and neurointerventional devices, remain monopolized by overseas companies, while domestic manufacturers continue to seek innovation and breakthroughs.

So, how can high-end domestically produced medical devices achieve independent innovation? How can they transition from imitation to original creation? After nearly a decade of exploration, Pulnovo Medical has provided a reference solution template.

Pulnovo Medical focuses on pulmonary hypertension, a clinical pain point that remains unresolved, and actively explores solutions.Pulmonary hypertension is a clinical and pathophysiological syndrome characterized by elevated pulmonary arterial pressure, with a significant likelihood of progressing to right heart failure and even death. As a condition with extremely high morbidity and mortality rates, often referred to as “the cancer of cardiovascular diseases,” pulmonary hypertension affects nearly 100 million patients worldwide. Today, it remains one of the lesser-known malignant diseases.

Currently, the treatment of pulmonary hypertension remains in an exploratory phase. Common therapeutic approaches include lung transplantation and pharmacological therapy. However, donor organs for lung transplantation are extremely scarce, and postoperative patients frequently experience complications such as infections and graft rejection. Furthermore, lung transplantation is a highly complex surgical procedure that necessitates long-term use of immunosuppressive medications. In addition, the high cost of lung transplantation places it beyond the financial reach of the vast majority of patients.

As for pharmacological treatment, there are also pain points such as poor therapeutic efficacy and high costs. Published in 2018 inLancet Respiratory MedicineThe article “Pulmonary hypertension: the unaddressed global health burden” shows that the annual cost of monotherapy for patients with pulmonary hypertension is approximately $80,000, an unaffordable expense for the vast majority of patients.

To address the lack of suitable treatment options for pulmonary hypertension, Pulnovo Medical pioneered the application ofPercutaneous Pulmonary Artery Denervation (PADN)Treatment of pulmonary arterial hypertension. According to reports,Percutaneous Pulmonary Artery Denervationis a minimally invasive interventional procedure, whoseBlocking pulmonary vascular intimal sympathetic nerves via radiofrequency ablation to reduce pulmonary arterial pressure,thereby treating pulmonary arterial hypertension orDelay Disease Progression。

To support percutaneous pulmonary artery denervation (PADN), Pulnovo Medical has independently developed high-end minimally invasive interventional devices, including high-frequency ablation systems and intravascular catheters. To date, the technology inventors have traveled to Europe, the United States, and Asia on multiple occasions to provide theoretical instruction and surgical demonstrations for the PADN procedure, offered on-site surgical guidance abroad, and delivered more than 20 invited academic presentations at international conferences.

As can be seen, percutaneous pulmonary artery denervation and its associated high-end devices not only provide a novel therapeutic option for patients with pulmonary hypertension worldwide but are also poised to save more lives thanks to their minimally invasive nature, efficacy, ease of operation, and cost-effectiveness.

Data shows that,Early 2021,Pulnovo Medical’s Self-Developed Radiofrequency Ablation Product Receives U.S. FDA Breakthrough Device Designation in Just 16 Days（FDA Breakthrough Designation）; In addition, Pulnovo Medical’s high-end medical device products completed patient enrollment for China’s registration clinical trials in June 2021.It is foreseeable that Pulnovo Medical’s rapid development capabilities will expedite product approval and market launch, thereby benefiting more patients with pulmonary hypertension.

In terms of product offerings, Pulnovo Medical’s radiofrequency ablation catheters demonstrate a leading edge over those of other companies. As a pioneer in the field, Pulnovo Medical has previously explored all available energy platforms; the energy source currently employed represents an optimized solution that is both stable and well-suited for the PADN procedure. Furthermore, Pulnovo Medical’s self-developed catheter design conforms more closely to the inner wall of the pulmonary artery, thereby enabling higher ablation efficiency, enhanced safety, and a significant reduction in procedural time.

From the perspective of innovation pathways, Pulnovo Medical centers on clinical needs, leads with technological innovation, and collaborates with engineers to deliver integrated solutions, ultimately achieving independent innovation in the field of high-end domestic medical devices.

Pulnovo Medical Limited (Pulnovo Medical) was established in 2013. Leveraging original technologies in the field of pulmonary hypertension, it has built a global platform for innovative medical device development. Its core products under development are all first-of-their-kind internationally. The company has secured more than forty invention patents domestically and abroad, successfully entered the China Food and Drug Administration’s (CFDA) Green Channel for Innovative Medical Devices, and obtained CE quality system certification. In February 2021, Pulnovo Medical’s proprietary radiofrequency ablation catheter received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA). As the first Chinese company in the pulmonary hypertension sector to receive FDA Breakthrough Device designation, Pulnovo Medical has emerged as a dark horse leading the field, creating a global platform for innovative medical device development with world-class proprietary technologies.