Pulnovo Medical Closes New Tens-of-Millions USD Funding Round to Accelerate Global Expansion

Recently, Pulnovo Medical announced the completion of a new round of financing worth tens of millions of dollars. This round was led by YuanSheng Ventures, with participation from OrbiMed, Qianji Capital, Lilly Asia Ventures (LAV), Gaorong Ventures, Huihe Capital, and GC&H Investments. All existing shareholders oversubscribed. The funds will be used primarily for continued R&D investment, clinical trials, product registration, and commercialization efforts — including building out teams at home and abroad — with a portion allocated to expanding the company's operational and manufacturing capabilities. Gaorong Ventures first invested in Pulnovo Medical in 2021 and added to its position in this round.

In 2022, Pulnovo Medical achieved multiple milestone accomplishments, strategically advancing across global markets including China, the US, and Europe — momentum that helped make this successful financing possible.

A Homegrown Chinese Medical Device

PADN Takes the Global Stage

Founded in 2013, Pulnovo Medical spent nearly a decade building its foundation before bringing PADN (Pulmonary Artery Denervation), its original innovation, to the international stage.

Pulnovo chose pulmonary hypertension as its first area of unmet clinical need because the condition has high mortality yet is frequently overlooked in clinical diagnosis, with treatment outcomes falling short. The pathophysiology involves elevated pulmonary artery pressure and increased pulmonary vascular resistance, typically leading to right heart failure and death. Globally, an estimated 40 million people suffer from pulmonary hypertension, and most cases cannot be cured.

This specialized perspective allowed Pulnovo to identify a gap in pulmonary hypertension treatment. Partnering with cardiothoracic physicians, the company embarked on pioneering exploration in this field, achieving a true zero-to-one breakthrough. Pulnovo's proprietary interventional therapy, PADN, offers patients an entirely new treatment approach. In 2021, the PADN product received FDA Breakthrough Device designation in just 16 days, and by December 2021, all patient follow-ups for the PADN-NMPA registration clinical trial were completed.

Moreover, confident in PADN's competitive potential in global markets, Pulnovo anchored its strategy internationally and made substantial progress in 2022. On the clinical trial front, the company successfully held a Pre-Submission meeting with the US FDA in July regarding PADN's global multi-center clinical trial — marking its formal entry into the FDA PMA (Premarket Approval) process.

In August 2022, PADN was included for the first time in the international 2022 ESC/ERS Guidelines for the Diagnosis and Treatment of Pulmonary Hypertension. In September 2022, Pulnovo was invited to present PADN-NMPA clinical trial data at TCT (Transcatheter Cardiovascular Therapeutics), the world's premier vascular intervention summit, where positive results drew global attention. The PADN global multi-center clinical study is now actively advancing, laying a more robust clinical foundation for leading device therapies and global commercialization in this field.

Clinical Value as the Driving Force

Building an OTM Platform from Operating Table to Market

Precise clinical insights from experts on the front lines, globally competitive original technology development, and efficient clinical trial execution — these underlying capabilities have enabled Pulnovo's rapid growth in its specialized domain. By integrating the full value chain of "physician-engineering-research-production-commercialization," Pulnovo has built an OTM (Operating Table to Market) platform for incubating innovative medical technologies and devices.

On this platform, Pulnovo first successfully incubated the PADN product family. In its long-term strategic planning, the company's pipeline will expand to cover heart failure, hypertension, diabetes, and other chronic diseases and related indications — all areas with enormous unmet clinical needs.

Drawing on its experience globalizing PADN clinically, Pulnovo aims to bring more first-in-class products to physicians and patients, with the goal of becoming a leading medical device company in global cardiopulmonary and chronic disease fields.

Cynthia Chen, Chief Strategy Officer of Pulnovo Medical, stated: "Going forward, Pulnovo will continue to use innovative technology R&D as our engine, persist in scientific exploration and clinical validation of breakthrough therapies, and pursue commercial expansion with broad international vision. We have always been patient-centric, focused on providing clinically valuable breakthrough therapies. In the long term, we will tackle more unmet clinical needs; take industry leadership as our mission; and strive to become a core force in China's innovative medical industry, contributing to the development and transformation of China's health care sector."

Lian Jia, CEO of Pulnovo Medical, said: "The Pre-Submission meeting with the US FDA in July, PADN's first inclusion in international ESC guidelines in August, and the company's first presentation of PADN-NMPA clinical results at the TCT conference in September — these milestones mark the recognition of this Chinese original technology by the global academic and clinical community in pulmonary hypertension treatment. Going forward, we will remain true to our original aspiration. We look forward to the PADN launch next year bringing benefit to more pulmonary hypertension patients. Pulnovo will grow into a company that physicians, patients, and investors can all look forward to, and we hope to achieve even greater development with support from all sides."

Yang Kun, Partner at Gaorong Ventures, commented: "Pulnovo Medical is a globally innovative medical device company that has opened a new treatment pathway for clinicians in the pulmonary hypertension field. At the same time, over the past year, the internationalized management team has successfully navigated numerous challenges including the pandemic, completed China's clinical trials on schedule, and initiated global registration clinical trials in the US. We expect Pulnovo's products to launch soon in the China market, taking an important step toward commercialization. Gaorong has always pursued globally innovative products and excellent operating teams in the healthcare space. We believe Chinese innovation in medical devices is on the rise, and we look forward to continuing our steadfast support for Pulnovo in bringing PADN to global markets."