Pulnovo Medical Secures Tens of Millions in New Equity Financing to Accelerate Global Strategy for Breakthrough PADN Therapy

Recently, VCBeat (WeChat ID: vcbeat) learned that Pulnovo Medical has completed a new round of financing amounting to tens of millions of U.S. dollars.

This round of financing was led byYuanSheng Venture CapitalLead Investor,OrbiMed, Qianji Capital, Lilly Asia Ventures (LAV), Gaorong Capital, Huihe Capital, GC&H InvestmentsJoint participation, with all existing shareholders fully oversubscribing.

This year, amid considerable uncertainties in the external environment and a decline in healthcare investment compared to last year, Pulnovo Medical has continued to forge ahead, achieving several milestone accomplishments and strategically advancing in multiple global markets, including China, the United States, and Europe.

Currently, China’s vascular interventional medical device industry is experiencing explosive growth, yet its products are primarily based on incremental innovations through imitation and improvement. As a participant in the exploration of innovative medical technologies, Pulnovo Medical, grounded in a differentiated perspective addressing unmet global clinical needs and leveraging its full-value chain integrating medicine, engineering, research, production, and commerce, is poised to become a leader in the field. Amidst the increasing rationality and normalization of the investment market, Pulnovo Medical continues to secure support from top-tier investment institutions within the industry. This not only demonstrates market recognition of the competitiveness of Pulnovo Medical’s proprietary technology, Pulmonary Artery Denervation (PADN), but also fully validates the market’s optimistic outlook on the prospects of original innovation.

Lian Jia, CEO of Pulnovo Medical, stated: “The proceeds from this financing will be primarily allocated to sustained R&D investment, clinical trials, product registration, and commercialization initiatives, including the establishment of domestic and international teams. A portion of the funds will also be used to expand the company’s operational and production capacity.”

Pulnovo Medical, which has chosen a path of global differentiated innovation, is rooted in China and has made multiple appearances in the global academic market. With rigorous clinical design and high-quality clinical data, it has garnered extensive attention from cardiologists worldwide. How is Pulnovo Medical embarking on its globalization journey? VCBeat (WeChat ID: vcbeat) recently interviewed Pulnovo Medical.

Pulnovo Medical was established in 2013. Over the past nine years, Pulnovo Medical has accumulated substantial expertise and achieved significant breakthroughs, bringing its original product, PADN, to the international stage.

Pulnovo Medical has selected pulmonary hypertension as the first area of unmet clinical need to explore, due to its high mortality rate, frequent oversight in clinical diagnosis, and suboptimal therapeutic outcomes. The pathophysiological characteristics of pulmonary hypertension include elevated pulmonary arterial pressure and increased pulmonary vascular resistance, which typically lead to right heart failure and death. In 2021, patients with pulmonary hypertension accounted for 1% of the global population, and the majority of cases remain incurable.

To address clinical needs, Pulnovo Medical has developed the PADN product series. The principle of PADN technology is based on the abnormal excitation of sympathetic nerves innervating the pulmonary arteries, which causes vasoconstriction; ablation of the proximal pulmonary sympathetic nerves leads to a reduction in pulmonary arterial pressure.

In the early stages of its establishment, Pulnovo Medical’s R&D team conducted extensive safety and efficacy trials to explore optimal product solutions. Taking energy sources as an example, Pulnovo Medical leveraged a combination of medical expertise and engineering to evaluate various viable energy source platforms, ultimately identifying the currently superior energy source. In response to clinical needs, Pulnovo Medical also independently developed a catheter shape that better conforms to the inner wall of the pulmonary artery, significantly reducing surgical time.Through extensive clinical trial validation, Pulnovo Medical has clearly defined ablation targets, established ablation parameters, and clarified the relationship between key parameters and patient prognosis.Mastered various know-how technologies.

Following rigorous preliminary clinical research, the PADN product obtained FDA Breakthrough Device designation in just 16 days in 2021. By December 2021, PADN had completed follow-up for all patients enrolled in its NMPA registration clinical trials.

In addition to developing PADN, a breakthrough therapy, another major highlight of Pulnovo Medical lies in its global strategic expansion.In the past, the primary arena for innovation in China’s medical device industry was often the domestic market. As an original product, PADN is viewed by Pulnovo Medical as highly competitive in the global market. In 2022, Pulnovo Medical achieved multiple substantive milestones in its globalization strategy.

Leveraging its clinical resources accumulated over the years, Pulnovo Medical has established a clear globalization strategy: to gradually build an evidence-based system through global clinical development and gain recognition from experts worldwide.

In terms of PADN clinical trials, Pulnovo Medical successfully held a Pre-Sub meeting with the U.S. FDA in July this year regarding the global multicenter clinical trial for PADN, marking the company’s formal entry into the FDA PMA (Premarket Approval) process.

Meanwhile, global recognition of Pulnovo Medical’s PADN product has also increased. 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.” The Guidelines specifically added an introduction and analysis of PADN in the section on treatment strategies for pulmonary arterial hypertension, affirming the significant academic value and clinical potential that PADN technology has already demonstrated in the field of pulmonary arterial hypertension treatment.

In September 2022, Pulnovo Medical was invited to present the clinical trial data of PADN-NMPA at TCT (Transcatheter Cardiovascular Therapeutics), the premier global summit on vascular intervention. The clinical results demonstrated that PADN improved exercise tolerance, hemodynamics, and clinical outcomes in patients with Group 1 pulmonary hypertension during the 6-month follow-up period.

Pulnovo Medical’s ability to rapidly advance in the global market is driven by its years of academic accumulation, clinical resource integration, industrial foresight, and commercial insight.

Lian Jia also highlighted that the rapid development was inseparable from team support: “The past period represented a critical juncture for Pulnovo Medical’s financing, as well as a key milestone for advancing various R&D projects and completing the closure of clinical centers. Despite numerous difficulties and challenges, Pulnovo employees worked together with extraordinary unity and resilience during this time. Some employees even stayed away from home for 60 days to ensure the smooth closure of clinical centers. Undaunted by hardships and committed to excellence, we have consistently strived to accelerate the market launch of our products.”

Currently, China’s cardiovascular industry has reached an inflection point in its development, moving in new directions compared to the past two decades.

Pulnovo Medical stated, “There have been two significant changes in the cardiovascular industry over the past decade. The first is a marked increase in market size.”The incidence of cardiovascular disease in China continues to rise, with a significant trend toward younger onset. It has now become one of the major diseases threatening public health, indicating substantial room for market expansion in vascular intervention. Taking percutaneous coronary intervention (PCI) procedures as an example, the number of PCI cases in China exceeded one million in 2021. However, compared with developed countries and regions, China still lags behind in terms of PCI procedures per capita, leaving a potential growth space of three to four times.

The second most significant change is the substitution with domestically developed original products., over the past two decades, international MNC medical device companies have played a leading role in China's cardiovascular intervention industry, with mature capabilities in both R&D and market promotion. However, in recent years, import substitution has become a widespread trend, and the rise of indigenous Chinese technologies will be the mainstream in the future.”

As China’s medical device industry enters a phase of strategic restructuring, industry resources are increasingly converging toward source innovation. Pulnovo Medical stands out with its global innovation capabilities, efficient clinical advancement, and forward-looking commercialization strategy.

Pulnovo Medical’s primary scarcity lies in its highly differentiated R&D technology platform and its capability for source innovation.Pulnovo Medical’s R&D model has always been driven by the perspective of frontline clinicians, focusing on selecting indications with unmet medical needs.

From a clinical perspective, Pulnovo Medical’s other pipeline initiatives also target significant unmet clinical needs. Taking the company’s focus on chronic diseases as an example, chronic conditions account for more than 70% of the total disease burden, representing a major constraint on public health. Furthermore, patients with chronic diseases require long-term or even lifelong follow-up visits and medication, imposing substantial psychological and financial burdens. Similar to pulmonary arterial hypertension, the field of chronic disease management urgently requires more efficient and precise technologies to address the current challenges of low patient adherence and heavy economic burden.

In addition to its deep commitment to innovative therapies, another key reason Pulnovo Medical has garnered favor from investment institutions lies in its understanding and practice of commercialization.

Commercialization capability is not merely reflected at the marketing and sales levels; in fact, it permeates every stage of the early value chain, from R&D to manufacturing and supply chain management.

As a globally first-of-its-kind product, Pulnovo Medical initiated commercialization research during the product development phase. A team with international perspective and localized experience participated in clinical development, market access, and commercialization, leading global commercial expansion.

Overall, in terms of pipeline progress, Pulnovo Medical has completed domestic clinical trials for its core products and is advancing global clinical trials, bringing the core products one step closer to commercial launch. In terms of team building, Pulnovo Medical has attracted numerous industry elites to join. Regarding intellectual property (IP), Pulnovo Medical has established a global layout, comprehensively protecting original IP by applying for and maintaining invention patents, methodological patents, and use-protection patents for its self-developed products. In terms of manufacturing capabilities, Pulnovo Medical currently operates an 800-square-meter production workshop at its Xishan factory in Wuxi. Meanwhile, its newly built R&D and production base in Huishan, Wuxi, covering over 4,000 square meters, will officially commence operations this November.

Precise insights from experts and scholars at the clinical frontline, original technology development with global competitiveness, and efficient execution of clinical trials—these foundational capabilities have enabled Pulnovo Medical to achieve rapid growth in its specialized field. Leveraging the comprehensive integration of the full value chain encompassing “medicine, engineering, research, production, and commerce,” Pulnovo Medical has established the OTM (Operating Table to Market) platform to incubate innovative medical technologies and device products.

On this platform, Pulnovo Medical has successfully incubated its PADN product series. In its long-term strategic planning, Pulnovo Medical’s pipeline will also cover heart failure, as well as a range of chronic diseases and related indications such as hypertension and diabetes. These disease areas currently present significant unmet clinical needs.

Drawing on the experience of promoting PADN globally, Pulnovo Medical is expected to bring more first-in-class products to physicians and patients, establishing itself as a leading medical device company in the fields of cardiovascular, pulmonary, and chronic diseases worldwide.

Pulnovo Medical’s rapid growth has also been driven by the sustained and robust support from investors at top-tier professional institutions.

Cynthia Chen, Chief Strategy Officer at Pulnovo Medical, who oversees the company’s capital markets operations and business development strategy, stated:“Amidst the capital winter, we are deeply honored by the steadfast support from both new and existing investors, which compels us to remain diligent and uncomplacent. The report delivered at the 20th National Congress of the Communist Party of China emphasized advancing the Healthy China initiative, prioritizing public health as a strategic development focus, and recognizing progress in the biopharmaceutical industry as a hallmark achievement in China’s emergence as an ‘innovative nation.’ Driven by national innovation leadership and policy support, Pulnovo Medical has entered a phase of rapid growth fueled by its original R&D capabilities, garnering endorsement and favor from leading domestic and international investment institutions, including OrbiMed Asia Partners, Qianji Capital, Lilly Asia Ventures, Gaorong Capital, and Huihe Capital. Looking ahead, Pulnovo Medical will continue to leverage innovative technology R&D as its engine, persisting in scientific exploration and clinical validation of breakthrough therapies, while pursuing commercial expansion with a broad global perspective. Guided by our patient-centric philosophy, we remain dedicated to providing patients with breakthrough therapies that deliver genuine clinical value. In the long term, we aim to address more unmet clinical needs, taking it as our responsibility to lead industry development and striving to become a core force in China’s innovative medical industry, actively contributing to the advancement and transformation of the nation’s healthcare sector.”

Pulnovo Medical CEO Lian Jia stated:“As a company truly driven by innovative technology, we are honored to have received support from multiple investment institutions in this financing round. Although the pandemic and the complex domestic and international policy environment posed significant challenges to the industry this year, Pulnovo Medical achieved remarkable results. In July, we held a pre-submission meeting with the U.S. FDA regarding the global multicenter clinical trial of PADN; in August, PADN was included in the international ESC guidelines for the first time; and in September, the company presented the PADN-NMPA clinical results at the TCT conference for the first time. These milestones signify that this original Chinese technology has gained recognition from the global academic and clinical communities specializing in pulmonary hypertension treatment. Moving forward, we will remain true to our original aspiration and look forward to bringing benefit to more patients with pulmonary hypertension following the market launch of PADN next year. Pulnovo is committed to growing into a reputable company worthy of trust from physicians, patients, and investors alike, and we anticipate achieving even greater development with the continued support of all stakeholders.”

Guo Leimin, Partner at Yuansheng Venture Capital, stated“Pulmonary arterial hypertension (PAH) is referred to as the ‘cancer of the cardiopulmonary vascular system’ and represents a global medical challenge, with significant unmet clinical needs. As one of the few domestic companies possessing global innovation capabilities, Pulnovo Medical has not followed the conventional path of developing ‘me-better’ incremental improvements. Instead, it has chosen a more arduous route: pioneering original products from scratch, driven by clinical needs. It is their decade-long perseverance and robust clinical research that have recently earned positive recognition in the 2022 ESC Guidelines and coverage by mainstream international medical media at the TCT conference. Yuansheng Venture Capital is committed to supporting Chinese local enterprises with global innovation capabilities. We look forward to the imminent domestic launch of Pulnovo Medical’s PADN, bringing hope to PAH patients in China, while also supporting the company in accelerating large-scale clinical trials in the United States to benefit PAH patients worldwide.”

Dr. Wang Guowei, Partner at OrbiMed, stated:“Since its first round of financing, Pulnovo Medical has achieved rapid business progress. The company’s management team has demonstrated exceptional efficiency in building its team and advancing clinical trials. The outstanding clinical results of the company’s first product have attracted significant attention from international pulmonary hypertension experts, and the product has now successfully entered the regulatory approval stage for market launch. We look forward to Pulnovo Medical’s continued dedication to pulmonary hypertension and related fields, leveraging its robust product pipeline and superior clinical outcomes to benefit more patients worldwide.”

Zhang Min, Managing Director at Qianji Capital, stated:“Qianji Capital is committed to identifying and investing in leading companies across various sub-sectors of the healthcare industry, providing long-term support for their growth. Since completing its investment in Pulnovo Medical last year, we have observed that Pulnovo has rapidly assembled a team with a global perspective and extensive experience in executive leadership at multinational medical device companies. The company has steadily and on schedule completed the registration clinical trials and regulatory submissions required by the National Medical Products Administration (NMPA). As one of the few Chinese companies to receive the U.S. Breakthrough Device Designation, Pulnovo has efficiently advanced the initiation of global multicenter clinical trial applications, backed by robust clinical data and academic achievements. By inviting Professor Dr. Gregg W. Stone, former Chairman of TCT, to serve as an expert on Pulnovo’s Scientific Advisory Board, the company has demonstrated its innovation and leadership in the field of pulmonary arterial hypertension. We look forward to seeing Pulnovo’s PADN product expand from the Chinese market to the global stage at an early date, thereby benefiting more patients with pulmonary arterial hypertension.”

Lilly Asia Ventures stated:“Congratulations to the company on completing its latest round of financing! Lilly Asia Ventures participated in the company’s initial funding round. Since then, the company has made remarkable progress in clinical research, team expansion, and new pipeline development. We are delighted to continue our support in this round and remain optimistic about the prospects of its original, clinical-value-driven technologies and the company’s future growth.”

Yang Kun, Healthcare Partner at Gaorong Capital, stated:"Congratulations to Pulnovo Medical on successfully closing a new round of financing amidst the current chill in the healthcare investment and financing market. Pulnovo Medical is a globally innovative medical device company that has opened up a new therapeutic pathway for clinicians in the field of pulmonary hypertension! Over the past year, its international management team has successfully navigated numerous challenges, including those posed by the pandemic, completed clinical trials in China as scheduled, and initiated global registration clinical trials in the United States. We look forward to the imminent launch of Pulnovo’s products in the Chinese market, marking a significant step toward commercialization. GaoRong Capital has always pursued globally innovative products and outstanding operational teams in the healthcare sector. We believe that innovation in China’s medical device industry is on the rise, and we therefore continue to firmly support Pulnovo, striving to facilitate the early global market deployment of PADN."

Zhou Yi, General Manager of Huihe Capital, stated: “Pulmonary arterial hypertension (PAH) is a progressive and life-threatening vascular disease. Traditional pharmacotherapies and multi-targeted combination therapies struggle to reverse disease progression, resulting in poor long-term quality of life and high mortality rates among patients. Pulnovo Medical has achieved numerous innovations in the anatomical localization of pulmonary artery sympathetic nerves, the design of its Pulmonary Artery Denervation (PADN) device, and the micro-mechanisms underlying the pathogenesis and treatment of PAH. Supported by robust and positive clinical trial results, these advancements hold great promise for delivering significant benefits to patients with PAH. The core team at Pulnovo Medical demonstrates profound industry insight, strong execution capabilities, and an unwavering commitment to independent research and development as well as technological innovation. We look forward to Pulnovo Medical’s continued product refinement and clinical expansion, anticipating greater achievements in the future that will benefit PAH patients worldwide at an earlier stage.

The exclusive financial advisor for this round of financing, the Healthcare and Life Sciences Group, stated:“We are honored to have assisted Pulnovo Medical in completing this round of financing. Innovation in medical devices must be rooted in clinical practice, with operator needs and patient outcomes playing a central role. Pulnovo’s product pipeline, from early-stage development to process design, is driven by clinical value, setting it apart in a highly competitive industry. We look forward to this financing round empowering the company to navigate challenges with confidence and bring more products of genuine clinical benefit to patients worldwide.”