‘Chinese medical device companies, represented by Pulnovo Medical, have always pursued medical innovation under the support of policies and capital. They have increasingly improved their technical innovation, strategic planning, and product competitiveness. Navigating the way through a dynamic, ever-changing market, Chinese medical device companies are making their voices heard in the global market.’
Over the past 40 years of reform and opening-up, China has continuously promoted its opening-up policy while practicing innovation, which has created opportunities for outbound investment. After joining the World Trade Organization (WTO), China has accelerated its opening-up process and realized the historical turn from "introducing" to "going out" and from following to leading.
As China's economy enters a new phase of steady growth, overseas markets become more attractive than in the past amid intensifying domestic volatility. In addition, the national government and relevant departments have been issuing a series of favorable policies in the field of international expansion. Besides, the increase in the level of openness towards the outside world has further motivated domestic brands to enter overseas markets. Lastly, the increasing improvement of the digital economy infrastructure including supply chain, mobile social commerce, the Internet and the rise of logistics, payment, SaaS/ERP and other tools have directly reduced the cost and significantly increased the convenience of going abroad.
As we step into this New Year, EqualOcean officially kicks off the project called "Global 100: Go Global and Co-creating the Future", in which our analysts will sit down with frontline industry practitioners and enterprise leaders to hear their opinions about Chinese brands going overseas. We hope to help brands be seen, recognized and valued through our professionalism and credibility.
The following is the fourth piece in this series, conducted by our analyst Mianmian Wang after her talk with Dr.Kenneth Lai, Chairwoman and Chief Strategic Officer of Pulnovo Medical (Chinese: 帕母医疗).
Established in 2013, Pulnovo is a globally recognized device pioneer in treatment for cardiopulmonary disease. Pulnovo innovates by starting the research and development at the operating table by doctor with the goal to market for patient.
Pulnovo's first core product, PADN catheter, a potential global first-in-class device, was recognized as a CFDA innovative medical device in 2018, and designated as a “breakthrough device” by the US FDA in 2021. These recognitions are testaments to our pioneering innovative capabilities also allow for prioritizing in subsequent regulatory submission review.
EqualOcean: Pulnovo Medical’s Pulmonary Arterial Denervation (PADN) series products have successfully obtained many patents and been highly recognized globally. What is the current progress of its clinical trial? When will this product be available to the public? What is the Company’s commercialization plan for PADN and how to tackle any potential operational barriers for the users as it is such high-end technology?
Pulnovo Medical: Clinical Trials Process: For the past 10 years, Pulnovo Medical has been dedicated to the technology exploration and product breakthroughs in the field of pulmonary arterial hypertension (PAH) . We had developed the pioneering PADN (pulmonary artery denervation) based on our registered clinical trials of this proprietary technology. The overactivation of sympathetic nerves is one of the important factor contributing in the progression of PAH. Pulnovo Medical’s PADN effectively uses radiofrequency ablation to block pulmonary intima sympathetic nerves and reduce pulmonary artery pressure to delay disease progression. Currently, PADN-CFDA clinical trial had all been completed. In addition, over the past decade, Pulnovo Medical had collected data from over 400 human clinical trials and officially launched the FDA global PADN multi-center clinical trial in 2022, which was led by Dr. Gregg Stone, internationally renowned cardiovascular expert, along with a panel of European and US cardiovascular or Pulmonary Hypertension experts.
Commercialization: PADN is an interventional vascular ablation therapy. The basic principle is to use radiofrequency ablation to block the pulmonary intima sympathetic nerves and reduce pulmonary artery pressure thereby delaying the progression of the disease. This type of procedure can be easily and learned and performed by physicians familiar with interventional surgeries such as PCI and EP. With the pending approval of the PADN series products and a short learning period for its procedure, a new era in the treatment of pulmonary hypertension (PH) will be more rapidly ushered in. As an innovative technology and products, our commercialisation strategy will focus on resource integration and the influence of top-level academics to radiate nationwide in facilitating the disease education and improve disease knowledge literacy. Pulnovois also committed to benefiting more patients in the field of radiofrequency ablation of pulmonary hypertension by utilising its original innovative technology advantages and developing multiple product pipelines.
EqualOcean: At present, PADN series products are mainly focusing on PAH, classified as the first category of PH. Will you improve or verify the products on other aspects? Will PADN be effective for patients with other types of PH? In addition to the cardiopulmonary field, will the company enter other fields?
Pulnovo Medical: With the upcoming approval of the products to the market, more and more patients will use PADN products. We will optimize the product according to a series of feedback such as performance and quality. At the same time, multi-dimensional validation will be carried out by expanding the product to other indications and launching global multi-centre clinical trials. It is expected that the innovative products will benefit more and more patients and provide better solutions.
Over the past decade, Pulnovo Medical has verified and validated the efficacy of PADN in other categories of PH. The PADN-5 study was a multi-centre, randomised controlled trial of nearly 100 Cpc-PH patients with heart failure. The results showed that pulmonary artery denervation significantly increased patients' walk distance by 6 minutes and significantly improved patients' haemodynamics compared to the sham drug-treated group. This study demonstrated the efficacy of the PADN technique in improving clinical cardiac function in Cpc-PH patients with heart failure. This is the world's first randomised controlled clinical trial to demonstrate the efficacy of pulmonary artery ablation in patients with heart failure. In 2021, our products were finally granted FDA Breakthrough Device Desitination in multiple subtypes of pulmonary hypertension based on our excellent clinical trial data performance in multiple subtypes of pulmonary hypertension. In the future, PADN will be expanded to multiple subtypes of pulmonary hypertension with the publication of clinical trial data from different types of pulmonary hypertension.
With regard to Pulnovo's product pipelines, we have focused on solving the world’s unmet clinical treatment needs since our inception, created the innovation platform of "OTM" (From Operating Table to Market), and relied on the full-value process of "medical industry research and production provider", which has successfully led to the development of several innovative products. tThe cardiopulmonary field is the first field of innovation and exploration of the OTM platform. With the support of PADN technology, we planned to radiate into the multi-dimensional market of cardiopulmonary field and create a full life-cycle innovation pipeline. The full-platform product line of heart failure had been launched, and several series of clinical trials in the field of heart failure have been carried out simultaneously. The principal investigators, led by the leading academics in China, will lead a large number of experts in the field of heart failure to accompany the series of heart failure products. In the future, with the mature experience and full value process of OTM innovation platform, Pulnovo Medical will be committed to providing new solutions for multiple unmet clinical needs.
EqualOcean: What is the strategic significance of overseas market for Pulnovo Medical? What is Pulnovo Medical’s international strategy?
Pulnovo Medical: Strategic significance: As one of the pioneers of innovative medical devices, Pulnovo Medical’s determination to go global has never changed. In the past, the main battleground for China domestic medical device companies was often the Chinese domestic market. As a potential global-first-in-class product, Pulnovo Medical is optimistic about the competitiveness of pulmonary artery denervation (PADN) in the global market. Looking back at the past 30 years of Chinese medical device, from API, generic device, to domestic substitution and independent innovation, Chinese medical device companies, represented by Pulnovo Medical, have always pursued medical innovation under the support of policies and capital. They have increasingly improved their technical innovation, strategic planning, and product competitiveness. Navigating the way through a dynamic, ever-changing market, Chinese medical device companies are making their voices heard in the global market.
Globalization Strategy: Pulnovo have great confidence in the substantial progress of our globalisation strategy. In terms of PADN-related clinical trials, Pulnovo Medical had successfully held several Pre-sub meetings with the US FDA on its global multi-centre clinical trials, making Pulnovo Medical as the first company in China to officially enter the FDA PMA (pre-market approval) process. In addition, the global recognition of PADN products has increased. In August 2022, PADN was included in the European 2022 ESC/ERS Guidelines for the Diagnosis and Treatment of Pulmonary Hypertension for the first time. In the introduction to therapeutic strategies for pulmonary hypertension, PADN is especially presented and analyzed in the Guidelines, which confirms the important academic value and clinical potential of PADN technology in the treatment of pulmonary hypertension. In September of the same year, Pulnovo Medical was invited to participate in the Latest Clinical Scientific Research (LBCS) special session of the American Transcranial Cardiovascular Therapy Conference TCT2022 again and published the clinical trial data of PADN-CFDA for the first time. The positive research results excited patients with pulmonary hypertension around the world. At present, Pulnovo Medical is actively preparing for a global clinical trial of PADN. The trial is expected to officially start in the United States later this year.
EqualOcean: What is the application prospect of radiofrequency ablation (RFA) in China? What are the shortcomings of similar domestic products compared with foreign products? What efforts are needed to enhance the market competitiveness of domestic products?
Pulnovo Medical: Prospect: Radiofrequency ablation technology has many advantages, such as ease of use, short operation time, accurate and controllable ablation, and cost-effectiveness. It can be widely applied in multiple fields including cancer, nodules, denervation, and cardiac electrophysiology.
Shortcomings: Historically, MNCs has dominated the vast majority share of the electrophysiological and the radiofrequency ablation technology market China’s new products and technologies are gradually appearing in the market. The actual realisation of domestic substitution also requires more perfect development in product refinement and technological innovation. Domestic competitiveness: In recent years, under the preferential dividend of national policies, the innovation and application of domestic products have been greatly expanded. To improve the competitive advantage of domestic products, it is necessary to make joint efforts of all sectors, not only in terms of policy, but also in terms of raw materials, clinical application and research and development process. First, in the basic field, it is necessary to ensure the supply of core components and optimise development to avoid the shortage of original production and supply. In the field of research and development, doctors should actively cooperate with the company to provide new solutions for unmet clinical needs from a clinical perspective. From the clinical and market point of view, domestic innovation is encouraged under the support of the product itself and the operation, and the original research improves life.
EqualOcean: What is the future trend and potential of the electrophysiology ablation market？
Pulnovo Medical: Future trend: In recent years, electrophysiological ablation technology has gradually evolved from two-dimensional ablation to three-dimensional ablation, and from DSA imaging to device imaging, so as to continuously reduce the radiation emission during interventional procedure, reduce the need for auxiliary devices during procedure, and reduce the radiation damage to operatorsand the cost of procedure. Meanwhile, companies in the electrophysiology ablation industry with a number of advantages may be exposed to centralised procurement and fierce competition risks in the future. So companies can only achieve sustainable development only by refining their products and technologies that can actually solve unmet clinical needs and benefit patients. Meanwhile, due to the multiple advantages of mature technology such as accessible operation and high economic benefit ratio, it will also face the risk of multi-party competition and government ‘group purchasing’ in the future. Only by concentrating on refining our own technology and products, offering products and technologies that can truly solve the unmet clinical needs, and taking the healthy resilience of patients as our own responsibility, can we sustain long-term development.
Potential: Electrophysiological ablation is a mature technology that has been widely used in various fields, and its application fields and implementation ability are also gradually developing. Due to its stable energy output mechanism and the advantage of spot localization , it can greatly reduce the injured area of patients and reduce the intraoperative pain. Secondly, with the development of technology, electrophysiological ablation will gradually integrate diagnosis and treatment into one. In combination its multiple advantages such as operational simplicity, ablation control accuracy, and substantial disease burden reduction, it will certainly be a great promoter for product innovationand enhance sustainable development.
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