Changde Medical Files for IPO: Building a Comprehensive Portfolio in Peripheral Vascular Intervention
Peripheral vascular disease (PVD) is primarily categorized into peripheral artery disease, peripheral venous disease, and lymphatic vessel disease. In terms of patient population alone, Frost & Sullivan has predicted that the number of patients with peripheral artery disease (PAD) in China will increase from 52 million in 2021 to 62 million in 2030; the number of surgical procedures is also projected to rise from approximately 163,000 in 2021 to about 602,000 in 2030, representing a compound annual growth rate (CAGR) of approximately 15.6%.
Compared with coronary intervention, the peripheral intervention market has a larger patient base and strong growth momentum. Meanwhile, peripheral interventional procedures are diverse, and the variety of dedicated therapeutic devices is richer, resulting in a broad market space. According to IQVIA research data, China’s peripheral intervention market reached RMB 12 billion in 2022 and is expected to continue growing at a compound annual growth rate (CAGR) of 15% over the next five years.
From the perspective of market participants, although multinational corporations possess a robust portfolio in the peripheral intervention sector, Chinese domestic vascular interventional medical device manufacturers have rapidly emerged in recent years, leveraging policy support, a favorable innovation ecosystem, and advantages in capital markets, thereby becoming formidable competitors in the peripheral intervention market.
Shanghai Changde Medical Technology Co., Ltd. (hereinafter referred to as “Changde Medical”) was established in November 2021. The company is committed to efficiently developing a comprehensive suite of solutions in the field of peripheral interventional devices, with sustained focus on therapeutic areas including endovascular treatment of lower extremity arterial stenosis, thrombus management, interventional therapy for venous diseases, and chronic disease management.
As a startup, Changde Medical has initiated the research and development as well as regulatory registration of more than ten projects since its establishment, including balloons, stents, thrombus aspiration devices, and catheters for the treatment of peripheral arterial stenosis and thrombosis, varicose veins and thrombosis, and other peripheral vascular diseases.
As of the first half of 2024, the company has obtained registration certificates for four of its products, and three peripheral interventional products have completed pre-market clinical trials and will submit registration applications to the NMPA in the near future.
Miao Zhenghua, Chairman and General Manager of Changde MedicalHe stated, “The company’s current achievements are primarily attributable to three key advantages. First, although Changde Medical is a startup, its team structure is already mature and well-established. Core team members, including myself, possess profound technical expertise, extensive experience, and keen market insights in the field of vascular intervention.”
“Second, prior to planning our product pipeline, we conducted in-depth research on key factors such as market size, future growth potential, and competitor concentration. Leveraging our profound industry insights, we identified strategic breakthroughs by focusing on the vascular and related fields, which are characterized by low penetration rates yet rapid development. Third, in addition to extensive R&D experience in interventional devices, the Changde team possesses mature expertise in clinical registration and commercialization, enabling us to collaboratively drive projects forward with high efficiency and stability.”
It is reported that Miao Zhenghua, a seasoned industry veteran with over 20 years of experience in the field of vascular intervention, previously served as the president of a publicly listed company specializing in cardiovascular interventions. Before founding Changde Medical, he successfully led this enterprise to become one of the first 25 companies listed on the STAR Market.
Leveraging the founding team’s accumulated experience and industry insights in vascular intervention, Changde Medical has achieved a diversified product portfolio spanning from peripheral arterial to peripheral venous diseases, from disease treatment to chronic disease management, and evolving from “me-too” and “me-better” to “me-only” innovations.
In February 2024, Changde Medical's independently developed Pearl-Flow®Intermittent Pulsed Compression Therapy Device Officially Approved for Market Launch. Autogenous arteriovenous fistulas are regarded as the lifeline for dialysis patients and represent the preferred type of vascular access for those undergoing hemodialysis. In clinical practice, autogenous arteriovenous fistulas typically require a maturation period of 1–3 months post-surgery, with a high rate of maturation failure that can significantly compromise the quality of dialysis treatment. Therefore, an effective method capable of shortening the maturation time of arteriovenous fistulas holds substantial clinical significance for hemodialysis patients.
Pearl-Flow®It is a solution designed to promote the maturation of autogenous arteriovenous fistulas (AVFs). By applying intermittent cuff compression to the patient’s limb, it increases blood flow velocity and volume in the treatment area, thereby facilitating AVF maturation and improving the success rate of fistula creation surgery.
Pearl-Flow®Intermittent Pulse Compression Therapy Device
Pearl-Flow®Its successful approval, on the one hand, provides a more efficient, safe, and comfortable solution to promote arteriovenous fistula (AVF) maturation after surgery in dialysis patients; on the other hand, it highlights Changde Medical’s strategic layout in building comprehensive solutions.
“As centralized procurement of pharmaceuticals and the DRG-based payment system continue to advance in China, it has become increasingly difficult for blockbuster products akin to coronary drug-eluting stents to emerge in the medical device sector. The era when a single product could sustain an entire enterprise has come to an end. Changde Medical aims to achieve profitability rapidly in the future by offering comprehensive product portfolios and leveraging synergies across high-margin and low-margin products to better amortize R&D, production, and sales costs,” introduced Miao Zhenghua.
In the process of accelerating the commercialization of its innovations, Changde Medical has also garnered favor from the capital market, successively completing financing rounds led byLegend Capital, Huajie Gaojing, Lilly Asia Ventures, Morningside Venture CapitalInvestment in the angel round and Series A financing.
Changde Medical has successively completed EF-Yangtze®Drug-Eluting Below-the-Knee Balloon Dilatation Catheter and EF-Don®The pre-market clinical trials for these two new peripheral interventional devices—the drug-coated high-pressure shunting balloon dilation catheter—are expected to be completed, with registration applications to be submitted within the year.
Vascular stenosis is one of the most common complications of vascular access in hemodialysis patients and a major cause of loss of dialysis function in arteriovenous fistulas. Percutaneous transluminal angioplasty (PTA) is currently the preferred treatment for arteriovenous fistula stenosis in hemodialysis patients. As an innovative product in the field of peripheral arterial intervention, drug-coated balloons can effectively reduce the risk of restenosis and improve therapeutic outcomes due to their unique drug-coating design.
At the 2024 New Vascular Conference, which just concluded on June 8, experts discussed Changde Medical’s EF-Yangtze®Sharing of Prospective, Multicenter, Randomized Controlled Trial Results for Below-the-Knee Drug-Coated Balloons. This pre-market clinical trial, led by Principal Investigator Professor Guo Lianrui from Xuanwu Hospital of Capital Medical University, enrolled a total of 221 patients and is currently undergoing the 6-month follow-up phase. Two enrolled cases presented at the meeting demonstrated patent blood flow in the lesion vessels post-procedure, and EF-Yangtze®The drug coating on the surface of the below-the-knee drug-coated balloon is uniform and compact, with no detachment observed, and the delivery system demonstrates good trackability.
EF-Yangtze®Drug-Eluting Below-the-Knee Balloon Angioplasty Catheter
This is because EF-Yangtze®The below-the-knee drug-coated balloon utilizes a carrier-free recrystallization technology. This technology not only enhances the adhesion of sirolimus to the balloon surface, ensuring safety and efficacy, but also enables rapid drug penetration into the intima, media, and adventitia of the vessel wall via uniformly sized needle-like crystals upon balloon expansion. Furthermore, it forms a thin drug layer on the vessel wall surface, facilitating sustained drug retention within the tissue.
From the perspective of differentiated advantages, currently only one paclitaxel-coated drug-eluting balloon for below-the-knee use has been approved in China, while EF-Yangtze®Rapamycin is the drug employed. Compared with paclitaxel, rapamycin has been proven to be a safe and effective cytostatic agent, and its superior anti-restenosis efficacy and safety profile over paclitaxel have been fully validated in coronary drug-eluting stents. However, as a weakly lipophilic drug, rapamycin exhibits short retention time in the bloodstream and limited duration of therapeutic effect. To address this, the R&D team at Changde Medical has focused on integrating the drug with the device to effectively prolong its retention time in tissues.
Meanwhile, Changde Medical is also developing a paclitaxel-coated drug-eluting balloon—EF-Don®Drug-Coated High-Pressure Balloon Dilation Catheter.EF-Don®This prospective, multicenter, randomized controlled trial, co-led by Principal Investigators Professor Shi Yaxue from Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine and Professor Zhao Yu from the First Affiliated Hospital of Chongqing Medical University, aims to evaluate EF-Don®Safety and Efficacy in Treating Stenotic Lesions of Autogenous Arteriovenous Fistula Dialysis Access in Hemodialysis Patients. Currently, EF-Don®Also in clinical follow-up.
EF-Don®Drug-Coated High-Pressure Shunt Balloon Dilatation Catheter
The pathological features of stenotic lesions in arteriovenous fistulas differ from those of atherosclerosis. Dense fibrosis of the venous segment at the stenosis or hyperplastic scar tissue at puncture sites makes some lesions difficult to fully dilate with standard-pressure balloons.EF-Don®It provides an integrated solution combining “high-pressure dilation + drug therapy”: while effectively dilating refractory stenotic lesions through high pressure, paclitaxel coated on the balloon surface acts directly on the vascular wall of the treatment area, thereby significantly reducing the probability of restenosis.
In addition to the two drug-coated balloon products mentioned above, Changde Medical’s independently developed EF-Volga™ Venous Closure System for the treatment of lower extremity varicose veins has currently submitted its registration materials. Miao Zhenghua commented, “At present, no similar venous adhesive products have been approved in the Chinese market. However, the technology aligns with the trend toward minimally invasive varicose vein surgeries and is poised to become one of the mainstream treatment modalities in China in the future.”
EF-Volga™ Venous Closure System
From a market perspective, the peripheral intervention sector is broad and expansive. Products in the field of peripheral arterial intervention continue to evolve and upgrade, ranging from bare-metal stents and plain balloon angioplasty catheters to drug-coated balloons (DCBs), vascular debulking devices, and drug-eluting stents, thereby providing physicians and patients with a wider array of therapeutic options. To further accelerate the development of its product portfolio and offer healthcare institutions more diversified diagnostic and therapeutic products and services, Changde Medical has adopted external collaborations, in addition to independent research and development, to expedite corporate growth.
In 2022, Changde Medical entered into a strategic partnership with Control Medical (USA) to jointly promote the commercialization and clinical application of imported mechanical thrombectomy kits in China. Miao Zhenghua elaborated, “Changde Medical currently offers two thrombectomy-related products: one is the Control™ Thrombectomy System developed in collaboration with Control Medical, and the other is a self-developed negative pressure suction pump and aspiration catheter system. Both products are scheduled to receive regulatory approval for market launch in the second half of 2024.”
Control™ Thrombectomy System
Specifically, the Control™ Thrombectomy System is primarily indicated for thrombus removal in peripheral vessels and coronary arteries. Having received U.S. FDA approval for market release, it has helped thousands of patients safely and effectively remove thrombi from the heart, legs, arms, abdomen, and brain.
The Control™ Thrombectomy System leverages an innovative manually operated thrombus aspiration device to deliver powerful suction, enabling physicians to perform thrombus aspiration more efficiently, controllably, flexibly, and conveniently. Furthermore, the product offers a comprehensive range of specifications and models to meet thrombectomy needs across diverse clinical scenarios.
“Through this international collaboration, the team has gained deeper insights into cutting-edge technologies and products in the industry. On the other hand, Control Medical’s thrombectomy system is a passive device, whereas Changde Medical’s product is an active device. The two differ in indications and target customers, creating strong complementary advantages that help Changde Medical build an integrated minimally invasive treatment solution for vascular diseases,” said Miao Zhenghua.
Upholding an open and collaborative approach, Changde Medical is also actively exploring integrated innovation with upstream and downstream partners in the peripheral vascular interventional device industry chain. It was revealed that the company is currently collaborating with university teams in Shanghai to enhance and achieve breakthroughs in manufacturing processes in specific areas, further optimize product performance, and ensure supply chain stability.
“For the overseas market, we have already initiated CE certification for one of our products. In the future, Changde Medical will adhere to a profit-driven strategy in its global expansion. Through independent research and development and deep collaboration with global partners, we will thoroughly address unmet clinical needs, continuously enhance the accessibility and user-friendliness of our products and services, and provide patients with optimal solutions that maximize the benefit-to-cost ratio,” stated Miao Zhenghua.
Impressively, during the discussion session at the 2024 New Vascular Conference, numerous professors from top-tier tertiary hospitals stated that Chinese domestic device companies are rapidly catching up with international trends in the technologies and concepts of endovascular treatment for lower extremity arterial disease. They found these innovative new devices to be inspiring. Meanwhile, as clinicians, the experts also expressed their expectations for Changde Medical®to bring its products to market as soon as possible, backed by robust clinical data, thereby providing safer and more effective treatment options for clinical practice.