Genetide Medical Files IPO Prospectus: Pioneering China's First Fully Domestic Vascular Debulking One-Stop Solution
Venous Thromboembolism (VTE) is a clinical condition characterized by obstructive venous return impairment due to thrombus formation within the veins. It is the third most common vascular disease, following ischemic heart disease and stroke, and is known as the "silent killer."
According to the latest data from the China VTE Prevention and Control Conference, the number of hospitalized patients with venous thromboembolism (VTE) in China has reached 1.802 million, with a prevalence rate of 127.8 per 100,000 population. In recent years, driven by the accelerating global aging process, the continuous rise in chronic disease incidence, and the rapid iteration of medical technologies, demand in the endovascular interventional therapy market has shown explosive growth. The industry is also accelerating its transition toward precision, intelligence, and minimally invasive approaches.
Against this backdrop, Jiangsu Jintai Medical Device Co., Ltd. (hereinafter referred to as “Jintai Medical”) has deeply focused on the field of interventional devices for peripheral vascular diseases. Leveraging its innovative R&D system and a platform of international expert resources, the company is committed to developing medical devices that meet advanced international standards. Currently, multiple “first-in-China” products from the company have received regulatory approval for market launch, breaking the technological monopoly held by foreign high-end medical device manufacturers and providing domestic patients with higher-quality treatment options.
Dr. Wang Yang, Chairman and Founder of Jintai MedicalHe introduced, “Although Jintai Medical is a startup, we have a mature staffing structure and a rich talent pool. The core members of our team have been deeply engaged in the field of peripheral vascular intervention for many years, accumulating extensive experience and profound technical expertise. In planning our product development roadmap, the core team leveraged keen market insights and comprehensive research findings to conduct an in-depth study of future market size and growth potential. We have decided to prioritize development in the area of venous thrombus debulking, where the penetration rate of domestically produced products is relatively low, and gradually expand towards peripheral arterial lumen debulking, ultimately building a comprehensive and robust product matrix for arteriovenous therapeutic solutions. Furthermore, we possess a professional and mature clinical registration team along with extensive commercialization experience, enabling us to effectively drive clinical project progress and ensure the efficient and stable advancement of company initiatives.”
In March 2025, Jintai Medical achieved another milestone with its independently developed TideFlow Max®Peripheral Venous Thrombus Aspiration Catheter Receives NMPA Approval for Market Launch: TideFlow Max®It is TideFlow.®an innovative upgrade from a completely new perspective, with comprehensive upgrades and redesign of the catheter structure, adopting a single-lumen aspiration design, combined with precise control via a torque-control connector, enabling accurate positioning and thrombus removal; meanwhile, compared to TideFlow launched by Jintai Medical in 2022®，TideFlow Max®Increased catheter shaft diameter and aspiration port diameter (8F), providing a more robust therapeutic option for interventional treatment of venous thrombosis.
“Rheolytic Thrombectomy” is a therapeutic method based on Bernoulli’s principle in fluid dynamics. It generates rheological water flow at high velocity to aspirate intraluminal thrombi into the outer lumen of the catheter, while simultaneously fragmenting the thrombi with powerful jet streams. The resulting thrombus particles are then extracted from the body, achieving complete thrombus clearance. Compared with other negative-pressure thrombectomy methods, rheolytic thrombectomy offers advantages such as shorter procedure time, fewer adverse reactions, protection of the vascular wall from injury, and favorable long-term prognosis.It has been included in multiple domestic and international clinical consensus statements and guidelines, such as the “Expert Consensus on Endovascular Treatment of Acute Deep Vein Thrombosis of the Lower Extremities,” and has become an internationally recognized first-line treatment strategy.
From an industry landscape perspective, Jintai Medical holds the “only domestic” invention patent in the field of rheolytic thrombectomy. Therefore, TideFlow Max®and TideFlow®Both peripheral venous thrombectomy catheters are “China-exclusive” rheolytic thrombectomy devices.
Specifically, these two peripheral venous thrombectomy catheter setsPharmacological Thrombolysis, Mechanical Thrombectomy, and Rheolytic ThrombectomyIntegrating three major functions into a single system, it offers significant advantages including rapid clearance, high safety, and ease of operation. One of its core capabilities is the emission of an ultra-fine water jet with a diameter of only 10 micrometers. These atomized jets diffuse and form a circulating flow within the vascular lumen, continuously flushing thrombi adhered to the vessel wall. Meanwhile, high-velocity water flow inside the catheter fragments the thrombus, achieving efficient thrombolysis and thrombectomy while preserving venous valve function. Testing has demonstrated that thrombus particles fragmented by the high-velocity water flow are smaller than 10 micrometers—less than one-tenth the volume of a red blood cell—thereby completely preventing capillary occlusion by emboli and avoiding the occurrence of Post-Thrombotic Syndrome (PTS).
Furthermore, compared with mechanical thrombectomy techniques such as metal stents, the mist-like water jet exerts minimal stimulation on the vascular wall, effectively avoiding damage to vascular valves caused by mechanical friction or compression, thereby significantly reducing surgical risks. While removing thrombi, these two products maintain intravascular isovolemia through continuous fluid infusion, preventing deformation of the vascular wall, thus comprehensively ensuring the safety and efficacy of the treatment.
More importantly, the organic integration of the three core functions—“pharmacological thrombolysis, mechanical thrombus fragmentation, and rheolytic thrombectomy”—endows these two products with broad applicability, unrestricted by patient age or physical constitution, enabling comprehensive management of both acute and chronic thrombotic conditions in arteries and veins. For instance, in the case of acute thrombosis, TideFlow®and TideFlow Max®Thrombi can be directly removed by activating the aspiration mode; for more refractory subacute and chronic thrombi, thrombolytic agents can be first sprayed in a targeted manner to soften the thrombus, followed by mechanical fragmentation and negative-pressure aspiration to achieve precise and rapid thrombus debulking.
In terms of clinical application, clinical trial results from eight domestic Grade A tertiary hospitals and post-marketing clinical data indicate that,TideFlow®Both the thrombus removal success rate and the recanalization rate reached 100%.. With significant clinical advantages and technological breakthroughs, TideFlow®The thrombectomy aspiration system has also been endorsed by the Chinese Medical Association in the “Chinese Expert Consensus on Standardized Application of Endovascular Debulking for Lower Extremity Arterial Disease (2024 Edition).”The only recommended domestically produced system。
At the end of 2024, TideFlow®Thrombus Aspiration Control System Wins MIIT’s “First Set (Batch)” Major Technological Breakthrough Equipment Award“First-of-its-kind” major technical equipment refers to independently developed equipment that achieves breakthroughs in variety, specifications, and technical parameters while possessing independent intellectual property rights. Such equipment is characterized by leading technological innovation, the ability to drive industrial development, and significant market potential. Therefore, this recognition not only serves as a high affirmation of Jintai Medical’s core competitiveness but also marks the significant contribution of this domestically pioneered product to promoting independent innovation and industrial upgrading in China’s medical device sector.
Since its establishment in 2016, Jintai Medical has actively advanced the research and development of interventional devices for peripheral arterial and venous thrombus debulking, striving to build a diversified product portfolio and provide clinicians with more advanced, accessible, and practical solutions for peripheral vascular debulking.As of April 2025, the company has completed registration and obtained NMPA approval for market launch of eight products, including TideFlow, its flagship peripheral debulking product.®、TideFlow Max®, SmartStream: AI-Powered Negative Pressure Volume Reduction Product®, TideFuse Thrombolysis Catheter®etc.
In addition to the newly approved TideFlow Max®, independently developed by Jintai MedicalTideSpin®Disposable Peripheral Vascular Atherectomy CatheterIt has passed the special review procedure for innovative medical devices of the National Medical Products Administration (NMPA) and is expected to be officially launched in 2025.
Clinically, arterial thrombosis is primarily managed using negative-pressure aspiration thrombectomy. While this approach is adequate for simple lesions, it proves insufficient when dealing with arterial plaques and chronic thrombi. In response, Jintai Medical has innovatively developed TideSpin®Thrombectomy System. With its innovative design, this system offers powerful thrombus fragmentation capabilities, enabling effective treatment of acute, subacute, and chronic thrombi. Meanwhile, the helical main spring of the rotational atherectomy catheter’sSpeeds of up to 60,000–80,000 rpm, while forcefully fragmenting thrombi, the main spring generates an Archimedean screw pump effect that promptly aspirates and further disintegrates the fragmented thrombi, evacuating them into the waste fluid bag to ensure the efficiency and safety of the therapeutic procedure.
Currently, TideSpin®Successfully completed a multicenter randomized controlled clinical trial. Clinical study results showed that TideSpin®The therapeutic efficacy was comparable to that of the control group, and investigators at all centers acknowledged its effectiveness and operational experience.
In addition, Jintai Medical has also developed therapies for the treatment of arterial stenosis caused by peripheral atherosclerosis or calcification.TideCutter®Peripheral Artery Cutting Balloon and TideShield®Distal Protection Umbrella for Peripheral Arteries, forming a “one-stop” domestic solution for peripheral artery interventional procedures.
Human blood vessels are akin to a city’s water supply pipes, delivering blood—the “water of life”—to various tissues and organs. During interventional procedures, if an arterial cutting balloon is used without a distal embolic protection device, dislodged emboli may occlude distal vessels, thereby cutting off blood supply to the affected tissues. TideCutter®Peripheral Artery Cutting BalloonThe cutting balloon is a specialized interventional medical device that improves upon traditional balloons by incorporating micro-blades or cutting elements on its surface. During dilation, these blades incise plaque and other diseased tissues. This mechanism allows for precise, controlled incisions in the plaque, rather than merely compressing it as conventional balloons do. By creating controlled, linear incisions in the vessel wall, the cutting balloon facilitates subsequent vascular dilation or stent implantation. This process is analogous to plowing furrows into hard soil before leveling it, thereby making subsequent work easier and more effective.
Compared with traditional balloon angioplasty, cutting balloons can more precisely treat lesion tissue, achieve more uniform vessel dilation, reduce irregular tearing of the vessel wall, and lower the risk of complications such as vascular dissection. TideShield®A distal embolic protection device for peripheral arteries functions like a precision filter, positioned distal to the diseased vessel segment. It captures dislodged emboli, such as thrombus fragments and atherosclerotic plaque debris. Once captured by the device, these emboli are prevented from traveling further with the bloodstream, thereby avoiding occlusion of smaller distal vascular branches. This effectively reduces the incidence of acute ischemic events caused by embolism, such as cerebral infarction and acute ischemic necrosis of the distal extremities.
Currently, these products have also been submitted for registration approval, with TideCutter expected to®、TideShield®with TideSpin®To be launched within 2025TogetherLaunch simultaneously to the market, enhancing the one-stop solution for arterial products.
Dr. Wang Yang pointed out, “With the gradual implementation of centralized pharmaceutical procurement and the DRG payment system in hospitals across China, clinical demand for arteriovenous therapy solutions continues to grow. Jintai Medical will leverage its diversified product portfolio to expand application scenarios, provide one-stop domestic substitution solutions, and enhance its market competitiveness.”
Currently, the “tariff war” is profoundly impacting global industrial chains and posing severe supply chain challenges to the global medical device market. For China’s medical device industry, this policy has not only inflicted significant shocks but also spurred multiple development opportunities, including the accelerated substitution of domestic products for imports, supply chain restructuring, and breakthroughs in technological innovation.
Against this backdrop, Jintai Medical has achieved full-chain independent control—from R&D and production to quality assurance—leveraging its robust independent innovation capabilities and comprehensive supply chain system.
In terms of innovative R&D, Jintai Medical has implemented a global strategic layout by establishing R&D centers in China and the United States, respectively, and continues to increase its investment in scientific research.To date, it has cumulatively secured over 70 invention patents., and on this basis, has formed a product matrix covering the full spectrum of arterial and venous treatment scenarios.
In terms of manufacturing, Jintai MedicalSuccessfully Overcame Technical Bottlenecks in Multiple Key Processes, Achieving 100% Domestic Substitution of Core Components, thoroughly eliminating dependence on imported components and effectively enhancing the level of independent control and supply security of its products. Meanwhile, the company actively integrates high-quality domestic industrial resources and establishes deep strategic partnerships with leading domestic suppliers, further improving its supply chain system. This effectively mitigates risks such as raw material supply disruptions and severe price fluctuations, thereby providing strong support for the continuous iterative innovation and stable mass production of its products.
In terms of production capacity and supply chain management, Jintai Medical possessesTwo ISO 13485-compliant Class 10,000 GMP cleanrooms and an R&D workshop, employing automated production lines and rigorous quality control processes to ensure product quality. The company also maintains a scientific and rational inventory management system, leveraging advanced information technology to adjust production plans in a timely manner, thereby ensuring stable and sufficient production capacity and on-time order fulfillment.
Looking ahead, Jintai Medical remains committed to its social responsibilities, dedicated to advancing domestic substitution and affordable alternatives to deliver high-quality services to clinicians and patients. In the future, Jintai Medical will continue to be customer-centric, providing stable, efficient, and innovative vascular interventional solutions. The company is eager to collaborate closely with clinical partners to safeguard patient health and contribute to the development of China’s healthcare industry.