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    Home > Active Ingredient News > Drugs Articles > A new cycle of medical device uplink

    A new cycle of medical device uplink

    • Last Update: 2022-10-12
    • Source: Internet
    • Author: User
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    The fate of the three musketeers of the science and technology innovation board medical equipment heart pulse medical, huitai medical treatment, and nanwei medicine was once stifling


    Innovation ability, growth logic is firm, the stock price once walked on a new high, but because of the collection of expectations suppressed, turned into a long downward cycle


    At the darkest moment of the global macroeconomy, the medical device industry unexpectedly flashed a dawn


    Bottoming out and reversing, medical devices have entered a new upward cycle, pressure and opportunities coexist, the stock market is still cruel, but enterprises with innovative genes will cross two seas - the sea and the blue ocean, opening up the surging growth space


    The 2.


    01 Out to sea with blue ocean

    01 Out to sea with blue ocean

    The two major pain points of domestic innovative pharmaceutical devices are the payment environment and internal volumeization


    There has been a marginal improvement


    The spiral downward cycle of the medical industry has finally found an equilibrium point, the policy bottom is being constructed, and the internal risks in the industry are far less than the external macro risks


    While retaining reasonable profits and promoting domestic substitution, the collection and procurement is also compressing the scale of the stock market, and those who lie flat will be eliminated, which requires enterprises to take the initiative to go out of the internal volume, and going to the sea and entering the blue ocean are the two major logics


    Going to the sea and entering the blue ocean are the two major logics


    At sea, medicine is not as good as weaponry


    According to the statistics of Southwest Securities, in this year's financial reporting season (July 1 to September 1), there are 6 overseas logic driving the main reasons for the top 10 stocks led by A-share equipment


    With the equalization of the technology gap, the overseas penetration rate of innovative devices has a broad space


    The vast blue ocean market in China is waiting to wake up


    The treatment penetration rate and the domestic substitution rate jump from a very low level, which is the double-click logic


    The treatment penetration rate and the domestic substitution rate jump from a very low level, which is the double-click logic


    02 Innovation Endowment

    Minimally invasive medical treatment is the only innovative medical device platform in China, constantly embracing new technologies and new tracks, and can enter the first camp
    in China in almost all fields of interventional devices.

    Heartpulse Medical also has an innovation endowment, and a total of 7 products have been approved by the State Food and Drug Administration to enter the "Special Review Procedure for Innovative Medical Devices", that is, the well-known Green Pass
    。 Among them, the Castor branched aortic laminated stent and conveyor system is the world's first branched aortic stent approved for listing, which has accumulated more than 12,000 implants after listing, and the sales revenue in the first half of this year was 183 million yuan, an increase of 37.
    82% year-on-year; Minos abdominal aortic laminated stent and conveying system is currently the only product in China with independent intellectual property rights to reduce the outer diameter of the conveying sheath to 14F (<5mm), and the sales revenue in the first half of this year is 0.
    75 billion yuan, an increase of 78.
    95% year-on-year; ReewarmPTX drug balloon expansion catheter, breaking the status quo of imported balloon monopoly, performance is not inferior to imported similar products, in the first half of this year due to the epidemic affected production capacity, sales revenue still reached 31 million yuan, an increase of 41.
    91%
    year-on-year.

    Cardiac pulse medical has achieved the dominant position of domestic aortic intervention, accounting for 32.
    4% of the domestic thoracic aortic surgery volume in 2021, ranking first, and the abdominal aortic intraluminal interventional stent is still dominated by foreign investment, which is also where the incremental space lies
    .
    In 2021, the company accounted for 23.
    1% of the domestic abdominal aortic surgery, and in the future, with the new products have been listed, the market share ratio will continue to expand, and the new generation of Aegis abdominal aortic laminated stent system has passed the PI ethical approval
    .

    Technology iteration, new products are released, and the market potential space
    of the aorta is unsealed.
    HeartPulse Medical's two newly listed Green Pass products are starting to increase volume, and it is expected to repeat the growth curve
    of Castor and Minos in the next few years.
    Talos straight-tube thoracic aortic laminated stent system is the world's first "breathable" laminated stent, the first clinical implantation was completed in July, Fontus branched intraoperative stent system is the world's first approved branched aortic surgery special stent, the first clinical implantation was completed in April and has been clinically applied
    in many hospitals.

    The international journey of innovative devices has just begun
    .

    HeartPulse Medical's existing overseas revenue accounts for about 5%, with a five-year target of 15% and a 10-year target of 30%.

    The latest sign of accelerated internationalization is the optimization and restructuring of existing international business units and the establishment of a North American R&D center, with Zhu Qing, the company's general manager, directly leading overseas markets
    .

    Heartbeat medical products have been sold in 21 countries
    .
    Now it has obtained the CE certificate of 5 products, accounting for 1% of the European market revenue, ranking eighth in the market share, and aiming to become the top three
    in the European market.
    The second generation of Castor and Talos will be clinically
    conducted in Europe.
    Castor and Minos hope to enter the high-end medical device market in the United States and lay out R&D centers and production bases
    .

    Capacity support in overseas markets, as well as marketing networks, clinical teams, and R&D product layouts, require a large amount of capital reserves
    .

    03 Second growth curve

    03 Second growth curve

    Does the market with a large patient base and few people being the bluest still exist?

    HeartPulse Medical's 516 million yuan fixed increase funds are planned to be used for peripheral and oncology product research and development, unlocking two big blue oceans
    .

    The entire peripheral intervention is a blue ocean, of which the peripheral veins are a bluer blue ocean, and the import market accounts for more than 95%.

    There are 11.
    39 million patients with coronary heart disease in China, 13 million stroke patients, 8.
    9 million heart failure patients, and the number of patients with venous disease is several times the sum of the above patients, but the penetration rate of interventional therapy is the lowest
    .
    Nationally, only 0.
    2% of patients with peripheral artery disease receive revascularization, and the overall treatment rate for venous disease is even lower
    .

    Heart Pulse Medical holds 4 heavy vein products, of which Fishhawk mechanical thrombotomy catheter and Vflower venous stenting system have entered the green pass
    .

    Heart Pulse Medical holds 4 heavy vein products, of which Fishhawk mechanical thrombotomy catheter and Vflower venous stenting system have entered the green pass
    .

    Deep vein thrombosis (DVT) is one of the most common peripheral venous diseases, with a domestic incidence of 1.
    5 million in 2019 and expected to increase to 3.
    3 million in
    2030.
    Pulmonary embolism, a complication caused by deep vein thrombosis, is the world's third largest vascular disease alongside ischemic heart disease and stroke, and treatment is still in the early stages
    of development.

    Percutaneous mechanical thrombotomy (PMT) is an important option
    for the treatment of deep vein thrombosis.
    Foreign countries have staged the miracle of the capital market in advance, the global mechanical thrombectomy device leader Penumbra, listed on the New York Stock Exchange in September 2015, the issue price of $30, so far the stock price has risen more than 5 times
    .

    Penumbra dominates the US deep vein thrombotic mechanical suction market, with peripheral product revenue of $408 million in 2021, an increase of 52.
    7% year-on-year, which has become the main driving force for
    performance.
    Launch the next-generation vascular aspiration product Lightning 12, which can be used to treat both deep vein thrombosis and pulmonary embolism
    .

    Domestic mechanical thrombotomy removal equipment, foreign capital (Biddy Medical, Boston Scientific) monopoly degree is extremely high
    .

    Cardiac Medical Fishhawk mechanical thrombotomy catheter successfully carried out pre-marketing clinical trials, does not require external equipment, easy clinical popularization, proximal balloon can temporarily block blood flow, prevent thrombosis drift to the proximal end, while the efficiency of thrombotomy and venous patency after thrombolus removal have been greatly improved, and reduce the risk
    of hematuria, wire rupture, pulmonary embolism complications.

    Vena cava filter is also one of the main interventional procedures for the treatment of deep vein thrombosis, domestic dominant, most products have a payback period of less than 1 month, and can not have both a payback period and a displacement risk
    .
    In practice, the recovery rate of the filter is low, because some patients fail to achieve the therapeutic effect within a short recovery period and do not take it out in time, while the filter stays in the body for a long time and will gradually bond with the blood vessel wall
    .
    Cardiac medical vena cava filter cracks clinical pain points, has a long recovery time window, high efficiency in intercepting thrombosis, barb and anti-puncture design protects venous vessels under the premise of keeping the filter not shifting, avoiding damage
    to surrounding organs.
    The recovery section is easy to capture and recycle, reducing manipulation and complications
    during recycling.

    Iliacular vein compression syndrome (IVCS) is also the most common venous disease, and venous stent involvement has become the mainstay of therapy
    .
    Until the beginning of 2019, there was no special intravenous stent in China, and arterial stents were often used in interventional surgery
    .

    At present, a total of 2 imported iliac vein stents (Cook Medical, Biddy Medical) have been approved in China, and only Tianhong Somerset has been approved
    in April this year.
    The Heart Pulse Medical Vflower Venous Stent System has completed all clinical enrollment, has a precise positioning function, and can control the stent to jump forward or release early, design different segmented mesh and segmented support force, and easy to place in
    the roundabout blood vessels.

    Domestic TIPS (transjugular venous intraportal vena cava stent shunt) laminated stent system, monopolized by overseas medical device giants Gore and Bard, there are few domestic layouts, and the market prospect is broad
    .

    Heart pulse medical key product TIPS laminated stent system, across the venous and tumor intervention field, is a new interventional radiology therapy for the treatment of portal hypertension and upper gastrointestinal bleeding, with small trauma, high success rate, reliable reduction of portal pressure, embolization of varicose esophageal and gastric fundus veins, good hemostasis, less complications, and direct performance benchmarking market benchmarking products
    .

    From 2021 to 2025, the market size of China's oncology interventional devices will grow from 10.
    91 billion yuan to 17.
    57 billion yuan, and the market size is twice
    that of peripheral arterial intervention.
    In the field of oncology intervention, a number of start-up companies have emerged to focus on the development of microsphere products
    .
    Embolized microspheres (especially drug-carrying microspheres) have extremely high technical barriers and are complex products
    supported by synthetic chemistry, biochemistry, microelectronics, pharmacology, and immunology.
    Microspheres are both rigid and elastic, mainly implanted through microcatheters, which will be compressed during injection and rebound quickly when they reach the lesion site, and their synthesis method is the core secret
    of each manufacturer.
    Cardiac Pulse Medical has more mature research and development experience and preparation technology for developing embolic microspheres, and has a relatively professional reserve of technical personnel, and the degradable microspheres developed can be degraded by the human body after completing the embolization task within a certain period of time, reducing the pain
    of patients.

    From 2021 to 2025, the market size of China's oncology interventional devices will grow from 10.
    91 billion yuan to 17.
    57 billion yuan, and the market size is twice
    that of peripheral arterial intervention.

    The new cycle of medical devices, the vitality is endless, and a large number of excellent companies
    will emerge.

    Heartbeat Medical has both offensive and defensive capabilities, with outstanding innovation ability and stable profitability, providing a classic growth template
    .

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