World's first implantation of biodegradable left atrial appendage occluder successfully completed

       Reference source: Home of Medical Devices, the WeChat Official Account.

The Hefei High-tech Cardiovascular Hospital recently successfully perfomed  world’s first implantation of the Bio-Lefort® Biodegradable Left Atrial Appendage Occluder (LAAO), which is independently developed and manufactured in China This groundbreaking procedure introduced a one-stop surgery that integrated catheter ablation with the closure of the left atrial appendage.

       The procedure utilized the Bio-Lefort® Biodegradable Left Atrial Appendage Occluder, which was independently developed by Lepu ScienTech TM. (ScienTech Medical). This surgical milestone also marked the official commencement of its clinical trial, ushering in a new era in the advancement of left atrial appendage closure interventional devices on a global scale. Furthermore, although it is a recent addition to the stock market, ScienTech Medical (stock code: 02291), witnessed a remarkable surge, which had been risen by approximately 7% in the afternoon of February 23rd, and reached an new high on the stock market--HKD 31.85. However, as of this afternoon, the stock was down 3% with each share now valued at HKD 30.6. The company made its stock launched on the main board in November 2022, with an issue price of HKD 29.15 per share.

The world's first implantation of the Bio-Lefort Biodegradable Left Atrial Appendage Occluder has been successfully completed

         This groundbreaking surgical achievement was conducted at the Hefei High-tech Cardiovascular Hospital and involved a collaborative effort of multiple experts from various medical institutions in China. It included the expertise of Professor Qin Yongwen and Professor Bai Yuan from the First Affiliated Hospital of Naval Medical University, Professor Cao Kejiang and Professor Ju Weizhu from Jiangsu Provincial People's Hospital, and Professor Duan Wei from Hefei High-tech Cardiovascular Hospital.

         With the research support of Professor Wang Yunbing, the Director of the National Biomedical Materials Engineering Technology Research Center at Sichuan University, Professor Yang Li and his research team from ScienTech Medical, a "one-stop" surgical procedure that combines catheter ablation and left atrial appendage closure (LAAC) was successfully performed on a patient with a history of high risks for stroke and bleeding due to atrial fibrillation (AF). This patient is the first subject enrolled into the clinical trial for the Bio-LefortTM Biodegradable Left Atrial Appendage Occluder.

        Herebefore, it is common knowledge that the material of currently available left atrial appendage occluders used in clinical practice are primarily nickel-titanium alloy frames,which may led to some complications because of metal residues in the human body, such as nickel allergies and potential damage to nearby structures. Therefore, a comprehensive “one-stop” procedure which combines catheter ablation and LAAC was introduced as a solution. The Bio-Lefort® Biodegradable Left Atrial Appendage Occluder, which is independently developed and manufactured by ScienTech Medical, a Chinese company, was used for this procedure. The decision to use this device was based on clinical evaluation results and the informed consent of the patients and their family members. The material of this device is biodegradable and is still under improvement. 

       The Bio-Lefort occluder incorporates a unique hemispherical inner plug design, which enable it to effectively block and cover the left atrial appendage This innovative design facilitates cell deposition and accelerates endothelialization so that it can provide a secure closure for the left atrial appendage like a “safety helmet.” By using medical-grade polymer materials, this device can bear the gradual degradation process after effective closure, and ultimately be absorbed by human body. This feature mitigates the risk of long-term complications like tissue wear and blood clots and ensures enduring benefits for the patients.

        Before clinical applications, the animal experiments of Bio-LefortTM implantation were performed on various animals including dogs and pigs. Subsequent evaluations revealed that the occluder remained stable, while newly formed tissue exhibited excellent compatibility with the left atrial structure. These findings offered compelling evidence for the feasibility and safety of this occluder used for LAAC procedures.

Admission and surgical condition

    The patient who accepted this surgical procedure was a 51-year-old male admitted to the hospital due to a 7- to 8-year history of recurring palpitations. His medical history revealed two episodes of cerebral infarction within the last 4 years. Upon admission, the patient displayed residual motor deficits in the right limb. The hospital suspected that these deficiencies may have been caused by thromboembolic events associated with AF.

    The preoperative examination revealed the following: Dynamic electrocardiogram (ECG) indicated irregular heart rhythm with AF; cardiac echocardiography (echo) revealed an enlargement of both left and right atria and reduced left ventricular systolic function; the CHA₂DS₂-VASc score of the patient for stroke risk in atrial fibrillation was 4 points; the HAS-BLED score for bleeding risk was 4 points. These findings indicated that the patient was at a high risk for both thromboembolic events and bleeding complications.

      Additional examinations that involved a combined transesophageal echocardiography (TEE) and computed tomography (CT) reconstruction, which revealed no apparent thrombus formation in the left atrium and left atrial appendage. However, it was observed that the left atrial appendage was slightly enlarged.

Preoperative angiography

     Intraoperative findings: Following the completion of RF ablation, the left atrial appendage occlusion was performed. The tug test during the procedure showed that the occluder was securely positioned and met the release criteria. The entire occluder release process was executed seamlessly.

      Postoperative findings: Postoperative imaging revealed no residual shunting. A subsequent ultrasound confirmed the favorable placement of the occluder and highly satisfactory occlusion results, which means the successful completion of the surgery.

Postoperative angiography

        Following the surgery, Professor Qin Yongwen stated, "The successful completion of this groundbreaking first case marks the official commencement of pre-market clinical trials for Bio-Lefort. It is a small step for Bio-Lefort but a significant stride for the future development of medical devices used for left atrial appendage occlusion It is another milestone in this field.”

Abundant product line—multiple products approved and in development

      Except the Bio-Lefort Biodegradable Left Atrial Appendage Occluder, ScienTech Medical's diverse product line contains the congenital occluder series for treating congenital heart disease, left atrial appendage occluder and patent foramen ovale occluder series for the prevention and treatment of cardioembolic stroke, as well as the bio-interventional valve series for the treatment of valve stenosis and insufficiency. This diverse range of products offers comprehensive solutions for interventions in structural heart disease.

Treatment solutions for congenital heart disease

      ScienTech Medical has developed an extensive portfolio of occluder products designed for congenital heart diseases, with a focus on conditions such as atrial septal defect (ASD), ventricular septal defect (VSD), and patent ductus arteriosus (PDA). The company has successfully acquired 13 Class III medical device registration certificates approved by National Medical Products Administration (NMPA) .

      Above figure displays the product structure of the solutions for treating congenital heart diseases, as well as products currently in the development phase.

Prevention solutions for cardioembolic stroke

      ScienTech Medical introduced its first-generation left atrial appendage occluder to the market in June 2020, and the first-generation patent foramen ovale occluder was  available in August 2012. The first-generation left atrial appendage occluder has Class III medical device registration certificate approved by NMPA, and the first-generation patent foramen ovale occluder also has valid CE marking.

Patent foramen ovale occluder 

Left atrial appendage occluder system

Treatment solutions for valvular heart disease

      Valvular heart disease is typically the result of narrowing or defects in one of the four heart valves (the aortic valve, pulmonary valve, mitral valve, and tricuspid valve). These conditions can lead to various heart-related issues.

      ScienTech Medical is actively involved in the development of heart valve products, and currently has one type of heart valve product which is still on review stage with the NMPA. Furthermore, an additional type is on pre-registration stage with the NMPA, four types are on clinical trials stage, six types are on the type inspection stage, and nine types are on the design stage.

  Above figure shows the product structure of the transcatheter implantable aortic valve system, which is a product currently under development.

    TMVCRS, TMVr-A systems, and TMVr-F system are all medical devices designed to treat mitral valve diseases and restore the normal functioning of the mitral valve.

  Above figure shows the product structures of TMVCRS, TMVr-A systems, and TMVr-F system, all of which are currently under development.

ScienTech Medical: Focused on structural heart disease medical intervention devices

      Lepu ScienTech Medical Technology (Shanghai) Co., Ltd., is dedicated to providing safe, effective, and innovative medical solutions. We are a leading player in the structural heart disease interventional medical device industry in China and one of the largest domestic suppliers of congenital heart disease occluders.

        ScienTech Medical’s primary focus revolves around R&D, manufacturing, and marketing of medical intervention devices for structural heart disease. Currently, we have a comprehensive product portfolio comprising a total of 50 different products either already launched in the market or on various stages of development. This includes 20 occluder products that are already available, 9 occluder products that are in the process of development, and 21 major cardiac valve products also under development.

     Our products have been successfully exported to 44 countries and regions around Asia, Europe, the Americas, and Africa. They are currently being utilized in over 800 medical institutions worldwide. Our commitment lies in fostering new beginnings through the provision of compassionate heart care.

    Thanks to our consistent investments in research and development, along with the continual exploration of new products and technologies, we possess robust R&D capabilities. We have acquired several innovative products with independent intellectual property rights, and have assumed a pioneering role in advancing biodegradable technology research. This dedication has translated into tangible benefits for a larger number of patients with structural heart disease, and has contributed to the larger cause of improving human health.

New innovative products are leading the way in technology

      In 2009, the "Development and Clinical Application of Occluder Series and Related Devices for Defective Congenital Heart Disease Intervention" project obtained the National Science and Technology Progress Award (Second Prize). As of October 18, 2022, the company held 232 registered intellectual property rights.

       In November 2022, the company was listed on the Hong Kong Stock Exchange's main board with an issue price of HKD 29.15 per share. Following the first clinical application of the Bio-Lefort Biodegradable Left Atrial Appendage Occluder, the company's stock saw significant movement. On February 23, 2023, the stock price surged by approximately 7% in the afternoon, reaching a historical high of HKD 31.85. However, as of this afternoon, it has receded to HKD 30.6 per share, with a high of HKD 33.2 and a low of HKD 28.6, resulting in a total market capitalization of HKD 10.61 billion.
According to the company's previous prospectus, its revenue for the years 2019, 2020, and 2021 stood at CNY 116 million, CNY 148 million, and CNY 223 million, respectively. During the same period gross profit was CNY 103 million, CNY 133 million, and CNY 198 million, with corresponding gross profit margins of 88.3%, 89.8%, and 88.8%, respectively.

    In the years 2018, 2019, and 2020 the company reported net profits of CNY 38.61 million, CNY 51.91 million, and CNY 68.77 million, respectively. The corresponding net profit margins for these years were 39%, 44.6%, and 46.4%, respectively.

     Notably, in the first half of 2022, ScienTech Medical reported revenue of CNY 125 million, which marked an increase compared to the CNY 110 million during the same period in the previous year. However, operating profit was CNY 34.36 million, down from CNY 45.66 million during the same period in the previous year. The operating profit margin decreased to 27.5% from 41.1%. The net profit was CNY 24.26 million, down from CNY 41.77 million during the same period in the previous year. This resulted in a lower net profit margin of 19.4%, as compared to the previous year's margin of 37.6% .

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      With its growing revenue, ScienTech Medical has increased its investment in research and development and has been consistently developing new products and technologies. This commitment to R&D has led to the development and successful clinical application of the Bio-Lefort Biodegradable Left Atrial Appendage Occluder. The journey from initial implantation tests in numerous experimental animals to the first clinical application has been a successful one, culminating in a highly effective clinical procedure.