On September 10, 2023, Lepu Medical (300003.SZ) announced the approval of its bioresorbable PFO occluder by NMPA.
Lepu Medical Technology (Beijing) Co., LTD. ("Lepu Medical" or "the Company") learned today that the MemoSorb® Bioabsorbable PFO Occluder, independently developed by its subsidiary Shanghai Shape Memory Alloy Co., Ltd., has officially received registration approval from the National Medical Products Administration (NMPA). The medical device registration certificate number is: NMPA Approval 20233131307.
The foramen ovale is a structure between the left and right atria of the heart. During fetal development, the foramen ovale remains open to allow blood flow between the left and right atria. After birth, with the establishment of pulmonary circulation, the secondary septum and primary septum of the atrial septum adhere and fuse to form a permanent atrial septum. If they fail to fuse, a patent foramen ovale (PFO) forms. Studies have found that the incidence of PFO is 30% in individuals aged 1-29 years, 25% in those aged 30-79 years, and 20.2% in those over 80 years old. It is generally believed that the incidence of PFO in adults is about 25%. PFO usually has no symptoms, but severe cases may present with various clinical manifestations, most commonly cryptogenic stroke and migraine. According to the "Chinese Expert Recommendations on the Management Strategy of Patent Foramen Ovale" and the "Chinese Expert Consensus on Preventive Closure of Patent Foramen Ovale".
"Understanding", "Chinese Expert Guidelines for the Prevention of Stroke Related to Patent Foramen Ovale", and studies at home and abroad show that PFO is not
One of the main pathogenic factors of cryptogenic stroke, and closely related to migraine, peripheral arterial embolism, decompression sickness, etc. In the etiology of embolic stroke of undetermined source (ESUS), PFO accounts for about 40%.
PFO Occlusion Can Effectively Prevent Related Strokes and Alleviate Symptoms of Related Diseases. However, Traditional Metal PFO Occluders Will Remain in the Patient’s Body for Life After Implantation, Which May Block Future Intervention Pathways to the Left Heart System and Could Also Cause Complications Such as Nickel Ion Release, Endocardial Tissue Erosion, Thrombosis, and Atrial Arrhythmias. The MemoSorb® Bioresorbable PFO Occluder, Independently Developed by the Company, Is Made from Biomedical Polymer Materials. After Implantation in the Human Body, It Acts as a Temporary Bridge, Guiding Autologous Tissue Regeneration and Then Gradually Degrading into Carbon Dioxide and Water, Which Are Excreted from the Body. While Successfully Closing the Foramen Ovale, It Achieves "Implantation Without Residue," Avoiding Potential Complication Risks Associated with Permanent Metal Occluders, Effectively Reducing the Incidence of Cardioembolic Stroke, and Alleviating Symptoms Such as Migraines and Dizziness. It Also Leaves a Safe Pathway for Future Interventions Like Atrial Septal Puncture, Bringing Long-Term Health Benefits and Improved Quality of Life to Patients.
In recent years, with the support of evidence-based medicine, PFO closure has developed rapidly. Its technique is one of the more mature areas in the field of interventional treatment for structural heart disease, and its operation and management have been standardized. In recent years, the number of PFO interventional treatments in China has grown rapidly. According to the "Annual Report on Interventional Treatment of Patent Foramen Ovale 2022," the number of PFO treatments (both interventional and surgical) in China reached approximately 40,000 cases in 2022, ranking first among all structural heart disease interventions. Currently, more than 200 hospitals in China are performing PFO interventional treatments, with over 300 doctors involved in this work.
The successful market launch of the MemoSorb® Bioresorbable PFO Occluder is of great significance for the prevention of cryptogenic stroke and the promotion of the "heart-brain co-treatment" discipline in China. In the future, with further clinical application, it will bring more benefits to a wide range of patients, especially younger patients.
After the new product is launched, its specific sales performance during the promotion process may be affected by factors including but not limited to clinical promotion, channel development, changes in competitive landscape, macro policies, etc. The impact of this product on the company's future performance is uncertain.