December 23, 2023Singular Medical Initiates First Clinical Enrollment for Implantable Cardiac Event Monitor (ICM);As of June 21, 2024,The 64th patient in this clinical trial has successfully completed enrollment.This milestone means that the first ICM made in China has been officially promoted to clinical application and serving more patients, taking a solid step forward.。
The 64 subjects enrolled in this project cover patients of multiple age groups and different conditions, ensuring the wide representativeness of the trial results.By the end of July, ICM had successfully recorded 16 cases of asystole, 6 cases of atrial fibrillation, 3 cases of ventricular tachycardia, and 23 cases of sinus bradycardia. Patients with relevant positive events have received precise ECG-assisted diagnosis provided by ICM, and some have already undergone further treatment.Improved quality of life, with no SAEs occurring.The effectiveness and safety of Singular Medical's ICM have been validated in the real world.
Singular Medical is always committed to the research and application of cutting-edge medical technologies. The ICM project is the crystallization of the company’s dedicated scientific research and technological innovation, and has entered China's special review process for innovative medical devices (Green Channel).We deeply understand that every patient is our valuable asset, and their health and happiness are our greatest pursuits.Therefore, we always prioritize the safety of patients, ensuring that every step is rigorous, meticulous, and compliant with ethical standards.We would like to express our special thanks to the medical experts from various centers for their hard work and valuable suggestions in completing the trial.Professor Yan-Gang Su from Zhongshan Hospital Affiliated to Fudan University, Professor Ruo-Gu Li from Shanghai Chest Hospital, Professor Huan-Yi Zhang from Taian Central Hospital, Professor Jing-Feng Wang from Sun Yat-sen Memorial Hospital of Sun Yat-sen University, Professor Wei Xu from Drum Tower Hospital Affiliated to Nanjing University Medical School, Professor Hui Li from the Second Affiliated Hospital of Soochow University, and Professor Xing-Bin Liu from West China Hospital of Sichuan University (in order of initiation),They led their respective teams and provided strong support for the high-quality and high-standard advancement of the trial with their professional knowledge and extensive experience.Looking ahead, Singular Medical will continue to increase its investment in the research and development of the ICM series, continuously optimize its design and functionality, enhance patient satisfaction, and help patients get rid of pain as soon as possible. With an open, cooperative, and win-win spirit, we will strengthen our collaboration with more experts, scholars, and enterprises to jointly promote the advancement and development of medical technology, contributing Chinese strength to the cause of human health!Company Profile:
Singular Medical is a hard-tech enterprise focused on the research, development, and industrialization of medical devices related to Cardiac Rhythm Management (CRM). The company's headquarters is located in the Suzhou High-Tech Zone Medical Device Park, with a 2,800-square-meter manufacturing plant, and offices in Beijing and Irvine, California.MingThe state has established a research and development center. Singular Medical started with the most technically challenging product in the CRM field, the ICD, and has built a complete CRM technology platform. It is growing into a supplier of full-line products in China's CRM field, capable of providing arrhythmia patients with a complete set of solutions from monitoring, diagnosis, treatment to postoperative follow-up.
