Suzhou Wushuang Medical's 'SiLv': China's First Domestic Implantable Cardiac Monitor Enters Innovative Review Pathway and Files IPO Prospectus

# Implantable Cardiac Monitor (ICM)

Cardiovascular disease is a chronic illness that seriously endangers people's lives, health, and quality of life. Over the past 30 years, the incidence rate, number of deaths, and absolute quantity of disability-adjusted life years caused by cardiovascular disease in China have sharply increased, with even faster growth between 2010 and 2019, highlighting the challenges faced in the prevention and treatment of cardiovascular disease. In the diagnosis and treatment process of cardiovascular disease, the most important aspect is prevention, and the key means of prevention is early screening and diagnosis – this is also the direction in which China’s healthcare system reform is focusing for the prevention and control of chronic diseases.

The origin of the Implantable Cardiac Monitor (ICM) is long-term cardiac monitoring.In 1947, the cardiac monitoring system designed and applied by Norman J. Holter could only record a few hours of data. With technological advancements, short-term (24-72 hours) dynamic electrocardiogram monitoring has evolved to cardiac event recorders capable of recording data for up to one month. Mobile cardiac telemetry devices have also been gradually developed and applied.

In the 1990s, the first generation of ICM was successfully developed and applied in patients with unexplained syncope. With technological advancements, by 2017 it had evolved to become smaller in size, with a longer battery life, simpler and more user-friendly implantation methods, compatibility with MRI, and the addition of "P-wave sensing," which allows for better identification and recording of atrial fibrillation.

ICM is an important tool for early screening and diagnosis of cardiovascular diseases.It is an electronic device implanted subcutaneously that can continuously monitor abnormal electrocardiographic activity for a long time., which is widely used in syncope, cryptogenic stroke, atrial fibrillation screening, and the management of atrial fibrillation before and after surgery., with high clinical value. In 2021, the number of implants in the United States exceeded 310,000 cases,In China, it is in the early stage of popularization.。

• Continuous Monitoring：Long-term monitoring of subcutaneous ECG signals for 1-3 years to improve the diagnostic rate of unexplained syncope and arrhythmia.
• Real-time transmission data of occurrence events:Professional doctors can promptly analyze and diagnose cloud-based events, providing treatment recommendations as soon as possible.
• Significant Effect in Detecting Atrial Fibrillation：Compared with conventional short-term electrocardiogram,Atrial fibrillation detection rate can be increased up to 5 times。

# Company Introduction

Singular MedicalFounded in 2017, it is in ChinaIndependent Research, Development, and Production of Cardiac Rhythm Management Medical DevicesA leader in the industry, the company's headquarters is located in Suzhou, with research and development centers in Beijing and California, USA, and a center for critical process R&D and small batch production in Minnesota, USA.The Chinese team exceeds 90 people, and the American team exceeds 30 people.

CompanyIn the fields of arrhythmia and heart failure, focusing on screening, diagnosis, treatment, and monitoring, developing and currently developing a range of products including cardiac disease screening, wearable cardiopulmonary monitoring, heart rhythm monitoring, remote follow-up systems, the Singular Cloud Platform, electrocardiogram recorders, pacemakers, defibrillators, and various other pacing/defibrillation leads, covering fromImplantable, Wearable, Digital Healthcare, to AIIn multiple fields such as .

Product lines coverImplantable Cardioverter Defibrillator (ICD), Implantable Cardiac Monitor (ICM), CSP Pacing System, and External Heart Failure MonitoringAnd other equipment. In 2022, Singular Medical was named "China's Best Medtech Company of 2022" by the U.S.-based Medtech Outlook magazine. In 2023, it was included in the Forbes Asia "100 to Watch" list, gaining international recognition for its professional capabilities.