Wushuang Medical Files IPO Prospectus Following 2023 Global Medical Technical Innovation Award for Pioneering ICD

May 02, 2024 00:01 CST Updated 00:01

Singular Medical

Developer, Manufacturer, and Seller of Cardiac Rhythm Management Products

Siyu MedTech selected a group of outstanding enterprises and products in early 2024 for their excellent performance in 2023.Among themSingular MedicalThe company was awarded“2023YearGlobal Medical Technology InnovationNew Award（2023 Global Medical Technical Innovation Award）”。

The reason for winning is:On September 7, 2023, Singular Medical's Implantable Cardioverter Defibrillator (ICD) passed the public announcement period of the Center for Medical Device Evaluation under the National Medical Products Administration, officially entering the Special Review Procedure for Innovative Products ("Green Channel").

This product is the first implantable cardioverter defibrillator (ICD) to enter the innovative special review process. This ICD has full independent intellectual property rights and can achieve automatic sensing and pacing, 40J energy charge and discharge, streamlined design, and Bluetooth telemetry, with performance comparable to mainstream imported products. As China's first ICD to break through technical barriers, it has completed type inspection and animal experiments, and has now entered the clinical stage.

Today, Siyu introduces this innovative company to the readers.

# Company Introduction

Singular Medical(abbreviation "Singular Medical"）was founded in 2017 and is a leader in the research, development, and production of cardiac rhythm management medical devices in China. The company's headquarters is located in Suzhou, with research and development centers in Beijing and California, USA, and a key process R&D and small-batch production center in Minnesota, USA. Its product line covers"Implantable Cardioverter Defibrillator (ICD), Implantable Cardiac Monitor (ICM), CSP Pacing System, and External Heart Failure MonitoringAnd other equipment. In 2022, Singular Medical was named "2022 Best Medtech Company in China" by the U.S.-based Medtech Outlook magazine. In 2023, it was included in the Forbes Asia "100 Companies to Watch" list, gaining international recognition for the company's professional capabilities.

# Industry Introduction

According to the data shown in the "China Cardiovascular Disease Report 2017" released by the National Cardiovascular Center in the first half of 2018, the incidence rate of sudden cardiac death in China is 41.8 per 100,000 people. More than 540,000 cases of sudden cardiac death occur each year, with an average of approximately 1,500 people passing away daily due to sudden cardiac death. Clinical studies have shown that for malignant ventricular arrhythmias, ICD is the preferred treatment method, and its efficacy far exceeds that of all anti-arrhythmic drugs on the market. In the U.S., European, and Chinese guidelines for the prevention of sudden cardiac death,ICD is listed as the only Class I recommendation and is also widely recognized as the "only effective" product.。

Compared with the high incidence of sudden cardiac death, in 2018, the annual number of ICD implants in China was only 5,192 cases. In contrast, in the United States, where the market is relatively mature, the number of ICD implant surgeries reached 200,000 in 2016. Currently, the number of ICDs per million people in China is only 2, whereas in European and American countries, the number of ICD implants per million people is as high as 600-800, which is more than 300 times that of China. According to statistics from the National Health Commission's online registration system, the number of ICD implants in China has been continuously increasing, with a growth rate of approximately 20% in recent years.

Given its "life-saving at any time" requirement, the ICD has extremely stringent demands for safety and effectiveness. Modern ICDs also encompass all the functions of a pacemaker, and can be described as "pacemakers with defibrillation capabilities." They have consistently played a leading role in the high-end medical device industry and are hailed as "the jewel in the crown of comprehensive cardiac devices."

As early as 1980, the world's first ICD had already been successfully implanted into a human body, but due to itsHigh technical barriers, complex system integration, the global ICD technology and market are currentlyMedtronic, Abbott, Boston Scientific, Biotronik, Sorin (acquired by MicroPort)Five companies have long monopolized.

In order to break the industry deadlock, since its establishment, Singular Medical has undergone three years of dedicated research, continuously delving into ICD technology, and is committed to becoming a pioneer in the research and industrialization of ICDs in China.

# Founder Introduction

According to Tianyancha information, the actual controller of Singular Medical isPing Li Chuan。

AndPing Li ChuanAndHongfengDr. for Singular MedicalCo-founder。

Dr. Ping Liuchuan, Singular MedicalFounder and CEO.Former member of the Nurotron US Technical Committee, Project Manager; Leading Talent of Suzhou New District, Key Innovation Team of Suzhou New District, Gusu Talent, Second Prize of Zhejiang Provincial Science and Technology Progress Award (Individual), United States; O1-A Visa (Extraordinary Ability); Visiting Scholar at the Keck School of Medicine, University of Southern California, Assistant Professor at the University of Notre Dame; Bachelor's degree from Harbin Engineering University, Ph.D. from the Institute of Acoustics, Chinese Academy of Sciences.

Dr. Hong Feng, Co-founder and CTO of Singular Medical. Over 10 years of experience in the development of cochlear implants made in China, fully responsible for the technical work at Singular Medical; Former Project Manager and Technical Committee Member at Nurotron USA, Bachelor’s degree from the Department of Electronic Engineering at Tsinghua University, Ph.D. from the Institute of Acoustics, Chinese Academy of Sciences.

# Product Introduction

1. Implantable Cardioverter Defibrillator

Currently recognized as the most effective treatment for preventing sudden death in the industry, which can quickly and automatically identify malignant arrhythmias, deliver antitachycardia pacing and electrical defibrillation, and promptly save patients' lives.

Product Features:

1. Fully Automatic Operation

Rapid Identification of Arrhythmia, Stratified Treatment, Leading Bluetooth Telemetry Technology.

2. Compact design, simple and efficient surgical operation

The streamlined shell is designed to fit the physiological curve of the human body, with a surgical incision of about 5cm, no need for thoracotomy, local anesthesia, and a surgery time of 1-2 hours.

3.High Defibrillation Efficiency

Powerful self-developed algorithm with SVT discrimination function, more effective high-energy shocks.

2. Programmable Instrument - Singular Medical^®

The pacemaker programmer of Singular Medical, together with implantable cardioverter defibrillators, pacemakers, and cardiac event monitors, forms a complete treatment system. It is clinically used for reading and analyzing data from cardiac implantable electronic devices (CIEDs), adjusting CIED parameters, archiving reports, remote follow-ups, etc.

3. Implantable Cardioverter Defibrillator Leads - Singular Agile^®

Implantable cardiac defibrillation leads connected to an implantable cardioverter defibrillator (ICD), implanted in the right ventricle of the human body, achieving the therapeutic functions of ICD sensing, pacing, and delivering electrical shocks for defibrillation.

Product Highlights:

1. Four-pole connection system

DF4-LLHO international standard port reduces pocket pressure from lead coiling and offers better handling than traditional DF1 defibrillation leads.

2.Single Defibrillation Coil

The single-coil design avoids adhesion of the superior vena cava defibrillation coil, making it more convenient to replace the lead in the long term. Clinically verified to be safe and reliable.

3. Active Helix

The true bipolar design provides more accurate sensing. The active fixation method allows for selective implantation sites, facilitating surgical procedures.

# Financing History

As of the date of publication, the company's financing history is as follows: