Hengsheng Medical Completes RMB 40 Million Pre-A Financing; Self-Perfusing Drug-Coated Balloon Set for Clinical Trial Completion in First Half of 2020

Following its full acquisition of NOYA’s sirolimus-eluting stent from Wanrui Feihong in early 2019, HENG SHENG MEDICAL, a leading R&D and manufacturer of coronary medical devices, has recently announced new developments.

VCBeat (WeChat ID: vcbeat) learned that on January 17, HENG SHENG MEDICAL completed a RMB 40 million pre-A round of financing. This financing was supported by the first phase of investment from the Changzhou Xitaihu Government Industrial Investment Fund, namely Changzhou Xitaihu Health Investment Company. The proceeds will be used for product manufacturing, research and development, and clinical trials.

This investment has received strong support from the Wujin District Government of Changzhou City and marks the implementation of HENG SHENG MEDICAL Group’s industrial layout. HENG SHENG MEDICAL will establish a 180-mu headquarters base at West Taihu Lake, achieving group-based operations and expanding production capacity. The new base will serve as an integrated hub for academia, research, production, and sales of high-value cardiovascular consumables, encompassing an Intravascular Imaging Academy, a Production and R&D Center, and a Warehousing and Logistics Center. As early as 2012, Mr. Zhao Xusheng, the founder, invested in establishing a medical device industrial park within the Shunyi Industrial Park of Zhongguancun in Beijing. With a construction area exceeding 20,000 square meters, this facility achieved large-scale production and operation of high-tech medical devices, accumulating valuable experience for the investment and establishment of the new headquarters base.

Since 2016, the successive rollout of policy initiatives such as “Healthy China 2030” and “Made in China 2025” has significantly accelerated the rapid development of China’s medical device manufacturing industry. By 2018, the market size of China’s medical device industry had reached RMB 530 billion, and China is poised to become the world’s largest medical device market in the future.

With the advent of population aging, cardiovascular diseases in China have become increasingly severe, making cardiovascular medical devices the most important segment of the medical device industry. According to data from the "Report on Cardiovascular Diseases in China 2017," the total number of people with cardiovascular diseases in China is nearly 290 million, and this figure continues to grow rapidly. The World Health Organization predicts that cardiovascular diseases account for more than 40% of all disease-related deaths among residents, becoming the leading cause of death in modern society. In 2018, the number of PCI (Percutaneous Coronary Intervention) procedures performed domestically increased to 915,000 cases, showing a clear upward trend year by year. Given the enormous growth potential of the domestic market for interventional cardiovascular medical device consumables, HENG SHENG MEDICAL has rooted itself in the field of cardiovascular interventional therapy, continuously innovating and developing, and investing in the production of interventional cardiovascular medical device consumables.

Currently, Hengsheng Medical Group is the third coronary medical device R&D and manufacturer, following Lepu Medical and MicroPort, to possess a complete production line encompassing drug-eluting stents, balloon catheters, and accessories. The company has been certified as a National High-Tech Enterprise, holds more than 30 patents (including pending applications), has obtained four EU CE certificates and nine China NMPA registration certificates, and has invested over RMB 500 million in cumulative R&D.

The core team is also trending towards globalization, having built a high-level management talent pool, production and R&D teams, and marketing teams. It has now formed a complete network for R&D, production, marketing, and services, with the capability to sell a full range of PCI interventional therapy products.

With the continuous improvement of interventional therapy standards and the ongoing development of interventional devices, the philosophy of interventional treatment is also advancing. “Intervention without Implantation,” as a novel concept in interventional therapy, is gaining increasing acceptance among clinicians and patients alike. The advent of drug-coated balloons represents a scientific application of this philosophy. Currently, imported products dominate the drug-coated balloon market in China, with a low level of domestic production. This presents significant potential for import substitution, while the market for drug-coated balloons remains in an educational phase.

However, as market acceptance gradually increases, 2020 will mark a growth period for drug-coated balloons (DCBs) and a developmental phase ushering in the “era of intervention without implantation.” Drug-coated balloons are high-end medical devices used in the interventional treatment of coronary artery disease. During the procedure, physicians insert a thin catheter and a drug-coated balloon through a minimal 2mm incision at the patient’s wrist or groin. The balloon is coated with medications that prevent thrombosis and vascular stenosis. The physician inflates the balloon for 30–45 seconds to adhere the drug to the diseased segment of the coronary artery, after which the balloon and catheter are withdrawn from the body, leaving no foreign material inside the patient.

Heng Sheng Medical Group has developed a range of balloon dilation catheters, with the fastest R&D progress seen in its drug-coated balloon dilation catheters. The drug-eluting balloon, which holds a significant position in Heng Sheng Medical’s product portfolio, innovatively applies the exclusive patented “self-perfusion” technology to drug-coated balloons. It has entered the late stage of clinical trials, is expected to complete clinical studies and submit registration applications in the first half of 2020, and is anticipated to obtain registration approval and be launched for commercial sale in 2021.

“Self-Perfusion” Drug-Coated Balloon:

This product, with Professor Huo Yong, a renowned cardiovascular disease expert in China, serving as the principal investigator, features an exclusively patented drug-eluting balloon with self-perfusion capability, allowing for a maximum wall apposition time of up to 60 minutes. It utilizes a paclitaxel drug coating without any excipients, significantly enhancing the deliverability of the drug-coated balloon.

“Self-perfusion” Drug-Eluting Balloon (Image provided by the company)

NOYA (Nuoyan) Coronary Drug-Eluting Stent System:

In addition to balloons, the NOYA drug-eluting coronary stent system is another flagship product of HENG SHENG MEDICAL. In 2018, Hengyi Medical, a subsidiary of HENG SHENG MEDICAL, acquired Wanrui Feihong, thereby obtaining the rights to NOYA, a domestically developed product. Approved for market launch by the National Medical Products Administration (NMPA) in 2013, NOYA was developed under the leadership of Chief Investigator Academician Gao Runlin from the Chinese Academy of Engineering. It is China’s first drug-eluting stent made of L605 cobalt-chromium alloy with a fully biodegradable coating. The stent utilizes sirolimus, which exhibits no cytotoxicity and helps prevent restenosis and the need for repeat revascularization procedures. The stent surface is coated with a biodegradable polymer (PDLLA), which reduces the incidence of late thrombotic complications.

Mr. Zhao Xusheng, the founder, revealed that the product lines for which R&D and clinical trials have been initiated also includeUltra-thin 99μm self-perfusing fully bioresorbable drug-eluting stent system, products in the field of peripheral vascular intervention, and world-leading intravascular imaging products,HENG SHENG MEDICAL will continue to innovate in the future, making significant investments in research and development to further extend its product line and enrich its product portfolio. Its independent R&D capabilities will reach a new level, successfully positioning the company among the pioneers in the field of cardiovascular interventional medicine and achieving the strategy of “digging a mile deep in an inch-wide space.”

To drive clinical research and new product development, HENG SHENG MEDICAL is currently conducting its Series A financing round. The company aims to seize opportunities in China’s medical device market, with the goal of expanding its coverage to 1,000 hospitals nationwide within three years and achieving rapid growth in product sales. Notably, HENG SHENG MEDICAL plans to accelerate its capital operations and initiate an IPO at an early stage to support the comprehensive development of the group.

Changzhou West Taihu Health Investment Co., Ltd. was established on January 12, 2016, and is located in the Changzhou West Taihu Science and Technology Industrial Park, focusing on providing investment in innovative projects within the health industry and support for enterprise incubation.