CardioRhythm Medical Completes Nearly RMB 100 Million Series B Financing to Advance Comprehensive Stroke Solutions

EO Intelligence, September 9 — HeartCare announced today that it has completed a Series B financing round of nearly RMB 100 million. The round was led by Hidea Investment, with participation from Sharewin Investment and Changjiang Guohong Investment. The successful completion of this financing will accelerate the clinical development of new products across HeartCare’s four major product lines, as well as the market promotion and industrialization of upcoming launches, further advancing its comprehensive solutions for stroke prevention and treatment.

HeartCare was established in 2016 and is located in the Medical Device Industrial Park within the Shanghai Zhangjiang Hi-Tech Park. The company specializes in the development of novel minimally invasive interventional products for the prevention and treatment of ischemic stroke. Currently, HeartCare offers four major product lines: "Stroke Prevention, Acute Stroke Thrombectomy, Stroke Access, and Treatment of Stenotic Stroke." Its two core products are: the Left Atrial Appendage (LAA) Occluder, a device used via percutaneous intervention to occlude cardiac structures requiring closure, with the intended use of sealing the left atrial appendage to prevent thromboembolism originating from it; and the Eruss Thrombectomy System, indicated for acute ischemic stroke caused by large artery occlusion, which removes thrombi from the intracranial large vessels of ischemic stroke patients to restore blood flow.

HeartCare focuses on ischemic stroke, commonly known as "stroke," which is a major disease threatening human health. According to data from the China Stroke Prevention and Treatment Report (2017), the number of people aged 40 and above in China who currently have or have previously had a stroke is 12.42 million, with a noticeable trend toward younger patients.

It is understood that 85% of stroke cases are caused by cerebral ischemia, primarily due to large vessel occlusion. Clinical studies have confirmed that early recanalization of the occluded vessels and restoration of blood flow to the ischemic brain tissue can prevent further brain damage and improve prognosis.

Currently, endovascular therapy dominated by stent retriever thrombectomy is regarded as the primary approach for managing acute large vessel occlusion in clinical practice. Products from international industry leaders, such as the Penumbra thrombectomy device, Solitaire stent retriever, Trevo stent retriever device, and Revive SE stent system, have become the mainstream products in the domestic market.

According to inquiries made on the official website of the National Medical Products Administration (NMPA) by EEO Health, currently only Jiangsu Niko Medical Device Co., Ltd.'s product, Reco, has obtained a medical device registration certificate in China. In addition, domestic companies including HeartCare, GuiChuang TongQiao, and LifeTech are also making significant efforts in this sector.

In terms of R&D capabilities and conditions, HeartCare has been approved for the Shanghai Municipal Major Special Project for Strategic Emerging Industrialization—Research and Development and Industrialization of Stroke Interventional Products. The company has established technical platforms for precision stent processing, precision braided catheters, and various balloon catheters. It operates a GMP-compliant workshop spanning over 1,000 square meters and has implemented a quality management system conforming to ISO 13485 standards. Of the more than 30 patents applied for, 13 invention patents have been published and are under examination, and 11 utility model patents have been granted.

Facing the Chinese thrombectomy market, which was projected to reach RMB 3 billion in 2020, Wang Guohui, General Manager of HeartCare, stated, “Although the domestic market for interventional stroke therapy is rapidly developing, it still faces a clinical shortage of interventional devices for stroke and import monopoly. There is an urgent need in China for more and better domestically produced interventional devices for stroke to be launched.”