Wallaby Medical Launches Esperance® Distal Access Catheter in China, Offering New Clinical Option for Stroke Intervention

On April 16, 2021, Wallaby Medical held the “New National Trend Esperance” event at the 18th China Cerebrovascular Forum^®“Distal Access Catheter” China Launch Event, Announcing Its Innovative Stroke Treatment Product Esperance^®Distal Access Catheter Officially Launched in China. Esperance® Distal Access Catheter (hereinafter referred to as Esperance^®) Suitable for general endovascular use, including the neurovascular and peripheral vascular systems. The distal access catheter can be used to facilitate the delivery of therapeutic devices. Esperance^®As Wallaby Medical’s first stroke interventional therapy product launched in the Chinese market, it was originally designed and developed to facilitate the safe and rapid positioning of stroke treatment devices in clinical practice, providing patients with a more convenient, efficient, and safe therapeutic solution, thereby saving more lives.

Professor Zhang Hongqi of Xuanwu Hospital, Capital Medical University; Professor Jiao Liqun of Xuanwu Hospital, Capital Medical University; Professor Peng Ya of Changzhou No. 1 People’s Hospital; Professor Zhang Yongwei of the First Affiliated Hospital of Naval Medical University; Professor Chen Wenhuo of Zhangzhou Hospital; Professor Hu Wei of the First Affiliated Hospital of University of Science and Technology of China; Professor Huo Xiaochuan of Beijing Tiantan Hospital, Capital Medical University; Professor Gao Peng of Xuanwu Hospital, Capital Medical University; as well as An Muke, Founder and CEO of Wallaby Medical, and Mr. Liu Bing, Co-founder and Chairman, attended the listing ceremony.

“Cerebral stroke,” also known as “stroke” or “cerebrovascular accident (CVA),” is an acute cerebrovascular disease. It refers to a group of conditions characterized by brain tissue damage resulting from the sudden rupture of cerebral blood vessels or from vascular occlusion that prevents blood flow to the brain. Stroke includes both ischemic and hemorrhagic types. Hemorrhagic stroke has a higher mortality rate, whereas ischemic stroke has a higher incidence, accounting for 60%–70% of all strokes. Occlusion and stenosis of the internal carotid and vertebral arteries can lead to ischemic stroke, which predominantly affects individuals over the age of 40 and is more common in men than in women. Severe cases can be fatal.

Stroke is characterized by high mortality and disability rates, as well as a high recurrence rate. In addition to causing death, most stroke survivors are left with varying degrees of disability, and many patients experience a recurrence within 2 to 5 years after the initial onset. China is one of the countries with the highest incidence of stroke worldwide, and the incidence rate has been rising year by year. The number of cases is projected to reach 31.77 million by 2030, with both the number of prevalent cases and the mortality rate per 100,000 population exceeding those of cardiovascular diseases. Furthermore, according to the Report on Nutrition and Chronic Disease Status of Chinese Residents (2015), the economic burden imposed by stroke in China is estimated to be as high as RMB 40 billion annually.

Treatment strategies for stroke vary by type, with neurointerventional therapy currently being a common clinical approach. The "Outline of the 'Healthy China 2030' Plan" mentions incorporating appropriate technologies for the early diagnosis and treatment of major chronic diseases, such as stroke, into routine clinical practice. In the promotion of these appropriate technologies, distal access catheters, as a category of access devices, are characterized by high R&D barriers and significant technical complexity. Furthermore, these devices must meet practical clinical needs, including excellent navigability, large inner diameter, and diverse specifications. This product segment has long been monopolized by foreign companies. Wallaby Medical has taken a solid step forward by overcoming technical barriers through medical-engineering collaboration and the translation of industry-academia-research achievements. The newly launched Esperance distal catheter offers strong applicability in addressing practical clinical challenges, such as complex vasculature and tortuous lesions that are difficult to navigate, in both hemorrhagic and ischemic stroke cases.

As a pathway product, Esperance focuses on precise delivery to the target site. Its meticulously designed distal tip features 2 cm of easy shapeability, a 15 cm ultra-soft segment, and a 60 cm dual-system hydrophilic coating, providing an enhanced delivery experience that accommodates the complex and variable vascular anatomy encountered in clinical practice (including tortuous and bifurcated vessels). Meanwhile, R&D efforts have overcome manufacturing challenges to achieve a large lumen, thin wall, and small outer diameter, facilitating easier catheter navigation to lesion sites such as the middle cerebral artery in the anterior circulation or the basilar artery in the posterior circulation. The double-layer nitinol flat-wire coil braided skeleton effectively resists kinking and maintains the integrity of the 071 extra-large inner lumen. A 14-segment transitional gradient design ensures ease of delivery and tracking. Various specifications facilitate coaxial compatibility, combination, and delivery of devices, making it well-suited for multiple endovascular therapeutic procedures, particularly for East Asian populations with a high prevalence of intracranial stenosis.

At the product launch event, Professor Zhang Yongwei from the First Affiliated Hospital of Naval Medical University stated, “Current clinical attention is focused on breakthroughs in the material and diameter of endovascular products. A larger lumen enables more effective thrombus aspiration, thereby improving the efficiency of vascular recanalization. Among devices with large lumens, those with thinner walls facilitate smoother catheter navigation within blood vessels, making it possible to rescue stroke patients more rapidly.”

“Wallaby Medical has been committed to becoming the medical technology company that saves the most stroke patients worldwide. The neurointerventional device sector features high entry barriers and significant R&D challenges, with the clinical and market landscapes long dominated by imported devices. In response, we have made substantial investments in R&D and quality control to rigorously overcome these barriers. Given the severe burden of stroke in China, we strive not only to provide clinicians with higher-quality products but also to alleviate the pressure on medical insurance funds, thereby benefiting a greater number of patients,” stated An Muke, Founder and CEO of Wallaby Medical.

Wallaby Medical is a medical technology company specializing in neurointervention, dedicated to becoming the global leader in saving the lives of stroke patients. Founded in July 2016, the company is headquartered and has its manufacturing base in Shanghai Med Valley, with an R&D center established in the United States. Wallaby Medical primarily focuses on the research, development, and production of innovative products for the treatment of advanced vascular diseases.

Wallaby Medical boasts a professional R&D team specializing in the field of neurointervention. Its U.S. R&D team and Chinese technical team collaborate to develop numerous groundbreaking neurointerventional products. Currently, the company is engaged in the R&D and clinical trials of multiple products and has secured dozens of patents both domestically and internationally. In 2018, Wallaby Medical became the first Chinese company to receive FDA approval for a neurointerventional therapy product, officially entering the international market in early 2019. Its products have been exported to more than 10 countries, including the United States, Germany, the United Kingdom, and Chile. The company maintains a production area of over 1,000 square meters and an office space of more than 500 square meters in Shanghai, equipped with advanced manufacturing facilities and testing laboratories. Its U.S. R&D center covers an area of approximately 300 square meters and is outfitted with state-of-the-art R&D and testing equipment.

Wallaby Medical’s “Wallaby Cerebral Aneurysm Embolization Coils” represent the company’s first neuro-embolization interventional medical product to receive certification from the U.S. FDA, the European CE mark, and Japan’s PMDA. The product was officially launched in the U.S. market in the second half of 2019 and has since been adopted by internationally renowned hospitals, including UCLA, Kaiser Permanente, Klinikum Stuttgart, and BHR Hospital. For domestic registration in China, the company has collaborated with top-tier hospitals such as Beijing Tiantan Hospital, Xuanwu Hospital, and Huashan Hospital to conduct clinical trials, laying the groundwork for rapid entry into the Chinese market.

On November 11, 2020, Shanghai Wallaby Medical Technology Co., Ltd. completed a Series C financing round amounting to hundreds of millions of RMB. The proceeds will be primarily used to advance the development of its global portfolio of treatments for hemorrhagic and ischemic stroke, deepen its market presence in overseas regions including Europe, the United States, Japan, and South America, and support two ongoing clinical trials. In 2021, its access product, Esperance^®Officially approved by China's NMPA.