HEMO Receives NMPA Approval for Afentta™ Aspiration Catheter

HEMO BIOENGINEERING LIMITED (“HEMO”), a Singapore-based medical device company with a focus on treating stroke patients, is pleased to announce that its Afentta™ intracranial thrombectomy aspiration catheter – a product developed by HEMO’s branch in China – has received pre-market approval from the National Medical Products Administration (“NMPA”), becoming the first approved domestic product of its kind in China. Developed on novel, proprietary technologies, Afentta™’s flagship aspiration catheter offers an efficacious, fast and safe direct aspiration treatment option for acute ischemic stroke thrombectomy and has demonstrated lower post stroke treatment disability rates and disease burden from clinical studies.

Stroke is the leading cause of mortality and disability among adults in China and is associated with high incidence, disability, mortality and recurrence rates, as well as high financial costs. Among the types of stroke, Acute Ischemic Stroke (“AIS“) accounts for approximately 70%[1] of stroke cases in China and has been associated with a 10% mortality rate within the first 90 days as well as disability rates in more than a third of patients. The National Health Commission (“NHC”)’s Healthy China Action (2019-2030) aims to lower mortality rates from cardiovascular and neurovascular diseases to the region of 20%[2], and more recently, the Bureau of Medical Administration under China’s National Health Commission has targeted to increase the rates of reperfusion therapy for acute cerebral infarctions[3].

Direct aspiration for AIS can achieve efficacious recanalization of neurovascular arteries, achieve timely reperfusion and improve prognosis, and has been globally recommended as a treatment approach. China’s leading physician in the field, Dr. Miao Zhongrong, Professor of Interventional Neuroradiology, Neurosurgery, and Neurology and Head of the Department of Interventional Neuroradiology at Beijing Tiantan Hospital (Capital Medical University), commented, “Afentta™ has demonstrated shorter procedure times, higher recanalization rates, lower disability rates and lower incidence of arterial dissection, presenting a more efficacious, faster and safer treatment option in interventional thrombectomy.”

The Afentta™ intracranial thrombectomy aspiration catheter is the flagship product developed by HEMO BIOENGINEERING (CHINA) LTD and has achieved the milestone of being China’s first domestically-produced aspiration catheter system. Dr. Jack Wang, HEMO’s Founder and Chief Technology Officer, commented, “HEMO BIOENGINEERING is committed to bringing together ‘smart’ resources to serve China’s needs in the neurovascular interventional space. With our professional management team of industry veterans and our diversified and global research and education resources, we are well-positioned to continue delivering world-leading, reliable and innovative medical devices.”