HeMo Bioengineering Receives China’s NMPA Approval for Flagship Afentta Aspiration Catheter

What Kind of Equipment is Used to Analyze DNA?

Below are some of a few basic processes followed throughout DNA testing. The general procedure entails:  • Isolating DNA from a sample containing the needed...

mJOULE Launches in the United Kingdom Reports Sciton

"Sciton is dedicated to worldwide support and growth. We continue to demonstrate our commitment to developing high quality devices and marketing efforts for our physician and medspa partners worldwide." says Lacee J. Naik, Vice President of Marketing and Public Relations.

FDA Issues Draft Guidance on Remanufacturing and Discussion Paper Seeking Feedback on Cybersecurity Servicing of Medical Devices

With this in mind, the FDA is issuing today's draft guidance to help clarify whether activities performed on medical devices are likely remanufacturing as well as a discussion paper on cybersecurity servicing of devices.

HeMo Bioengineering Ltd (“HeMo”), a Singapore-based medical device company with a focus on treating stroke patients, announced 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%, 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.

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.”

HeMo has entered into technology partnerships with U.S.-based Imperative Care, Inc. and Tsinghua University’s Department of Chemical Engineering, and has embarked on clinical trial collaborations with Beijing Tiantan Hospital (Capital Medical University). HeMo has also obtained patent protections for the proprietary technologies associated with its aspiration catheter system. Moving forward, HeMo is committed to accelerating the rapid development of China and APAC markets’ interventional domain.



Hyperfine Adds Medtech Leader and Visionary Scott Huennekens as Executive Chairman

Mr. Huennekens’ public boards include Chairman of Acutus Medical (IPO August 2020); Chairman of Envista (IPO September 2019); and board member of Nuvasive. He also serves as a board member and past Chairman of the Medical Device Manufacturer’s Association (MDMA).

One Drop Reports Carrie Siragusa, CPA Appointed VP of Commercial Strategy, Biosensor

Formerly Head of Innovation and Diabetes Portfolio at Sanofi, Siragusa will be part of a team bringing a multi-analyte dermal sensor (biosensor) with continuous health sensing capabilities to market with a mission to provide broader access to continuous glucose monitoring.

Barbara Moorhouse Appointed as Medica Non-Executive Director

Barbara has extensive business and management experience in the private, public, and regulated sectors.

Subscribe to Medical Device News Magazine here.

Related Articles