Venus MedTech Completes Acquisition of Keystone Heart, Introducing an Integrated Portfolio of Innovative Cerebral Protection Solutions

VCBeat (WeChat: vcbeat) has learned that Hangzhou Venus Medtech, Inc. (“Venus Medtech”), a leading provider of comprehensive minimally invasive solutions for heart valve therapy in China, announced on December 26, 2018, the completion of its acquisition of Keystone Heart Ltd., the manufacturer of the TriGUARD 3 cerebral embolic protection device.

TriGUARD 3 is the world’s first and only cerebral protection device designed to cover the entire aortic arch to prevent cerebral embolism, thereby minimizing the risk of brain injury during cardiovascular surgery and providing comprehensive protection for brain tissue. For this product, Keystone Heart Ltd. has established mature clinical trial and sales systems in Europe and the United States.

Mr. Zi Zhenjun, Co-founder and CEO of Venus Medtech, stated, “It is vital that Venus Medtech’s products save patients’ lives and improve their quality of life; this is also the company’s core mission. Our transcatheter heart valve systems provide life-saving support to patients. The acquisition of Keystone Heart Ltd. not only gives us the opportunity to reduce the risk of brain injury in patients during cardiac procedures, but also enables deeper penetration into the U.S. and European markets, thereby introducing a comprehensive portfolio of innovative products. Meanwhile, we will deliver broader benefits to Chinese patients through an integrated solution that combines cerebral protection devices with Venus Medtech’s independently developed TAVR products.”

Keystone Heart, Inc. is dedicated to protecting brain tissue from embolic events and reducing the risk of stroke during transcatheter aortic valve replacement (TAVR), surgical valve replacement, catheter ablation for atrial fibrillation, and other cardiovascular procedures. The company is currently enrolling patients in the U.S.-based REFLEC trial to evaluate and validate its TriGUARD 3 device. Patient enrollment is expected to be completed in early Q1 2019, with approval from the U.S. Food and Drug Administration (FDA) anticipated in Q3 2019. CE marking in the European Union is expected to be obtained by the end of Q1 2019.

Chris Richardson, President and Chief Executive Officer of Keystone Heart, stated, “We are delighted to join Venus Medtech, a truly innovative and entrepreneurial company. Providing cerebral protection devices for every TAVR patient will differentiate Venus Medtech’s product portfolio, setting it apart from competitors through distinct competitive advantages. Our commitment to excellence and focus on patient safety will further strengthen and solidify Venus Medtech’s leadership in the field of structural heart disease treatment. This partnership creates unique opportunities for the growth of both companies. We look forward to the widespread adoption of cerebral protection devices, which will help improve the quality of life for an increasing number of patients undergoing structural heart interventions. We remain fully committed to advancing novel, cutting-edge therapies into the United States and European markets.”

Venus Medtech was established in 2009 and is located in the Hangzhou National High-Tech Industrial Development Zone (Binjiang). The company is dedicated to the development and industrialization of minimally invasive treatments for heart valve diseases. TAVR is a minimally invasive interventional procedure used to repair damaged aortic valves. A damaged aortic valve impedes blood flow from the heart into the aorta and subsequently to the rest of the body; if left untreated, it can lead to death. Approximately 160,000 TAVR procedures will be performed worldwide this year.

VenusA-Valve, the company’s transcatheter artificial aortic valve replacement system, is the first transcatheter heart valve system approved for market launch by the China Food and Drug Administration (CFDA), ushering in a new era of transcatheter aortic valve replacement (TAVR) in China. Venus Medtech is also the first Chinese valve manufacturer to conduct global clinical studies. The European Union (CE) clinical study for the VenusP-Valve, a transcatheter pulmonary valve, was officially launched in September 2016 and has completed patient enrollment. The company’s next-generation products under development are poised to achieve further breakthroughs and innovations in terms of safety, long-term durability, and health economics of valve products. Venus Medtech will continue to dedicate itself to the research, development, and commercialization of medical devices for the treatment of structural heart disease, accelerating Chinese innovation to benefit the world.

Keystone Heart, Inc. is a medical device company that develops and manufactures cerebral protection devices designed to reduce the risk of cerebral embolism during cardiovascular procedures. The company is dedicated to protecting the brain from embolic events, thereby lowering the risk of stroke in transcatheter aortic valve replacement (TAVR), atrial fibrillation ablation, and other cardiovascular interventions.

During these procedures, emboli originating from the aortic valve, ascending aorta, and other sites may occur, leading to cerebral infarction. Procedure-related cerebral embolism can result in potentially severe consequences, including stroke, dementia, and cognitive decline.

Moderate to mild brain injuries caused by new cerebral lesions may affect patients’ information processing speed, executive function, memory, and basic skills such as language and balance. These lesions may be associated with changes in how the brain operates or processes information. Meanwhile, brainstem lesions can impair essential physiological functions, including respiration, swallowing, heart rate, blood pressure, level of consciousness, and alertness or fatigue. The location of these lesions determines the extent of brain damage and clinical symptoms, while the potential sites of lesion occurrence are unpredictable. The TriGUARD 3 product series is designed to help interventional cardiologists, electrophysiologists, and cardiac surgeons protect patients’ brain function during these procedures.

Keystone Heart Ltd. is headquartered in Israel, with its U.S. operations based in Tampa, Florida. The company is dedicated to enhancing patient care through innovative technologies and clinical research. Its management team possesses extensive experience in interventional cardiology and medical devices.

Source: Hangzhou Qiming Medical Devices Co., Ltd.

Reprinted from: PR Newswire