Venus Medtech Inc., the preeminent Chinese transcatheter heart valve company, announced it has signed an agreement to acquire Keystone Heart Ltd., a privately-held medical device company and makers of TriGUARD 3™. The acquisition gives Venus Medtech international rights to TriGUARD 3, the first Cerebral Embolic Protection Device designed to provide complete coverage to all brain regions for patients undergoing cardiac procedures.
“It is of utmost importance to us that our devices improve the quality life of the patients whom receive them,” said EricZi, co-founder and CEO of Venus Medtech. “Our transcatheter heart valve systems offer patients life-saving support – acquiring Keystone Heart allows us the opportunity not only to reduce the risk of brain injury during cardiac procedures but establishes our presence in the US and EMEA through which we can introduce our entire portfolio of products.”
Keystone Heart is focused on protecting the brain from emboli to reduce the risk of brain infarcts during TAVR, surgical valve replacement, atrial fibrillation ablation and other structural heart procedures. The company is currently enrolling patients in the REFLECT trial in the US to evaluate TriGUARD 3, anticipating enrollment completion in the early part of the first quarter of 2019 and FDA review in the first half of 2019. CE mark approval for Europe is anticipated by the end of this year.
“We are excited to be joining a truly entrepreneurial company like Venus,” said Chris Richardson, president and CEO, Keystone Heart, LTD. “Providing brain protection for every TAVR patient will differentiate Venus Medtech and position them as a leader in structural heart therapies – underscoring its dedication to excellence, determination to provide a total solution for patients undergoing TAVR procedures and focus on patient safety. This partnership provides us the unique opportunity to improve the lives of patients undergoing structural heart procedures with cerebral embolic protection and the ability of bringing new cutting-edge therapies into the US & EMEA.”
The merger is expected to close in the fourth quarter of 2018, subject to customary closing conditions.
How TriGUARD 3™ Works
TriGUARD 3™ is designed to help interventional cardiologists and electrophysiologists protect the brain during cardiovascular procedures. During these cardiovascular procedures, debris from the aortic valve, ascending aorta and other sources may embolize and cause cerebral infarction. Embolic brain lesions resulting from these procedures may lead to potentially devastating outcomes — stroke, dementia and cognitive decline. Moderate to mild brain injuries, which are caused by new lesions in the brain, can affect the patient’s processing speed, executive function, and fundamental skills such as memory, language, and balance.i These lesions may be related to changes in the way your brain functions or processes information, and lesions in the brain stem can impact basic body functions such as breathing, swallowing, heart rate, blood pressure, consciousness, and whether one is awake or fatigued.ii The location of these lesions determines the damage and clinical symptoms, and where a lesion may occur is unpredictable. The TriGUARD 3 Cerebral Embolic Protection Device is designed to cover all three major cerebral branches to minimize the risk of brain damage during cardiovascular procedures.
Highlighting this issue, the number of TAVR procedures conducted annually worldwide has increased exponentially over the past 6 years.iii A total of 13 studies conducted in the US and Europe have shown that a median of 80% of patients have new brain lesions following TAVR. In recent research from leading US institutions, the NeuroTAVR study demonstrated that 94% of patients had new lesions in the brain following the TAVR procedure, one out of four have some neurologic impairment after TAVR, and four out of 10 have some neurocognitive worsening one month after TAVR when compared to pre-TAVR scores.
About Transcatheter Aortic Valve Replacement (TAVR)
TAVR, which is also referred to as transcatheter aortic valve implantation (TAVI), is a minimally invasive surgical procedure conducted to repair a damaged aortic valve. A damaged aortic valve obstructs blood flow from the heart into the aorta and onward to the rest of the body, and if left untreated, may lead to death. There will be approximately 125,000 TAVR procedures conducted this year worldwide.
About Venus Medtech (HangZhou) Inc.
Venus Medtech (HangZhou) Inc. is a leading heart valve developer in China. Its transcatheter aortic valve was the first CFDA (China Food and Drug Administration) approved technology. Its transcatheter pulmonic valves are currently completing clinical trials. They are also developing the next-generation structural heart technologies designed for increased safety, long term durability and healthcare economics. Venus Medtech’s goal is to be a worldwide transcatheter heart valve company.
About Keystone Heart
Keystone Heart Ltd. is a medical device company developing and manufacturing cerebral embolic protection devices intended to reduce the risk of brain embolization associated with cardiovascular procedures. The company is focused on protecting the brain from emboli to reduce the risk of brain infarcts during TAVR, atrial fibrillation ablation and other cardiovascular procedures. The TriGUARD 3 product pipeline is designed to help interventional cardiologists, electrophysiologists and cardiac surgeons preserve brain reserve while performing these procedures.
Headquartered in Israel with US operations in Tampa, FL, Keystone Heart is dedicated to advancing patient care through innovative technology and clinical research. The company’s management has extensive experience in the fields of interventional cardiology and medical devices.