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Devices Interventional Cardiology

 News Release - March 2, 2017

Keystone Heart and Venus Medtech Announce Partnership for Cerebral Embolic Protection with Transcatheter Heart Valve Systems (TAVR) in China and Key Asian Markets

CAESAREA, Israel and TAMPA, Fla. and HANGZHOU, China, March 2, 2017 -- (Healthcare Sales & Marketing Network) -- Keystone Heart Ltd., a medical device company focused on developing cerebral embolic protection devices for patients undergoing cardiac procedures, and Venus Medtech (Hangzhou) Inc., the preeminent Chinese transcatheter heart valve company, today announced a partnership agreement to provide Venus Medtech's TAVR system in combination with Keystone Heart's TriGuard Cerebral Embolic Protection Device. This agreement, covering China and key Asian markets, will allow physicians and patients in this region to benefit from TAVR while simultaneously receiving an embolic protection device intended to provide complete three vessel protection for the brain. The combination is unavailable in any other market or from any other company.

"It is of utmost importance to us that our devices improve the quality life of the patients whom receive them," said Eric Zi, president and CEO of Venus Medtech. "Our transcatheter heart valve systems offer patients life-saving support -- and collaborating with Keystone Heart allows us the opportunity to reduce the risk of brain injury during the procedure. No other company offers this combination."

In February 2017, the Neurologic Academic Research Consortium (NeuroARC) published formal guidelines that establish and provide standardized consensus definitions for neurologic endpoints in cardiovascular clinical trials. Released in the Journal of American College of Cardiology and the European Heart Journal, these guidelines highlight a growing body of evidence pointing to the existence of "covert" brain injury to patients undergoing TAVR and other cardiovascular procedures.

Highlighting this issue, over the last 5 years, 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 in leading US institutions, the NeuroTAVR study demonstrated that 94% of patients had new lesions in the brain following the TAVR procedure, 22.6% of patients had new neurologic impairment post TAVR, and 41% of patients had declining neurocognition at 30 days when compared to pre TAVR scores.

"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 and focus on patient safety," said Chris Richardson, president and CEO, Keystone Heart, LTD. "This partnership provides us the opportunity to make an impact in the fast growing structural heart space in an extraordinarily important geographic market."

China is an emerging market for TAVR procedures. Venus Medtech expects its TAVR device will be the first device approved by CFDA for marketing in China. Experts predict that there will be more than 10,000 procedures conducted in the first 3 years following approval and the market is expected to grow 30-50% per year in the following years.

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 valves have completed clinical trials and follow-up studies, and are pending China Food and Drug Administration (CFDA) clearance. Its transcatheter pulmonic valves are completing clinical trials. Both of the valves are expected to be the first transcatheter valves approved in China. They are also developing the next-generation heart valves designed for increased safety and long term durability. Venus Medtech's goal is to be a worldwide transcatheter heart valve company. For more information visit: www.venusmedtech.com.

About The TriGuard™ Cerebral Embolic Protection Device

Keystone Heart's TriGuard is the only cerebral protection device designed to provide full coverage to all brain territories to minimize the risk of cerebral damage during TAVR and other cardiovascular procedures. The CE marked TriGuard device is shaped to accommodate anatomic variations of the aortic arch. Formed to withstand potential interface with the TAVR delivery system and other procedure related accessories, it uses a Nitinol® frame and mesh — flexible and atraumatic, yet robust and sturdy.

The TriGuard Cerebral Embolic Protection Device is placed via one of two femoral artery access ports typically used in TAVR, thereby eliminating the need for a third puncture site. It deploys rapidly, and self-positions through a small 9F catheter. TriGuard provides stable, atraumatic protection, with simple retrieval.

The TriGuard Cerebral Embolic Protection Device has been granted the CE Mark in the European Union and is commercially available in Europe. In the United States, the device is currently available for investigational use only.

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 product pipeline is designed to help interventional cardiologists, electrophysiologists and cardiac surgeons to 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. For additional information, please contact us or visit: www.keystoneheart.com.


Source: Keystone Heart

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