MOST INNOVATIVE TOP 10 PRODUCT OF THE YEAR CARDIOVASCULAR DEVICES COMPANIES - 2020

The company partnered with and his resting heart rate has been CSIRO, Australia’s national science significantly lowered, demonstrating Foldax agency, to formulate LifePolymer for that his heart does not have to heart valve applications. It also built work as hard as it did prior to the Foldax - Reinventing the Artificial a partnership with Caltech, whose procedure. team includes a Nobel Prize-winning Heart Valve scientist and who has deep experience Bringing Robotics in fluid and biomechanical design, to to Heart Valve mong the many companies innovating in the develop the Tria valve. The company Manufacturing cardiovascular space, Foldax® stands out as an has assembled world-class scientific The manufacturing process involved entity that is essentially reinventing artificial heart and medical advisory boards to help in present-day tissue valves – the A Foldax is laser-focused guide the entire development journey. most popular type of valves used valves as they are known today through novel biomaterial development, computer-aided design, and the first-ever use on delivering on our today - is complex. According of robotics in heart valve manufacturing. Opportunities Across to heart valve leader Edwards Artificial heart valves have traditionally had trade-offs mission of revolutionizing Valves in the Heart Lifesciences, producing just one – you could have a durable mechanical valve that required the industry with the first The first Tria heart valve is designed of their tissue valves takes 150 lifelong use of anticoagulants, or a tissue valve that didn’t for surgical aortic valve replacement. employees, 40 days of production require anticoagulants but was not durable, was difficult successful biopolymer The company is also working on a and 5-6 weeks of testing and to manufacture, and held the risk of disease. Foldax is heart valve, ultimately version of its valve for transcatheter packaging. Creating an all-new designing its Tria biopolymer valves to last a lifetime and aortic valve replacement (TAVR), address these historical tradeoffs. improving the lives the fastest-growing replacement “With our Tria™ heart valves, we can help humanity, valve surgery due to its less bend the healthcare cost curve downward, and improve of millions of patients invasive nature. As TAVR use A Promising Future access to care. Manufacturing our valves robotically can worldwide expands to younger patients, Foldax’s surgical aortic valves significantly decrease the overall complexity in making there are concerns about are the first polymer heart heart valves and is extremely cost-effective compared to durability, as artificial valves approved by the FDA TAVR valves long-term traditional artificial valves,” states Ken Charhut, So, Foldax engineered a proprietary biopolymer at for human clinical trials, durability is unknown. executive chairman of Foldax. a molecular level – called LifePolymer™ - for and soon, the company’s Foldax expects that use specifically in the human heart, and surgical mitral valve and its transcatheter The Making of the Tria computer-designed a valve from that transcatheter aortic valve heart valve made with Heart Valves material to overcome the substantial will also move into clinical LifePolymer may provide Historically, companies have tried to strains of the human heart. The new trials. extended longevity. resolve the inherent issues of artificial LifePolymer material enabled the With the goal of offering heart valves by using off-the-shelf company to create ultra-thin yet durable and life-sustaining materials or modifying existing strong leaflets that can rapidly Promising Early heart valves to patients with designs. However, Foldax took an open and close, enabling excellent Results heart valve disease, Foldax has unconventional approach by creating hemodynamics. Computer-design The company has performed an successfully combined innovations its Tria heart valve from the ground up. was used in the unique shape early feasibility human study and in design, material science and From the start, the company looked at of the valve’s leaflets and in the extensive pre-clinical bench and biopolymer material enabled the manufacturing process automation to material, design and manufacturing frame design, which is customized animal testing to date. The animal company to do something the heart deliver artificial heart valves intended process working in concert to optimize for valves for both the aortic and studies have shown no calcification valve industry had never done before to last a patient’s lifetime. results and costs. In reviewing previous mitral positions in order to accommodate or blood clotting on the heart leaflets, – manufacture an artificial heart valve “Foldax is laser-focused on polymer valve development efforts, they each position’s different opening and and bench testing has shown excellent robotically. Robotic manufacturing of delivering on our mission of recognized there was no existing material closing dynamics. The material and durability and performance of the the Tria heart valves decreases the revolutionizing the industry with the that could effectively resist calcification design work together to optimize the valves. The first patient treated with time and complexity of its assembly first successful biopolymer heart and withstand the stresses and distribution and absorption of a Tria valve recently reached his one- and reduces human handling, thus valve, ultimately improving the lives strains of the human stress and increase year anniversary with the valve, and is making valve production dramatically of millions of patients worldwide,” heart for a lifetime. durability. now able to run and take long walks, less expensive. concludes Charhut. Ken Charhut, Executive Chairman

38 July - 2020 July - 2020 39 MOST INNOVATIVE TOP 10 PRODUCT OF THE YEAR CARDIOVASCULAR DEVICES COMPANIES - 2020

The company partnered with and his resting heart rate has been CSIRO, Australia’s national science significantly lowered, demonstrating Foldax agency, to formulate LifePolymer for that his heart does not have to heart valve applications. It also built work as hard as it did prior to the Foldax - Reinventing the Artificial a partnership with Caltech, whose procedure. team includes a Nobel Prize-winning Heart Valve scientist and who has deep experience Bringing Robotics in fluid and biomechanical design, to to Heart Valve mong the many companies innovating in the develop the Tria valve. The company Manufacturing cardiovascular space, Foldax® stands out as an has assembled world-class scientific The manufacturing process involved entity that is essentially reinventing artificial heart and medical advisory boards to help in present-day tissue valves – the A Foldax is laser-focused guide the entire development journey. most popular type of valves used valves as they are known today through novel biomaterial development, computer-aided design, and the first-ever use on delivering on our today - is complex. According of robotics in heart valve manufacturing. Opportunities Across to heart valve leader Edwards Artificial heart valves have traditionally had trade-offs mission of revolutionizing Valves in the Heart Lifesciences, producing just one – you could have a durable mechanical valve that required the industry with the first The first Tria heart valve is designed of their tissue valves takes 150 lifelong use of anticoagulants, or a tissue valve that didn’t for surgical aortic valve replacement. employees, 40 days of production require anticoagulants but was not durable, was difficult successful biopolymer The company is also working on a and 5-6 weeks of testing and to manufacture, and held the risk of disease. Foldax is heart valve, ultimately version of its valve for transcatheter packaging. Creating an all-new designing its Tria biopolymer valves to last a lifetime and aortic valve replacement (TAVR), address these historical tradeoffs. improving the lives the fastest-growing replacement “With our Tria™ heart valves, we can help humanity, valve surgery due to its less bend the healthcare cost curve downward, and improve of millions of patients invasive nature. As TAVR use A Promising Future access to care. Manufacturing our valves robotically can worldwide expands to younger patients, Foldax’s surgical aortic valves significantly decrease the overall complexity in making there are concerns about are the first polymer heart heart valves and is extremely cost-effective compared to durability, as artificial valves approved by the FDA TAVR valves long-term traditional artificial valves,” states Ken Charhut, So, Foldax engineered a proprietary biopolymer at for human clinical trials, durability is unknown. executive chairman of Foldax. a molecular level – called LifePolymer™ - for and soon, the company’s Foldax expects that use specifically in the human heart, and surgical mitral valve and its transcatheter The Making of the Tria computer-designed a valve from that transcatheter aortic valve heart valve made with Heart Valves material to overcome the substantial will also move into clinical LifePolymer may provide Historically, companies have tried to strains of the human heart. The new trials. extended longevity. resolve the inherent issues of artificial LifePolymer material enabled the With the goal of offering heart valves by using off-the-shelf company to create ultra-thin yet durable and life-sustaining materials or modifying existing strong leaflets that can rapidly Promising Early heart valves to patients with designs. However, Foldax took an open and close, enabling excellent Results heart valve disease, Foldax has unconventional approach by creating hemodynamics. Computer-design The company has performed an successfully combined innovations its Tria heart valve from the ground up. was used in the unique shape early feasibility human study and in design, material science and From the start, the company looked at of the valve’s leaflets and in the extensive pre-clinical bench and biopolymer material enabled the manufacturing process automation to material, design and manufacturing frame design, which is customized animal testing to date. The animal company to do something the heart deliver artificial heart valves intended process working in concert to optimize for valves for both the aortic and studies have shown no calcification valve industry had never done before to last a patient’s lifetime. results and costs. In reviewing previous mitral positions in order to accommodate or blood clotting on the heart leaflets, – manufacture an artificial heart valve “Foldax is laser-focused on polymer valve development efforts, they each position’s different opening and and bench testing has shown excellent robotically. Robotic manufacturing of delivering on our mission of recognized there was no existing material closing dynamics. The material and durability and performance of the the Tria heart valves decreases the revolutionizing the industry with the that could effectively resist calcification design work together to optimize the valves. The first patient treated with time and complexity of its assembly first successful biopolymer heart and withstand the stresses and distribution and absorption of a Tria valve recently reached his one- and reduces human handling, thus valve, ultimately improving the lives strains of the human stress and increase year anniversary with the valve, and is making valve production dramatically of millions of patients worldwide,” heart for a lifetime. durability. now able to run and take long walks, less expensive. concludes Charhut. Ken Charhut, Executive Chairman

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