Among the many companies innovating in the cardiovascular space, Foldax^® stands out as an entity that is essentially reinventing artificial heart valves as they are known today through novel biomaterial development, computer-aided design, and the first-ever use of robotics in heart valve manufacturing.

Artificial heart valves have traditionally had trade-offs – you could have a durable mechanical valve that required lifelong use of anticoagulants, or a tissue valve that didn’t require anticoagulants but was not durable, was difficult to manufacture, and held the risk of disease. Foldax is designing its Tria biopolymer valves to last a lifetime and address these historical tradeoffs.

“With our Tria^™ heart valves, we can help humanity, bend the healthcare cost curve downward, and improve access to care. Manufacturing our valves robotically can significantly decrease the overall complexity in making heart valves and is extremely cost-effective compared to traditional artificial valves,” states Ken Charhut, executive chairman of Foldax.

The Making of the Tria Heart Valves

Historically, companies have tried to resolve the inherent issues of artificial heart valves by using off-the-shelf materials or modifying existing designs. However, Foldax took an unconventional approach by creating its Tria heart valve from the ground up. From the start, the company looked at material, design and manufacturing process working in concert to optimize results and costs. In reviewing previous polymer valve development efforts, they recognized there was no existing material that could effectively resist calcification and withstand the stresses and strains of the human heart for a lifetime.

So, Foldax engineered a proprietary biopolymer at a molecular level – called LifePolymer™ - for use specifically in the human heart, and computer-designed a valve from that material to overcome the substantial strains of the human heart. The new LifePolymer material enabled the company to create ultra-thin yet strong leaflets that can rapidly open and close, enabling excellent hemodynamics. Computer-design was used in the unique shape of the valve’s leaflets and in the frame design, which is customized for valves for both the aortic and mitral positions in order to accommodate each position’s different opening and closing dynamics. The material and design work together to optimize the distribution and absorption of stress and increase durability.

The company partnered with CSIRO, Australia’s national science agency, to formulate LifePolymer for heart valve applications. It also built a partnership with Caltech, whose team includes a Nobel Prize-winning scientist and who has deep experience in fluid and biomechanical design, to develop the Tria valve.