Foldax Advances the Next Big Thing in Heart Valves: Robotic Manufacturing

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For the serial medtech entrepreneurs who founded Foldax, incrementally improving heart valve implants wouldn’t serve their goal of making a massive impact on valvular heart disease. Instead, they’re revolutionizing the design, manufacturing, and cost structure of aortic, mitral, and other valves to come, with a polymer-based technology amenable to computer-aided design and robotics.

Ken Charhut, co-founder and executive chairman of Foldax Inc., says his company is operating in the Heart Valve 4.0 generation. Foldax is making use of advanced chemistry, computer-aided engineering, and robotics to create a new generation of heart valves that won’t require patients to make a devil’s bargain with their lives—they won’t have to choose between tissue valves that degrade over time, such that younger patients would have to undergo future surgeries, or the alternative: mechanical heart valves, which are durable, but come with the lifestyle consequences of forever being on blood thinners.

In 2013 Charhut founded Foldax with three of his compatriots from his alma mater, Edwards Lifesciences Corp., to solve these and other outstanding problems with heart valves. The founding team includes VP of R&D Jason Beith, PhD, whose recent career experience was at AorTech International PLC, where he developed polymer heart valves, and CEO Frank Maguire, who previously held the CEO position at AorTech. Fourth co-founder Mory Gharib, PhD, is the Hans W. Liepmann Professor of Aeronautics and Bioinspired Engineering at Caltech. In their past medical device experiences, founding team members frequently called upon Gharib for his expertise in fluid and vortex dynamics.   

In a field currently dominated by valves created from animal-sourced tissue (bovine, porcine, or ovine) Foldax is developing polymer valves designed to last a lifetime while eliminating the need for anticoagulants. 

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