MPO Staff03.07.22
Foldax Inc. is touting positive clinical results for its TRIA biopolymer heart valve.
An early feasibility study conducted on the first polymer valve to be implanted in humans showed TRIA met all primary endpoints at one year, including improvement in valve effective orifice area (EOA), clinically significant improvement in New York Heart Association (NYHA) class, and safety. “We are pleased the TRIA valve demonstrated the excellent hemodynamics it was designed to achieve and that we expected to see in its first clinical study,” stated Frank Maguire, CEO of Foldax. “The combination of our proprietary polymer, optimized design and robotic manufacturing promises a level of performance, durability and precision that has never been seen before in a prosthetic heart valve. We look forward to seeing results from the expanded study early next year and to moving forward with our U.S. pivotal trial in the next year.”
The TRIA valve combines the company’s proprietary biopolymer—LifePolymer—with a valve design intended to resist calcification, withstand stresses and strains without failure, and restore patient quality of life without requiring lifelong use of anticoagulants.
Summarizing the study results, Dean Kereiakes, M.D., FACC, FSCAI, president of The Christ Hospital Heart and Vascular Institute at The Christ Hospital Health Network in Cincinnati, Ohio, said, “The TRIA valve demonstrated marked and sustained improvements in transvalvular gradients, valve EOA and NYHA clinical class out to one-year following valve implant. Safety outcome measures appear comparable to those reported for bioprosthetic (animal tissue) heart valves.”
Detailed one-year results from the early feasibility study indicated:
“The heart valve options we have today are not perfect. Mechanical valves require daily use of anticoagulants that may infringe on patient lifestyles and are associated with significant bleeding complications, while tissue or bioprosthetic valves have limited durability. The biopolymer valve we studied offers the potential to improve patient outcomes, as the polymer and design work together to optimize the properties and performance of the valve leaflets,” said Kereiakes.
The company’s second device, a mitral surgical valve, was approved by the FDA for a U.S. early feasibility study last year and is currently enrolling patients. The third valve product is a transcatheter aortic valve replacement (TAVR), which is in the pre-clinical testing phase.
The TRIA valves are the first and only heart valves to be robotically manufactured, reducing variability and enabling high precision, repeatability and quality, while substantially improving the economics of heart valve manufacturing.
The Tria heart valve is considered investigational in the U.S. and is not available for commercial sale in the United States.
Headquartered in Salt Lake City, Foldax develops surgical and transcatheter valves. Foldax investors include Angel Physicians Fund, Biostar Capital, Caltech, Kairos Ventures, Memorial Care Innovation Fund and Sayan Bioventures.
An early feasibility study conducted on the first polymer valve to be implanted in humans showed TRIA met all primary endpoints at one year, including improvement in valve effective orifice area (EOA), clinically significant improvement in New York Heart Association (NYHA) class, and safety. “We are pleased the TRIA valve demonstrated the excellent hemodynamics it was designed to achieve and that we expected to see in its first clinical study,” stated Frank Maguire, CEO of Foldax. “The combination of our proprietary polymer, optimized design and robotic manufacturing promises a level of performance, durability and precision that has never been seen before in a prosthetic heart valve. We look forward to seeing results from the expanded study early next year and to moving forward with our U.S. pivotal trial in the next year.”
The TRIA valve combines the company’s proprietary biopolymer—LifePolymer—with a valve design intended to resist calcification, withstand stresses and strains without failure, and restore patient quality of life without requiring lifelong use of anticoagulants.
Summarizing the study results, Dean Kereiakes, M.D., FACC, FSCAI, president of The Christ Hospital Heart and Vascular Institute at The Christ Hospital Health Network in Cincinnati, Ohio, said, “The TRIA valve demonstrated marked and sustained improvements in transvalvular gradients, valve EOA and NYHA clinical class out to one-year following valve implant. Safety outcome measures appear comparable to those reported for bioprosthetic (animal tissue) heart valves.”
Detailed one-year results from the early feasibility study indicated:
- Mean pressure gradients improved from an average of 33.3 mmHg at baseline to an average of 9.5 mmHg at one year
- Effective orifice area Increased from 1.2 cm2 at baseline to 2.0 cm2 at one year
- Patients’ NYHA classification was improved and sustained, with 66.7 percent of patients designated Class I at one year versus 33.3 percent at baseline
- No patients were NYHA Class III or IV at one year
- There were no device-related deaths
“The heart valve options we have today are not perfect. Mechanical valves require daily use of anticoagulants that may infringe on patient lifestyles and are associated with significant bleeding complications, while tissue or bioprosthetic valves have limited durability. The biopolymer valve we studied offers the potential to improve patient outcomes, as the polymer and design work together to optimize the properties and performance of the valve leaflets,” said Kereiakes.
The company’s second device, a mitral surgical valve, was approved by the FDA for a U.S. early feasibility study last year and is currently enrolling patients. The third valve product is a transcatheter aortic valve replacement (TAVR), which is in the pre-clinical testing phase.
The TRIA valves are the first and only heart valves to be robotically manufactured, reducing variability and enabling high precision, repeatability and quality, while substantially improving the economics of heart valve manufacturing.
The Tria heart valve is considered investigational in the U.S. and is not available for commercial sale in the United States.
Headquartered in Salt Lake City, Foldax develops surgical and transcatheter valves. Foldax investors include Angel Physicians Fund, Biostar Capital, Caltech, Kairos Ventures, Memorial Care Innovation Fund and Sayan Bioventures.