June 23, 2020 – Heart valve start-up Foldax is looking to reinventing several aspects of the prosthetic heart valve, from material used, design and use of robotic manufacturing, announced the closing of a $20 million Series D round of funding.
The use of funds will continue to add patients to the recently completed a clinical trial for the company’s surgical aortic Tria biopolymer heart valve, initiate and enroll patients into the clinical trial for the surgical mitral valve, as well as continue development of the transcatheter aortic valve replacement (TAVR) device for the first-in-man clinical study.
The Tria valve reimagines the heart valve by incorporating a new, proprietary biopolymer, what the vendor calls LifePolymer, with an innovative valve design intended to eliminate calcification, withstand stresses and strains without failure, and restore patient quality of life without lifelong use of anticoagulants. Tria is also the first heart valve to be robotically manufactured, reducing variability, enabling high precision, repeatability and better quality control, while substantially improving the economics of heart valve manufacturing.
MemorialCare Innovation Fund (MCIF) led the round, with Angel Physicians Fund (APF) and Sayan Bioventures joining as new investors. All existing investors also participated in the round, including BioStar Capital, Kairos Ventures and Caltech. Brant Heise, MCIF Managing Director, joined the board in conjunction with the investment.
“We are enthusiastic about the potential for Foldax’s technology to positively impact healthcare systems in our drive to enhance both clinical outcomes and quality of life for patients suffering from cardiovascular disease," said Brant Heise, Managing Director of MCIF. "The creativity demonstrated by the company in overcoming traditional obstacles has been striking, and we look forward to being part of its continuing innovation of the heart valve space.”
“We are excited to support Foldax in the development of a truly revolutionary heart valve technology that has the potential to transform cardiac care on a global scale. We have been impressed by the Tria heart valve design and the impact it may make in the lives of patients suffering from valvular heart diseases. We applaud the tireless efforts of a very experienced management team at Foldax in making this a reality,” explained Manish Bhandari, M.D., managing partner at APF and Sayan Bioventures.
“We are pleased that our technology has attracted the interest of healthcare provider-based investors who have recognized its broad potential to improve the treatment of valvular disease. These partners will allow us to accelerate our development and clinical plan,” said Foldax CEO Frank Maguire. “Calcification is a root cause of heart valve failure, in both human and artificial tissue valves. We asked ourselves, if we could start from scratch, what would we do differently to solve this and other persistent heart valve problems? The result was the invention of a new biopolymer, a purpose-built valve design and the first use of robotic manufacturing in heart valves, which are brought together in the Tria valve,” he continued.
Headquartered in Salt Lake City, Utah, Foldax wants to reinventing many aspects of the artificial heart valve, from material to design to manufacturing, to develop surgical and transcatheter valves designed to last a lifetime addressing historical tradeoffs. The company is developing its Tria valve technology in partnership with Caltech and CSIRO, Australia’s science agency.
For more information: https://foldax.com/
FDA Approves IDE Study for Foldax Biopolymer Heart Valve Platform
October 23, 2024 
