Foldax is looking to reinvent every aspect of the heart valve—from material, to design, to manufacturing
CEO: Frank Maguire
Based: Salt Lake City, Utah
The scoop: Foldax is working on a next-gen heart valve alongside new manufacturing processes that tap robotic technology to make production more efficient and pandemic-proof.
What makes Foldax fierce: Every commercial heart valve replacement comes with trade-offs.
Heart valves made from animal tissue have limited durability, come with a risk of disease and require complex manufacturing by hand. Mechanical heart valves, meanwhile, can be durable but compromise patient quality-of-life by requiring lifelong dependence on blood thinners.
To overcome this, Foldax is developing three so-called Tria valves, which look to reimagine the heart valve by incorporating new biopolymers and position-specific valve designs that aim to last a lifetime without relying on anticoagulants.
“The novel biopolymer used in the Tria valve was purpose-built at a molecular level to withstand greater stresses than the human heart can produce, and to be biocompatible and biostable in any valve position,” explained Ken Charhut, executive chairman at Foldax.
The first of the company’s products, an aortic surgical heart valve, is currently enrolling a U.S. clinical study following an FDA go-ahead for an expanded study last October. Its second device, a mitral surgical valve, was greenlit by the FDA for a U.S. trial at the end of 2020, while the third product is a transcatheter aortic valve replacement in the preclinical testing phase.
It's not just the tech itself but the manufacturing process that makes this company fierce. Charhut said that global tissue valve manufacturing, the standard method for many heart valves, “takes hundreds of thousands of square feet and thousands of people to hand-make tissue valves—it is an incredibly complex and inefficient process.”
He points to a recent report by Edwards Lifesciences, a rival heart valve maker, which calculated that making just one of its surgical heart valves takes more than 130 steps, 150 employees, five to six weeks of testing and final packaging, and 1,100 stitches—nearly 40 days of production altogether, not counting the six weeks it takes to train each assembler.
“Contrast that to our robotic manufacturing process, which takes less than 10,000 square feet, three robots and 10 people to manufacture all the mitral and aortic surgical heart valves needed in the U.S. in one year, which is around 100,000 valves,” he said.
He figures the company's robotic manufacturing takes up less than 5% of the space and less than 1% of the people needed for tissue valve manufacturing to make the same quantity of valves.
There’s an added bonus amidst a pandemic, too: “Our robots live in a clean room and have been immune from the pandemic; they have not lost one day of manufacturing and they dramatically reduce our reliance on labor-intensive processes.”
People, however, are still needed for the overall process, and Foldax has been working through the pandemic under new methods. “Like many medical device companies, we have implemented a virtual workplace model for all employees who are not involved with R&D, quality and manufacturing," Charhut said. "For those employees, their jobs require them to come into the plant/office, so we check temperatures upon entry, wear masks, conduct socially distanced meetings and constantly clean and disinfect areas incorporating all the CDC, state and local health guidance.”
He said the company is, however, “very used to working virtually,” given that it’s based in Salt Lake City, Utah, and has an R&D facility in Irvine, California.
The medtech firm raised a $20 million Series D last summer, so an IPO might be in the cards. “It is certainly a possibility,” Charhut said of going public. “As we develop the company toward commercial status, we are always looking for the best way to capitalize that journey.”
“With our three product platforms—aortic, mitral and TAVR—we represent a disruptive pure-play covering the majority of the $100 billion public market cap attributed to this market.”
Investors: Foldax raised a $20 million Series D round in 2020 led by MemorialCare Innovation Fund, with additional contributions from the Angel Physicians Fund, Sayan Bioventures, BioStar Capital, Kairos Ventures and Caltech.