Foldax | Top Medtech Startup 2021

MedTech Outlook Magazine

Foldax
A Lasting Solution for Healthy Cardiovascular Functioning

Ken Charhut, Executive Chairman, FoldaxKen Charhut, Executive Chairman
The human heart consists of four biological valves called the pulmonary, tricuspid, mitral, and aortic valve; one for each chamber. Any damage to these delicate structures due to a disease or an accident can lead to various life threatening situations, which are obviously highly undesirable. Many medical device companies produce both biological and mechanical valves to help patients lead normal lives after their valves needed replacement. However, there is no ideal heart valve; biological tissue valves offer a better quality of life without anticoagulants, but have limited durability, and mechanical valves offer durability, but come with a lifetime of anticoagulation. It stands to reason that, while patients today are served well by the current options that exist in the marketplace, there is one patient group that does not enjoy similar privileges—those patients suffering with rheumatic fever, a disease related to the mitral heart valve. This is one of the biggest concerns the modern medical community has today, as the number of patients affected by rheumatic fever currently stands at nearly 33 million. When a person first contracts the disease, the issue may not seem dire at first. This alludes to the fact that rheumatic fever related mitral valve disease usually occurs nearly ten or 20 years after the actual illness. And now, instead of attacking the throat or causing a fever, the bacteria damage the mitral valve. The small, flap-like tissue in the heart is responsible for ensuring no backflow of blood, and if the valve fails, it may need to be replaced.

Today, Foldax, a medical device developer from Salt Lake City, has showcased a promising new product, called TRIA LifePolymer heart valve, that is designed to provide patients a lifetime of healthy heart function without the potential for multiple interventions—a better quality of life option than the traditional tissue & mechanical valves. However, the rheumatic fever mitral replacement needs remains an unmet need. “So, we see this valve as a worldwide valve, opening a solution to patients that didn’t exist before. Being able to get it into the clinic is super exciting for us.”

The issue with rheumatic mitral patients is that they tend to be in developing countries with less developed healthcare systems and have difficulty tracking and controlling anticoagulation levels. Moreover, since the procurement of effective anticoagulants is difficult in many parts of the world, the TRIA heart valve should prove to be extremely desirable in international marketplaces as well.

So, we’re talking about folks (rheumatic mitral patients) that could be anywhere from their thirties to fifties; a long life ahead of them. And so, we saw this as a very important product to bring to market

Such patients also tend to be younger as noted in first paragraph and therefore need a more durable solution—tissue valves are less durable in this younger group and if they get a mechanical valve, they have a lot more lifetime to experience a bleeding problem.

volutionize the heart valve market with new, innovative technology and manufacturing practices. The company’s proprietary biopolymer—LifePolymer—is immaculately designed to eliminate the challenges faced currently with prosthetic heart valves. Foldax has spent the last year researching and collecting data, and has recently completed enrollment of 40 patients in its surgical aortic valve study. “Additionally, they are nearly halfway completed with their surgical mitral valve study. “Being able to get our products—especially the TRIA mitral valve—into the clinical stage and providing clinicians a solution that previously did not exist to help their patient population achieve a better quality of life is super exciting,” states Charhut. Foldax’s ability to perfectly combine a biocompatible material with intuitive, well-engineered designs allows it to tackle the longevity problem of biological valves in a multifaceted manner, avoiding conventional complications. The TRIA valve mimics the physiological functions of human heart valves, producing the same level of performance as that of a patient’s original valve. Charhut and his team have taken every measure to ensure the TRIA valve’s effectiveness; they were extremely careful with the thickness of the material and how well the product could regulate blood pressure gradients. What makes Foldax all the more competitive revolves around its automated computercontrolled and robotically assisted manufacturing process which is allows for highly precise and high-volume production all year round.

With such an incredible offering to the medical community, the company stands among the leaders in the field. The promise of a lifelong biopolymer valve solution with less morbidity sounds hopefully apt for heart valve patients everywhere, and Foldax is set to be the vehicle that drives this innovation forward. Moving ahead, Charhut expects 2022 to be eventful, with new changes and additions to the company alongside continued TAVR innovation.

Top 10 Medtech Startups - 2021

Company
Foldax

Management
Ken Charhut, Executive Chairman

Description
Founded in 2014, Foldax was established to revolutionize medical devices for the structural heart market with new, innovative manufacturing practices. The company’s proprietary biopolymer—LifePloymer—is immaculately designed to eliminate the challenges faced when dealing with prosthetic heart valves

Foldax News

Foldax Spells Out Regulatory Plans for Tria Mitral Surgical Heart Valve

The Salt Lake City, UT-based company will seek approval in India first and then bring the technology to the U.S.
At a Glance
• The company hopes for its first regulatory approval in India later this year.
• The Tria mitral surgical heart valve showed promising 30-day results in a multicenter study.
• Foldax plans to leverage positive study outcomes from India to support FDA approval for its polymer heart valve.
Foldax is targeting India for the first approval of its polymer mitral surgical heart valve. The Salt Lake City, UT-based company spoke with MD+DI regarding its regulatory plans after reporting positive 30-day results from a prospective, multicenter, single-arm, clinical study of the Tria mitral surgical heart valve with LifePolymer conducted in India at the New York Valves: The Structural Heart Summit 2024.
“Our first regulatory approval will be in India,” Ken Charhut, Foldax CEO told MD+DI. “We expect that to happen later this year. One of the reasons we picked India is because it has a very high incidence of rheumatic heart disease. Rheumatic heart disease patients tend to be younger. You get it as a child and if it is untreated… some years later your mitral valve begins to kind of disintegrate. Most importantly this can happen with young women of child-bearing age. If they get a mechanical valve it necessitates the need for long-term blood thinners, which negates their opportunity to start a family.”
The Tria mitral surgical valve study enrolled 67 patients ranging from 19 to 67 years of age at eight sites across India. The device stands out because of the LifePolymer component.
“The LifePolymer material is uniquely formulated for heart valves and has been shown in animal studies to resist calcification, which can lead to stiffening leaflets that restrict blood flow through the valve,” said Isaac George, MD, Surgical Director of the Heart Valve Center at Columbia University in a press release. “Now, in the India study, imaging of the Tria mitral surgical valve in humans at 30 days shows no sign of calcifying or deteriorating leaflets. A durable non-animal tissue heart valve that may not require long-term anti-blood clotting medication could be transformative in providing new options for patients suffering from mitral valve disease,” he said.
Charhut said the study is significant because there haven’t been a great deal of studies published on surgical mitral valves lately.
“On the surgical mitral side, there hasn’t been a published study for almost 20 years until recently… when Edwards Lifesciences published the COMMENCE Trial data for their Mitrus product. So, while not exactly matching patients [COMMENCE] is a comparator for us to look at the performance of our device. We are meeting or exceeding what [Edwards] was reporting with their Mitrus Mechanical Valve at the same time point.”
The company said it will focus on obtaining approval in the US, too.
“What we’ve presented with these 30-day data is a trial that was presented under the same rigors of the same type of trial we would do in the US for approval,” Charhut said. “We’ve been partnering with FDA to bring this polymer valve to the U.S. for many years. They have been very encouraging, and we have been very open with what we’re doing. So, we’re working this year to get the final data to begin a U.S. pivotal trial of the mitral valve. We hope to begin that trial next year.”