The story of 4C Medical Technologies—like so many great startup origin stories—starts in a garage.

In 2016, Saravana Kumar (Ph.D. ’11) was leading R&D efforts at a startup called Coventus, which was developing a suite of medical devices for orthopedic surgery.

That’s when he was contacted out of the blue by Jeffrey Chambers, M.D., director of research at the Metropolitan Heart and Vascular Institute in Minnesota. Chambers had done his internship/residency in internal medicine at the U of M, along with a Cardiovascular Diseases and Interventional Cardiology Fellowship. Kumar had studied mechanical engineering at the University, where he was known as Saravana Kumar Balasubramanian.

Chambers had patented an idea for a new kind of artificial heart valve designed to treat mitral valve regurgitation, or mitral regurgitation (MR), a disease where blood leaks backward into the heart. He was looking for an engineer who could bring the concept to life. Chambers contacted Kumar because of his prior work at medical device giant St. Jude Medical, where Kumar had helped develop and commercialize one of the most widely used artificial heart valves ever created.

Chambers wanted to know whether Kumar could do it again, albeit with a radically new type of artificial valve designed for a different part of the heart.

For Kumar, it was too enticing an offer to pass up.

“It was a completely out-of-the-box idea; no one else is doing anything like this,” Kumar says. “After Jeffrey reached out to me, we decided to try out the idea and built a couple of prototypes in my garage so we could try it out with animals. When we realized that it was actually working, we decided to move forward with 4C, raise some money, and start hiring.”

Each year, about 250,000 people in the U.S. are diagnosed with severe MR, and an estimated 10 million people live with the disease globally. It’s the most common type of heart valve disease, and although the symptoms typically start out mild—shortness of breath and some light chest pain—as the disease progresses, itoften leads to heart failure and, soon after, death.

The human heart consists of four chambers—a right and left atrium and a right and left ventricle—that work together to circulate blood through the body. In a healthy heart, blood flows into the right chamber and is pumped into the lungs to be oxygenated before returning to the left chamber to be pumped into the rest of the body. The mitral valve is one of four valves, and if it doesn’t close properly when the heart contracts, blood streams back into the pool in the left atrium rather than being pumped into the body by the ventricle.

One common way to treat MR is to replace the patient’s faulty valve with an artificial one. That involves inserting a catheter carrying the artificial valve into the patient’s leg and snaking it up to the heart for insertion.

“The challenge [with that] is that you’re working in a chamber that is the engine for your heart, and it’s incredibly dynamic,” says Kumar. “What a lot of companies try to do is take tissue from a cow or a pig, put it on a metal frame, and try to completely replace the patient’s existing valve. But if you don’t insert it correctly in this very dynamic environment, then you can end up blocking the flow of blood to the body and creating more issues for the patient.”

This problem is compounded by the fact that most MR patients are elderly, which limits their tolerance for invasive treatments such as catheters or open-heart surgery.

First as vice president of R&D of the Maple Grove, Minnesota-based 4C Medical, and now as president and CEO, Kumar has spent the last seven years leading a team of engineers who are developing this new valve. Chambers, chair of the board, noted in 2022 when Kumar was named CEO that the company believed his focus and goal-oriented approach would be crucial as 4C moved into its next growth stage of enhancing the company’s transseptal delivery system.

The device, called the AltaValve, looks something like a miniature Fabergé egg, and its unique latticed design allows it to avoid many of the complications of earlier artificial mitral valves.

And unlike conventional artificial mitral valves, which are inserted directly into the annulus—the ringlike structure of tough, fibrous tissue that forms the foundation of a heart valve—4C’s AltaValve is placed above it. This allows it to flex in sync with the heart’s contractions and avoids complications that come with placing a rigid structure directly into the valve.

“The question was whether it would actually help patients or create any new complications. But over the past six years, we’ve generated a lot of data to show that it actually works and benefits patients,” Kumar says.

In 2022, Kumar and his team inserted the device into a human patient for the first time. Since then, the company has treated more than 75 MR patients as part of a phase I clinical trial with promising results. Last year, the FDA granted the AltaValve “breakthrough device” status, which will help accelerate the device’s progress through a much larger phase II clinical trial, a critical milestone toward getting the device into the hearts of millions of patients in need.

In October 2024, 4C began enrolling patients in something called ATLAS (A TransseptalLeft Atrial System for Treatment of Mitral Regurgitation) trial in Europe andthe U.S. Kumar says collecting enough patient data to show the FDA that the device is both safe and effective will take another two to three years. It’s a familiar journey for Kumar, who has brought several medical devices to market throughout his career. But none of them have captured this engineer’s heart quite like AltaValve.

“It’s not often that you get to work on a technology that is truly different from what everyone else is doing and I think that’s beautiful,” says Kumar. “We’re showing that you can do something very different and be successful. Structural heart problems are very challenging to solve, but coming up with solutions to treat these patients is something that I truly enjoy."

Daniel Oberhaus is a freelance writer in Brooklyn, New York.

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