Wearable vein dilation device could help dialysis patients

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When Tej Singh, MD, became a vascular surgeon and started performing arteriovenous fistula procedures to prepare patients for dialysis, he noticed that their veins just weren’t getting big enough. Seeing no better option for venous dilation, he decided to invent one.

Singh’s company, Fist Assist Devices, has now received FDA Breakthrough Device Designation for its Model FA-1 Fist Assist device for use as a vein dilation solution for patients who need dialysis. The wearable already has 510(k) clearance as a pneumatic compression device for arm massage and increased venous circulation in the United States, and is sold outside the United States (India, Europe , Australia and New Zealand) as a venous dilation device. It is designed to be worn on the patient’s arm and is battery operated. The device consists of a balloon and is designed to inflate and deflate to increase the size of the user’s veins.

“Basically, it’s a dilation of the veins. In America, the FDA wants us to call it a massager to increase arm circulation, which most people know means to enlarge the veins,” Singh said. DM+DI in a recent interview.

Fist Assist plans to launch a four-month crowdfunding campaign starting May 1, through a partnership with KorConX, targeting up to $2.5 million. If successful, Singh said 90% of that $2.5 million would be invested in sales marketing efforts.

To date, the company has not raised any venture capital. Singh said the company was fully funded by angel investments and had “no major debt”.

The rest of the interview is below, edited for clarity and length.

Image courtesy of Fist Assist Devices

DM+DI:WWhat was your inspiration for the device? You said you were in medical school when you invented the device, so I’m guessing it was in response to some unmet need?

Singh: I was very lucky at the University of Chicago as a medical student, and even as an undergrad, to start being exposed to connected arteries and veins in the research lab. As I was connecting these arteries and veins, we were trying to get the arteries to grow and to figure out why the arteries were getting bigger. I started to see that veins were getting bigger and vein research wasn’t really popular.

When I finished my training at Stanford in general vascular surgery and started practicing, I started making fistulas on people’s arms to enlarge their veins for dialysis and they never got big enough. So I said, ‘We need to enlarge the veins.’

It was then that I resumed my research. I went into the medical device world and nobody – Amanda, nobody – cared about arm veins. But if you think about it, they are so important to health care.

MD+DI: Especially, as you said, people on dialysis, right? I mean, it seems like a pretty critical need.

Singh: Critical. Fortunately, we were able to obtain the breakthrough designation from the FDA that we are treating a life-threatening condition like kidney failure with a new device, and [the agency said]”Your trials have shown that your device can be considered a breakthrough.”

We’re just waiting for a final clarification from the FDA on what to do, and we’ll probably submit the official request for venous dilation to help patients with kidney failure. [prepare for dialysis] This year.

MD+DI: Awesome. You mentioned that you did some testing that led to this groundbreaking designation. What kind of learnings have you gathered from this trial?

Singh: WWe have launched a global three-centre trial called the Fist Assist Clinical Trial (FACT). The FACT trial started at the University of Chicago, we added a site in Mississippi, and then we added a site in India. We basically had [close to 50] patients wear our device for three months before they need fistula treatment, so we chose patients with kidney failure. And what we showed was that there was significant enlargement if patients wore our device about 0.4 millimeters on average, or even more, to enlarge their veins so they could have a fistula. … If you take someone whose veins are maybe 1.6 millimeters and you increase it to 2.2 or 2.3 millimeters, for example, they can have a fistula instead of living with a catheter or not having a fistula.

The trial was therefore very positive, it led to our revolutionary designation, but at the same time our device does not only want to be a dialysis device. There are many patients who need chemotherapy, for example. Many women who have had a mastectomy on one side cannot use their arm for veins to draw or infuse blood on that arm, so they must switch to the other arm. … We believe we have the world’s first home physiotherapy device for arm vein health.

MD+DI: great. So how often and for how long should patients wear the device before they are ready for dialysis?

Singh: People wear it for an hour or two in the morning and two hours in the afternoon. So four hours a day. IIf you wear it for an hour in the morning and an hour in the afternoon, you probably get the benefits, because the real benefit of this device is that while it adjusts the shear stress of the wall, the tensile stress of the wall, it really changes the nitric oxide in the veins, and that helps the veins get bigger.

MD+DI: Makes sense. It sounds so simple, and as with most things like this, the question is, why didn’t anyone think of it sooner?

Singh: People say, ‘who’s the competitor?’ Because of our intellectual property, there is no competition, but the competition is people who go to the gym, people who use a soft ball, people who do strength training, people who do exercise, people keeping their arms warm. So our competition is heat, exercise, softballs, and you know, some people are arm-tightening and doing rubber band treatments, that sort of thing.

MD+DI: I got you. What are your next steps after going through the FDA process? Are you looking to develop the device further? Or maybe develop other similar devices? Will it be a technology platform or will it be standalone?

Singh: So, the company itself is at a very important moment right now. Just to clarify, we have 510(K) clearance. [for the massage indication]. And we’re now kicking this off with a [U.S. distribution] partnership with Airos Medical, they are out of the Philadelphia area, in addition to a few other international distribution partners, and we have a website where people can buy it. The hope, as we uncover the trajectory of the device, is to add new technology, perhaps a Bluetooth component. … to finally make one [reimbursable] device for Medicare so that any patient in America who feels they need their veins enlarged before dialysis can get the device. Right now, it’s a direct-to-consumer device, without a prescription, for $249 to buy, and you can have an arm vein physiotherapy device at home.

MD+DI: Perfect. I can definitely see the need for something like this in the market, I have a lot of friends who unfortunately are on dialysis, or have been in the past – I actually lost a friend the last year who had kidney disease – so I can see the need for him for sure. What kind of feedback have you received from your medical colleagues in the field?

Singh: WWe started a global path for this device in 2018…and we’ve probably shown the device at more than 20-25 conferences around the world. It’s incredible. You’ve already started by saying the most common thing doctors say: “Why didn’t I think of that?” Nurses all have stories. The family members all have stories. … They all want their patients not to have to struggle with blood tests [or dialysis] … There is an element of hope in this device. Think of the 120,000 American women today who had a mastectomy in 2021, they won’t be able to use their arm [on the mastectomy side] if they need chemotherapy [or] the blood draws.

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