Fist Assist Devices | Tej Singh, Founder & CEO

Speakers

Tej Singh

Tej Singh

Founder & CEO, Fist Assist Devices
Read Biography
Wearable device for vein identification and enhancement for the ESRD patient.

(Transcript)

Tej Singh  0:02  

Thank you, everybody. Thanks for the opportunity to present here. I want to thank Scott Pantel  and the LSI team deserve third you're presenting and we're really honored to be here. So I'd like to share with you the journey of fist assist. I am a vascular surgeon. I am the CEO and founder of Fist Assist Devices which we have intellectual property on ARM vein enhancement and arm vein dilation globally. I'm actually wearing the fist assist device as I'm presenting here on my left arm. In the United States Fist Assist is now cleared for superficial arm massage, and increased circulation as a 510. outside the US Fist Assist, marketed and cleared for ARM vein dilation, fistula maturation for renal failure, and we'll share some of that information. Our mission and this is a third year at LSI for our devices to increase arm vein circulation for ARM vein wellness, support chronic kidney disease and end stage renal disease and making a product available for the global community. Basically, the science is very simple veins and arteries adapt while shear stress while tensile stress and nitric oxide changes make veins bigger, make arteries bigger. This science has been studied for many years. We heard from the previous speaker that chronic kidney disease is a real global opportunity and continues to grow. One in 10 adults will have some form of chronic kidney disease 40 million Americans have currently classified as having some type of chronic kidney disease and the numbers are enlarge, increasing globally. And there is a need for a simple cost reducing patient empowering device in this space. And we think fist Assist is that device. Many patients who need dialysis need to have a fistula a fistula is a connection between the artery and the vein. And the problem with the fistula is that arteries and veins aren't always perfect, especially veins and as a vascular surgeon that led to this device in my mind. Basically, when you don't have a good vein, you're having significant costs, you're having poor outcomes and the patient experience is miserable Fist Assist, hopefully we'll attack one aspect of this, which is a very important aspect. We know that pneumatic compression helps with circulation in the legs never has a device been made for the upper arm. And the fist assist device is the world's first intermittent focal arm compression device. Seriously simple device. It's worn very comfortably below your shoulder in this particular example that I'm wearing, it's a easy application device. It's an external device it has high patient compliance, it basically goes to a pressure of 60 millimeters of mercury for 20 seconds and is very cyclic. The device is very simple. And as I said it's 510 K approved as a massager. Many patients want to make their veins bigger, they have different ideas and options from rubber bands, to Squeezy balls to even devices that basically pump blood from your neck into your arm veins to make your veins bigger. All these technologies are available to help make things bigger. And the fist assist device is a different version of all those devices. We are regulatory approved for sales all over the world and the United States of America. And we are launching, which I will describe here in a little while. Once again, we have one present patent, actually two present patents and a third patent that's pending. We are launching we just announced a major distribution deal with Australia, New Zealand, but are active in India, Europe, and Canada. We have money approved papers that highlight the benefits of pneumatic compression for this space. And these are all papers that are available showing our research recently just completed a very important FDA trial which was the fact trial basically saying that this device in three centers across the world was significant and was very powerful in dilating arm veins. So if you want arm veins bigger here's a device that is now in trials proving that the device is very simple. We had a simple three months trial with this device and I won't get into the details but basically in the forearm we enlarge the veins by point six millimeters and then the upper arm one full millimeter and those numbers are significant for procedures significant for fistula placement, significant for any type of arm vein help or enhancement or dilation that you need depending on your region of the world. These papers were immediately published by the Journal of Vascular Access and Aascular Disease Management. The vascular disease management paper showed that even with our device, the perforator veins enlarged and those are very important for endo vascular AV fistulas.Where do we think this device fits? I think the fist assist device will eventually continue to expand its role today as a dilation device. Eventually into maturation and cannulation is all to help the AV fistula in the renal space It is a one stop solution for patients, physicians, healthcare systems, techs, nurses, insurance companies. The fist assist really is one of those devices that really can enamor and engage the whole community of Renal Care. It's also a hope device. This device is one of the few devices that's a wearable that engages, educates, enables and empowers patients for their wellness and for their renal journey. A big announcement came for our device. In December, just literally three months ago, we received the FDA breakthrough device as one of the first wearables to help dilate veins for renal failure. This is a big announcement and proves that even the FDA and various regulatory people feel that arm vein care is a lacking need and opportunity for improvement in patient care with renal failure. Now, there are other markets that are developing for Fist Assist rapidly. There's the infusion care model, many patients receive cancer treatments. They don't have suitable arm veins. They need catheters, they need infusion needles. The Fist Assist space for infusion is very strong. The home phlebotomy market is increasing in in our country. And there's an indication there that physicists can help with home phlebotomy. So these are new markets that are developing for this arm wearable technology. We are based in headquartered now in Las Vegas. Initially from Silicon Valley. We have everything in place for our global launch, which is actively now in the process of developing. We have global distribution partners United States with Eros medical we just yesterday announced our distribution agreement with regional healthcare in Australia. We are available in India with Mehta focus, and of course have a partnership with Amazon in Europe. But that is also all in flux as we continue to expand arm vain, identification and wellness in America and in the world. The global opportunity for markets and renal failure, infusion and phlebotomy all rely on ARM veins. And a quality arm vein is what fist assist provides. But if you look at these markets, these markets all are struggling with poor arm vain care And in a lot of ways I'm probably one of the only vascular surgeons in the world who promotes arm vein wellness. And with arm vein wellness, you can help many patients with renal failure, cancer care and home phlebotomy. We have had this device globally presented for the last five years all over the world we have won awards with the fist assist and now with the FDA breakthrough  resignation, we are launching a very successful product for the global community. We of course are seeking funds like limited companies here we are looking for obviously ongoing Angel commercialization round joint ventures acquisition discussions, but on May 1 Fist Assist will launch a Reg D crowdfunding which really was in a lot of ways supported by LSIs ideas. We will launch with our partners core connects who are here at LSI, Eros Medical, Regulation de Resources who is also here, and we also market on May 1 a reg D equity crowdfunding campaign to not only raise awareness of this device to grow ambassadors for this device, but to do a significant sales marketing commercialization launch this summer for the Fist Assist device which will be marketed on television, marketed on the news channels and marketed on wellness. TV shows all across America. You have heard it here first, you will be seeing Fist Assist this summer on television. So where are we we have developed a device we are honored to be presenting here at LSI. We truly have a device that enlarges our veins. We have a device that's a wellness device. That's a massager that increases circulation, a device that can help renal failure patients, a device that's proven in science to benefit and now with an ongoing reg equity crowdfunding you can own a piece of Fist Assist, you can be a part of the sales and marketing campaign for a global device. Thank you very much

 

 

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