KoreClient Spotlight: Fist Assist

Fist Assist Devices, LLC, a medical device company from Las Vegas, NV, is on a mission to increase and improve arm circulation around the world. As the brainchild of Dr. Tej Singh, a vascular, endovascular, and vascular access surgeon trained at Stanford University Hospital, First Assist aims to solve a common problem he saw in many patients needing focal arm circulation benefits. Currently, the Fist Assist is an FDA 510k Authorized, minimally invasive device that a patient would wear on their arms to increase focal arm blood flow and relieve pain. However, the company had also been designated  Breakthrough Device status by the FDA for potential arm vein dilation to assist the renal failure community (Formal FDA submission pending for this Indication ).

 

“Throughout my surgical training, first at the University of Chicago, then at Sanford University, I always thought there had to be a way to make a wearable device that could help patients with their veins, especially on the arms. The basic science, clinical science, and exercise science were all there. When we’re looking at arm veins, we’re thinking of patients who need those veins for their medical care, whether it’s for IV placement, chemotherapy access, or possible dialysis access. Arm veins are really important,” said Dr. Singh, CEO and Founder of Fist Assist. In one study, it was reported that 59.3% of highly complex patients exhibit difficult venous access, meaning that for these patients, who may have heart disease, liver failure, diabetes, or other chronic conditions, healthcare providers often have difficulty when attempting to start an IV or draw blood. This often causes pain and discomfort for the patient, as multiple attempts are often required before it can be successful. 

 

“Right now patients have limited choices to improve arm circulation. If they need a medical procedure and it requires access to their arm veins, they’re at the mercy of whatever arm veins they have that distend. If someone is active and they exercise, they probably have decent veins, but if someone doesn’t have good arm veins, there was nothing out there to help them except a compression ball,'” Dr. Singh added. He continues: “Our device is a battery-operated pneumatic focal compression device that you wear below your shoulder or elbow. It gives intermittent compression to your arm up to a pressure of 60 mmHg and can be worn for 1-2 hours a day to increase circulation and decrease present and future pain in your arm in America. In the rest of the world, it can do vein dilation and help with vascular access based on regulatory approvals,” said Dr. Singh.

 

Fist Assist is currently raising capital through RegCF to finance its future FDA submissions and commercialize its product and expand its availability through direct-to-consumer, direct-to-business, and direct to big box stores. The company is excited about its crowdfunding and its upcoming FDA submissions which Will allow more patients to have this device. Outside of the US, the device has been granted CE Mark and approved to sell in Europe, Canada, Australia, and India as an arm massager, a vein dilation device, and to assist dialysis.

 

Dr. Singh said “After being designated as an FDA Breakthrough for potential vein dilation to renal failure patients in December 2021,  we need to formally show the FDA the complete dataset for eventual DeNovo authorization for the renal failure community. If we clear the final FDA hurdles, one day these wearable devices will be marketed to increase arm vein size to help renal failure patients receive better care, meaning they’re able to get a fistula or get better dialysis because they have a better arm vein. That hopefully will translate into significant changes to the way physicians treat and care for renal failure patients with better outcomes and fewer costs. Helping the global community for improved arm blood circulation is our important Mission and its important”, added Dr. Singh

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Regulation CF(RegCF), D (RegD), A (RegA+) Disclaimer


This communication may be deemed to be a solicitation of interest under Regulation CF (RegCF), D (RegD), A (RegA+) under the Securities Act of 1933, in which case the following applies:

  • No money or other consideration is being solicited, and if sent in response, will not be accepted;
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