Fist Assist Devices, LLC Announces Completion of the Non-Significant Risk FACT Trial

Significant Superficial Arm Vein Dilation Reported with the FA-1 Device

LOS ALTOS HILLS, Calif.--(BUSINESS WIRE)--Fist Assist Devices, LLC, announces completion of the non-significant risk FACT Trial (Fist Assist Clinical Trial). FACT evaluated the use of an intermittent pneumatic compression device, model FA-1, that was developed by Fist Assist Devices, to promote vein dilation in patients with kidney disease, to enable creation of arteriovenous fistulas and to ensure the safety of the device in this patient population.

“We are ecstatic to complete FACT and are very thankful to all patients, physicians, and hospitals that worked to complete this trial during the COVID pandemic, which was possible as the device is a patient centric, wearable in the home” said Mary Hammes, D.O., Primary Investigator of the FACT Trial and Associate Professor of Medicine and Director, Chronic Hemodialysis, at the University of Chicago. “This is a landmark, global trial evaluating the effectiveness of the FA-1 intermittent compression device on pre-surgery, stage 4 chronic renal failure patients. Patients were enrolled in three locations: The University of Chicago Medical Center, Chicago, Illinois; a medical clinic in Greenwood, Mississippi under the direction of Dr. John Lucas; and MS Ramaiah Medical Center under the direction of Dr. Sanjay Desai in Bangalore, India. On preliminary analysis, most enrolled patients showed statistically significant superficial vein dilation (p < .05) without any safety concerns. This will be a gamechanger for the over 40 million Stage 4 chronic kidney disease patients in the United States alone because larger veins will help ensure better AV Fistulas, whether created surgically or by new EndoAVF procedures. This data will also be the foundation for additional indications of use for the Fist Assist device and continues to add more information on novel ways to increase pre-surgery vein size and distensibility for eventual dialysis.”

“This is groundbreaking research that will drive efficiencies in the ESRD community as it really proves that intermittent compression enlarges superficial veins, and larger veins provide better surgical / EndoAVF options and outcomes” said Dr. John Ross, Director of Regional Medical Center in South Carolina and Inductee in the American College of Surgeons and Academy of Master Surgeon Educators. “Plus, with the recent focus of fistulas being created percutaneously through EndoAVF technology, this data is critically important as larger, pre-surgical veins will enable more patients to be candidates for the less invasive EndoAVF procedures. This data could and should even drive CMS reimbursement as larger superficial veins will help improve outcomes, which drastically reduces the cost burden on the patient, providers, and the entire healthcare system.”

About Fist Assist Devices, LLC

Fist Assist Devices is a privately held company from Silicon Valley, California that has developed the Fist Assist technology over the past 30 years. The Fist Assist technology is patent protected and is focused on developing an intermittent, external wearable pneumatic compression for arm massage and increased vein circulation in the United States and increased forearm vein enhancement and AV fistula dilation/maturation in India, Canada, Europe, Australia, and New Zealand. The Fist Assist FA-1 device is distributed in India via an alliance with Medifocus (http://medifocusindia.com) and in the United States via an alliance with AIROS® Medical, Inc. (www.airosmedical.com)

For further information, connect to www.fistassistdevices.com.