Fist Assist Devices has announced a three-year affiliation with Regional Health Care Group to commercialise and launch sales of the Fist Assist Model FA-1 device in Australia and New Zealand.
The FA-1 device is a wearable, patent-protected, intermittent compression device that has European CE-mark clearance for use in conditions where vein dilation is desired in patients that will require or have already undergone arteriovenous fistula placement for eventual haemodialysis.
In addition, it is intended to help with infusion arm vein access for chemotherapy, radiology or phlebotomy access support. FA-1 also recently received US Food and Drug Administration (FDA) Breakthrough Device designation for presurgical vein dilation in patients with end-stage kidney disease.
“We are thrilled to combine forces with Regional Health Care Group for the official launch of the Fist Assist Model FA-1 device in Australia and New Zealand,” said Tej Singh, chief executive officer and founder of Fist Assist. “This is a huge milestone, as we now have a committed, dedicated, and exceptional commercialisation arm that is poised to deeply penetrate the Oceania market.”
“We are excited to distribute and commercialise the innovative FA-1 device,” said Scott Clissold, national business development manager of Regional Health Care Group. “We have been watching the Fist Assist technology and patiently awaiting the right time to commercialise a ground-breaking, market-changing and innovative device that will improve the patient journey with renal and cancer care in Australia.”