Fairway, Kan. – September 26, 2018 – Flow Forward Medical Inc. (Flow Forward), a medical device company focused on improving outcomes for hemodialysis patients through the rapid creation of high-quality vascular access sites, today announced it has raised an additional $1.2 million in Series A financing from a group of investors, including Mid-America Angels, bringing the total funding raised to date to more than $8 million. Additionally, Flow Forward announced that the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH) recently awarded the company a $225,000 Phase 1 SBIR grant to continue the development of the Company’s Arteriovenous Fistula Eligibility (AFE) System™, a medical device that uses rapid non-pulsatile blood flow to dilate peripheral veins prior to the creation of arteriovenous fistula (AVF) vascular access sites.
“Currently, there are 2.5 million hemodialysis patients worldwide and a majority of these patients will experience difficulties establishing or maintaining vascular access sites,” stated Laura McCoolidge Classen, Managing Director of Mid-America Angels. “Each site failure puts patients at risk for a cycle of difficult and expensive repair or replacement procedures. We believe that Flow Forward’s approach to addressing the long-standing medical need to develop better vascular access sites has the potential to be a powerful solution for patients.”
“We are grateful for the support from our investors and the National Institutes of Health as we work to develop innovative products to establish high-quality vascular access sites for hemodialysis,” stated F. Nicholas Franano, President and CEO of Flow Forward. “These additional resources will support the advancement of the AFE System into a first-in-human clinical trial, which we plan to initiate in 2019, and where we hope to show the potential of the AFE System to help physicians rapidly create fully mature and usable AVF vascular access sites that are reliable and long-lasting.
About Hemodialysis and Vascular Access Failure
Hemodialysis is a lifesaving treatment for more than 2.3 million patients worldwide with end-stage renal disease (ESRD). Before patients can receive hemodialysis, a reliable vascular access site must be created. An AVF, which surgically connects an artery to a vein, typically in the arm, is preferred over other forms of vascular access due to improved patient survival, reduced complications and hospitalization rates, and large reductions in the cost of care. However, nearly 40 percent of U.S. hemodialysis patients do not currently use an AVF for vascular access, primarily due to inadequate vein diameter and high rates of AVF failure (up to 60 percent) following conventional surgical placement. There are currently no products approved by the U.S. Food and Drug Administration (FDA) to increase AVF eligibility or unassisted AVF maturation, the process by which an AVF becomes ready for hemodialysis.
About Flow Forward Medical
Flow Forward is developing a novel approach to rapidly establish high-quality vascular access sites for hemodialysis. Our AFE System comprises a small external blood pump designed for temporary use to stimulate flow-mediated vein dilation to make more patients eligible for an AVF and increase success rates after surgery. Establishment of a reliable AVF reduces morbidity and mortality in hemodialysis patients, as well as the overall cost of care. For additional information, please visit www.flowforwardmedical.com.
F. Nicholas Franano, MD, CEO
Flow Forward Medical, Inc.
MacDougall Biomedical Communications