An additional $1.2 million in Series A financing puts Fairway-based medical technology company Flow Forward closer to human clinical trials for hemodialysis patients, said Dr. Nicholas Franano.
The new investment — from a group of investors, including Mid-America Angels — brings Flow Forward’s total funding raised to date to more than $8 million, said Franano, founder of the pre-revenue startup, which appeared on Startland’s recent Top Venture Capital-Backed Companies in Kansas City list.
Flow Forward also announced a $225,000 Phase 1 SBIR grant from the National Institute of Diabetes and Digestive and Kidney Diseases, part of the National Institutes of Health. The funds should bolster development of Flow Forward’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.
“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,” said Franano, who serves as president and CEO. “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.”
The 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, according to the company, which was founded in 2014.
Establishment of a reliable AVF reduces morbidity and mortality in hemodialysis patients, as well as the overall cost of care — promising outcomes, said Laura McCoolidge, managing director of Mid-America Angels.
“Currently, there are 2.5 million hemodialysis patients worldwide and a majority of these patients will experience difficulties establishing or maintaining vascular access sites,” she said. “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.”
No products currently are 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, according to Flow Forward.