When veins are hard to access during hemodialysis procedures, the morbidity increases. Kansas hemodialysis startup Flow Forward Medical is developing a way to ease access to the veins, and just raised a new chunk of capital.
It just tacked on another $1.3 million to its previous $4.4 million Series A to build out a small, minimally invasive blood pump system that’s meant to quickly dilate the peripheral veins to make arteriovenous fistula surgery easier.
The startup also just raised a $225,000 Phase 1 SBIR grant, with aims to test peripheral vein dilation. The device is called the Arteriovenous Fistula Eligibility System. It’s not yet FDA approved.
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MedCity News profiled Flow Forward Medical last year:
The AFE System is essentially a blood pump with an external controller. Instead of taking blood from the artery to the vein, the blood’s taken from the pump, “dramatically” reducing the amount of scar tissue, [CEO Nick] Franano said. Right now, the standard of care is for the blood’s pulsitility to stretch the vein: Every time the heart pumps, the vein stretches a little bit. That results in “a lot” of scar tissue, Franano said.
Typically, dilation of the vein is dependent on the speed of blood, resulting in a “Goldilocks phenomenon,” Franano said. But, a blood pump that works more naturally with the body’s processes would allow for more control over the speed of the blood, and therefore more control over dilation and scarring. The speed of bloodflow can be adjusted as the vein dilates.
The AFE System has the potential to sufficiently dilate the vein, creating a vascular access site for the procedure, in less than two weeks compared to about 12 weeks today, Franano said. In a recent comparative study, Franano said the vein dilation in the AFE System was 20 times faster than dilation achieved with traditional surgery and the scar tissue that formed in the vein was 75 percent less.
“Many of the two million patients on hemodialysis worldwide who undergo conventional surgical AVF creation each year experience vascular access site failure, which is associated with increased morbidity,” Tom Krol, Managing Director at KBA and a member of Flow Forward’s board of directors, said in a statement. He continued:
In early studies conducted in a challenging nonclinical model, the company has shown much more rapid vein dilation, large increases in blood flow and a significant reduction in vein wall scarring, when compared with conventional AVF creation. We believe that the AFE System has the potential to drive broad increases in AVF eligibility as well as large reductions in AVF failure.
