Flow Forward Medical, armed with promising data, has a device that aims to help make more patients eligible for arteriovenous fistula — connecting an artery to a vein, and eventually hemodialysis. If successful, it would also help the more than 60 percent of patients with maturation failure, meaning they can’t get AVF without further surgery. Hemodialysis is the most viable treatment available for end-stage renal disease.
Flow Forward’s device, the Arteriovenous Fistula Eligibility (AFE) System, doesn’t have a sexy name, but it does have promising ROI opportunities: There are nearly 400,000 ESRD patients in the U.S., with more than $34 billion spent on treatment annually.
AVF is the National Kidney Foundation’s preferred method of treatment, because of its lower rates of infection, complication and mortality. That also means lower costs.
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But to be eligible for AVF, a patient must have a vein large enough–at least 6 mm–to make the connection and the blood flow must increase to 600 ml a minute, CEO Dr. Nick Franano said.
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, 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.
In the data collected so far, the PMA-path device could dilate the vein as much as 1 mm a day, creating “a big, beautiful vein to make an AVF with,” Franano said.
Because of the dilation the device could afford, the company hopes to push many more of the 45 percent of American patients ineligible for AVF toward eligibility. Plus, more than 60 percent of would-be candidates have maturation failure, meaning they have an AVF they can’t use without further surgery.
The company spun out from Novita Therapeutics earlier this year, and is now on the hunt for $6 million to $9 million for Series B for its first in-man trial. Flow Forward’s major investors have already committed to Series B, he said. The company raised $4.5 million in tranches for its Series A, closed in 2013. Franano has raised plenty of money for prior projects, including his Johns Hopkins spinout Proteon Therapeutics (yes, this Proteon Therapeutics).
Current investors include: Open Prairie Ventures, Kansas Bioscience Authority and individual and groups of angel investors.
Flow Forward is headquartered in Olathe, Kansas, but has its R&D lab as a presence in Boston.
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