Flow Forward Medical Inc. Closes $1.3 Million Of Additional Series A Financing And Appoints Kurt Dasse To The Board Of Directors

Company Awarded $225,000 in NIH Grant Funding to Support Product Development

OLATHE, Kan.--(BUSINESS WIRE)--Flow Forward Medical Inc. (Flow Forward), an early-stage company focused on improving outcomes for hemodialysis patients through the rapid creation of high-quality vascular access sites, today announced that it has closed a $1.3 million round of additional Series A financing, led by existing investor, the Kansas Bioscience Authority (KBA). Flow Forward previously raised $4.4 million in Series A funding, bringing the total in equity funding raised to date to approximately $5.7 million. Series A proceeds will be used to continue the development of Flow Forward’s Arteriovenous Fistula Eligibility (AFE) System™, a small, minimally invasive blood pump system designed for temporary use to rapidly dilate peripheral veins through flow-mediated vascular remodeling prior to arteriovenous fistula (AVF) surgery.

“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. With its AFE System, Flow Forward is addressing issues known to contribute to AVF failure”

Flow Forward also announced today that it will receive a $225,000 Phase I Small Business Innovation Research (SBIR) grant from the National Institutes of Health (NIH). The SBIR funding will be used to test peripheral vein dilation with the AFE System prior to AVF creation in a nonclinical model.

“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. With its AFE System, Flow Forward is addressing issues known to contribute to AVF failure,” said Tom Krol, Managing Director at KBA and a member of Flow Forward’s board of directors. “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.”

Flow Forward also announced today the appointment of Kurt Dasse, PhD, to its board of directors. Dasse has spent nearly three decades conducting cardiovascular research and developing products to treat heart, lung and kidney diseases. He is currently President and CEO of GeNO LLC, a biopharmaceutical company developing next-generation delivery systems for inhaled nitric oxide, a pharmacologic blood vessel dilator. He was previously President and CEO of Levitronix LLC, a developer and manufacturer of rotary blood pump systems for cardiopulmonary support that was acquired by Thoratec Corporation in 2011.

“I am pleased to have additional financial resources from KBA and the NIH’s SBIR program to accelerate the development of the AFE System. I also welcome Kurt to our Board. His decades of industry experience and deep domain experience in cardiovascular biology and physiology will be invaluable as we work to realize our goal of providing physicians more and better options when creating vascular access sites for hemodialysis patients,” said F. Nicholas Franano, MD, President and CEO of Flow Forward.

About Hemodialysis and Vascular Access Failure
Hemodialysis is a lifesaving treatment for end-stage renal disease (ESRD), which affects an estimated two million patients worldwide. Before patients can receive hemodialysis treatment, a reliable vascular access site must be created. An arteriovenous fistula (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, approximately 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 ineligibility 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. The AFE System is a small, external blood pump designed for temporary use to stimulate flow-mediated dilation to make more patients eligible for an arteriovenous fistula (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.

The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

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