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Vascular Therapies Announces Preliminary Results from its Phase 3 AV Fistula Study

CRESSKILL, NJ (Nov. 9, 2017) – An innovative, investigational treatment approach is showing the potential to address an important, unresolved problem encountered by patients with kidney failure on dialysis.

At the recent annual meeting of the American Society of Nephrology (ASN), Vascular Therapies, Inc. presented preliminary results relating to analysis of the first 18 (open-label) patients from its U.S. Phase 3 study.

The study is testing the effect of the Sirolimus-eluting Collagen Implant on arterio-venous fistula outcomes. The results suggest this investigational treatment approach may reduce a patient’s dependence on the extended use of catheters – the way most patients begin dialysis treatment.

Currently in the U.S., about 80% of patients with kidney failure begin dialysis using a catheter. Catheter use is associated with a high incidence of infection, mortality and morbidity and may add to the cost of patient care. The National Kidney Foundation’s preferred alternative to the catheter is an arterio-venous (AV) fistula.

To create an AV fistula, the surgeon connects an artery and vein, generally in the forearm near the wrist or the upper arm near the elbow. While patients wait for their AV fistula to mature, (fistula maturation signals its suitability for dialysis use), they continue dialysis using a catheter.

In the clinical trial, using Vascular Therapies’ proprietary system, surgeons deliver the drug sirolimus to the AV fistula at and around the regions where the vein and artery are surgically connected. The trial is testing whether this treatment approach will increase the proportion of fistulae that become suitable for dialysis use, thereby reducing the patient’s dependence on catheters.

Nationally, between 40% and 60% of AV fistulae are not suitable for dialysis. In the ongoing Vascular Therapies’ trial, 89% (16/18) of the AV fistulae in the open label patients were suitable for dialysis use at six months. Additionally, currently in the U.S., dialysis patients remain on catheters for a median time of 111 days. In the open label patients, this wait time was reduced by about 40% to a median of 64 days.

“These encouraging outcomes from the 18 open label patients are consistent with what was seen in the 30-patient, single arm Phase 2 study,” said Dr. Maria DeVita, Senior Nephrologist at Lenox Hill Hospital in Manhattan and medical monitor for the study. “In the Phase 2 study, the median time to first dialysis was 42 days and 76% of the fistulae were suitable for dialysis at six months.”

Dr. Nelson Kopyt, Chief of Nephrology at Lehigh Valley Hospital in Allentown, PA and a study investigator said, “Improving the proportion of fistulae that are suitable for dialysis and reducing catheter dwell times have remained frustratingly elusive goals. A positive trial and product approval will be transformational for hemodialysis vascular access management.”

Vascular Therapies is currently enrolling patients in its Phase 3 randomized controlled study which is being performed under a Special Protocol Assessment (SPA). Topline results are expected in 2019.