The Latest News from Vascular Therapies

Vascular Therapies Appoints John McDermott as Chief Executive Officer

CRESSKILL, NJ (January 15, 2019) –Vascular Therapies, a biotechnology company focused on improving outcomes for patients with advanced kidney disease today announced the appointment of John McDermott as the Company’s Chief Executive Officer.

Bob Croce, Chairman of the Board of Directors of Vascular Therapies, Inc. commented “We are very pleased to welcome John as our Chief Executive Officer. John has nearly 30 years of experience in the vascular industry and has led the development and successful commercialization of multiple ground-breaking new technologies. Dr. Sriram Iyer, founder of Vascular Therapies, has done an excellent job leading the Company since inception and will continue as its Chief Scientific Officer.”

John McDermott said “I am honored to be named as Chief Executive Officer of Vascular Therapies. The company is developing a promising new local vascular drug-delivery technology intended to improve outcomes for patients with advanced kidney disease I look forward to working with the team at Vascular Therapies and collaborating with physicians to provide this important new therapy to patients worldwide.”

Mr. McDermott, brings to Vascular therapies nearly 30 years of executive leadership experience in vascular technologies. Previously he was the CEO of Endologix, a developer of aortic stent grafts. Prior to Endologix, John was the President of Bard Peripheral Vascular, a division of C.R. Bard (now owned by Beckton Dickenson). Before Bard Peripheral Vascular, John was the Chief Operating Officer at IMPRA, a developer and manufacturer of vascular grafts.

About Vascular Therapies (www.vasculartx.com): Vascular Therapies, Inc. (“VT”) a privately‑held, clinical stage biotechnology company is developing a patented sirolimus formulation for local, perivascular drug delivery. The goal of this therapeutic approach is to address the important unmet medical need of vascular anastomosis failure. This investigational therapy is currently being evaluated in a Phase 3 randomized clinical trial which is being performed under a Special Protocol Assessment (SPA).  The drug development program has received Fast Track status from the FDA and sirolimus has Orphan Drug status for the dialysis vascular access indications in the U.S. and E.U.

 

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.

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