Brookhaven Medical, Inc., an Atlanta based medical device company with interests in dialysis devices and advanced wound care, announced today that it has made a strategic investment of up to $5 million into CreatiVasc Medical, Inc. of Greenville, South Carolina.
CreatiVasc Medical has developed an innovative Hemoaccess Valve System® which is currently undergoing clinical trials at Johns Hopkins Medicine in Maryland. The new device allows blood flow to a dialysis graft to be selectively turned on for dialysis, then turned off afterward, restoring normal circulation between dialysis treatments. Currently, patients with dialysis grafts universally suffer a high rate of complications that frequently require surgical intervention. CreatiVasc believes these expensive and repetitive complications can be significantly reduced when normal circulation is restored in these patients when they are not on dialysis.
After an extremely competitive evaluation process, CreatiVasc Medical was selected by the FDA in 2012 as one of the three companies in the U.S. to be included in its Innovation Pathway program. This new FDA initiative was created to accelerate important breakthrough technologies through the regulatory approval process without compromising patient safety.
The FDA believes these innovations can be “disruptive technologies” with great potential to improve patient outcomes and also result in significant savings in healthcare costs. The FDA made a decision to initially launch the Innovation Pathway with a focus on End Stage Renal Disease, a $47 billion chronic disease.
John Feltman, chairman and CEO of Brookhaven Medical and a “serial medical device entrepreneur,” has joined the Board of CreatiVasc Medical.
“We believe that once approved, the CreatiVasc Hemoaccess Valve System will bring innovation to a field that has had very little over the last 30 years” said Mr. Feltman, calling it “a very important and valuable new device that can greatly improve the quality of life for dialysis patients while providing significant savings for Medicare by reducing the number of surgical interventions required.” The cost of End Stage Renal Disease is covered by Medicare regardless of the patient’s age.
Mr. Feltman praised the inventor of the device, Dr. David Cull, a vascular surgeon at Greenville Health System and Clinical Professor with the new University of South Carolina School of Medicine at Greenville, saying that “Dr. Cull, CEO Steve Johnson, and the rest of the CreatiVasc team has done an outstanding job in developing this important new technology over the last six years.” CreatiVasc CEO Steve Johnson said that, “the relationship that CreatiVasc has developed with Brookhaven is a model of how investors, business managers, and clinicians can work together to improve patient care with new technologies while at the same time reducing the healthcare cost burden in our country.”