CreatiVasc Medical selected as one of first three companies for FDA’s Innovation Pathway
Greenville-based CreatiVasc Medical has been selected as one of the first three companies for the FDA’s Innovation Pathway program that uses collaboration with innovators to speed important medical devices to market while safeguarding patient safety.
“Being selected from all the other great companies out there to be part of FDA’s new program reinforces our high expectations for our system and validates the outstanding confidence of CreatiVasc’s local investors, “ said Steve Johnson, President and CEO of CreatiVasc.
The company has developed an innovative device for dialysis patients called the Hemoaccess Valve System that attaches to a patient’s arterial graft. It allows blood flow to be turned on through the patient’s graft only when it is needed for dialysis, then turned off afterward, alleviating much of the suffering and complications that come from current tubes or “grafts.”
The valve system device is currently in Phase I human clinical trials.
The FDA competitively evaluated innovations being developed in the End Stage Renal Disease field and selected CreatiVasc and its Hemoaccess Valve System because of its potential to improve the quality of life of dialysis patients as well as reduce complications and costly interventional surgery.
FDA officials said they were “impressed with the company’s commitment to serving this patient population.”
The agency selected one of the most dreaded and costly chronic diseases, End Stage Renal Disease, for the focus of the first rollout of the Innovation Pathway program.
Kidney failure and associated dialysis costs the U.S. healthcare system over $46 billion annually and the highest concentration of the disease is here in the Carolinas and Georgia.
Many dialysis patients have a Teflon tube implanted in their arm to provide vascular access for dialysis. They present a constant challenge because they frequently clot and require costly interventional surgery.
The average annual cost of dialysis and its associated complications for the 380,000 dialysis patients in the U.S. is more than $82,000 per patient, according to the 2011 U.S. Renal Data Survey,
The Innovation Pathway program will provide a totally new way for medical device companies and FDA to collaborate to assure that promising new technologies are rigorously reviewed but are also guided through the FDA device approval process as rapidly as possible without compromising patient safety: the ultimate goal of the companies selected and the agency.
CreatiVasc was founded in Greenville, SC in 2004 by Dr. David Cull, a vascular surgeon with the Greenville Hospital System. The company began full-time operations in 2007. During that time, the Hemoaccess Valve System has matured from drawings on paper to a rough prototype to a finished device that is now in Phase I human clinical trials at the Greenville Hospital System University Medical Center. The company has multiple issued patents on the device both in the U.S. and around the world.
Johnson said that 95% of their investors were from the Upstate of South Carolina. He also reinforced the value to the company from two capital infusions from SC Launch, a start-up seed capital program run by SCRA’s Technology Ventures sector. Based on a review of its SC Launch program, SCRA was named the national nonprofit of the year in 2011. Additionally, the program was selected by Forbes magazine as one of the top entrepreneurial support programs in the country. Johnson also lauded support from SCBIO, the state’s biotechnology industry organization.
“We congratulate CreatiVasc on this significant accomplishment and are pleased to be a part of their success,” said SCRA CEO Bill Mahoney. “The company’s partnership with the SC Launch program, the Greenville Hospital System, SC Bio and Clemson University is the perfect example of Knowledge Economy development in South Carolina. We look forward to CreatiVasc’s continued progress.”
CreatiVasc and FDA will begin the collaboration behind the company’s Hemoaccess Valve System in early May