FDA selects CreatiVasc for new Innovation Pathway program

Greenville-based CreatiVasc Medical has been selected as one of the first three companies for the FDA’s new 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 and universities 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®, which has the potential to significantly reduce the complications, expense and suffering associated with End Stage Renal Disease patients on dialysis.
The valve system device is now in Phase I human clinical trials. Unlike current dialysis-access graft devices which are prone to clotting and early failure, the CreatiVasc technology is implanted when a patient’s access graft is created and allows blood flow to be turned on through the patient’s graft only when it is needed for dialysis, then turned off afterward. CreatiVasc and FDA will begin their collaboration in early May. Johnson said he hoped the device would be in the market and available for patients within 24 months.
The FDA selected CreatiVasc’s Hemoaccess Valve System technology because of its potential to improve the quality of life of dialysis patients as well as reduce complications and costly interventional surgery, said Megan Moynahan, associate director for technology and innovation at FDA’s Center for Devices and Radiological Health.
End Stage Renal Disease, the focus of the first Innovation Pathway, affects more than 571,000 Americans and is considered one of the most costly chronic diseases. Kidney failure and associated dialysis cost the U.S. healthcare system more than $46 billion annually, and the highest concentration of the disease is here in the Carolinas and Georgia. The primary causes of end-stage renal disease are diabetes, obesity and hypertension.
Many dialysis patients have a Teflon tube implanted in their arm to provide vascular access for dialysis. Such tubes present a constant challenge because they frequently clot and require costly interventional surgery. According to a study published in the New England Journal of Medicine, more than 75% of dialysis grafts fail and require surgical intervention within the first year after placement. Early research shows that the CreatiVasc Hemoaccess Valve System allows selective blood flow into these grafts only when it is needed for dialysis, which is believed to reduce such universal complications.
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 new FDA 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.
CreatiVasc was founded in Greenville, S.C., in 2004 by Dr. David Cull, a vascular surgeon with the Greenville Hospital System (GHS) who developed the new technology after seeing first-hand the problems associated with traditional dialysis-access grafts. The company began full-time operations in 2007. Since 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 trials at GHS. The company has multiple issued patents on the device both in the U.S. and around the world.
“CreatiVasc is excited and honored to be selected as one of the companies for the FDA Innovation Pathway Program,” said Cull. “The program creates a unique partnership between our company and the FDA that will streamline development of our device. This is a great example of how government and the private business sector can work together to advance technology that will benefit patients nationwide.”
Johnson said that 95% of the company’s investors were from the upstate of South Carolina. He also credited the company’s early success to two capital infusions from SC Launch, a start-up seed capital program run by the S.C. Research Authority’s Technology Ventures sector. SC Launch has been selected by Forbes magazine as one of the top entrepreneurial support programs in the country. Johnson also credited 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, GHS, SCBIO and Clemson University is the perfect example of Knowledge Economy development in South Carolina. We look forward to CreatiVasc’s continued progress.”

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