CreatiVasc Medical to move manufacturing from Boston, merge with Brookhaven Medical and Texas firm
CreatiVasc, designer of a vascular device used for dialysis, announced at the SCBIO conference this week that it will design and manufacture its devices in South Carolina, moving from Boston.
Brookhaven Medical, which invested $5 million in CreatiVasc last year, will merge with CreatiVasc and Texas-based FutureMatrix Interventional in November, said Brookhaven CEO John Feltman. CreatiVasc and Brookhaven are set to merge initially by Nov. 7. FutureMatrix Interventional produces balloons used in catheters and other medical devices.
After FDA approval of CreatiVasc’s Hemoaccess Valve System, Brookhaven expects to have an initial public offering, probably in early 2016, said Feltman.
The Hemoaccess Valve System works as an on/off switch to provide blood flow to a graft needed during dialysis. The valve provides blood flow on demand rather than all the time, which often causes failure when a patient comes for dialysis.
CreatiVasc CEO Steve Johnson said that the device was one of three nationwide selected for the U.S. Food and Drug Administration’s (FDA) Innovation Pathway, speeding up the process of approval for use. It was also classified as a device “with no predicate in the world,” said Johnson.
There has been little innovation in the field of dialysis in the last three decades, said Johnson. “They [FDA] are intent on speeding this product to the market because of the need in the market.”