Devax Inc., an Irvine-based startup medical device maker, raised $32 million in a fourth round of venture funding last week.
The round brings Devax’s total raised to $48.4 million in its six-year history.
Devax said it plans to use the money to finance a study and international marketing of its lead product, the Axxess drug-coated stent to treat heart and vessel ailments.
The stent is a self-expanding nickel titanium alloy device that is designed to conform to a lesion and delivers a drug to treat the problem.
InterWest Partners, a venture capital firm with offices in Menlo Park and Dallas, and Menlo Park-based U.S. Venture Partners led the investment.
Bio-Star Private Equity Fund LLC, which was founded by Michael Henson, a longtime Orange County medical device entrepreneur, also pitched in.
Michael Sweeney, a general partner at InterWest, and Casey Tansey, a general partner at U.S. Venture Partners, joined Devax’s board.
In a release, Sweeney said that InterWest believes that Axxess “addresses one of the interventional cardiologist’s most difficult patient problems.”
“We’re serving a niche market,” said Jeff Thiel, Devax’s chief executive. “The literature says that about 15% of the patients who undergo (angioplasty) have a disease that involves a significant bifurcation.”
Thiel described the condition as “like coming to the Y in the road.”
Traditional, balloon-expandable stents aren’t specifically designed or approved for bifurcations, according to Devax. The company also says that current treatments can result in restenosis, or reblockage, rates that are three or four times higher than non-bifurcated lesions.
Devax still is some years away from selling Axxess in the U.S. The device maker intends to file an investigational drug application with the Food and Drug Administration at the end of the year, start the clinical trial in the second half of 2006 and submit for approval to regulators at the end of 2007, Thiel said.
Commercialization is “going to be late 2007, early 2008, depending upon the timing flows,” Thiel said.
Devax is planning to launch Axxess in Europe in the second half of 2006. It received European Union clearance in 2003.
The company has nine full-time workers.
On the question of Devax possibly going public or being acquired, “Options are always available down the road for somebody like us,” Thiel said.
“At this point, we’ve got sufficient funds to launch in Europe, to do our U.S. (work) and get the product going in the U.S., and I guess whatever happens, happens,” Thiel said.
Devax was started in 1999 in the Minneapolis-St. Paul area, a hub of medical device activity. The company came to OC, another device hub, in late 2001 following its second round of venture funding, which totaled $6.2 million, according to Thiel.
“They came because Mike Henson was involved,” Thiel said. “The MedFocus Fund was involved in the series B, so they brought it out to kind of restart it in Mike’s incubator.”
MedFocus Fund LLC, another Henson project, was established in 2001 with the intent of incubating new biomedical businesses.
Thiel joined Devax in 2003. Prior to taking the company’s helm, he spent nearly eight years at Radiance Medical Systems Inc., another OC device maker that Henson was involved with.
Thiel served in several positions at Radiance, including chief executive from early 2001 to mid-2002.
