CoreValve Inc., a French heart valve developer, is switching its headquarters from Paris to Irvine with an eye toward raising money to fund the development of its product.
“There is no doubt that we’re going to need more money,this is a heart valve,” said Rob Michiels, CoreValve’s chief operating officer and president.
Options to raise money could include another round of venture funding. Or it could seek to go public, “if we’re far enough along or if there could be a market window in the U.S.,” Michiels said.
CoreValve’s investors have included Sofinnova Partners, a Paris venture capital firm.
The company has raised $30 million so far and estimates it needs another $30 million to continue work on its heart valve, Michiels said.
The prospect of a public offering “is definitely the underlying reason why we have done the flip-flop and become a U.S. corporation so that door could be open to us,” Michiels said.
CoreValve is in the process of shifting its headquarters from France to Irvine, Michiels said. The company opened its Irvine office in 1994. At that time, CoreValve was working on a catheter for delivering heart valves that didn’t require open-heart surgery.
Now CoreValve is working on its own valve. It’s one of several contenders in the fledgling market for heart valves that don’t require major surgery.
CoreValve decided to develop its own valve after it found those from other companies “had too much tissue mass to be able to make the device smaller,” Michiels said.
“We have completely redesigned a tissue heart valve, our own design,” Michiels said.
CoreValve said late last month that 50 patients at seven sites in Canada, Germany, the Netherlands and Belgium have had less-invasive heart valve replacement procedures.
The company is looking to get European Union approval for its valve by early 2007, Michiels said.
In the meantime, CoreValve is putting information together for an investigational device application with the Food and Drug Administration, Michiels said. That submission, he said, should go in around the same time that the device maker gets European study data.
After that, CoreValve hopes to start a clinical study for an FDA pre-market application, Michiels said. The company’s valve won’t be sold in the U.S. until the end of this decade or early next decade, he said.
“The 2010-2011 time frame is a reasonable assumption to make at this point in time,” Michiels said.
The company’s technique is called Percutaneous ReValving and can be done on a beating heart, cutting the need for open-heart surgery.
For now, CoreValve is looking for its product as a replacement for the heart’s aortic valve, which controls blood flow from the left ventricle to the aorta. Later, CoreValve’s product could be used to replace the mitral valve, the inflow valve for the left side of the heart.
Catheter-based heart valve replacement is expected to play a bigger part in heart surgery. The first valves under development aren’t expected to be available until the end of the decade.
Analysts and industry figures have estimated that the market for such valves could reach $1 billion within 10 years after they’re approved.
Irvine’s Edwards Lifesciences Corp., the leader in conventional heart valves, paid $125 million two years ago for Percutaneous Valve Technologies Inc., a maker of catheter-inserted heart valves.
Other companies that are working on less-invasive products include Medtronic Inc., which has a plant in Santa Ana, and 3F Therapeutics Inc., a Lake Forest company that’s being acquired by ATS Medical Inc. of Plymouth, Minn., for $58 million.
“This will be straight up competition,” Michiels said. “We will be going after the very high risk surgical patients.”
CoreValve plans to expand its work force from 12 people to about 20 by year’s end, Michiels said.
Michiels held various global sales and marketing jobs with Edwards when it was part of Baxter International Inc.’s cardiovascular unit.
