Direct Flow Medical Inc., a Northern California-based medical device company with a manufacturing hub in Lake Forest, has received European regulatory approval for its less-invasive replacement heart valve.
It is the first product approved for market by the startup, which said it plans to begin sales in Europe immediately.
Direct Flow makes aortic transcatheter replacement valves that are used to treat patients with severe aortic stenosis, or a narrowing of the arteries.
Direct Flow Chief Executive Bernie Lyons said the company would use a direct-sales and clinical force in major European markets and specialty distributors in others.
Direct Flow also said last week that it hired industry veteran Dan Rose as vice president of sales and marketing, a new position.
Rose was most recently vice president of commercial operations for Sequana Medical AG, a Switzerland-based maker of implantable pumps. His background also includes stints with device maker Medtronic Inc., which is based in Minneapolis and has 700 workers at operations in Orange County.
Rose held sales and marketing-leadership positions at Medtronic’s European operations for interventional cardiology and cardiac surgery.
His experience in positioning devices “to drive clinical adoption will contribute to our success as we launch in Europe,” Lyons said.
Direct Flow touts its valve as different from other less-invasive entries such as the Edwards Sapien by Irvine-based Edwards Lifesciences Corp., Medtronic’s CoreValve, and Portico, a recently approved valve from St. Jude Medical Inc., another Minnesota-based company with OC operations. Director Flow bills a flexible design for its valves as a key to eliminating aortic regurgitation, which can cause complications in surgery.
Animal Tissue
Direct Flow came to Orange County because it was looking for workers with expertise in animal tissue, Lyons told the Business Journal late last year.
“If you’re doing anything with tissue, either in the heart valve space or the ophthalmic space, if you’re not in Southern California, specifically in the Irvine area, you really don’t have much in the way of presence,” Lyons said. “For us, once we knew this concept was going to be very attractive to the marketplace, we made the decision to strategically locate a facility” in Orange County.
The company’s 2,500-square-foot facility in Lake Forest opened about five years ago and features a “clean room” for manufacturing.
Its location just east of Irvine places Direct Flow at the county’s hub of medical businesses ranging from a steady stream of startups to long-established companies such as Edwards and Santa Ana-based Abbott Medical Optics, a unit of Abbott Laboratories Inc. in Abbott Park, Ill.
Lyons said Direct Flow would add to its current OC work force of about 20 with an unspecified number of new hires related to sales in Europe.
“As we go forward, the significance of Southern California will grow because that’s where all the tissue processing is being done currently,” he said.
A domestic clinical trial on the valve is scheduled to start this year.
Lyons said earlier that he didn’t expect a Food and Drug Administration decision until late 2016 or 2017.
“Redundant Manufacturing”
The company also makes its valve at its corporate base in Santa Rosa, where it has about 50 employees, including executives. Lyons said in an earlier interview that the company wanted to have “redundant manufacturing” in case there’s an earthquake or other natural disaster in Southern California.
Direct Flow has raised $75 million in three rounds of funding since its establishment in 2004, according to the company.
It says its investors include New Leaf Venture Partners in Menlo Park, Massachusetts-based Spray Venture Partners, and the venture-capital arms of Abbott Laboratories and New Brunswick, N.J.-based Johnson & Johnson, among others.
