SANTA ROSA – Direct Flow Medical Inc., a developer of transcatheter aortic replacement valve systems, is expanding its headquarters in northwest Santa Rosa by 9,000 square feet to support additional staff as it embarks on key clinical trials toward full U.S. approval.
Earlier this year, the 10-year old company announced it received CE Mark approval in the European Union for its 29mm transcatheter aortic heart valve replacement, while simultaneously completing its first U.S. clinical trial and the eventual commencement of a larger pivotal trial, after which the U.S. Food and Drug Administration will weigh final approval.
That came shortly after Direct Flow received $50 million in venture capital, which along with the bigger patient trials is prompting the company to nearly double its workforce from 160 to more than 300 across the globe. The bulk of employees will be in Santa Rosa, at its existing 12,000 square-foot location at 451 Aviation Blvd., and the newly leased 9,000 square feet at the adjacent 475 Aviation Blvd.
Michal Burgess, vice president of finance for Direct Flow, said demand is growing after the January approvals in Europe.
“Customer demand from physicians has been very strong since we were approved to market our device in Europe in early 2013,” Mr. Burgess said. “We are also progressing on our U.S. regulatory path, getting us one step closer to U.S. availability. As a result, we are expanding our headquarters in Santa Rosa to accommodate our growth now and in the future. We are maintaining our headquarters in Santa Rosa because the area has a depth of medical device expertise and a great quality of life for our team.”
[caption id="attachment_89943" align="alignleft" width="400"] Direct Flow will occupy another 9,000 square feet at 475 Aviation Blvd.[/caption]
While Direct Flow’s transcatheter aortic valve system is not the only such product on the market, the company has said its version is the “first fully repositionable” 29mm transcatheter aortic heart valve.
Both Irvine-based Edwards Life Sciences and Medtronic have achieved U.S. Food and Drug Administration approval for similar valves. Each transcatheter aortic valve system is inserted through the femoral artery near the groin region and threaded up into the aortic valve, a far less invasive procedure than open-heart surgery for patients who suffer from aortic stenosis, a congenital condition where the opening of the aortic valve is narrowed, which then decreases blood flow from the heart to the rest of the body.
But Direct Flow Medical has said its system differs in several key respects, chiefly that it’s fully repositionable, whereas other valves are more difficult to adjust during implementation. If the valve is not placed precisely in the native annulus, blood leakage around the replacement aortic valve can lead to aortic regurgitation, which has been shown to increase mortality rates for patients. Additionally, because of its non-metallic design, the company said it is the lowest profile device on the market and is more flexible, which allows it to navigate challenging vascular anatomies that are common in such patients.
The property is owned by an affiliate of Basin Street Properties, which was represented by Shawn Johnson and Danny Jones of Keegan & Coppin Co., Inc./ONCOR International in the lease deal. Austin Barrett of T3 Advisors represented Direct Flow.
