Medical device maker Direct Flow Medical Inc., which maintains a Lake Forest manufacturing hub, is pursuing a three-pronged plan for progress under new leadership.
The company, headquartered in Santa Rosa, makes less-invasive replacement aortic heart valves.
Direct Flow says its product is distinguished from those of market leaders—such as Irvine-based Edwards Lifesciences Corp.’s Sapien and Dublin, Ireland-based Medtronic PLC’s OC-developed CoreValve—because of its ability to be repositioned inside the heart, among other features.
Chief Executive Daniel LeMaitre, who joined the company in May, laid out Direct Flow’s plans in an interview last week:
n “We need to continue to show folks that we are a competitive device with the very same products we’ll face when we enter the U.S. market,” LeMaitre said, adding that Direct Flow is also “highly focused” on its ongoing product rollout in Europe.
Direct Flow received European regulatory clearance nearly three years ago for patients who have aortic stenosis, or a narrowing of the artery, who would be at extreme risk under surgery.
“We have between 3% and 5% of the European market,” LeMaitre said, adding that there is space for market growth because the company’s valve is available in only about 15% of Europe’s 450 transcatheter aortic valve implant centers.
Direct Flow still has “quite a bit of runway in front of us,” he said.
n To enroll patients in its Salus domestic clinical trial “on a timely basis,” LeMaitre said. “I truly believe that most folks will view the clinical enthusiasm for the product based on the pace of enrollment.”
Direct Flow is scheduled to complete Salus enrollment sometime next year, which could put it in a position to file for Food and Drug Administration approval in early 2018, according to LeMaitre.
Discover
The company also recently released data from its Discover post-market study at last month’s Transcatheter Cardiovascular Therapeutics meeting in San Francisco showing 82% freedom from all causes of death and 90% freedom from cardiovascular mortality.
“Overall, the data demonstrate excellent results and low complications,” said Dr. Federico De Marco, a researcher with Policlinico San Donato in Milan, Italy, adding that the consistency between Direct Flow’s performance in the post-market study and a premarket trial was “impressive.”
n To return to its roots through developing less-invasive replacement mitral valves.
“We have a lot going down on the mitral side,” LeMaitre said. “We haven’t made a lot of noise about it. You’ll be hearing more about it … over the next six to nine months.”
Direct Flow, which is 11 years old, was originally focused on a mitral valve, LeMaitre said.
Company founder Gordon Bishop, who is also its chief technical officer, did the original valve design work for the mitral.
“Gordon and the team pivoted back in 2004 to an aortic story because there was a lot of interest at the time,” LeMaitre said. “With more capital now available to us as we move forward, we’re taking those plans off the shelf and fully funding our mitral program.”
Revenue, Investors
Privately held, venture-backed Direct Flow has revenue of what LeMaitre said is more than $20 million annually. The company has 260 workers, about 60 of whom work in Lake Forest.
Direct Flow’s investors include EDF Ventures in Ann Arbor, Mich.; New York-based New Leaf Venture Partners; Spray Venture Partners in Newton, Mass.; and Boston-based Flare Capital Partners.
Direct Flow’s plans, however, don’t call for a headquarters move to Orange County, even though LeMaitre has run OC-based companies, including Irvine-based CoreValve Inc., before its 2009 acquisition by then-Medtronic Inc.
“We have the luxury of having very senior talent in the company in Lake Forest; we split our management meetings up between Lake Forest and Santa Rosa. But there would be no intention at this point to move the headquarters to Lake Forest.”
LeMaitre said Direct Flow uses distributors and some direct salespeople for its overseas sales and will later determine how it will distribute its device in the U.S.
