Direct Flow Medical Inc., a Santa Rosa-based heart valve startup that manufactures its devices in Lake Forest, has had a busy January.
The company makes replacement aortic transcatheter valves used to treat patients with severe aortic stenosis, or a narrowing of the body’s primary artery. It first opened its facility, which features a “clean room” for manufacturing, in 2008.
The company’s action began some two weeks ago when it announced it received European approval for what it says is “the first fully repositionable 29mm transcatheter aortic heart valve.” It said the approval expands the treatable patient population to patients who have annuluses, or rings of connective tissue where heart valves are anchored, ranging from 21 millimeters to 28 millimeters.
Chief Executive Bernie Lyons said in a news release that patients who have large annulus sizes had “limited options” prior to the European approval of Direct Flow, the company’s namesake valve.
The company has touted its valve as being different from entries such as Irvine-based Edwards Lifesciences Corp.’s Edwards Sapien and Minneapolis-based Medtronic Inc.’s OC-developed Medtronic CoreValve because of its ability to be repositioned, among other things.
Direct Flow’s valve lineup, which is commercially available only in Europe, also includes transcatheter aortic valves that are 25 millimeters and 29 millimeters in diameter.
Concurrently, Direct Flow said it completed enrolling patients in a U.S. trial that will assess the safety of its heart valves for treating patients with severe aortic stenosis who are at “extreme risk” in the event of needing replacement of a diseased aortic valve.
The company said it’s working with the Food and Drug Administration and plans to initiate a pivotal trial this year that will be larger and more rigorous. It’s also required for regulatory approval.
Direct Flow said the trial will be nonrandomized and conducted at multiple centers. Drs. Murat Tuzcu and Patrick McCarthy are the principal investigators. McCarthy is a consultant with Edwards who invented the Myxo heart device.
Lyons told the Business Journal in 2012 that the company chose to put Direct Flow’s manufacturing in OC because of a workforce with expertise in animal tissue.
“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],” he said.
Sabra Announces Offering
Irvine-based Sabra Health Care REIT Inc. said this month that certain of its subsidiaries are starting a tender offer to buy any and all of their outstanding $211.25 million worth of senior notes that will mature in 2018.
Sabra said holders that validly tender their notes before the withdrawal deadline this Wednesday would receive just under $1,100 for each $1,000 principal amount of notes that are tendered, including a $30 consent payment. Those who tender after the deadline would receive only the offer consideration, which doesn’t include a consent payment.
The owner of nursing homes and other forms of healthcare-related real estate didn’t disclose what it planned to use the proceeds for.
Bank of America Merrill Lynch is acting as the transaction’s dealer manager and solicitation agent. New York-based D.F. King & Co. acted as the offer’s tender and information agent.
The offer is scheduled to expire Feb. 5 unless the issuers extend the time, Sabra said.
Allergan Cuts Jobs
Irvine-based drug maker Allergan Inc. has cut 150 jobs companywide as part of a restructuring.
The company makes wrinkle-remover Botox and eye drugs, among other products.
Some of the cuts are at Allergan’s research and development facility in Goleta in Santa Barbara County.
The changes will affect some 300 workers, inclusive of the job cuts, Allergan spokesperson Bonnie Jacobs said in published reports.
She said some employees might be moved to other company sites and that Allergan will add jobs at some of its other facilities, including those in Bridgewater, N.J.; Austin, Texas; and Westport, Ireland.
Sovereign Health Group Moves
Addiction and mental healthcare provider Sovereign Health Group Inc. said it recently moved its corporate headquarters to 1211 Puerta del Sol in San Clemente in order to facilitate growth. Sovereign Health began operations five years ago with six treatment beds, but it now has more than 100 treatment beds and more than 100 workers, according to the company.
