A federal approval and newly released clinical trial results have put a spotlight on Direct Flow Medical Inc., a Santa Rosa-based heart valve startup that makes its devices in Lake Forest.
Direct Flow makes replacement heart valves used to treat patients with severe aortic stenosis, or a narrowing of the body’s primary artery. The company has said the ability of its valve to be repositioned, among other features, makes it different from those of larger competitors, such as Irvine-based Edwards Lifesciences Corp.’s Edwards Sapien and Minneapolis-based Medtronic Inc.’s Medtronic CoreValve.
The company said in late May that it received approval from the Food and Drug Administration to start the pivotal phase of a trial that will evaluate Direct Flow’s valve at up to 30 sites.
The approval followed a “collaborative effort with the FDA,” said Dr. Charles Davidson, the company’s chief medical officer.
“The technology has shown outstanding performance in clinical trial and commercial settings,” he said.
Direct Flow also presented results from its European Discover trial in late May at a medical conference in Paris. The company said 12-month results from the trial showed a 90% survival rate, continuing “the initial positive trend of 99% survival after 30 days.”
The company’s Direct Flow Medical Transcatheter Aortic Valve system received European approval in early 2013.
Analyst Praises Masimo Buyback
Irvine-based Masimo Corp.’s recent repurchase of 1 million shares of its common stock “reinforces long-term shareholder value,” according to a late May report by Newport Beach-based Roth Capital Partners LLC.
Masimo makes patient monitoring devices. It disclosed the buyback in a Securities and Exchange Commission filing on May 20 after the market closed for the day.
Chris Lewis, a Roth medical technology analyst, estimated the buyback’s price at about $23.4 million based on the company’s average closing price of $23.38 a share since May 5. Masimo’s board authorized the repurchase of up to 6 million shares of common stock in February 2013.
Lewis also mentioned that Masimo ended its first quarter with $117.5 million in cash and no debt on its balance sheet besides the stock buyback.
“While not overly aggressive, we would anticipate the market to view the buyback as a positive indicator for the stock and the company’s confidence in its prospects and long-term outlook,” wrote Lewis, who has a “buy” rating on Masimo’s stock.
Shares of the company are down 15% since the start of the year, with a recent market value of $1.4 billion.
Digital Healthcare Explored
The Center for Digital Transformation is planning a June 10 program in the Calit2 auditorium at the University of California-Irvine to look at how the increasing use of electronic health records, mobile devices and cloud computing are catalyzing forces in healthcare.
The event is billed as a look at how “this transformation to a more digital and data-driven future can improve quality of care, increase satisfaction levels, reduce costs and change the entire dynamic between healthcare providers, practitioners and patients for the better.”
Speakers slated for the event include Scott Joslyn, senior vice president and chief information officer of Fountain Valley-based MemorialCare Health System, and Dr. Scott Shreeve, who is chief executive of Aliso Viejo-based Crossover Health.
Bits & Pieces
Placentia-Linda Hospital said its urgent care clinics are now known as MedPost Urgent Care. The clinics, in Brea and Anaheim Hills, previously operated under the name of Urgent Care by Placentia-Linda Hospital. Placentia-Linda is one of three OC hospitals owned by Dallas-based Tenet Healthcare Corp. … Irvine-based DevicePharm hired Rick Andersen as a managing director. Andersen has 30 years of experience in medical technology, diagnostic and healthcare marketing. DevicePharm is a marketing company that offers strategy and planning, brand development, digital and interactive media, and consumer marketing. … Newport Beach-based BioCell Technology LLC said new findings from a pilot placebo-controlled clinical trial on its collagen product will be presented this month at the International Society of Sports Nutrition conference. BioCell researches, develops, brands and distributes raw material ingredients for health and beauty uses. … SevenPoint2, a nutritional supplement company based in Newport Beach, opened an office in Seoul.
