Masimo Corp. in Irvine got CE marking for its O3 regional oximetry sensor in some pediatric settings, which allows it to be sold throughout Europe and other countries.
The device maker can now sell its O3 sensor for use with patients who weigh less than 88 pounds in countries that accept CE marking for regulatory approval of medical products. Most are in Europe—CE is a French acronym for “European Conformity”—though some non-European countries also recognize the designation, such as Australia.
Masimo has been known for pulse oximetry—measuring oxygen in arterial pulsing, such as in the fingers, forehead or feet. It more recently has been adding regional oximetry monitoring, which measures oxygen saturation in body tissue.
“We believe we have the best (pulse oximetry) technology across the board to all populations,” said Masimo Chief Operating Officer Anand Sampath. “This brings our core expertise to a new area.”
The company got CE marking for the O3 18 months ago for use on adults. Food and Drug Administration clearance for use on adults came earlier this year. The FDA hasn’t cleared the O3 for pediatric use here.
Sampath declined to say whether Masimo would pursue approvals for O3 use with infants, including premature babies, within four weeks of birth.
Allegro Board Growing
Allegro Ophthalmics LLC in San Juan Capistrano added Dr. Ronald Kurtz and Mark Livingston to its board.
The late-stage, prerevenue biotech company is developing therapies for vitroretinal diseases. Its lead drug candidate, Luminate, is in second-phase clinical studies.
Kurtz is chief executive of Calhoun Vision Inc., a Pasadena-based development-stage company working on an intraocular replacement lens. He co-founded two eye care companies later sold to larger firms; Calhoun’s eye care device efforts dovetail with Allegro’s pharmaceutical work.
Livingston is chief executive of PrimaPharma Inc. in San Diego, Allegro’s contract manufacturer, and brings a finance background to the board through co-founding an accounting firm.
Allegro President and Chief Medical Officer Vicken Karageozian said the additions reflect the company’s transition into a full-fledged pharmaceutical firm.
“We’re going from proof of concept (to studies with) hundreds of patients.”
Studies scheduled to finish by the first quarter of next year are meant to show “definitively the drug works,” after which Allegro would “go for one more round of testing” before seeking regulatory approval.
Final-stage testing requires thousands of patients and often a partner to pay for it by licensing, an acquisition or an initial public offering.
Seoul-based Hanmi Pharmaceutical Co., which has about $665 million in annual sales, invested $20 million in Allegro in January of last year, which included licensing Luminate for sale in South Korea and China.
“We’ve talked with seven or eight (companies)” about partnerships with Allegro, Karageozian said.
Allegro’s board now has seven members, and “eventually you get more—typically from the partners.”
CalOptima New Board
OC Supervisors named members of a board for CalOptima, the county’s publicly funded health insurance provider for low-income patients.
The 10-member board includes:
• Ria Berger, chief executive of nonprofit Healthy Smiles for Kids of Orange County.
• Ron DiLuigi, a retired health system executive.
• Nikan Khatibi, a pain and addiction medicine specialist.
• Alexander Nguyen, a resident in psychiatry at Harbor-UCLA Medical Center.
• Lee Penrose, chief executive of St. Jude Medical Center.
• J. Scott Schoeffel, an attorney with Buchalter Nemer.
• Paul Yost, an anesthesiologist at CHOC Children’s and St. Joseph Hospital.
Remaining seats are filled by county Supervisors Lisa Bartlett and Andrew Do, and by Mark Refowitz, director of the Orange County Health Care Agency. Supervisor Todd Spitzer is an alternate.Â
CalOptima has 795,000 members, 7,000 doctors and specialists, and 30 hospitals.
Bits & Pieces
Publicly traded investor Vemanti Group Inc. in Newport Beach agreed to buy Long Beach-based MedicatedOne LLC, a medical cannabis product incubator. … Fountain Valley Regional Hospital & Medical Center Chief Executive B. Joseph Badalian was named chief operating officer of the six-hospital Verity Health System in Redwood City; an interim chief in Fountain Valley has not yet been named. … Soberlink in Huntington Beach said its portable alcohol breathalyzer received 510(k) premarket clearance from the FDA for medical use by healthcare providers to remotely measure alcohol in human breath.
— Reporter Paul Hughes contributed to this column.
