The Orange County medical device scene continues to bustle with activity. Here are the latest cases in point:
Light Therapy
The latest addition to BioPhotas Inc.’s Celluma Series is a hand-held medical device that addresses the growing consumer medical wearables industry. The Food and Drug Administration-cleared, patent-pending Celluma Pod uses light therapy to treat acne, wrinkles and musculoskeletal pain.
The move to enter the consumer market makes sense—the global market for wearable medical devices is projected to reach nearly $20 billion in 2021, according to market research by ReportLinker.
“Typically, hand-held light therapy devices are configured for a single purpose, like treating pain or acne,” said Chief Executive Patrick Johnson. He said that unlike other hand-held LED devices, the Pod not only addresses multiple conditions, its design “allows the user to lay the device on the surface of the skin in a hands-free fashion.”
The Anaheim-based device maker’s Celluma series product is based on NASA technology using blue, red and near-infrared light energy to treat a wide range of musculoskeletal and skin conditions. The longer the light’s wavelength, the deeper the penetration.
BioPhotas has nine FDA-approved indications, including three in skincare and six in pain management. The Celluma device is approved for dermal wound healing in Europe.
Johnson said that another benefit of having the three-in-one Pod is cost savings. Pod is retail-priced at $299, compared to buying three separate devices that could cost as much as $600 total. The device will be publicly introduced this month at the Facial Aesthetics Conference and Exhibition in London and the International Esthetic, Cosmetic and Spa Conference in Las Vegas.
Positive Outcomes
Lake Forest-based NaviGate Cardiac Structures Inc. said it received positive one-year, post-procedure results of the first patient implanted with its transcatheter tricuspid atrioventricular valve stent. The procedure was performed at the Cleveland Clinic in Ohio.
Sixteen patients have been treated with the valve for severe tricuspid regurgitation, according to the company.
NaviGate develops less-invasive transcatheter treatments of mitral and tricuspid valve regurgitation. The medical device company licensed its valve technology, including mitral valve replacement technology and tissue-preservation techniques from Cleveland Clinic.
Meanwhile, Anaheim-based ClearFlow Inc. announced positive clinical trial results at the National Teaching Institutes and Critical Care Exposition’s annual meeting last month in Boston. The study’s principal investigator was Dr. Yvon Baribeau of Catholic Medical Center in Manchester, N.H.
Data evaluates the use of the company’s PleuraFlow Active Clearance Technology System for post-heart surgery patients in intensive care units. Results of the study show that the chest tube reduces clinical complications of retained blood and reduces the length of hospital stays and costs related to those complications.
ClearFlow’s product pipeline is based on its proprietary active clearance technology designed to reduce catheter clogging, including urinary catheters, gastrointestinal catheters and wound drainage. PleuraFlow is approved for use in the U.S., Europe, Australia, Brazil, Canada, Mexico and countries in Asia and the Middle East.
Brain Test
Aliso Viejo-based assay maker NanoSomiX Inc. said it received a patent on its proprietary technology for exosome isolation and detection of biomarkers—including from blood plasma. It’s designed to detect and access Alzheimer’s disease and other neurodegenerative disorders.
The company said the diagnosis and monitoring of the progression of brain dysfunction is currently challenging and costly. Existing approaches usually involve brain scans, spinal taps and subjective testing for mental acuity. Its technology, however, requires only a simple blood test.
Bits & Pieces
Newport Beach-based Concierge Key Health received a bronze Stevie Award at the 16th Annual American Business Awards event for startup of the year in the consumer services industries category. Its platform allows users to get on-demand access to medical specialists for a fee. … Hoag Memorial Hospital Presbyterian received the heart failure and stroke gold-plus quality achievement awards from the American Heart Association and the American Stroke Association. It’s the first year Hoag has received the gold-plus award for heart failure care and the eighth consecutive year for stroke care.
