Stem cell applications company Aivita Biomedical, of Irvine, Calif., said the U.S. FDA cleared its investigational new drug application for a phase II clinical trial investigating the company's Root of Cancer technology in patients with glioblastoma multiforme. It will be the third investigation of Aivita's platform cancer immunotherapy, which is currently the subject of a phase II clinical trial in ovarian cancer in the U.S., and a commercialization effort in melanoma in Japan.
Continuous monitoring firm Earlysense Ltd., of Ramat Gan, Israel, reported that a study presented at the 2018 American Thoracic Society Conference shows that its system detects and alerts for respiratory depression with a high positive predictive value. The study analyzed 6,590 hospitalization days of more than 160,000 hours monitored by the Earlysense system. The system detected 91 events of respiratory depression. The positive predictive value of 70 percent of events detected were classified as respiratory depression or sleep apnea related. Additionally, the study indicated a very low false alarm rate, less than one in 5,000 hours of monitoring.
Grifols SA, of Barcelona, Spain, reported that the U.S. FDA approved the Procleix Zika virus assay for the detection of the virus in individual or pooled plasma specimens from human donors, including volunteer donors of whole blood and blood components for transfusion. The Zika virus assay is also approved for testing plasma or serum specimens to screen other living (heart-beating) or cadaveric (non-heart beating) organ donors and human cells, tissues,and cellular and tissue-based products. In 2016 the assay was CE marked for use in European countries.
San Diego-based Inova Diagnostics Inc. said that the U.S. FDA cleared the Quanta Flash HMGCR marker, one of 30 FDA-cleared assays available on Bio-Flash, a random access chemiluminescent system. Quanta Flash HMGCR aids in the diagnosis of idiopathic inflammatory myopathy, a group of conditions that affect the skeletal muscles and can result in progressive muscle weakness that in some cases leads to tissue necrosis and disability.
Viveve Medical Inc., of Englewood, Colo., reported the initiation of Liberate-International, a multicenter, randomized, double-blinded, sham-controlled trial to evaluate the safety and efficacy of its cryogen-cooled monopolar radiofrequency technology for the improvement of stress urinary incontinence in women. The first-subject-first-visit has now been completed under an approved investigational testing application with the Canadian Ministry of Health and central investigational review board approval. Viveve also reported regulatory clearance in Argentina for use of the Viveve System, for the improvement of urinary incontinence.