SK Biopharmaceuticals Co. Ltd.'s three-pronged plan for tackling epilepsy is going strong, with lead drug cenobamate for drug-resistant focal-onset seizures nearing the finish line, and earlier-stage programs for a mRNA-based approach and a digital therapeutic in the works.
Resapp Health Ltd. saw its stock shoot up 35% on the heels of positive clinical results for its new smartphone-based COVID-19 screening test. In a pilot clinical trial of 741 patients recruited in the U.S. and India, digital health company Resapp’s screening test, which uses machine learning to analyze the sound of a patient’s cough, correctly detected COVID-19 in 92% of people with the infection.
After a challenging 2021, nerve repair company Axogen Inc. is focusing on building clinical data to turn around its luck. The Alachua, Fla.-headquartered company reported disappointing fourth quarter results, with procedure volume negatively impacted due to COVID-19 and hospital staffing. The Nasdaq-listed company is anticipating results from a major phase III pivotal study comparing its flagship nerve graft product Avance to commercially available products in the second quarter of 2022.
Biological Dynamics Inc.’s Verita platform correctly identified 96% of patients with stage I pancreatic cancer, a study in Nature Communications Medicine demonstrated. The platform uses protein biomarkers present in extracellular vesicles and showed an overall 71% sensitivity and 99.5% specificity in pathologically confirmed stage I and II pancreatic, ovarian and bladder cancer.
Clinical researchers from Karl Landsteiner University in Krems, Austria, have been conducting a prospective study of a new diagnostic technique for bronchoscopy tissue sampling aimed at patients with unclear diffuse parenchymal disease. They have assessed morbidity and 30-day and 90-day mortality following transbronchial lung cryobiopsy. The team recently published their findings in Therapeutic Advances in Respiratory Disease.
At the AD/PD 2022 international conference on Alzheimer’s and Parkinson’s Diseases, AC Immune SA presented images showing its positron emission tomography (PET) tracer detecting pathological alpha-synuclein (a-syn) in human subjects’ brains. The abnormal accumulation of a-syn, a natively unfolded and soluble presynaptic protein, is a neuropathological feature of neurodegenerative disorders.
For about one-third of stroke patients, the cause of their cerebrovascular accident (CVA) is unknown at the time of hospitalization, but crucial to determine to prevent subsequent strokes. Electrocardiogram (ECG) monitoring in the 24 to 48 hours after a stroke detects atrial fibrillation (AF) in about 5% of patients. Remote monitoring with a noninvasive device detects far more cases and provides the opportunity to quickly head off secondary strokes, preserving lives and reducing costs of care, according to a study published by Royal Philips NV researchers.
Lumithera Inc. has completed the acquisition of Diopsys Inc. to expand its footprint of ocular disease care. Under the terms of the agreement, Pine Brook, N.J.-based Diopsys is now a wholly owned subsidiary of Poulsbo, Wash.-based Lumithera, with its electroretinography technology adding to Lumithera’s photobiomodulation (PBM) Valeda light delivery system for dry age-related macular degeneration (AMD) treatment.
A thin film electrode platform technology developed by Neuroone Medical Technologies Corp. could be used to treat chronic back pain according to new tests. Eden Prairie, Minn.-based Neuroone said it concluded initial testing that demonstrate the electrode could provide chronic stimulation at typical stimulation parameters currently used to treat patients suffering with chronic back pain due to multiple failed back surgeries.
Several recent studies highlight the rapidly expanding applications for neuromodulation using bioelectronic devices. A pair of articles in the Journal of the American Heart Association and Journal of the American College of Cardiology focused on the benefits to patients with heart failure and those at risk of post-operative atrial fibrillation, respectively. A study published in Brain Stimulation found that 85% of tinnitus patients experienced resolution of their symptoms when using a neuromodulation device.