Wearable Cognixion ONE Axon named FDA breakthrough device

Cognixion’s flagship device Cognixion ONE Axon, a product designed to improve communication in people with severe motor impairments, has beed granted breakthrough device designation by the U.S. Food and Drug Administration (FDA). The wireless device is specifically designed for people with people with amyotrophic lateral sclerosis (ALS)…

MRI scans of the brains of people with amyotrophic lateral sclerosis (ALS) have identified a neurochemical called N-acetyl aspartate (NAA) whose levels correlate with the loss of motor function, a study reports. A drop in NAA levels was associated with the breakdown in communication between the primary motor cortex…

May has always been my favorite month of the year. Here in Maryland, the trees have filled in with lush green leaves, commercial crabbing boats have begun to quietly travel my small creek in the early dawn hours, and mallard ducks have returned to my yard. The evenings stay lighter…

Cellenkos has dosed the first patient in the Phase 1/1b clinical trial that’s evaluating its regulatory T-cell-based therapy CK0803 for the treatment of amyotrophic lateral sclerosis (ALS). The patient will be one of six participants included in the Phase 1 run-in period of the REGALS clinical trial…

Health Canada has resumed its review of AB Science’s application seeking approval of masitinib, an oral add-on therapy for amyotrophic lateral sclerosis (ALS), after the agency halted its review late last year. In 2022, the agency agreed to review the application under the notice of compliance with…

Apellis Pharmaceuticals has discontinued treatment with pegcetacoplan (APL-2), its investigational therapy for amyotrophic lateral sclerosis (ALS), in the open-label stage of the MERIDIAN trial. The decision follows a review of trial data by an independent data monitoring committee, which concluded that the available results did not…

The Poling family. From left, Liam, Erika, Bayler, and Seth. (Photos courtesy of Seth Poling) This is Seth Poling’s story: Hello, my name is Seth Poling, and I’m a 36-year-old husband to my beautiful wife, Erika, and a father of two sons, Liam and Bayler. I live in Morgantown,…