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.

Australia’s Therapeutics Goods Administration (TGA) cleared Orthocell Ltd.’s regenerative nerve repair device, Remplir, a biological scaffold that mimics the outer layer of the peripheral nerve to facilitate nerve repair.

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.

Medications are available to treat many mental disorders, but they’re only effective if patients adhere to the treatment. A distribution agreement between Beckman Coulter Inc. and Saladax Biomedical Inc. aims to improve patient outcomes by providing health care professionals with tests to assess treatment compliance and individual patient drug response.

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.

Oculogica Inc. has signed an agreement with Minnetronix Inc. to launch a diagnostic device that tracks eye movements to detect possible brain concussion, this after receiving FDA clearance in December for its fourth iteration of the artificial intelligence-driven, battery-operated Eyebox.

Woebot Labs Inc. secured a $9.5 million investment from Leaps by Bayer, the impact investment arm of Bayer AG, to speed development of its artificial intelligence (AI)-enhanced behavioral health platform and digital therapeutics. The new infusion tops up Woebots fundraising, bringing its total to date to $123.5 million. The Woebot investment marks Leaps by Bayer’s first foray into mental health.

Neuton Health Co. Ltd.’s virtual reality (VR)-based therapy for acrophobia has been given class II medical device approval from China’s NMPA. The VR therapy, known as Specific Fear Rehabilitation Training Software, was co-developed with the Shanghai Mental Health Center. The digital therapy company said it is the first VR device of its kind for a specific phobia approved in the world.

Developed by Infrascan Inc., the FDA-cleared Infrascanner device was touted as the first hand-held device to help detect bleeding in the skull and supported financially by the U.S. military anxious to treat moderate to severe traumatic brain injury in wounded service members. The FDA has now expanded the Infrascanner’s use to traumatic intracranial hematomas or brain bleeds in pediatric patients aged 2 years and older.

Saluda Medical Pty Ltd. raised $125 million in equity financing to commercialize and scale up its Evoke spinal cord simulation system for chronic pain and to advance its technology platform across an emerging portfolio of neuromodulation therapies.