The news from Quanterix Corp. has come fast and furiously this week. The company reported that Chairman and CEO Kevin Hrusovsky will step down on April 25 and become executive chairman of the board, while current company President Masoud Toloue will assume the CEO position and join the board of directors. Hrusovsky became CEO in 2014 and Toloue joined Quanterix in June 2021 from Perkinelmer Inc. The company also revealed that it has built on its collaboration with Indianapolis-based Eli Lilly and Co. for new tools to diagnose, monitor and treat Alzheimer’s disease (AD) and presented its fiscal 2021 financial results, which showed a 28% increase in total revenue, largely attributable to its neurology segment.

Cvaid Medical Ltd. secured $4 million in a series A financing to further develop its mobile stroke diagnostic, monitoring and treatment platform. The Israeli Rad Biomed investment fund led the round with participation from Philips Ventures and Sanara Capital. As part of the financing, a representative from Philips will join the board. The smartphone-based system, Cvaid uses artificial intelligence to process and analyze video and voice recordings to identify and assess the severity of patients experiencing stroke, also called cerebrovascular accidents.

A Seattle-based startup has secured breakthrough device designation for its blood-based Alzheimer’s disease (AD) test. Altpep Corp.’s Soba-AD platform is designed to selectively detect toxic forms of amyloid-beta peptide associated with AD progression. The company said early data indicated the assay can detect AD before symptoms including cognitive impairment and neurodegeneration arise.

Neurosigma Inc. has received FDA breakthrough device designation for its Monarch ETNS system to treat drug-resistant epilepsy (DRE). The neuromodulation therapy uses noninvasive external trigeminal nerve stimulation (ETNS) to treat neurological and neuropsychiatric indications. The technology is currently commercialized for pediatric ADHD treatment.

The FDA has approved Medtronic plc’s next-generation sacral neuromodulation (SNM) system, Interstim X, giving patients a recharge-free option with a 10-year+ lifespan. This newest member of the Interstim portfolio joins the rechargeable Interstim Micro as a treatment for overactive bladder (OAB), chronic fecal incontinence (FI) and nonobstructive urinary retention.

A neurostimulation device developed to treat focal epilepsy has received breakthrough device designation from the FDA. Precisis AG’s Easee [Epicranial Application of Stimulation Electrodes] minimally invasive system is designed to deliver individualized brain stimulation without neurosurgery. The electrode is placed subcutaneously on the cranium and a current is applied to the affected brain area to prevent or mitigate seizures.

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.

Mindmaze SA continued to add significant funds to its coffers with $105 million as part of a series B financing round, following a $125 million debt financing in October. The new money brings total funding to more than $300 million for the company’s virtual reality-based digital neurotherapeutics platform. Its successful fundraising has pushed the company into unicorn status, making it the first Swiss firm to be valued at more than $1 billion.

With an ambitious goal of bringing 24/7 electroencephalogram (EEG) capabilities to hospitals across the country, Epitel Inc. closed a $12.5 million series A financing round that it plans to use to fund the initial pilot for commercialization of its wearable, wireless EEG platform. The Epilog platform received FDA clearance for use in hospital emergency departments and critical care units last year.