Neurovalens Receives FDA Clearance for Anxiety Treatment Device

Neurovalens Achieves FDA Clearance for Anxiety Treatment Device

Neurovalens, a pioneering health technology company headquartered in Belfast, Northern Ireland, has recently achieved a significant milestone with the receipt of regulatory clearance from the US Food and Drug Administration (FDA) for its groundbreaking Modius Stress device. This innovative device is specifically engineered to address anxiety, a prevalent and debilitating condition affecting millions of individuals worldwide.

The Modius Stress device represents a breakthrough in non-invasive medical technology, delivering targeted electrical stimulation to key areas of the brain and nervous system without the necessity for surgically implanted electrodes. By utilizing this device for just 30 minutes before bedtime, individuals diagnosed with Generalized Anxiety Disorder (GAD) can experience relief from symptoms while engaging in other activities such as reading or watching television.

This regulatory approval marks a pivotal moment for Neurovalens, affirming the safety and efficacy of its cutting-edge technology in the treatment of anxiety. The clearance by the FDA follows rigorous clinical trials conducted in the UK, Ireland, and India, overseen by esteemed institutions including Ulster University and the Indian Center of Neurophysiology (ICN).

In addition to its recent achievement in obtaining FDA clearance for the Modius Stress device, Neurovalens has also made significant strides in securing funding to support its ongoing research and development efforts. The company recently concluded a successful £2.1 million funding round with participation from existing investors, further bolstering its financial resources. This funding, combined with previous investments totaling approximately £11 million from prominent UK-based backers, positions Neurovalens for continued growth and innovation in the field of neurotechnology.

Looking ahead, Neurovalens is poised to embark on a Series B fundraising round, with anticipated funding ranging between $40 million and $50 million. This substantial investment will enable the company to accelerate its expansion efforts, particularly within the US market where there is a significant demand for effective anxiety treatment options.

Dr. Jason McKeown, CEO of Neurovalens, underscored the importance of obtaining FDA clearance for the Modius Stress device, emphasizing its potential to revolutionize the treatment landscape for anxiety and other related conditions. With GAD affecting an estimated 6.8 million adults in the US alone, Neurovalens is committed to delivering innovative, non-invasive solutions that address the underlying issues and improve the lives of patients.

As Neurovalens continues to push the boundaries of medical innovation, its dedication to advancing the field of neurotechnology remains unwavering. By leveraging the latest scientific insights and technological advancements, Neurovalens is poised to make a lasting impact on the healthcare landscape, offering hope and relief to individuals suffering from anxiety and other neurological disorders.

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