Nēsos receives FDA Breakthrough Device Designation for its disease-modifying digital therapeutic for Rheumatoid Arthritis
Nēsos, the company developing disease-modifying digital therapeutics for inflammation-mediated disorders, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to its digital therapeutic for patients with rheumatoid arthritis (RA) who have had an inadequate response or intolerance to disease-modifying anti-rheumatic drugs (DMARDs). The company, supported by a strong investor group that includes Mayfield Fund, DigiTx Partners, and new investors Astellas Rx+ Business Accelerator, LLC, and Amazon Alexa Fund, has initiated the next phase of clinical testing of its prescription rheumatoid arthritis asset towards an FDA approval. Additionally, Nēsos is advancing the clinical development of its neurological and mental health assets.
The Breakthrough Devices Program was launched by the FDA to give patients and health care providers faster access to medical devices that have the potential to provide more effective treatment over existing approved products for life-threatening or irreversibly debilitating diseases. “The interactive communication with the FDA and the priority regulatory review enabled under the Breakthrough designation fast track framework would be key in expediting time to market,” said Konstantinos Alataris, Ph.D., President and CEO of Nēsos. “Additionally, the Breakthrough designation can help facilitate reimbursement support and enhance patient access following an FDA approval”
There are more than 2 million Americans diagnosed with RA. Despite the available pharmaceutical options, many patients either do not respond, lose therapeutic response or are intolerant to these medications. The Nēsos digital therapeutic, developed on its ē-mmunotherapy platform, utilizes engineered electrical pulse sequences delivered by purpose-built earbuds, to modulate the central nervous system (CNS) pathway that helps control immune response. Rheumatoid arthritis patients, enrolled in a proof-of-principle study published in Lancet, Rheumatology, had a sustainable and clinically meaningful improvement. If this initial clinical experience is validated in the required further clinical testing, the Nēsos digital therapeutic can potentially provide a new treatment option with top-of-the-line efficacy and a significantly improved safety profile.
Learn more at Nesos.com.
The interactive communication with the FDA and the priority regulatory review enabled under the Breakthrough designation fast track framework would be key in expediting time to market,” said Konstantinos Alataris, Ph.D., President and CEO of Nēsos. “Additionally, the Breakthrough designation can help facilitate reimbursement support and enhance patient access following an FDA approval.”
Nēsos aims to treat diseases, by modulating central nervous system (CNS) pathways that control immune function. Using engineered electrical signals delivered by a noninvasive brain interface. Nēsos is guided and supported by clinical and scientific collaborators from top academic institutions, including Stanford, Vall d’Hebron, Harvard, Mount Sinai, Feinstein Institute, University of California, San Diego, and the University of California, San Francisco. For more information, visit www.nesos.com.
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