Adaptyx Biosciences, a Stanford University spin-off developing wearable biosensing technology, has received Breakthrough Device Designation from the US Food and Drug Administration (FDA) for its continuous cortisol monitoring device.
The company has also joined the FDA’s Total Product Life Cycle Advisory Program (TAP).
The device is being developed to continuously monitor cortisol and support the diagnosis and management of conditions associated with abnormal cortisol levels.
These include hypercortisolism, such as Cushing syndrome, and hypocortisolism linked to adrenal insufficiency.
The FDA’s Breakthrough Device programme provides expedited review and increased interaction with the agency for devices intended to address serious conditions.
Through TAP, Adaptyx will receive structured feedback during development and engage earlier with healthcare providers and payers to support regulatory and reimbursement planning.
The company’s platform uses engineered DNA strands, known as molecular switches, which change shape when they bind to specific target molecules and generate an electrical signal.
This approach is designed to enable continuous monitoring of biomarkers beyond those commonly measured by existing enzyme-based systems.
Adaptyx plans to advance a pivotal clinical programme covering adrenal insufficiency, Cushing syndrome, mild autonomous cortisol secretion, difficult-to-control type 2 diabetes and resistant hypertension.
Source: www.globenewswire.com
