AdapTyX Biosciences granted FDA Breakthrough Device Designation for continuous cortisol monitoring technology
核心洞察
The FDA granted Breakthrough Device Designation to Adaptyx Biosciences (搜索)' continuous cortisol monitoring device (搜索), a wearable designed to track the hormone in dermal interstitial fluid.
Adaptyx was also accepted into the FDA's Total Product Life Cycle Advisory Program, pairing it with dedicated review teams and early payer engagement.
The company plans a pivotal clinical program in adrenal insufficiency (搜索), Cushing syndrome (搜索), Mild Autonomous Cortisol Secretion (搜索), difficult-to-control type 2 diabetes (搜索) and resistant hypertension (搜索).
Adaptyx Biosciences (搜索), a Stanford University spinoff in Menlo Park, California, said the FDA has granted Breakthrough Device Designation to its continuous cortisol monitoring device (搜索) and accepted the company into the agency's Total Product Life Cycle Advisory Program (TAP). The designation provides expedited FDA review and more frequent, structured interaction with the agency during development. TAP pairs Adaptyx with dedicated FDA review teams for proactive feedback and early access to payers and provider organizations, aligning regulatory and reimbursement strategy in parallel.
The device is designed to support diagnosis and management of suspected and active excess cortisol states, known as hypercortisolism (搜索), which can result from Cushing syndrome (搜索) and other conditions, and low cortisol states, or hypocortisolism (搜索), which can be caused by adrenal insufficiency (搜索). Adaptyx said these adrenal conditions are chronically underdiagnosed and difficult to manage because clinicians have relied on single-time-point blood draws to characterize a hormone that fluctuates throughout the day.
The company's Continuous Molecular Monitoring platform uses programmable, DNA-based molecular switches, engineered DNA strands that change shape and emit an electrical signal when they bind their target, to read hormones, drugs, pharmaceutical compounds, electrolytes and other biomarkers continuously in dermal interstitial fluid. Adaptyx plans to use its accelerated FDA engagement to advance a pivotal clinical program covering hypocortisolism (搜索) in adrenal insufficiency (搜索), hypercortisolism (搜索) in Cushing syndrome (搜索), Mild Autonomous Cortisol Secretion (搜索), difficult-to-control type 2 diabetes (搜索) and resistant hypertension (搜索). The company has raised $23 million in seed financing, holds an exclusive license to nine Stanford patents and has filed 18 additional patents since founding.
Source: markets.businessinsider.com