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American Diversified Holdings Corporation (ADHC) Receives Favorable FDA Review
American Diversified Holdings Corporation (ADHC) Receives Favorable FDA Review.
About this update from American Diversified Holdings Corp.
[{"type":"text","content":"\r\n\r\n \r\n \r\n American Diversified Holdings Corporation (ADHC) Receives Favorable FDA Review\r\n \r\n \r\n\r\n\r\nAmerican Diversified Holdings Corporation (ADHC) Receives Favorable FDA Review\r\n\r\n\r\n\r\nNewsfile Corp.\r\n\r\n\r\nNewsfile Corp\r\n\r\n\r\nDr. Stephen C. Weber, MD, FACS Head of ADHC's Medical Advisory Board To Lead Next Stage Of GlucoGuard Development\r\nDel Mar, California--(Newsfile Corp. - April 29, 2025) - American Diversified Holdings Corporation (OTC Pink: ADHC) is pleased to announce the company has received extensive feedback on the Break Through Device Application.\r\nDr. Stephen C. Weber, MD to head of ADHC's Medical Advisory Board engaged in Extensive dialogue with senior FDA official resulting in the assessment below.\r\nADHC will now proceed with rapidly completing the FDA recommendations. Additional developments on Financing and Valuation and strategic partnerships will be announced in the near future.\r\nDr. Weber's Assessment\r\nADHC recently received the FDA's review of the GlucoGuard Breakthrough Device Application Q250233. The GlucoGuard® device is a unique oral retainer device worn while sleeping and is the only medical device designed to automatically deliver glucose intraorally when needed and reduce the risks associated with nocturnal hypoglycemia in type I diabetics. The GlucoGuard® oral retainer device incorporates proprietary patent pending technology that facilitates effective use with existing Continuous Glucose Monitors (CGM). Virtually all of the requirements for Breakthrough Designation were acknowledged by the FDA to have been fulfilled in the GlucoGuard® application (FDA Guidance Breakthrough Devices Program accessed at: https://www.fda.gov/media/162413/download). Specifically, the FDA acknowledged that:\r\n\r\n The GlucoGuard® device clearly represents Breakthrough technology, as they could not identify any currently cleared or approved alternatives that provides treatment for the type I diabetic patient with nocturnal hypoglycemia.\r\n The GlucoGuard® device has the potential to provide significant advantages over current options to treat nocturnal hypoglycemia, which represents a significant healthcare challenge.\r\n The device has the potential to fulfill an unmet need in the management of type I diabetics.\r\n Furthermore, the GlucoGuard®...