Glucoguard Receives Scope Of Work (SOW) Proposal From Arete Bioscience For FDA Recommended Sleep Study

2025-10-14 06:07:21

(MENAFN- Newsfile Corp) Del Mar, California--(Newsfile Corp. - October 14, 2025) - American Diversified Holdings Corporation (OTCID: ADHC) announces today the GlucoGuard received a formal SCOPE OF WORK (SOW) from Arete Bioscience in response to the company's recent meeting with FDA officials.

The FDA had indicated during this meeting that all criterion were met to approve the Break Through Device (BTD) Application but concerns about a sleeping patient potential for aspirating on the proposed quantity of glucose gel into the patient's buccal cavity. Additionally, the FDA requested a recording of the patient's glucose level before and after the administration of the glucose to determine if the patient would bee end points required to increase the patient's blood glucose from a Hypoglycemic state into the normal range.

Glucoguard's Medical Advisory Board, led by Dr. Stephen Weber, MD submitted research studies that established positive results on both points in neo-natal patients. Based upon this research coming from highly reputably studies in New Zealand and Ireland the Medical Advisory Board is confident the sleep study will achieve favorable results.

GlucoGuard's previous BTD application included in depth research involving both issues with neo natal patients, adequately establishing both a nominal risk of aspiration and a successful increase in the blood glucose level in newborn babies. Based upon this research it is the opinion of the GlucoGuard team that these two issues can be successfully addressed in the study that will be conducted by Dr. Sur and the Arete Bioscience team.

"After meeting with several sleep study labs and conferring with other experts in the field, Arete has been able to submit a comprehensive SOW, that is projected to meet all of the FDA's concerns," commented ADHC.

It is anticipated the sleep study will be initiated in the near term pending normal scheduling issues. Additionally, ADHC is continuing to engage investment banking concerns to support the Glucoguard project. More news on this front should be forthcoming soon.

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