ADHC Update on FDA Review of GlucoGuard's Breakthrough Device Application

Monday at 10:00am ADT · September 22, 2025 5 min read

Final Issues Have Been Clarified Identifying Basic Safety Concerns

Del Mar, California–(Newsfile Corp. – September 22, 2025) – American Diversified Holdings Corporation (OTCID: ADHC) today the GlucoGuard development team has completed meetings with FDA officials pursuant to the company’s Breakthrough Device Application.

In attendance at the meeting were three senior FDA officials and the GlucoGuard development team. The GlucoGuard team was led by Dr. Steven Weber, MD, FACS (former FDA official and Professor of Medicine at Johns Hopkins School of Medicine), Dr. Kunal Sur, Phd (CEO Arete Bio Science) and Zachary Smith, BA, MS (Bio Medical Device Engineering).

The purpose of the meeting was two-fold:

  1. Presentation of the mouthguard prototype, ensuring the device is compatible with the oral anatomy of a type 1 diabetic patient. It was confirmed that the prototype compatibility was adequately clarified.

  2. Further explanation from the FDA of the last remaining requirement for BTD designation approval was in regard to the potential aspiration of the glucose solution by a non-responsive patient and the effect of the glucose dosage on blood sugar level upon administration.

Dr. Weber, Dr. Sur and Co-Founder Zachary Smith engaged in lengthy conversations with the FDA officials and formulated a plan to address these final two issues.

The meeting concluded with Dr. Sur being tasked to prepare a research protocol study to address this issue. The study will include introducing the glucose solution to a patient and monitoring both the absorption of the solution into the buccal membrane, the potential of aspiration and the effect of the solution on the blood sugar of the patient.

The GlucoGuard 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 a very positive meeting with the FDA officials, GlucoGuard has moved closer to receiving BTD designation. The FDA has indicated that the application has shown the required elements for approval but required basic safety information to proceed. We believe we can provide the required research data to the FDA in the near future as previous research involving newborn babies and successfully addressed this safety issue. Upon the Arete team completing its research protocol and compiling the required data, the team is confident that the BTD designation has a high likelihood of being granted. ADHC will keep shareholders updated very soon,” commented ADHC.

Contact:
Phone: 817-525-0057 
www.GlucoGuardSleep.com
www.UniversalWellnessAI.com

John Cacchioli, CEO 
American Diversified Holdings Corporation 
Telephone: (212) 537-5900 
Email: JC@American-Diversified.com

Social Media: 
Twitter: @ADHCManagement
(This Twitter page is the only official Twitter page for ADHC.)

SAFE HARBOR FORWARD-LOOKING STATEMENTS: This press release may contain forward-looking statements that are based on current expectations, forecasts, and assumptions that involve risks as well as uncertainties that could cause actual outcomes and results to differ materially from those anticipated or expected, including statements related to the amount and timing of expected revenues related to our financial performance, expected revenue, contracts, and future growth for upcoming quarterly and annual periods. These risks and uncertainties are further defined in filings and reports by the Company with the U.S. Securities and Exchange Commission (SEC) and on the OTC Disclosure & News Service (OTCDNS). Actual results and the timing of certain events could differ materially from those projected in or contemplated by the forward-looking statements due to a number of factors detailed from time to time in our filings with the SEC and/or OTCDNS. Among other matters, the Company may not be able to sustain growth or achieve profitability based upon many factors including but not limited to the risk that we will not be able to find and secure construction contracts and the necessary assets that will enable us to become profitable. Reference is hereby made to cautionary statements set forth in the Company’s most recent SEC and/or OTCDNS filings. We have incurred and will continue to incur significant expenses in our development stage, noting that there is no assurance that we will generate enough revenues to offset those costs in both the near and long term. New lines of business in the construction industry may expose us to additional legal and regulatory costs and unknown exposure(s), the impact of which cannot be predicted at this time. Words such as “estimate,” “project,” “predict,” “will,” “would,” “should,” “could,” “may,” “might,” “anticipate,” “plan,” “intend,” “believe,” “expect,” “aim,” “goal,” “target,” “objective,” “likely” or similar expressions that convey the prospective nature of events or outcomes generally indicate forward-looking statements. You should not place undue reliance on these forward-looking statements, which speak only as of this press release. Unless legally required, we undertake no obligation to update, modify or withdraw any forward-looking statements, because of new information, future events or otherwise.

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