$ADHC -ADHC Update on FDA Review of GlucoGuard's Breakthrough Device Application
Newsfile Corp
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:
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.
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
hone: 817-525-0057
www.GlucoGuardSleep.comwww.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.)
Newsfile Corp
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:
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.
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
hone: 817-525-0057 www.GlucoGuardSleep.comwww.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.)
