American Diversified Holdings Corporation (ADHC) Receives Favorable FDA Review
American Diversified Holdings Corporation (ADHC) has received positive feedback on their Break Through Device Application for GlucoGuard, a revolutionary medical device for type I diabetics. The device, designed as an oral retainer worn during sleep, automatically delivers glucose intraorally to combat nocturnal hypoglycemia.
The FDA acknowledged that GlucoGuard represents breakthrough technology with no current alternatives in the market. Led by Dr. Stephen C. Weber, Assistant Professor at Johns Hopkins School of Medicine and former FDA Medical Officer, the device shows potential to provide significant advantages in treating nocturnal hypoglycemia.
Key FDA acknowledgments include:
- No currently approved alternatives exist
- Potential for significant advantages over current treatment options
- Fulfills an unmet need in type I diabetes management
- Addresses healthcare disparities through low-cost, at-home treatment
The FDA has suggested developing a prototype to confirm physical compatibility and conducting an Early Feasibility study to verify safety for sleeping patients.
American Diversified Holdings Corporation (ADHC) ha ricevuto riscontri positivi sulla loro domanda di dispositivo innovativo per GlucoGuard, un dispositivo medico rivoluzionario per diabetici di tipo I. Il dispositivo, progettato come un apparecchio orale da indossare durante il sonno, somministra automaticamente glucosio per via intraorale per contrastare l'ipoglicemia notturna.
La FDA ha riconosciuto che GlucoGuard rappresenta una tecnologia all'avanguardia senza alternative attualmente disponibili sul mercato. Guidato dal Dott. Stephen C. Weber, Professore Associato alla Johns Hopkins School of Medicine e ex ufficiale medico della FDA, il dispositivo mostra potenzialità significative nel trattamento dell'ipoglicemia notturna.
Principali riconoscimenti della FDA includono:
- Assenza di alternative approvate attualmente
- Potenziale di vantaggi significativi rispetto alle opzioni di trattamento esistenti
- Soddisfa un bisogno non coperto nella gestione del diabete di tipo I
- Affronta le disparità sanitarie tramite un trattamento a basso costo e domiciliare
La FDA ha suggerito di sviluppare un prototipo per confermare la compatibilità fisica e di condurre uno studio di fattibilità precoce per verificare la sicurezza nei pazienti durante il sonno.
American Diversified Holdings Corporation (ADHC) ha recibido comentarios positivos sobre su solicitud de dispositivo innovador para GlucoGuard, un dispositivo médico revolucionario para diabéticos tipo I. El dispositivo, diseñado como un retenedor oral que se usa durante el sueño, administra automáticamente glucosa por vía intraoral para combatir la hipoglucemia nocturna.
La FDA reconoció que GlucoGuard representa una tecnología innovadora sin alternativas actuales en el mercado. Liderado por el Dr. Stephen C. Weber, Profesor Asistente en la Johns Hopkins School of Medicine y ex funcionario médico de la FDA, el dispositivo muestra potencial para ofrecer ventajas significativas en el tratamiento de la hipoglucemia nocturna.
Los principales reconocimientos de la FDA incluyen:
- No existen alternativas aprobadas actualmente
- Potencial para ventajas significativas sobre las opciones de tratamiento actuales
- Cumple una necesidad no satisfecha en el manejo de la diabetes tipo I
- Aborda disparidades en la atención médica mediante un tratamiento económico y domiciliario
La FDA ha sugerido desarrollar un prototipo para confirmar la compatibilidad física y realizar un estudio de factibilidad temprana para verificar la seguridad en pacientes durante el sueño.
American Diversified Holdings Corporation (ADHC)는 제1형 당뇨병 환자를 위한 혁신적인 의료기기인 GlucoGuard의 혁신적 장치 신청에 대해 긍정적인 피드백을 받았습니다. 이 장치는 수면 중 착용하는 구강 유지장치로 설계되어 야간 저혈당을 방지하기 위해 자동으로 구강 내 포도당을 공급합니다.
FDA는 GlucoGuard가 현재 시장에 대체품이 없는 획기적인 기술임을 인정했습니다. 존스 홉킨스 의과대학 조교수이자 전 FDA 의료 담당관인 스티븐 C. 웨버 박사가 이끄는 이 장치는 야간 저혈당 치료에 있어 상당한 이점을 제공할 잠재력을 보여줍니다.
FDA의 주요 인정 사항은 다음과 같습니다:
- 현재 승인된 대체품이 없음
- 현재 치료 옵션에 비해 상당한 이점 가능성
- 제1형 당뇨병 관리에서 충족되지 않은 요구 해결
- 저비용 가정 치료를 통해 의료 격차 해소
FDA는 물리적 적합성을 확인하기 위한 프로토타입 개발과 수면 환자의 안전성을 검증하기 위한 초기 타당성 연구 수행을 제안했습니다.
American Diversified Holdings Corporation (ADHC) a reçu des retours positifs concernant leur demande de dispositif innovant pour GlucoGuard, un dispositif médical révolutionnaire destiné aux diabétiques de type 1. Ce dispositif, conçu comme un appareil buccal à porter durant le sommeil, délivre automatiquement du glucose par voie intraorale pour lutter contre l'hypoglycémie nocturne.
La FDA a reconnu que GlucoGuard représente une technologie de rupture sans alternatives actuelles sur le marché. Dirigé par le Dr Stephen C. Weber, professeur adjoint à la Johns Hopkins School of Medicine et ancien officier médical de la FDA, le dispositif montre un potentiel important pour offrir des avantages significatifs dans le traitement de l'hypoglycémie nocturne.
Les principales reconnaissances de la FDA incluent :
- Aucune alternative approuvée actuellement
- Potentiel d'avantages significatifs par rapport aux options de traitement existantes
- Répond à un besoin non satisfait dans la gestion du diabète de type 1
- Réduit les disparités en matière de santé grâce à un traitement à domicile peu coûteux
La FDA a suggéré de développer un prototype pour confirmer la compatibilité physique et de réaliser une étude de faisabilité précoce afin de vérifier la sécurité des patients pendant le sommeil.
American Diversified Holdings Corporation (ADHC) hat positive Rückmeldungen zu ihrem Antrag auf ein bahnbrechendes Gerät für GlucoGuard erhalten, ein revolutionäres medizinisches Gerät für Typ-1-Diabetiker. Das Gerät, konzipiert als Mundretainer, der während des Schlafs getragen wird, liefert automatisch Glukose intraoral zur Bekämpfung der nächtlichen Hypoglykämie.
Die FDA erkannte an, dass GlucoGuard eine bahnbrechende Technologie darstellt, für die es derzeit keine Alternativen auf dem Markt gibt. Unter der Leitung von Dr. Stephen C. Weber, Assistenzprofessor an der Johns Hopkins School of Medicine und ehemaliger FDA-Mediziner, zeigt das Gerät das Potenzial, erhebliche Vorteile bei der Behandlung der nächtlichen Hypoglykämie zu bieten.
Wichtige Anerkennungen der FDA umfassen:
- Derzeit keine zugelassenen Alternativen
- Potenzial für signifikante Vorteile gegenüber aktuellen Behandlungsoptionen
- Erfüllt einen ungedeckten Bedarf im Management von Typ-1-Diabetes
- Adressiert gesundheitliche Ungleichheiten durch kostengünstige, häusliche Behandlung
Die FDA hat vorgeschlagen, einen Prototyp zu entwickeln, um die physische Kompatibilität zu bestätigen, sowie eine frühe Machbarkeitsstudie durchzuführen, um die Sicherheit bei schlafenden Patienten zu überprüfen.
- FDA acknowledges GlucoGuard as unique breakthrough technology with no current approved alternatives
- Device meets FDA 2023 Breakthrough Guidance preferences for healthcare accessibility
- Addition of former FDA Medical Officer Dr. Stephen Weber as Medical Advisory Board head strengthens regulatory expertise
- Product addresses unmet market need in Type 1 diabetes management
- Low-cost solution potential indicates strong market accessibility and adoption potential
- Additional prototype development still required before FDA approval
- Further clinical studies needed to confirm safety of unattended glucose administration
- Timeline for completion of FDA recommendations not specified
- Financing details and strategic partnerships still pending announcement
Dr. Stephen C. Weber, MD, FACS Head of ADHC's Medical Advisory Board To Lead Next Stage Of GlucoGuard Development
Del 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.
Dr. 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.
ADHC 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.
Dr. Weber's Assessment
ADHC 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:
- 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.
- The GlucoGuard® device has the potential to provide significant advantages over current options to treat nocturnal hypoglycemia, which represents a significant healthcare challenge.
- The device has the potential to fulfill an unmet need in the management of type I diabetics.
- Furthermore, the GlucoGuard® device met the FDA 2023 Breakthrough Guidance preference for devices that reduce disparities in health and health care, especially "accessibility to quality health care." By providing a low-cost, effective, at-home treatment of nocturnal hypoglycemia, the GlucoGuard® device will significantly affect disparities in health care, especially for those populations living alone or without a competent partner.
With these important criteria met, the FDA made several suggestions that would allow completion of successful Breakthrough Designation. These suggestions included development of a prototype device confirming that the proposed device would be physically compatible with the oral anatomy of an adult user while also containing the volume of proposed fluid, dispensing mechanism, and associated electronics. While FDA acknowledged the widespread, accepted use of buccal glucose in emergency situations when patients are unconscious or unable to physically consume oral glucose, FDA felt that the clinical information needed to be modestly extended to confirm the safety of unattended administration of liquid glucose to a sleeping patient.
With these valuable suggestions in mind, IMD Solutions is in the process of developing the prototype device, and constructing an FDA sanctioned Early Feasibility study to provide proof of concept for this important addition to the safe and effective care of type I diabetes.
Thanks for letting me participate in this work.
Stephen C. Weber, M.D.
Stephen C. Weber, M.D.
Assistant Professor
Department of Orthopedics
The Johns Hopkins School of Medicine
ABOUT DR. STEPHEN WEBER, MD
Dr. Weber is currently an Assistant Professor at the Johns Hopkins School of Medicine. He previously served as a Medical Officer and Clinical Reviewer at The US Food and Drug Administration (FDA) and practiced medicine as an Orthorpaedic Surgeon for over 25 years.
Dr. Weber will lead the team in advancing the development of GlucoGuard in collaboration with the founders.
"Dr. Weber's vast experience as a practicing physician, Johns Hopkins School of Medicine Faculty Member and FDA official will be an invaluable addition the management team", commented ADHC. "He will be introducing the company to additional acquisition opportunities as well as leading the development efforts of GlucoGuard. We couldn't be more pleased with his commitment to the shareholders of the company," concluded ADHC.
ABOUT DR. STEPHEN WEBER, MD, FACS
ASSISTANT PROFESSOR
JOHNS HOPKINS SCHOOL OF MEDICINE
Dr. Stephen Weber, MD Assistant Professor John Hopkins School of Medicine. Dr. Weber did his undergraduate and medical school at University of Michigan, where he was an Alpha Omega scholar. His internship and residency was completed at University of California at Davis, where he was outstanding resident of the year on two occasions. He then studied in Basel, Switzerland with the A.O. group as the Jack Daniel's Award recipient from this group, followed by a three month tenure in Hassan, India as a volunteer performing polio surgery with Orthopedics Overseas. He then had the privilege of working with Dr. Richard Caspari completing an arthroscopy fellowship in 1986. Dr. Weber was in private practice with an active clinical research practice in Sacramento, California from 1986 until 2016, where he published numerous papers, clinical articles, and book chapters. He was team physician for Sacramento City College, and University of California at Davis, as well as covering the Sacramento Capitals tennis team, the Sacramento Steelheads, the World Pro Ski Tour, and the US Olympic trials. He is a reviewer and editor for numerous journals, including the Journal of Shoulder and Elbow Surgery, Assistant Editor, Sports Medicine and Arthroscopy, Assistant Editor, Techniques in Shoulder and Elbow Surgery, and Assistant Editor, and the American Shoulder and Elbow Editor for Arch Orthop Trauma Surg. He is a member of the Arthroscopy Association of North America, the American Orthopedic Society for Sports Medicine, and the American Shoulder and Elbow Surgeons, where he has held numerous committee and teaching positions. In 2015 he was awarded a lifetime achievement award from the American Academy of Orthopedic Surgeons and in 2016 he was awarded the Smith and Nephew/James C. Esch Award for Outstanding Clinical Research from the Arthroscopy Association of North America, in Boston. Dr. Weber previously worked at the Food and Drug Administration (FDA) as a Medical Officer and Clinical Reviewer. He also works as an Independent regulatory consultant, evaluating and clearing orthopedic and related devices for the FDA and EU. He remains an avid tennis player and musician.
ADHC and GLUCOGUARD COMPANY OVERVIEW
Key Development Partnerships
The GlucoGuard system is being developed in collaboration with three key partners:
- A leading U.S. research university.
- A highly respected biomedical and defense engineering firm.
- A top publicly traded company in the Continuous Glucose Monitoring (CGM) sector.
Further details on these collaborations will be disclosed soon.
Cutting-Edge Technology for Unmet Medical Needs
GlucoGuard combines advanced engineering, artificial intelligence (AI), and mobile app-based monitoring to create an innovative solution for managing nocturnal Hypoglycemia. The GlucoGuard mouthpiece continuously monitors glucose levels during sleep and automatically administers glucose when hypoglycemic levels are detected. Sophisticated AI algorithms facilitate this process, ensuring effective glucose management without disturbing the patient's rest.
About Artificial Intelligence and Health Care
A recent report from the Mayo Clinic identified three potential benefits of AI in healthcare:
- Improving outcomes for both patients and clinical teams.
- Lowering healthcare costs.
- Benefitting population health.
From preventive screenings to diagnosis and treatment, AI is being used throughout the continuum of care today. Two examples are Preventive Health Care and Risk Assessment.
Cancer Screenings that use radiology can leverage AI to help produce results faster. A noted example is analyzing kidney images in a laborious 45 minute process. AI automated process can reduce this analysis to minutes, saving time, money and giving a more accurate diagnosis.
Pre-diabetes patients with no notable symptoms can be screened using AI to determine which type of diabetes they are at risk for and begin preventative care.
See AI in healthcare: The future of patient care and health management - Mayo Clinic Press.
About the Diabetes Market
The diabetes market is poised for substantial growth, with the U.S. market valued at
For more information on the
The Continuous Glucose Monitoring (CGM) sector, valued at
For details on the CGM market, visit: Continuous Glucose Monitoring Market.
Image 1
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About IMD Solutions, Inc.
IMD Solutions, Inc. is a Nevada-based medical device company developing GlucoGuard, a patent-pending nocturnal glucose monitoring and delivery system for diabetic patients. The system helps prevent the dangerous effects of low blood sugar during sleep, including the potentially fatal "Death in Bed" phenomenon. Collaborating with a leading U.S. research university, a prominent biomedical engineering firm, and a major CGM company, IMD Solutions is at the forefront of diabetes management technology.
For more information, visit: www.GlucoGuardSleep.com.
Contact: Phone: 817-525-0057
Email: info@GlucoGuardSleep.com
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About AMERICAN DIVERSIFIED HOLDINGS CORPORATION
www.UniversalWellnessAI.com
www.UniversalWellnessShop.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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FAQ
What is GlucoGuard and how does ADHC's device help Type 1 diabetics?
What FDA breakthrough status feedback did ADHC receive in April 2025?
Who is leading ADHC's GlucoGuard development in 2025?
What are the next steps for ADHC's GlucoGuard development?
How does ADHC's GlucoGuard address healthcare disparities?
