Intraorally Anchored develops a reversible, patient‑removable enteral feeding device that anchors an orogastric tube inside the mouth, providing a non‑surgical alternative to traditional nasogastric or gastrostomy tubes. The system has completed an FDA pre‑submission, holds two issued U.S. patents, and demonstrated zero serious adverse events across 334 device‑days in a 16‑patient feasibility study. It aims to improve comfort and safety for the 600,000 Americans who rely on tube feeding each year.
Funding
Funding not disclosed
Founders
Product
Problem
Patients requiring long-term enteral nutrition must choose between uncomfortable nasogastric tubes that are visible and require frequent replacement, or surgical gastrostomy tubes that involve invasive procedures. Both options limit quality of life and have been unchanged for decades.
Solution
Intraorally Anchored has created an invisible, reversible enteral feeding tube that is anchored intraorally and can be removed by the patient without medical assistance. The device eliminates the need for facial tubing or surgical implantation, providing a discreet and patient‑controlled feeding route. A first‑in‑human feasibility study in 16 adults demonstrated zero serious adverse events over 334 tube‑days, supporting safety and tolerability. FDA pre‑submission feedback aligns the product with a 510(k) pathway using an orogastric predicate, enabling a streamlined regulatory path. The system is protected by two issued U.S. patents and an active pipeline of additional filings, securing the underlying technology.
Target Audience
Primary customers are clinicians and healthcare facilities that provide long‑term enteral nutrition to adults, including hospitals, home‑care providers, and specialty nutrition centers.
Features
- Invisible intraoral anchor design that conceals the feeding tube during daily activities
- Patient‑removable mechanism allowing self‑extraction without clinical intervention
- Reversible placement that avoids permanent surgical alteration of the gastrointestinal tract
- Clinical evidence of zero serious adverse events across 334 device‑days in a feasibility trial
- Patent‑protected architecture with two issued U.S. patents and ongoing international filings
- FDA‑aligned 510(k) regulatory strategy based on an orogastric/oroenteric predicate