The invisible feeding tube. A platform built to scale.
Alsteni Medical is developing the first intraorally-anchored enteral feeding system: a patent-protected platform targeting enteral nutrition, with architecture designed to support future clinical applications. Published clinical data. Defined 510(k) pathway. Experienced medtech team.
A stagnant market.
A platform that unlocks it.
The U.S. enteral nutrition device market alone is valued at $2.1 billion, but the devices patients actually use have not fundamentally changed in decades. The Alsteni System is designed to be the first new access modality for enteral feeding since the introduction of PEG in 1979.
The U.S. enteral nutrition device market encompasses feeding tubes, delivery pumps, administration sets, and specialized formulas: a large, stable segment driven by chronic disease prevalence.
Revenue model spans enteral nutrition (initial 510(k) indication), with platform architecture designed to support future clinical applications. Detailed projections available in the investor deck.
Widely cited by the Feeding Tube Awareness Foundation and the Oley Foundation. Globally, over 3 million people depend on tube feeding at any given time.
Patients requiring enteral nutrition today face two options: a nasogastric tube taped across the face, or a gastrostomy tube placed through a surgical opening in the abdomen. Both deliver nutrition effectively. Neither was designed for the patient experience. The visibility, discomfort, and social stigma of current devices contribute to treatment non-adherence and reduced quality of life, documented extensively in clinical literature.
The Alsteni System introduces a third option: an enteral feeding tube anchored inside the mouth that is completely invisible between uses. No facial tape. No abdominal stoma. No visible indication of tube feeding.
The same intraoral anchor and tube platform is designed to support clinical applications beyond enteral nutrition. Published research observed that delivery of nutrients to the jejunum produced a measurable physiological response that differed from oral intake in a feasibility-stage study (Beale & Horowitz, Nutrition, 2022; Beale et al., Nutrition & Diabetes, 2020). These findings suggest potential applications in metabolic health, a market where patients have demonstrated willingness to pay and where current therapies face significant adherence challenges.
Future indications would require separate clinical evidence and regulatory submissions. The initial 510(k) is for enteral nutrition only. Platform expansion represents upside beyond the base investment case.
Patent-protected.
Published clinical data.
The Alsteni System consists of three integrated components: an intraoral anchor (custom-fitted oral appliance cemented to the upper teeth), a removable feeding tube (8 French polyurethane, gastric or jejunal lengths), and an ENFit-compatible adapter for standard feeding equipment. No proprietary consumables. No specialized capital equipment.
U.S. Patents 10,744,070 & 12,336,797, 2 issued patents · Active prosecution at Knobbe Martens · Lead inventor: Dr. Elizabeth Beale
PCT international filing · Additional patents in prosecution
Evidence of
forward motion.
Pre-Submission Completed.
510(k) in preparation.
Alsteni completed FDA Pre-Submission Q252869 for the Alsteni System. FDA recommended an orogastric/oroenteric enteral feeding tube predicate under 21 CFR 876.5980 and indicated that limited 60–90 day clinical data focused on tolerability, nutrition delivery, and safety of the intraoral tube position may support preparation of a future 510(k) submission for adult enteral nutrition. Investigational device. Not FDA cleared or approved.
| Target Date | Milestone | Status |
|---|---|---|
| Q1–Q2 2026 | FDA-required clinical study protocol development | In progress |
| Q2 2026 | Protocol submission to FDA | Upcoming |
| Q3 2026 | FDA protocol feedback | Upcoming |
| Q1 2027 | IRB approval + trial enrollment start | Upcoming |
| Q2 2027 | Clinical trial complete (25–30 patients, 60–90 days) | Upcoming |
| Q3 2027 | 510(k) submission | Upcoming |
| Q4 2027 | Target FDA clearance | Target |
The team that
executes.
Raising $4M Seed
Alsteni Medical is raising $4 million in seed funding to finance a 24-month program from clinical trial through preparation of a future 510(k) submission and commercial launch readiness. The development budget covers product development, the FDA-required clinical study, design verification testing, regulatory submission preparation, and quality and IP infrastructure.
Milestones Funded
See the full
investment case.
The investor deck includes published clinical data, competitive landscape analysis, detailed regulatory timeline, financial projections, and raise details. Request a copy and we’ll follow up within 24 hours.