The Platform

One anchor.
Nothing visible.

The first enteral feeding platform anchored entirely inside the mouth. No tube on the face. No surgical opening.

In Development — Not Yet Available for Sale

Investigational device undergoing FDA review. Not available for commercial sale or clinical use.

Enteral Access Routes in Human Medicine

Six.

In 3,500 years of medicine, six ways to deliver enteral nutrition have been developed. The fifth — percutaneous endoscopic gastrostomy — was first performed in 1979.

We’re building the sixth.

3,500 years of enteral access

Every fundamentally new route to the gastrointestinal tract — and the void between PEG and Alsteni.

~1500 BCE

Lower GI Ancient Egypt & Greece. Nutrient delivery via lower tract. Abandoned.

1617

Oral / Orogastric Fabrici d’Acquapendente. Silver cannula through the mouth.

1846

Surgical Gastrostomy Sédillot. Open abdominal incision into the stomach.

1910–1921

Nasal (NG / NJ) Einhorn, Levin. Through the nose to stomach or jejunum.

1979

PEG Gauderer & Ponsky. Percutaneous endoscopic access. Last new route.

47 years — no new access route

Better materials. Better connectors. Better imaging.
But the same five paths into the body.

2026

The Alsteni System™ Intraoral anchoring. No nose. No abdominal wall. No surgery. The sixth route.

Every enteral feeding device on the market uses one of five access routes developed before 1980. The Alsteni System is the sixth.

Minard G, Nutrition in Clinical Practice, 2006 · AGA Clinical Practice Update, Gastroenterology, 2025
Gauderer & Ponsky, J Pediatr Surg, 1980 · Beale et al., Nutrition & Diabetes, 2020

The Problem

The devices haven’t changed. The patient experience hasn’t either.

Tube feeding is a lifeline for patients with cancer, neurological disease, head and neck conditions, and critical illness. The clinical need is clear and well-established.

The two options available today — nasogastric tubes taped across the face and gastrostomy tubes placed through a surgical opening in the abdomen — were designed for clinical function, not for the people who have to live with them. Both deliver nutrition effectively. Neither is tolerable long-term for many patients.

The human cost is documented in the clinical literature: patients withdraw from social life, refuse treatment, and experience significant psychological distress. Not because the therapy doesn’t work — because the device is intolerable.

Every other field of medicine has moved toward minimally invasive, patient-centered design. Enteral nutrition has stood still.

The Platform

Three components. One integrated system.

The Alsteni System consists of three components — an intraoral anchor, a feeding tube, and a standard connector — designed for clinical compatibility and ease of use across dental and medical settings.

Detailed technical specifications are available under NDA for qualified partners and investors.

Request Technical Specifications

The Workflow

Coordinated clinical workflow.

The Alsteni System involves a simple coordinated workflow between a dental professional and a physician. The procedure is non-surgical, requires no sedation, and takes place in standard clinical settings.

Detailed clinical protocols are available for healthcare professionals exploring the platform.

Request Clinical Protocol

Published Research

Built on data. Not assumptions.

Published, peer-reviewed results from the Alsteni feasibility study — the first published human data on an intraorally-anchored feeding system.

Safety

Zero

serious adverse events

334 tube-days

No device-related hospitalizations across all enrolled patients. The study established an initial safety signal for the intraoral anchoring approach in a feasibility-stage population.

Study details

Patients enrolled 16 (6 completers)

Total tube-days 334

Longest single wear 60+ days continuous

Emergency dislodgements 0

Device-related hospitalizations 0

First-in-human feasibility study. Results represent early-stage safety data from a prototype device and are not evidence of safety or effectiveness for a commercial product.

Tolerability

334

tube-days completed

Bimodal adaptation pattern

The feasibility study identified a clear adaptation pattern: most withdrawals occurred in the first 7–10 days, primarily related to prototype device limitations. Patients who adapted past this window tolerated the device for extended periods.

Adaptation data

Enrolled 16 patients

Completers 6 (38% completion rate)

Withdrawal pattern Most within first 7–10 days

Post-adaptation Remaining patients tolerated device for full study duration

Prototype vs. production Feasibility used an early prototype. Production anchor incorporates significant design improvements for stability.

Tolerability is the primary variable for the upcoming FDA-required clinical study. The production anchor design is engineered to address the mechanical limitations observed in the feasibility prototype.

Publication

Nutrition & Diabetes

Full results published in a peer-reviewed Springer Nature journal. Open access. The only published clinical data on intraorally-anchored feeding. PMID: 32555148.

Publication details

Full citation Beale et al., Nutrition & Diabetes (2020)

PMID 32555148

Publisher Springer Nature

Study type First-in-human feasibility (IRB approved)

Significance Only published data on intraoral feeding access

What’s Next

FDA-Required Clinical Study

A prospective safety and tolerability study with protocol in development, designed to support the 510(k) submission for enteral nutrition.

Study design

Primary endpoints Safety, device tolerability, nutrition adequacy

Study design Informed by FDA Pre-Submission meeting feedback

Duration rationale Duration designed to demonstrate tolerance across multiple tube replacement cycles

Regulatory purpose Clinical evidence package for 510(k) submission

Design approach FDA-aligned per Pre-Submission feedback

Study protocol is in active development. Design parameters reflect FDA guidance received during the Pre-Submission process.

Beale et al., Nutrition & Diabetes, 2020 (PMID: 32555148)

Regulatory Pathway

Real milestones. Defined next steps.

Alsteni Nourish is on a 510(k) pathway for enteral nutrition. Key early milestones are complete, and the clinical study is in active preparation.

2020

Feasibility Trial
Published

Complete

2025

FDA Pre-Submission
Meeting

Complete

2026

FDA-Required Clinical Study Protocol
Development & 510(k) Prep

In Progress

510(k) Submission
& Review

FDA Clearance &
Commercial Launch

Next Steps

See the full picture.

Whether you’re a clinician, researcher, or potential collaborator — we’d welcome the conversation.

Get in Touch Published Research