Intraorally Anchored · FDA 510(k) Pathway Confirmed

The first new enteral access route since PEG·1979

Invisible. Reversible. Patient-removable.

First new enteral access route since 1979  ·  Nutrition & Diabetes (Springer Nature, 2020)  ·  FDA 510(k) Pathway Confirmed  ·  USC Techstars ’25
The proof
Backed by Wallace H. Coulter Foundation National Science Foundation Techstars
Supported by USC '25 · I‑Corps · Coulter Advisors from Mayo Clinic · Columbia · USC Keck · U. Adelaide
View All Credentials ↓

Institutional Affiliations

Mayo Clinic — Advisory board (ASPEN Board members)
Columbia University — Advisory board (clinical nutrition research)
USC Keck School of Medicine — Founder affiliation, clinical study site
University of Adelaide — Co-investigator (Prof. Michael Horowitz)
Creighton University — Clinical trial site (Dr. John Anwar, faculty champion)
Washington State University — Alumni network, faculty research collaborations

Funding & Programs

Coulter Foundation — Grant recipient
National Science Foundation — Grant recipient
USC Techstars 2025 — Inaugural cohort

Published Science

Zero serious adverse events across 334 device-days
2.4 kg mean weight loss in 14 days (p=0.008)
Statistically significant GLP-1 and PYY elevation

Intellectual Property & Regulatory

US Patent 10,744,070 — Issued
US Patent 12,336,797 — Issued
PCT WO2025235457 — International protection filed
2 issued patents · Active pipeline in prosecution at Knobbe Martens
FDA Pre-Submission Q252869 — 510(k) pathway confirmed, December 2025

Over
600,000
Americans depend on tube feeding each year. The tubes work. The experience doesn’t.

Today’s options force an impossible choice: a nasogastric tube taped across the face, or a gastrostomy tube requiring surgery. In more than four decades, no fundamentally new approach has reached patients.

Today’s standard
Nasogastric Tube
or worse
Today’s standard
Gastrostomy (PEG) Tube

Not a new version of the same tube.
A fundamentally different approach.

Invisible Between Uses
No visible hardware. Ever.

The anchor lives inside the mouth. When the tube isn’t in use, there’s nothing visible — no tape, no tubing, no external hardware. Patients look exactly as they did before.

No Surgery. No Stoma. No Scar.
Placed in minutes. Removed just as easily.

The Alsteni System requires no surgical opening. Placement takes minutes in an outpatient setting. No incision, no wound care, no permanent change to the body.

Patient-Controlled
Designed for daily life, not just clinical settings.

Patients place and remove the tube themselves. No clinic visit required between feeds. Feed at home, sleep normally, go to work. The device fits into life — not the other way around.


Grounded in peer-reviewed data.

One published study. Next-stage clinical studies planned. Every claim on this site traces to primary data.

Beale et al., 2020 — Nutrition & Diabetes

Journal
Nutrition & Diabetes
Springer Nature
PMID
32555148
Design
IRB-approved feasibility study
Population
Adults with intraoral feeding tube
Key Finding

The study completed 334 tube-days with zero serious adverse events, establishing an initial safety signal for the intraoral anchoring approach.

View full research page
Safety
334 tube-days · Zero serious adverse eventsNo dislodgements requiring emergency intervention across all patients and tube-days in the published feasibility trial.
In Development
What’s Next
OASIS-90 TrialFDA-required next-stage clinical study. IRB protocol in development with academic medical center partner.

One platform. Designed to grow.

The Alsteni System is a modular enteral feeding platform. The same anchor, tube, and adapter architecture is designed to support multiple clinical applications — beginning with enteral nutrition.

Alsteni Nourish

Designed for patients who depend on tube feeding

An invisible, non-surgical alternative to NG and PEG tubes — for patients with cancer, dysphagia, neurological conditions, or any diagnosis requiring sustained enteral nutrition. Designed to support patient dignity and treatment adherence without a visible tube on the face.

Alsteni Reset

A metabolic therapy program currently in development

Exploring the use of intraoral-anchored enteral delivery as a targeted metabolic intervention — leveraging the same platform architecture to support caloric control and metabolic health. Currently in pre-clinical development.

Future indications may be pursued under Phase 2 label expansion following 510(k) clearance for enteral nutrition. Not currently under FDA review.

The Alsteni System is built on three integrated components: an intraoral anchor, a patient-managed feeding tube, and a standardized adapter architecture — designed to support multiple clinical applications from a single platform.


Built by operators. Guided by experts.

63 issued patents. $1.5B+ in commercialized medical device revenue. Published researchers. Former FDA reviewers. A team built to take this from prototype to patients.

Advisory Network
Dr. John Anwar
Clinical Study Lead
Kwame Ulmer
Former FDA CDRH Reviewer · Regulatory Strategy
Dr. Demetrios Demetriades
USC Division of Trauma Surgery
Dr. David Seres
Columbia University · ASPEN Board
Dr. Hongsheng Tong, DDS, PhD
Co-founder InBrace · Raised $173–219M