The first new enteral access route since PEG·1979
Invisible. Reversible. Patient-removable.
Published in Nutrition & Diabetes (Springer Nature), 2020. IRB-approved feasibility study in 16 adults. Zero device-related hospitalizations across all enrolled patients.
Beale et al., Nutrition & Diabetes, 2020 · PMID: 32555148
Two issued US patents anchor the device, with the core protection spanning nearly two decades. An active pipeline of additional filings is in prosecution at Knobbe Martens, covering multiple dimensions of the device architecture. The estate is built and maintained with disciplined capital efficiency — and continues to grow.
FDA Pre-Submission complete (Q252869). Class II medical device pathway. Next-stage clinical studies planned to support the 510(k) submission for enteral nutrition.
FDA Pre-Submission · MedTech Impact Partners, Regulatory Strategy
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.
-
Taped across the face — visible to everyone
A prospective study found 53% of NG tube patients reported significant body image disturbance, with many describing feelings of shame, embarrassment, and social withdrawal directly linked to the tube’s facial visibility.
Ojo et al., Journal of Human Nutrition and Dietetics, 2019
-
Dislodges regularly, requiring reinsertion
NG tube displacement rates range from 21–58% across published studies. Each reinsertion carries risk of misplacement into the lungs, with reported rates of pulmonary insertion between 1.3–2.4% — a potentially fatal complication.
Sparks et al., Nutrition in Clinical Practice, 2011; Metheny et al., American Journal of Critical Care, 2019
-
Patients report avoiding social situations and public spaces
Qualitative research shows tube-fed patients consistently describe social isolation as a primary burden — avoiding restaurants, declining invitations, and eating in private. Visibility is cited as the leading reason patients decline NG tubes.
Brotherton et al., Journal of Human Nutrition and Dietetics, 2006; ASPEN Clinical Guidelines, 2024
-
Requires a surgical opening in the abdomen
PEG placement carries a procedure-related mortality rate of 0.5–2% and a 30-day mortality as high as 24% in certain elderly populations. Despite being intended as "temporary," many patients retain PEG tubes for years due to the invasiveness of removal.
Defined for removal: Rahnemai-Azar et al., International Journal of General Medicine, 2014; Janes et al., BMJ, 2005
-
Daily wound care and ongoing infection risk at the stoma site
Peristomal wound infections occur in 4–30% of PEG patients, making it the most common complication. Other risks include buried bumper syndrome (0.3–2.4%), peritonitis, and tube migration — each requiring additional clinical intervention.
Blumenstein et al., World Journal of Gastroenterology, 2014; Hucl & Spicak, Best Practice & Research Clinical Gastroenterology, 2016
-
Permanent scarring, even after removal
After PEG removal, persistent gastrocutaneous fistula occurs in up to 44% of patients, often requiring surgical closure. All patients are left with a visible scar. For patients whose underlying condition resolves, the physical reminder of the tube remains indefinitely.
Löser et al., Endoscopy, 2005 (ESPEN Guideline); Gordon & Lovat, Frontline Gastroenterology, 2019
Not a new version of the same tube.
A fundamentally different approach.
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.
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.
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
The study completed 334 tube-days with zero serious adverse events, establishing an initial safety signal for the intraoral anchoring approach.
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.
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.
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.
Where would you like to start?
Whether you’re evaluating the science, the clinical pathway, or the patient experience — we’ll point you in the right direction.
Review the company
Review the regulatory pathway, published data, and team behind the Alsteni System.
See the published research
Review the clinical data, study design, and technical specifications.
Learn how it works
Understand the Alsteni System and what to expect from the technology.
Get in touch
Press inquiries, partnerships, or general questions about Alsteni Medical.