Website Launched
Alsteni Medical launches alstenimedical.com with technology information, published research, team profiles, and investor resources.
Active Development
What we’re
building.
Milestones, publications, and interactive data from the team developing the first invisible feeding tube.
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Alsteni Insights
Interactive data experiences exploring the obesity treatment crisis
Interactive Data
The Obesity Treatment Desert
An interactive map of treatment access across all 50 states. Toggle 5 data layers, explore state-by-state briefings, and see where the crisis is worst.
Explore the mapNot yet made publicly available
92%quit within 3 years
4×faster regain than dieting
1.7yrto full weight regain
Interactive Data
The 92% Problem
What happens when GLP-1 drugs stop working. Animated weight curves, discontinuation data, and a personalized lifecycle simulator.
See the dataNot yet made publicly available
Coming Soon
The Type 2 Diabetes Remission Gap
Experience 3 in our interactive data series. Exploring the evidence on intervention timing and type 2 diabetes remission.
Company Timeline
20263 updates
Contract Manufacturing Phase 1 Complete
Phase 1 development with contract manufacturing partner completed, including design verification and prototype tube fabrication. Phase 2 clinical trial supply manufacturing initiated.
Clinical Study Academic Lead Confirmed
Academic lead confirmed for the prospective FDA-required clinical study evaluating the Alsteni System. Protocol development underway.
20255 updates
FDA Pre-Submission Completed
Alsteni completed FDA Pre-Submission Q252869. 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 may support preparation of a future 510(k) submission. Investigational device. Not FDA cleared or approved.
PCT International Patent Application Filed
PCT application WO2025235457 filed, extending patent protection to international markets covering the intraoral anchoring system, feeding tube configuration, and metabolic therapy protocol.
FDA Pre-Submission Filed
Pre-Submission Q252869 filed to request formal FDA feedback on regulatory pathway, clinical study design, and predicate device strategy.
USC Techstars 2025 Graduation
Alsteni Medical graduated from the inaugural USC Techstars accelerator, gaining commercial mentorship and access to Techstars’ global investor and mentor network.
Advisory Board Expansion
Advisory board expanded to include key opinion leaders from Mayo Clinic, Columbia University, and the University of Adelaide, spanning 5 institutions across 2 continents, with 2 members serving on the ASPEN Board.
20242 updates
U.S. Patent Issued
U.S. Patent 10,744,070 issued, protecting the core intraoral feeding device and anchor system. Active pipeline of additional filings in prosecution at Knobbe Martens.
Seed Fundraising Initiated
Company raised initial capital from Techstars and founder investment to fund regulatory and product development activities.
20231 update
Alsteni Medical Founded
Alsteni Medical, Inc. incorporated in Delaware to commercialize a decade of university-funded research into intraoral enteral feeding. Built on published clinical data (Beale et al., 2020, Nutrition and Diabetes, Springer Nature) demonstrating zero serious adverse events across 334 tube-days.