Key milestones and updates from Alsteni Medical as we work toward FDA clearance and commercial launch.
ALST.001A continuation patent received a Notice of Allowance from the USPTO, expanding protection for additional design embodiments of the Alsteni System. This patent joins issued U.S. Patent 10,744,070 B2 (protection through 2039) in building a comprehensive IP portfolio around the platform.
Alsteni Medical held a Pre-Submission teleconference with the FDA Division of Renal, Gastrointestinal, Obesity, and Transplant Devices on December 17, 2025. The Agency confirmed the 510(k) regulatory pathway and defined a 60–90 day clinical study scope focused on tolerability and safety. Written feedback was received December 11; meeting minutes were submitted December 18.
Pre-Submission package Q252869 submitted to the FDA, seeking guidance on regulatory classification, non-clinical testing requirements, and clinical data needs for the Alsteni System.
Alsteni Medical graduated from the USC Techstars accelerator program, gaining mentorship, network access, and strategic guidance for commercializing the Alsteni System.
Dr. Elizabeth Beale published the results of the Free2Go feasibility pilot in Nutrition & Diabetes (PMID: 32555148), demonstrating zero serious adverse events across 334 tube-days and 4.9% average weight loss among completers eating ad lib. This peer-reviewed publication forms the clinical evidence foundation for the Alsteni platform.
U.S. Patent 10,744,070 B2 issued, protecting the fundamental intraorally-anchored feeding tube system design, anchor mechanism, and tube routing method through 2039.
Follow our progress as we work toward FDA clearance. Reach out if you'd like to learn more about the Alsteni System.
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