510(k) pathway confirmed by FDA. Clinical study scope defined. Clear timeline from where we are to FDA clearance.
21 months from funding to anticipated FDA clearance, with parallel device development and clinical validation.
Pre-Submission package Q252869 submitted to FDA Division of Renal, Gastrointestinal, Obesity, and Transplant Devices.
CompleteReceived written feedback December 11 and held teleconference December 17. FDA confirmed 510(k) pathway and defined 60–90 day clinical study scope. Meeting minutes submitted December 18.
CompleteALST.001A continuation patent received Notice of Allowance, expanding protection for additional design embodiments. Issuance imminent.
Complete$2.75M target to fund clinical trial, device development, and regulatory submission. Provides 26 months of runway — 21 months to clearance plus 5-month buffer.
In ProgressOASIS-90 clinical trial protocol submitted for FDA feedback. Designed to demonstrate tolerability, nutrition adequacy, and safety over 60–90 days.
UpcomingOASIS-90 trial begins enrollment. 25–30 patients, single site in Los Angeles. 90-day study demonstrating 2–3 tube replacement cycles.
Upcoming90-day data collection complete. Primary endpoints: tolerability, nutrition adequacy, and safety profile established with production device.
UpcomingComplete 510(k) premarket notification submitted to FDA with clinical data, bench testing, and biocompatibility documentation.
UpcomingAnticipated 510(k) clearance enabling commercial launch of Alsteni Nourish for enteral nutrition. Alsteni Reset launches as physician-directed metabolic therapy using the same cleared platform.
TargetThree questions submitted. Three clear answers received. The regulatory pathway is defined.
Is the 510(k) pathway appropriate with an enteral feeding catheter as predicate?
Is the proposed bench testing, biocompatibility, and human factors program sufficient?
Is a prospective clinical study required given the non-clinical evidence package?
Orogastric Alsteni System for Intermittent Support. A prospective, single-arm feasibility study designed to meet FDA requirements for 510(k) clearance.
Primary Endpoints: Tolerability (completion rate, time to withdrawal, patient-reported comfort), nutrition adequacy (caloric delivery, weight maintenance, biomarkers), and safety (adverse events, tissue assessment, device malfunctions).
Academic Lead: Dr. John Anwar, Creighton University. Principal Investigator: Dr. Elizabeth Beale.
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