Alsteni Medical

Market position

The company states that more than 600,000 Americans depend on tube feeding each year and that every enteral feeding device on the market uses one of five access routes developed before 1980, with nasogastric and gastrostomy tubes as the current standards. Alsteni presents its intraoral route as the sixth access route and the first new one since PEG in 1979. It reports the 2020 Nutrition & Diabetes study as the only published clinical data on intraorally anchored feeding.

Alsteni distinguishes its device from nasogastric tubes, which are visible on the face and prone to displacement (reported rates of 21-58%, with pulmonary misplacement in 1.3-2.4% of reinsertions), and from PEG tubes, which involve a surgical opening, procedure-related mortality of 0.5-2%, peristomal infection in 4-30% of patients, and persistent gastrocutaneous fistula in up to 44% after removal. Its stated points of difference are no visible external hardware, no surgery, stoma or scar, patient-controlled placement and removal at home, and a non-pharmaceutical, fully reversible approach.

Technology

The Alsteni System is an enteral feeding platform anchored entirely inside the mouth, consisting of an intraoral anchor, a feeding tube and a standard connector. It requires no nasal route, no abdominal wall penetration, no surgical opening, no stoma and no sedation; placement takes minutes in an outpatient setting and the tube can be placed and removed by the patient, leaving nothing visible between uses. The approach delivers nutrients to the upper intestine. Intellectual property includes U.S. Patents 10,744,070 (in force through 2039) and 12,336,797, U.S. Patent 12,599,544 ("Intraoral Gastrointestinal Access Device and Related Methods," issued 14 April 2026, protecting the system through May 2045), PCT international application WO2025235457, and additional filings in prosecution at Knobbe Martens. Named inventors include Elizabeth Beale, Todd Oda and Nicholas Demetriades.

Go-to-market

The near-term plan is regulatory: completing a prospective FDA-required safety and tolerability clinical study with primary endpoints of safety, device tolerability and nutrition adequacy, designed per Pre-Submission feedback, to support a 510(k) submission, followed by FDA clearance and commercial launch. Manufacturing partnerships are in place with Medical Murray (tube fabrication), APP Medical (anchor MIM components) and Universal Orthodontics (TPA fabrication). Clinical sites and academic relationships include USC Keck School of Medicine and Creighton University. The President and Co-Founder leads commercial execution, investor relations and fundraising, including a $4M seed round.

Patients requiring enteral nutrition, including those with cancer, neurological disease, head and neck conditions and critical illness, as well as adults with obesity and type 2 diabetes addressed in the feasibility study population. Clinical delivery involves dental professionals and physicians in outpatient settings.

Geography

Headquartered in Sierra Madre, California, United States; incorporated in Delaware. Clinical and advisory relationships span U.S. institutions (Mayo Clinic, Columbia University, USC Keck School of Medicine, Creighton University, Washington State University) and the University of Adelaide in Australia. A PCT application extends patent protection to international markets.

History

Following incorporation in 2023, the company initiated seed fundraising in 2024 with capital from Techstars and founder investment, and U.S. Patent 10,744,070 was issued covering the core intraoral feeding device and anchor system. In May 2025 the advisory board was expanded to include opinion leaders from Mayo Clinic, Columbia University and the University of Adelaide, spanning five institutions and including two members of the ASPEN Board. The company graduated from the inaugural USC Techstars accelerator in August 2025, filed FDA Pre-Submission Q252869 in October 2025, filed PCT application WO2025235457 in November 2025, and completed the Pre-Submission on 17 December 2025. In January 2026 an academic lead was confirmed for the FDA-required prospective clinical study; in February 2026 Phase 1 development with a contract manufacturing partner was completed and Phase 2 clinical trial supply manufacturing began; the company website launched in March 2026; and U.S. Patent 12,599,544 issued on 14 April 2026.

Risks & controversies

The device is investigational and is not FDA cleared or approved, and is not available for commercial sale or clinical use; clearance depends on completing a prospective clinical study and a 510(k) submission. The published feasibility study was small, used an early prototype, and had a 38% completion rate (6 of 16 enrolled), with most withdrawals occurring in the first 7-10 days and attributed primarily to prototype device limitations; the company identifies tolerability as the primary variable for the upcoming study. The company states that feasibility results are early-stage data from a prototype and are not evidence of safety or effectiveness for a commercial product. The company is small (1-10 employees), with commercial execution run by a single operational founder.