Built by operators.
Guided by experts.
63 issued patents. $1.5B+ in commercialized medical device revenue. Published researchers. A former FDA reviewer. A team assembled to take an idea from published feasibility data to FDA clearance and commercial launch.
The core team
A physician who invented the device, an operator who builds the business around it, an executive who has commercialized $1.5B+ in devices, and an engineer with 51 issued patents.
Board-certified endocrinologist (American Board of Internal Medicine). MRCP (UK). MD from the University of Adelaide, Australia. 30+ years of clinical practice including the Los Angeles County Department of Health Services. Former Associate Professor, USC Keck School of Medicine.
Lead inventor on three U.S. patent filings covering the intraoral gastrointestinal access device, dental anchor system, and metabolic therapy protocol. Led the FDA Pre-Submission process (Q252869, December 2025) confirming the 510(k) regulatory pathway.
Principal investigator on the proof-of-concept study published in Nutrition & Diabetes (Nature Publishing Group, 2020) — 16 patients enrolled, zero serious adverse events across 334 device-days. Co-author, Nutrition (2022). 45+ peer-reviewed publications across endocrinology, metabolic medicine, and gut hormone physiology. Designed the Metabolic Therapy Program protocol based on the DiRECT trial framework adapted for jejunal nutrient delivery.
Washington State University alumnus. USC Techstars 2025 inaugural cohort. Former U.S. Marine — 0311 Infantry, Reserves. Prior to Alsteni, built and ran the digital marketing engine that generated $30M+ in international property sales for Leptos Group — Cyprus’s largest private property developer — on track for Marketing Director before leaving to commercialize the Alsteni System.
Named inventor on U.S. Patent 12,599,544, "Intraoral Gastrointestinal Access Device and Related Methods," issued April 14, 2026. Co-inventors: Elizabeth Beale, MD (CEO, inventor of record) and Todd Oda (CTO). Part of a portfolio that includes US 10,744,070 (issued, through 2039), a PCT international filing (WO2025235457), and multiple pending continuations.
Operates as the sole operational founder, directing AI as a full-stack execution layer across fundraising, investor relations, regulatory strategy, competitive intelligence, and go-to-market — replacing the output of 5–10 early hires. Manages a 2,000+ contact CRM, cold outreach infrastructure, financial models, clinical site coordination, and the company’s full commercial operating system. Currently leading Alsteni’s $4M seed round.
25+ years in medical device commercialization. $1.5B cumulative revenue. 100+ products commercialized spanning Class II and III devices. 8 issued patents. Former senior roles at Medtronic Diabetes, GE Healthcare, Cardiac Science, and Bear Medical Systems. Founded AdMIT Therapeutics. Former Spacelabs Medical and Sensatex. MS in Biomedical Engineering.
Leads manufacturing partnerships with Medical Murray (tube fabrication), APP Medical (anchor MIM components), and Universal Orthodontics (TPA fabrication). Oversees clinical operations planning for the OASIS-90 trial. Deep expertise in FDA 510(k) and PMA submissions, design controls, and production scale-up from prototype through commercial launch.
51 issued U.S. patents in medical device design and orthodontic systems. Led development of the Ormco Damon System ($150M+ annual revenue), the 3M Victory Series Active Bracket and Buccal Tubes, and the InBrace Gen 2 System. Named inventor on multiple Alsteni Medical patent filings including U.S. Patent Application 19/199,999.
Designed the current-generation Alsteni anchor system addressing all mechanical failure modes from the proof-of-concept study — including the flexible connector with safety mechanisms, revised anchor profile for low-profile molars, and elimination of the sharp edge that caused prototype-related adverse events. Leads product development from Gen 1 production design through Gen 3 non-dental anchor concepts.
Orthodontic design, small-form-factor medical devices, design for manufacturability, and metal injection molding (MIM). Former product innovation engineer at Becton Dickinson. Extensive IP strategy work with Knobbe Martens (Alsteni’s patent counsel).
World-class domain expertise
Six advisors from institutions that define the standard of care — spanning gut physiology, enteral nutrition, trauma surgery, clinical nutrition, orthodontic anchoring, and clinical trial oversight.
Strategic guidance
The professional infrastructure
The specialized firms and consultants executing the regulatory, IP, reimbursement, and clinical workstreams that move the device toward clearance.
The professional infrastructure behind the science.
Want to learn more?
Whether you’re a clinician, researcher, or potential collaborator — we’d welcome the conversation.