Category I CPT Code Effective Jan 1, 2026
Company secured a Category I CPT code effective January 1, 2026, shifting focus from access creation to commercial execution; management cited this as a major catalyst enabling scaled reimbursement efforts and stated the combined coverage footprint now exceeds 100 million covered lives (company statement).
Major Payer Policy Coverage — ~45 Million Members
In December the company obtained written medical policy coverage from a major national insurer representing approximately 45 million health plan members; this coverage provided immediate full reimbursement (no prior authorization required with correct diagnosis codes) and helped drive a favorable mix shift in Q4.
Federal Supply Schedule (FSS) Contract with VA
Awarded an FSS contract enabling access to the U.S. Department of Veterans Affairs (serving ~7 million active patients annually); management reported multiple VA facilities placing orders and early reorders, representing a new federal channel for growth.
Revenue and Unit Growth
Q4 2025 revenue $968k, up 27% vs Q4 2024 ($761k); Q4 unit deliveries increased 35% y/y. Fiscal 2025 revenue $3.6M, up 33% vs FY2024 ($2.7M); fiscal unit deliveries increased 44% y/y. Company reported the seventh straight quarter of double-digit unit growth.
Commercial Scaling and Reimbursement Infrastructure
Management outlined targeted commercial initiatives (engagement with ~75 children's hospitals, CME presentations, payer-focused marketing, expansion of prior-authorization team) and hiring plans for MSLs, market development specialists, digital marketing, and sales to support 2026 commercialization.
Clinical and Regulatory Progress
Key clinical/regulatory milestones achieved: FDA indication expansion to functional abdominal pain and functional dyspepsia (children and adults), label expansion to ages 8+, increase to four devices per treatment, publication of NASPA/academic society guidelines, initiation of a Cleveland Clinic randomized controlled trial in adults, and other ongoing RCTs (cyclic vomiting syndrome, a 300‑patient post-op UPMC study).
Improved Liquidity and Cash Position
Cash on hand as of 12/31/2025 was $5.0M; Q4 free cash flow was $2.5M (exceeding core quarterly burn of $1.5M). Since quarter end the company raised an incremental $2.6M (ATM and warrant exercises) and reported current cash >$6M with ~$1.2M remaining on the ATM, indicating sufficient near-term liquidity per management.