Access earnings results, analyst expectations, report, slides, earnings call, and transcript.
The earnings call reveals mixed sentiments. Basic financial performance shows revenue growth but also increased losses and expenses. Product updates, like the RED launch, face adoption challenges, and there's uncertainty in market strategy due to reliance on the new CPT code. The Q&A highlights cautious optimism but lacks concrete details, leading to investor uncertainty. Despite positive long-term prospects, short-term hurdles and management's vague responses temper enthusiasm. Overall, the sentiment remains neutral, expecting minimal stock price movement in the short term.
Revenue Revenues in the third quarter of 2025 were $811,000, up 22% compared to $677,000 in the third quarter of 2024. The increase was driven by a 38% rise in unit deliveries, primarily due to volume growth from patients in the company's financial assistance program, which provides discounts to those without insurance coverage.
Gross Margin Gross margin in the third quarter of 2025 was 83.3%, compared to 85.4% in the third quarter of 2024. The decline was due to higher discounting on devices sold through the Financial Assistance Program, stronger unit growth in the lower-margin Financial Assistance Program, and expired RED inventory charges.
Operating Expenses Total operating expenses in the third quarter of 2025 were $2.8 million, an increase of 25% compared to $2.2 million in the third quarter of 2024. The increase was driven by higher sales commissions, targeted advertising and marketing costs, and the introduction of a long-term incentive plan.
Net Loss Net loss in the third quarter of 2025 was $2.1 million, 21% higher compared to $1.8 million in the third quarter of 2024. The higher loss was due to increased operating expenses, despite higher gross profit from increased sales.
Cash on Hand Cash on hand as of September 30, 2025, was $4.4 million. The company improved its liquidity position in October 2025 by raising an additional $2.8 million through an at-the-market equity offering and the exercise of warrants.
IB-Stim: Neuromodulation technology for pediatric and adult patients. Achieved FDA indication expansion to Functional Abdominal Pain and Functional Dyspepsia with associated nausea symptoms in adults. Category 1 CPT code effective January 1, 2026, expected to streamline coding and reimbursement.
RED (Rectal Expulsion Device): Device for chronic constipation. Existing Category 1 CPT code with strong reimbursement. New CPT code expected January 1, 2026, with potential impact on reimbursement.
Pediatric Market Expansion: Focus on securing medical policy coverage for IB-Stim, emphasizing pediatric coverage. Engaged with major insurers and academic societies to advocate for coverage.
Adult Market Expansion: FDA clearance for IB-Stim in adults. Approaching market through randomized controlled trials, Federal Supply Schedule contract for VA access, and limited market release to gauge insurance acceptance.
Revenue Growth: Achieved 22% year-over-year revenue growth in Q3 2025, marking the fifth consecutive quarter of double-digit growth.
Gross Margin: 83.3% in Q3 2025, slightly down due to higher discounting and expired inventory charges. Expected recovery in 2026 with new CPT code.
Operating Expenses: Increased by 25% year-over-year in Q3 2025, driven by higher sales and marketing expenses and research and development activities.
Category 1 CPT Code Implementation: Effective January 1, 2026, expected to improve reimbursement and physician adoption for IB-Stim.
Commercial Readiness: Focused on education and outreach to children's hospitals and stakeholders to ensure adoption of IB-Stim with the new CPT code.
Insurance Coverage and Reimbursement: The company faces challenges in securing national policy coverage and permanent CPT codes, which are critical for broader adoption of IB-Stim. Current revenue growth is limited as providers are treating only a fraction of the addressable market due to these issues. Policy changes and prior authorization improvements are expected to unfold gradually, delaying broader adoption.
Adult Market for IB-Stim: Although FDA clearance for adults has been obtained, it is based on extrapolated data from adolescents, leading to potential coverage and reimbursement issues in 2026. This could limit market penetration in the adult segment.
RED Device Commercialization: The RED device faces challenges in adoption due to required practice flow changes and physician habit adjustments. Additionally, uncertainty around a new CPT code effective January 1, 2026, could impact reimbursement and market acceptance.
Financial Assistance Program: Higher discounting on devices sold through the Financial Assistance Program has led to lower gross margins. The program's growth in volume has not yet translated to full reimbursement revenue, impacting profitability.
Operating Loss and Cash Burn: The company reported a 27% increase in operating loss year-over-year, with a net loss of $2.1 million in Q3 2025. Free cash flow burn remains at $1.5 million per quarter, raising concerns about liquidity and financial sustainability.
Market Readiness for 2026: Hospitals may face workflow challenges and early payer hurdles as they transition to the new Category 1 CPT code. Initial revenue conversion may lag, impacting short-term financial performance.
Revenue Growth: Stronger growth is expected in 2026 and beyond, driven by the commercialization of IB-Stim and RED products, as well as the implementation of the new Category 1 CPT code effective January 1, 2026.
Insurance Coverage Expansion: Efforts are focused on securing broader medical policy coverage, particularly for pediatric patients, with progress expected through the first half of 2026. The new CPT code is expected to streamline reimbursement and improve access.
Category 1 CPT Code Implementation: The new CPT code, effective January 1, 2026, is anticipated to significantly enhance reimbursement processes, introduce work RVUs for providers, and reduce barriers to access.
Adult Market Expansion: Plans include conducting a randomized controlled trial for IB-Stim in adults, pursuing a Federal Supply Schedule contract for access to the Veterans Administration, and exploring private and commercial market opportunities.
RED Product Outlook: The RED device's market potential is being evaluated, with a new CPT code expected to impact reimbursement starting January 1, 2026. Efforts are underway to explore its adoption in the VA market.
Commercial Readiness for 2026: The company is prioritizing education and outreach to children's hospitals, ensuring readiness for the new CPT code implementation, and aligning commercial efforts to drive adoption.
Financial Projections: Revenue growth is expected to continue in Q4 2025 and accelerate in 2026 with the new CPT code. Gross margins are projected to recover as discounted device sales transition to full reimbursement.
The selected topic was not discussed during the call.
The earnings call reveals mixed sentiments. Basic financial performance shows revenue growth but also increased losses and expenses. Product updates, like the RED launch, face adoption challenges, and there's uncertainty in market strategy due to reliance on the new CPT code. The Q&A highlights cautious optimism but lacks concrete details, leading to investor uncertainty. Despite positive long-term prospects, short-term hurdles and management's vague responses temper enthusiasm. Overall, the sentiment remains neutral, expecting minimal stock price movement in the short term.
The earnings call revealed strong revenue growth (39% in Q1 2025) and a significant increase in unit sales (58% YoY), despite a slight decline in gross margin. Operating expenses and losses decreased, showing improved cost management. The Q&A highlighted positive responses from insurance payers and potential for expanded insurance coverage, which could boost future sales. While there are uncertainties in policy writing speed and coverage timelines, the overall sentiment is positive due to revenue growth, cost management, and optimistic insurance coverage outlook.
The earnings call reflects strong financial performance, with a 25% revenue increase and improved margins, alongside positive product development updates. The Q&A highlights significant market expansion opportunities and favorable insurance coverage impacts. Concerns exist regarding regulatory risks and competitive pressures, but the company has a solid plan for growth and breakeven achievement. Overall, the sentiment is positive, indicating a likely stock price increase in the short term, despite some risks.
All transcripts are sourced directly from the official live webcast or the company’s official investor relations website. We use the exact words spoken during the call with no paraphrasing of the core discussion.
Full verbatim transcripts are typically published within 4–12 hours after the call ends. Same-day availability is guaranteed for all S&P 500 and most mid-cap companies.
No material content is ever changed or summarized in the “Full Transcript” section. We only correct obvious spoken typos (e.g., “um”, “ah”, repeated 10 times”, or clear misspoken ticker symbols) and add speaker names/titles for readability. Every substantive sentence remains 100% as spoken.
When audio quality is poor or multiple speakers talk over each other, we mark the section instead of guessing. This ensures complete accuracy rather than introducing potential errors.
They are generated by a specialized financial-language model trained exclusively on 15+ years of earnings transcripts. The model extracts financial figures, guidance, and tone with 97%+ accuracy and is regularly validated against human analysts. The full raw transcript always remains available for verification.