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The earnings call reveals several concerns: a decrease in product and license revenue, increased net loss, and reduced cash reserves. While there are positive clinical outcomes and ongoing strategic partnerships, the company's avoidance of specific operational details and reliance on Zimmer for sales and marketing raise uncertainties. The Q&A section highlights operational risks, market penetration challenges, and competitive pressures. Despite some positive product developments, the overall sentiment is negative due to financial underperformance and unclear future guidance.
Product Revenue $2.9 million in Q1 fiscal 2026, down from $3.3 million in Q1 fiscal 2025 (a decrease due to Zimmer's initial stocking in Q1 fiscal 2025). Sequentially, revenue increased 5.5% from $2.7 million in Q4 fiscal 2025.
License Revenue $0 in Q1 fiscal 2026, compared to $3 million in Q1 fiscal 2025 (decrease due to the absence of license revenue from the expanded exclusive distribution agreement with Zimmer in Q1 fiscal 2025).
Product Gross Profit $1.6 million or 54.2% of revenue in Q1 fiscal 2026, compared to $1.9 million or 38.9% of revenue in Q1 fiscal 2025 (improvement in gross profit margin). Sequentially, gross profit increased 2.6% from $1.5 million in Q4 fiscal 2025.
Operating Expenses $3.3 million in Q1 fiscal 2026, compared to $3.2 million in Q1 fiscal 2025 (slight increase).
Research and Development Expense $1.4 million in Q1 fiscal 2026, compared to $1.2 million in Q1 fiscal 2025 (increase due to accelerated program development).
Selling, General and Administrative Expense $1.9 million in Q1 fiscal 2026, down 7.7% from $2 million in Q1 fiscal 2025 (decrease due to cost management).
Net Loss $1.4 million or $0.03 per share in Q1 fiscal 2026, compared to net income of $1.8 million or $0.06 per share in Q1 fiscal 2025 (change due to absence of $3 million license revenue in Q1 fiscal 2025).
Cash and Cash Equivalents $3.6 million as of December 31, 2025, compared to $6.6 million as of September 30, 2025 (decrease due to operational expenses).
Working Capital $6.8 million as of December 31, 2025, compared to $7.9 million as of September 30, 2025 (decrease due to reduced cash reserves).
Debt Outstanding $0 as of December 31, 2025 (no change).
OneRF brain ablation system: Sales increased sequentially, with nearly half of all ablations performed since launch occurring in Q1 2026. A registry is being established to capture outcomes, with enrollment expected by the end of Q3 2026.
OneRF trigeminal nerve ablation system: Limited commercial launch initiated, with 9 patients treated across 3 centers, all reporting pain relief. The system offers advantages over traditional systems by reducing patient discomfort. Discussions are ongoing for potential licensing.
Drug delivery program: Program accelerated, with devices expected for commercial use and investigational studies by Q3 2026. Advisory board of oncology experts being organized to guide applications for brain tumor therapies. Discussions with pharma and biotech companies for potential collaborations are ongoing.
Lower back pain management programs: Progress on two technologies: a percutaneously placed pad electrode (animal study planned) and a base vertebral nerve ablation system (advisory board meetings held). Both technologies are in discussions for potential partnerships.
International expansion: Working towards ISO 13485 certification as a step towards international commercialization.
Revenue growth: Projected fiscal 2026 revenue of at least $10.5 million, a 17% increase from fiscal 2025. Q1 2026 product revenue was $2.9 million, up 5.5% sequentially.
Cost management: Selling, general, and administrative expenses decreased by 7.7% year-over-year in Q1 2026.
Strategic partnerships: Ongoing diligence discussions with strategic organizations for licensing and partnerships across multiple technologies.
Leadership appointment: Jason Mills appointed to the Board of Directors, bringing expertise in strategy and business development.
Revenue Dependency on Initial Stocking Orders: The company's revenue in Q1 fiscal 2026 was lower compared to Q1 fiscal 2025 due to the absence of initial stocking orders, which had boosted prior year revenues. This indicates a dependency on such orders for revenue spikes.
Limited Commercial Launch Challenges: The limited commercial launch of the OneRF trigeminal nerve ablation system is still in its early stages, with only 9 patients treated across 3 centers. This limited scale could delay broader adoption and revenue generation.
Regulatory and Certification Hurdles: The company is working towards ISO 13485 certification to commercialize internationally. Delays or failure in obtaining this certification could hinder international market entry.
Cash Flow and Funding Risks: Cash and cash equivalents decreased from $6.6 million to $3.6 million within one quarter. Although the company is funded through fiscal 2026, any delays in achieving key milestones could strain financial resources.
Strategic Partnership Uncertainty: The company is in diligence discussions with strategic partners for multiple technologies. Delays or failures in forming these partnerships could impact commercialization and revenue growth.
Operational and Development Risks: The company is accelerating its drug delivery program and other development projects. However, these initiatives carry risks of delays, technical challenges, and increased R&D expenses.
Market Penetration Challenges: Despite positive outcomes, the adoption of new technologies like the OneRF brain ablation system and trigeminal nerve ablation system is still in progress, which could slow revenue growth.
Economic and Competitive Pressures: The company faces competitive pressures in the medical technology space, which could impact its market share and pricing strategies.
Revenue Projections: The company is projecting fiscal year 2026 sales to be at least $10.5 million, representing a minimum 17% increase from fiscal year 2025.
OneRF Brain Ablation System: The company is establishing a registry to capture patient outcomes and aims to enroll the first patient by the end of the third fiscal quarter of 2026. Additionally, there is an opportunity for international commercialization, with efforts underway to receive ISO 13485 certification.
OneRF Trigeminal Nerve Ablation System: The limited commercial launch is expected to be completed by the end of Q2 fiscal 2026. Discussions are ongoing with a strategic partner to potentially license this technology.
Drug Delivery Program: The program has been accelerated, with devices expected to be available for commercial use and investigational clinical studies by Q3 fiscal 2026, approximately six months earlier than planned. An advisory board of oncology experts is being organized to guide the system's use for brain tumor therapies. Discussions with pharma and biotech companies are ongoing for potential use in animal and investigational human studies for gene and cell therapies.
Lower Back Pain Management Programs: For the percutaneously placed pad electrode system, a long-term animal study is planned to begin next month, with preparations for the first human implant underway. For the base vertebral nerve ablation system, product requirements have been validated, and manufacturing partners for access tools are being identified. Discussions with strategic partners for both technologies are ongoing.
The selected topic was not discussed during the call.
The earnings call reveals several concerns: a decrease in product and license revenue, increased net loss, and reduced cash reserves. While there are positive clinical outcomes and ongoing strategic partnerships, the company's avoidance of specific operational details and reliance on Zimmer for sales and marketing raise uncertainties. The Q&A section highlights operational risks, market penetration challenges, and competitive pressures. Despite some positive product developments, the overall sentiment is negative due to financial underperformance and unclear future guidance.
The earnings call reveals strong financial performance with significant improvements in gross margins and a reduced net loss. The strategic plan outlines ambitious growth prospects, including new product developments and market expansions. Although some uncertainty exists around partnerships and timelines, the overall sentiment is optimistic with increased revenue guidance and improved financial health. The Q&A section did not highlight any major concerns, supporting a positive outlook. Given these factors, a positive stock price movement is likely over the next two weeks.
The earnings call reveals strong financial performance, with significant revenue and margin growth, reduced expenses, and improved net loss. The partnership with Zimmer Biomet and international expansion plans are promising. Despite management's cautious stance on 2026 guidance, the optimistic FY 2025 outlook and strategic partnerships suggest a strong positive sentiment. The Q&A session highlights potential growth areas and addresses concerns, further solidifying the positive outlook. Given the context and potential for expansion, a strong positive stock price movement is expected, likely exceeding 8%.
The earnings call highlights strong financial performance, including record revenue and gross margins, a significant partnership with Zimmer Biomet, and improved net loss figures. The Q&A reveals reliance on Zimmer for revenue and some uncertainty regarding non-Zimmer revenue, but overall sentiment remains positive due to the partnership's potential and no debt. The capital raise ensures financial stability, and the addition of a Chief Medical Advisor indicates strategic growth. Despite some risks and uncertainties, the overall outlook is positive, likely resulting in a stock price increase of 2% to 8%.
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