- XAIR +2.94%
Strategic Execution and Operational Scaling
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Revenue grew 105% year-over-year to $2.2 million, driven by expanded adoption of the first-generation LungFit PH system across more than 45 hospitals.
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Customer retention exceeds 90% with over half of the current customer base secured under multiyear agreements, providing a stable foundation for future Gen II conversion.
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The commercial strategy has shifted toward high-priority hospitals that are likely to adopt Gen I immediately and expand usage once the transport-compatible Gen II system is approved.
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The divestiture of the NeuroNOS subsidiary to XTL Biopharmaceuticals allows the company to focus resources on core commercial operations while retaining a 19.9% equity stake and up to $31.5 million in milestones.
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Operating expenses were reduced by 36% year-over-year, reflecting disciplined cost-cutting in SG&A and the completion of major R&D spending for the Gen II regulatory filing.
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International expansion reached 40 countries, with management noting a transition from initial device placement to recurring revenue from accessory reorders.
Regulatory Timeline and Commercial Readiness
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FDA decision for the second-generation LungFit PH system is expected before the end of calendar 2026, subject to regulatory review and contract manufacturer inspections.
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The Gen II system is designed to expand the addressable market by introducing compatibility with air and ground transport, a key feature requested by clinicians.
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Management anticipates that overall cash burn will continue to decline as revenue grows, though inventory building for the Gen II launch may temporarily impact cash flow.
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Current capital resources, including recent equity financing and credit lines, are projected to provide a cash runway into calendar year 2027 and potentially to profitability.
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Phase Ib oncology studies for Beyond Cancer remain a strategic priority, but full funding commitment is contingent on reaching a more comfortable path to profitability.
Strategic Transactions and Structural Improvements
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Completed a $5 million financing in January 2026 and secured a $32 million equity line of credit to support commercial readiness.
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Achieved the first commercial sale to a VA Medical Center via partner TrillaMed, establishing a foothold in the largest U.S. healthcare network.
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Gen II system reliability testing has surpassed the 3,000-hour mark, which is expected to triple the service interval compared to Gen I and improve long-term gross margins.
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The 1-for-20 reverse stock split effective July 14, 2025, is reflected in the reported net loss of $0.85 per share.
Q&A Session Highlights
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Management clarified that products are offered through the ECAD catalog, allowing direct access for VA customers outside of traditional RFP processes.
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The initial sale to a single VA hospital serves as a critical entry point for broader adoption across the entire federal network.
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The typical sales cycle remains 6 to 9 months, though highly organized hospitals can complete evaluations in 4 to 5 months.
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Management is mitigating 'wait-and-see' behavior by focusing Gen I sales on non-transport clinical settings, while positioning Gen II specifically for transport-heavy requirements.
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Management expects the Gen II system to improve gross margins, driven by significantly lower service requirements as the service interval increases from 10 months to at least 30 months.
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Gen I margins are expected to stabilize in the 50% to 60% range, depending on final market pricing dynamics.
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The primary gating factor is the completion of work at the contract manufacturer to allow for a final FDA inspection.
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Management expressed high confidence in the timeline, stating there are no major regulatory hurdles and all reliability testing requirements have already been met.
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