# Beyond Air, Inc.

> Clarifo company profile — qualitative business description generated from
> the company's filings. Financial statements, charts and ratios are
> available on Clarifo (https://www.clarifo.com/en/companies/Beyond Air, Inc.).

## Overview

Beyond Air, Inc. is a U.S.-based medical technology company built around its LungFit® platform, which generates nitric oxide for hospital and clinical use. Its commercial focus has been on LungFit® PH, while it also maintains earlier-stage programs in oncology through Beyond Cancer and in neurology through NeuroNOS. The company markets directly to hospitals and healthcare systems, using field sales and clinical specialists to support adoption and training. Beyond Air remains in an early commercialization phase and is still funding product rollout, clinical development, and pipeline advancement.

## Products & services

• LungFit® PH nitric oxide delivery system
• Consumable supplies and device-related products
• Clinical training and implementation support
• Contract manufacturing and logistics for device supply
• Beyond Cancer gas-based oncology programs
• NeuroNOS nNOS inhibitor program for ASD

- **Commercial respiratory device platform** (85%) — LungFit® PH systems and related consumables used to deliver nitric oxide in hospital settings.
- **Clinical services and deployment support** (10%) — Training, field support, and implementation services that help hospitals adopt and use the system.
- **Pipeline development programs** (5%) — Preclinical and clinical-stage programs in oncology and neurology that are not yet material revenue drivers.

- LungFit® PH nitric oxide delivery system
- Consumable supplies and device-related products
- Clinical training and implementation support
- Contract manufacturing and logistics for device supply
- Beyond Cancer gas-based oncology programs
- NeuroNOS nNOS inhibitor program for ASD

## Customers

Beyond Air sells primarily to hospitals and healthcare providers that use LungFit® PH for patient care, with revenue currently tied to hospital contracts in the United States. The company also targets larger healthcare purchasing channels such as group purchasing organizations and integrated delivery networks, which can accelerate multi-site adoption. Access to Department of Defense and Veterans Affairs hospitals is an additional customer pathway through its TrillaMed agreement. For future growth, the company is also building international commercial relationships and may rely on local partners in certain geographies. In the pipeline businesses, the eventual customers would be physicians, hospitals, and payors if the programs reach approval and commercialization.

- **U.S. hospitals** (primary) — Buy LungFit® PH systems and consumables for clinical use; they matter because current revenue growth is driven by additional hospital contracts.
- **Government and veteran healthcare facilities** (secondary) — Accessed through TrillaMed to broaden procurement into Department of Defense and VA hospitals.
- **Group purchasing organizations and integrated delivery networks** (secondary) — Buy or influence purchasing decisions across multiple hospitals to speed adoption and improve scale.
- **International healthcare partners** (emerging) — Support expansion into non-U.S. markets where local distribution and regulatory access are needed.
- **Future neurology and oncology end users** (emerging) — Potential future buyers of NeuroNOS or Beyond Cancer therapies if clinical development succeeds.

- Hospitals buying LungFit® PH for inpatient respiratory care
- Department of Defense and Veterans Affairs hospitals accessed via TrillaMed
- Group purchasing organizations seeking standardized hospital procurement
- Integrated delivery networks that can roll out devices across systems
- International healthcare channels for future expansion
- Future physicians and payors if pipeline products are approved

## Geography

The company is headquartered in the United States and manages invoicing and cash collection from Garden City, New York, with a central warehouse in Atlanta, Georgia. Commercial activity is currently concentrated in the U.S., where management specifically cited additional hospital contracts as the driver of revenue growth. Manufacturing is outsourced to third-party partners, including Spartronics and Medisize in Ireland, which makes supply continuity dependent on external production capacity. Beyond Air also maintains subsidiaries and development entities in Israel, Ireland, Australia, Cyprus, Bermuda, and the U.S., reflecting a geographically distributed R&D and corporate structure. The company is also pursuing global expansion through commercial partnerships, which increases exposure to regulatory, reimbursement, and logistics differences across markets.

- United States is the core commercial market and current revenue driver
- Atlanta warehouse supports staging and deployment of LungFit® devices
- Garden City, New York handles invoicing and cash collection
- Ireland-based contract manufacturing supports commercial supply
- Israel is important for R&D and subsidiary operations
- International expansion is being pursued through local partners

## Strategy

Beyond Air is focused on expanding commercial adoption of LungFit® PH while conserving cash and reducing operating complexity. Management has signed channel agreements with TrillaMed, Healthcare Links, and Business Asia Consultants to broaden access to government hospitals, purchasing networks, and international markets. At the same time, the company has reduced staffing, cut back-office footprint, and paused the VCAP study pending future funding, showing a clear emphasis on capital preservation. The company is also trying to stabilize its balance sheet by eliminating debt obligations and reducing near-term financing pressure. Longer term, it is keeping pipeline optionality alive through Beyond Cancer and NeuroNOS, but those programs remain dependent on external funding and clinical progress.

- **Commercialize LungFit® PH through broader hospital access** (short-term) — The company needs recurring product revenue from its approved platform to offset operating losses and support the business.
- **Preserve cash and reduce operating costs** (short-term) — Management disclosed substantial doubt about going concern and expects additional funding within one year.
- **Build international commercialization capability** (medium-term) — Future growth depends on expanding beyond the U.S. while managing local market access and distribution complexity.
- **Advance pipeline programs selectively** (long-term) — Beyond Cancer and NeuroNOS provide long-term optionality but require capital and clinical validation.

- Expand LungFit® PH sales through hospital and channel partnerships
- Use TrillaMed to access Department of Defense and VA hospitals
- Use Healthcare Links to reach GPOs and integrated delivery networks
- Pursue international commercialization through Business Asia Consultants
- Conserve cash by reducing headcount and back-office costs
- Prioritize only the most fundable clinical programs and pause others
- Reduce leverage and financing burden to support near-term operations

## Risks

Beyond Air faces significant going-concern and financing risk because it continues to generate losses and has stated that additional funding will be needed within one year. Commercial execution risk is also high because the company has limited experience selling medical devices at scale and must build a sales force and reimbursement pathway while competing against larger, better-funded rivals. Supply chain and manufacturing risk is meaningful because production is outsourced to third parties, and the company depends on contract manufacturers and logistics providers to deliver devices and consumables. Regulatory and clinical risk remain central because pipeline programs such as Beyond Cancer and NeuroNOS have not yet been approved and may never reach commercialization. The business is also exposed to cybersecurity, geopolitical, and natural-disaster risks because it handles protected health information, relies on IT systems, and depends on a global supply and distribution network.

- **Going-concern and liquidity shortfall** [critical] — Management disclosed substantial doubt about the ability to continue as a going concern and said additional funding will be required within one year.
- **Commercial adoption and reimbursement risk** [high] — LungFit® PH depends on physician, hospital, and payor acceptance, and pricing pressure can limit margins and sales growth.
- **Third-party manufacturing dependence** [high] — The company relies on Spartronics and Medisize for commercial manufacturing and on logistics providers for warehousing and distribution.
- **Clinical and regulatory development risk** [high] — Beyond Cancer and NeuroNOS are precommercial programs with no FDA-approved therapies in their target areas, so success is uncertain.
- **Cybersecurity and data protection risk** [medium] — The company stores PII and PHI and depends on IT systems that could be disrupted or breached.
- **Geopolitical and supply-chain disruption** [medium] — Global operations and outsourced manufacturing expose the business to war, natural disasters, pandemics, and transport interruptions.

- Going-concern and financing risk due to recurring losses and cash burn
- Commercial adoption risk if hospitals and payors do not accept LungFit® PH
- Reimbursement and pricing pressure from competitors and payors
- Third-party manufacturing and logistics dependence
- Clinical and regulatory failure risk for Beyond Cancer and NeuroNOS
- Cybersecurity and PHI/PII protection risk
- Geopolitical, disaster, and supply-chain disruption risk

## Accounting

The most important accounting issue is revenue recognition for a business that is still early in commercialization and may have multiple elements such as devices, consumables, and support services. Because revenue is still small and tied to hospital contracts, quarterly results can be volatile and sensitive to the timing of installations, shipments, and customer acceptance. Another major judgment area is accrued research and development expense, where management must estimate third-party clinical and development costs that have been incurred but not yet invoiced. The company also records fair value changes on derivative and warrant liabilities, debt extinguishment losses, and fixed-asset impairments, all of which can create non-operating volatility in reported earnings. Investors should also watch for stock-based compensation, non-controlling interests, and the accounting effects of outsourced manufacturing and capitalized device inventory as commercialization scales.

- **Revenue recognition** — Can shift reported revenue and gross margin between periods
- **Accrued research and development expenses** — Affects operating loss and period-end liabilities
- **Fair value of derivative and warrant liabilities** — Impacts net loss and earnings volatility
- **Debt extinguishment accounting** — Affects financing costs and comparability across years
- **Stock-based compensation** — Impacts SG&A and R&D expense trends

- Revenue recognition timing for device, consumable, and service components
- Quarterly volatility from small revenue base and hospital contract timing
- Accrued R&D estimates for third-party clinical and development vendors
- Fair value accounting for warrant and derivative liabilities
- Debt extinguishment and related non-operating gains/losses
- Stock-based compensation and non-controlling interest allocations
- Inventory, fixed asset, and impairment judgments as commercialization changes

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*Last updated: 2026-08-11T04:46:23.638774+00:00*
