Established therapy. New access model. Where the patients already are.
An issued U.S. patent, a fully functional chamber built, testing passed, and a clear regulatory pathway. FDA 510(k) submission next.
FDA 510(k) submission next. Device not yet cleared for sale or clinical use.
Request Access to Investor MaterialsHyperbaric oxygen therapy (HBOT) is clinically validated, FDA-cleared, and reimbursed — yet remains concentrated in fewer than 1,400 facilities across the United States.
The result is a clear gap between proven treatment and real-world access.
RxAir360 intends to address that gap by enabling physician-based access — bringing HBOT closer to the environments where patients already receive care. FDA 510(k) submission next.
Market sizing distinction: 300,000+ U.S. private practices represent the broad market universe. RxAir360's initial addressable physician-office market is the approximately 50,000 priority specialty practices.
Note: RxAir360's device is in pre-revenue stage. HBOT therapy at existing cleared facilities is FDA-cleared for certain indications; the RxAir360 chamber has not received FDA clearance and is not yet cleared for sale or clinical use.
This is not a new therapy.
It is a new way of delivering it.
Healthcare has already undergone this transition in other categories:
Dialysis moved into outpatient centers
Imaging expanded into freestanding facilities
Surgery shifted into ambulatory environments
Each shift increased access and expanded the market.
Hyperbaric medicine may be positioned for the same
transition.
RxAir360's physician-integrated model is designed to:
Designed to extend HBOT beyond hospital systems into physician offices
Intended to align with existing Medicare and insurance frameworks
Designed to fit into everyday clinical workflows seamlessly
The focus is not just technology — but enabling access at scale. FDA 510(k) submission next.
FDA 510(k) submission next. Device not yet cleared for sale or clinical use, and cannot be marketed for clinical use until regulatory clearance is obtained.
Investment Thesis
The engineering, regulatory, clinical and operating foundation is already in place. Established therapy. New access model.
U.S. Patent No. 11,648,164 B2, issued May 16, 2023 — covering a vertical monoplace HBOT system designed for the physician office.
Fully functional chamber built. Engineering and manufacturing foundation established with Electroimpact (aerospace automation) and ABW Technologies (ASME pressure-vessel fabrication, U/U2 authorized).
Commercial-scale production has not yet begun.
Testing passed. FDA 510(k) submission is next. Designed to ASME PVHO-1, IEC 60601-1, and NFPA 99 standards.
Medical Advisory Board co-chaired by Tyler Sexton, MD and Jeffrey A. Niezgoda, MD — current and past Presidents of the American College of Hyperbaric Medicine. Clinical Advisory Board chaired by Amy E. Stokes, DPT, CSCS.
1. FDA 510(k) Submission
Next regulatory step
2. Clearance
Pending FDA review
3. Priority Market Deployment
~50,000 priority specialty practices
4. Regional & National Expansion
Broad 300,000+ practice universe
FDA 510(k) submission next. Device not yet cleared for sale or clinical use. Detailed transaction terms and unit economics are shared only in controlled investor discussions.
Management-prepared, unaudited financial statements
prepared on the accrual basis in accordance with U.S. GAAP.
Quarterly disclosure statements prepared in connection with the Company's OTC Markets disclosure and quotation process. These reports include corporate disclosures, capitalization information, issuance history, business operations, management certification, and incorporate the Company's financial statements by reference.
RxAir360's financial statements are management-prepared, unaudited, and presented on the accrual basis in accordance with U.S. GAAP.
The OTC Markets Disclosure Statements are prepared in connection with the Company's OTC Markets disclosure and quotation process and incorporate the Company's financial statements by reference where applicable.
Access detailed materials designed to provide a clear, controlled view of the RxAir360 investment thesis, market opportunity, business model, and development progress. Detailed transaction terms and unit economics are shared only in controlled investor discussions.
RxAir360 is positioned to expand access to hyperbaric oxygen therapy within an underserved outpatient market — 300,000+ U.S. practices broadly, with an initial addressable market of ~50,000 priority specialty practices.
This is not an offer to sell or solicitation of securities. Available to accredited investors only.
Available to qualified and accredited investors.
Request Access to Investor MaterialsCommunity Initiative: Through RxAir Cares, a registered 501(c)(3) nonprofit, RxAir360 is actively supporting initiatives focused on expanding access to hyperbaric oxygen therapy in underserved populations.
Additional resources for shareholders, analysts, and prospective investors.
Investment in RxAir360 involves substantial risks, including the risk of total loss of investment. This is not investment advice.
Forward-Looking Statements
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Investment Risks
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