Voluntary Investor Disclosure Statement
Ticker Symbol
Pending
Market
OTC Pink
Market Maker
Glendale Securities
Filing Status
Form 211 Filed
This voluntary disclosure provides comprehensive information about RxAir360 Inc. for current and prospective investors. While OTC Pink markets do not require ongoing disclosure, we are committed to transparency and providing institutional-grade information to our investor community.
Document Status: This is a voluntary information statement and does not constitute an offer to sell or solicitation to buy securities. All information is provided for informational purposes only and should be reviewed in conjunction with our risk factor disclosures.
Current status of securities, trading details, and capital structure as of January 2026
RxAir360 has filed Form 211 with FINRA through our designated market maker, Glendale Securities, LLC. The filing is currently under FINRA review.
A ticker symbol will be assigned by FINRA upon approval of Form 211. The symbol will be announced through press release and updated on this page.
OTC Pink Current Information - The company will qualify for the "Current Information" tier by providing voluntary disclosure through OTC Markets' OTCIQ platform.
Glendale Securities, LLC
FINRA-registered broker-dealer sponsoring RxAir360's Form 211 application
As of January 31, 2026
Share structure information reflects the most recent capitalization as reported. Investors should contact the company for the most current information.
Authorized Shares
1.0B
Common Stock, $0.0001 par value
Outstanding Shares
890,225,597
Common Stock
Restricted Shares
948,503,992
Subject to Rule 144 restrictions
Dynamic Stock Transfer
1110 Bonifant Street, Suite 310
Silver Spring, MD 20910
For questions regarding share certificates, transfers, or account information, shareholders should contact the transfer agent directly.
FINRA-registered and DTC-eligible
Electronic and physical certificates available
Online shareholder portal access
Corporate history, mission, and strategic positioning in the hyperbaric oxygen therapy market
RxAir360 Inc.
Delaware C-Corporation
Incorporated in 2022
5555 West Loop South, Suite 150
Bellaire, TX 77401
NAICS: 339112 - Surgical & Medical Instrument Manufacturing
December 31
To democratize access to clinically-proven Hyperbaric Oxygen Therapy (HBOT) by making it accessible, affordable, and available in physicians' offices nationwide — enabling treatment where patients already receive care.
To become the leading provider of in-office hyperbaric oxygen therapy solutions, establishing HBOT as a standard component of medical practice across multiple specialties and improving outcomes for millions of patients.
Despite FDA clearance for 14 medical conditions and strong clinical evidence supporting HBOT efficacy, access remains severely limited due to infrastructure constraints of traditional hyperbaric facilities.
Total HBOT facilities in the entire United States
Estimated patients annually with FDA-cleared conditions who lack access
Average distance patients must travel to reach HBOT facility
Traditional chambers cost $1M-$3M+ and require 2,000-5,000+ sq ft
Requires dedicated staff, specialized training, and complex logistics
Facilities concentrated in urban areas, leaving rural populations underserved
Daily treatments over weeks require significant time, travel, and cost
RxAir360 has developed a revolutionary compact, vertical hyperbaric oxygen chamber specifically designed for in-office physician use — eliminating traditional barriers while maintaining clinical efficacy and safety standards.
Designed to fit within the footprint of a standard physician exam room (approximately 100–120 square feet) — 80-90% smaller than traditional chambers
Priced at ~$500K — significantly below the $1M-$3M+ range of traditional systems
Simplified operation with automated controls and minimal staff training required
RxAir360 Inc. incorporated in Delaware; initial concept development and market research initiated
Raised seed capital from 50+ physician-investors; began engineering partnership with Electroimpact
Completed initial prototype; began third-party validation testing with Eurofins
Advanced discussions with FDA; independent valuation established at $632M; Form 211 filed for OTC market access
Patent Protection SecuredFDA 510(k) submission anticipated Q1 2026; clearance timeline estimated based on standard FDA review process
Detailed specifications, clinical applications, and regulatory pathway for the RxAir360 Compact Vertical Chamber
Representative hyperbaric chamber technology (actual RxAir360 design may vary)
A revolutionary hyperbaric oxygen therapy device engineered specifically for physician office integration — combining clinical-grade performance with unprecedented compactness and ease of operation.
Our proprietary vertical chamber architecture reduces footprint by 80-90% compared to traditional horizontal chambers while maintaining equivalent therapeutic pressure and oxygen delivery — enabling installation in standard medical exam rooms.
Standard Exam Room
Designed to fit within the footprint of a standard physician exam room (approximately 100–120 square feet)
Up to 3.0 ATA
Therapeutic-grade HBOT pressure
100%
Medical-grade O₂ delivery
Single
One patient per treatment cycle
24VDC / 120VAC
24VDC 3A primary + 120VAC 15A UPS backup
2-3 Days
Turnkey installation included
The FDA has cleared hyperbaric oxygen therapy for 14 medical conditions. RxAir360's chamber, upon FDA clearance, will enable physicians to treat these conditions in their offices for the first time.
Lower extremity wounds in diabetic patients
Chronic refractory wounds
Late radiation tissue injury
Enhancement of healing in problem grafts
Acute traumatic peripheral ischemia
Clostridial myositis and myonecrosis
Acute carbon monoxide intoxication
Diving-related conditions
Arterial gas embolism
Necrotizing soft tissue infections
Exceptional blood loss anemia
Brain abscess treatment
Acute thermal burn injury
Refractory osteomyelitis
Note: The RxAir360 chamber is pending FDA clearance and is not yet approved for any medical use. The indications listed above represent FDA-cleared uses for hyperbaric oxygen therapy generally, which RxAir360 will pursue clearance to treat upon FDA approval.
RxAir360 is pursuing FDA clearance through the 510(k) pathway, demonstrating substantial equivalence to legally marketed predicate devices. This pathway is appropriate for medical devices that are substantially equivalent to existing cleared devices.
Predicate Device Strategy:
RxAir360 will reference existing FDA-cleared monoplace hyperbaric chambers designed for therapeutic pressure applications. Specific predicate devices will be disclosed in the formal 510(k) submission to the FDA.
The RxAir360 device has NOT received FDA clearance and cannot be marketed or sold until clearance is obtained. The anticipated timeline is based on management's best estimates and experience with similar device submissions. There is no guarantee that FDA will clear the device, that clearance will occur within the anticipated timeframe, or that additional testing or modifications will not be required. Any delay in FDA clearance will materially impact the company's commercialization timeline and financial projections.
Current financial position, valuation, and forward-looking market opportunity
RxAir360 is currently a pre-revenue, development-stage medical device company. We have not yet received FDA clearance and have not generated any product sales revenue. All financial information provided is unaudited and for informational purposes only.
Accounting Standard: Financial statements prepared in accordance with U.S. Generally Accepted Accounting Principles (GAAP) for development-stage enterprises. No independent audit has been conducted.
Fair Market Value
Independent Third-Party Valuation
Valuation Date: February 2025
Performed by independent third-party valuation specialist
Discounted Cash Flow (DCF) Analysis
Pre-FDA clearance valuation (Feb 2025)
Total Addressable Market
~$13B+
Estimated U.S. opportunity (equipment + services)
Target Customer Base
140K-155K
Private practices in target specialties (initial addressable market)
Potential Patients Annually
10M+
Estimated underserved with FDA-cleared conditions
Primary revenue stream from RxAir360 chamber sales to physician practices
~$500K
Average selling price (target)
Planned service contracts, consumables, and RxAir Capital financing solutions
Multiple Streams
Service, parts, financing revenue
Raised from 50+ physician-investors
Use: Product development, prototype engineering, initial testing
Information available to qualified accredited investors
Use: FDA submission, manufacturing scale-up, market launch preparation
Manufacturing Parts, Tooling, Materials & First 25 Chambers
Steel, acrylic, machining, QA test units, tooling, fabrication deposits, supplier MOQs, manufacturing line readiness
Operations: Facility, Warehouse, Equipment, Insurance, Logistics
Facility build-out, pallet racks, cranes/handling equipment, calibration systems, liability insurance, logistics partnerships
Regulatory (FDA 510(k) Submission, Testing, Eurofins Validation)
Bench testing, structural analysis, biocompatibility verification, document preparation, consultant fees
Engineering, Design for Manufacturability & Safety Systems
Pressure-vessel optimization, HMI engineering, software logic, integration, safety redundancies, ASME PVHO-1 compliance
Team Expansion & Compensation
Key hires across engineering, operations, compliance, manufacturing supervision, sales & physician onboarding support
Sales, Marketing & Commercial Rollout
Rep onboarding, CRM buildout, market education, physician outreach, specialty campaigns, conferences, digital content
Research & Development (R&D)
HBOT protocol studies, HMI refinements, long-term chamber variants in pipeline
General Working Capital & Contingency Reserve
Cash buffer for unforeseen expenses, timeline fluctuations, supplier volatility
All financial projections, market size estimates, and revenue targets are forward-looking estimates based on management assumptions and have not been independently verified. Actual results may differ materially. RxAir360 is a pre-revenue company with no operating history. There is no guarantee of achieving profitability or any specific financial outcome. All financial information is unaudited and for informational purposes only.
While OTC Pink does not require ongoing financial disclosure, RxAir360 is committed to providing voluntary updates to our investor community through this page and OTC Markets' disclosure platform.
Quarterly Updates
Material developments & milestones
Press Releases
Significant company events
Investor Contact
Direct communication available
Executive leadership, strategic advisors, and corporate governance structure
RxAir360 is led by a seasoned team combining deep expertise in medical device development, regulatory affairs, clinical medicine, and business operations. Our leadership has successfully navigated FDA clearance processes, scaled medical device companies, and brings decades of combined experience in the healthcare sector.
Multi-disciplinary executive team
Engineering & Operations
Product development & manufacturing oversight
Regulatory Affairs
FDA strategy & compliance management
Business Development
Market strategy & commercial planning
Design & Manufacturing Partner
Aerospace engineering leader providing world-class manufacturing expertise for precision medical device production
Third-Party Validation
Independent safety certification and testing to international standards
50+ Physician-Investors
Practicing physicians providing clinical input and early market validation
Legal Entity
Delaware C-Corporation
Incorporation Date
2021
Board of Directors
Independent and management directors overseeing strategy and fiduciary responsibilities
Legal Counsel
Corporate and securities law representation
Financial Advisors
Independent valuation and financial advisory services
Regulatory Consultants
FDA regulatory strategy and compliance experts
For inquiries regarding company information, investor relations, or questions about this disclosure statement, please contact our investor relations team directly.
Phone
(206) 535-3190
Our team typically responds to investor inquiries within 1-2 business days. For urgent matters, please indicate "Urgent" in your subject line.
Contact UsINVESTMENT IN RXAIR360 INVOLVES SUBSTANTIAL RISKS. You should carefully consider the following risk factors before making any investment decision.
An investment in RxAir360 securities is speculative and suitable only for investors who can afford a complete loss of their investment. The risks described below are not the only risks facing the company. Additional risks and uncertainties not currently known to us or that we currently deem immaterial may also materially adversely affect our business, financial condition, results of operations, and prospects.
Highest impact — critical to business viability
The RxAir360 device has NOT received FDA clearance and cannot be marketed or sold until clearance is obtained. There is no guarantee that the FDA will clear our device through the 510(k) pathway or that clearance will be granted at all. The FDA may:
Impact: Any delay or denial of FDA clearance would materially harm our business and could result in total loss of invested capital.
Our anticipated FDA clearance timeline (early 2026) is based on management estimates and industry experience but is subject to significant uncertainty. Delays in FDA review, additional information requests, or changes in FDA policy could extend the timeline by months or years, exhausting our capital reserves and requiring additional financing on unfavorable terms or preventing commercialization entirely.
Even if we obtain FDA clearance, we will be subject to ongoing FDA requirements including Quality System Regulations (QSR), post-market surveillance, adverse event reporting, and potential FDA inspections. Failure to comply with these requirements could result in warning letters, product recalls, fines, or revocation of clearance.
Commercial execution and market acceptance risks
RxAir360 is a pre-revenue, development-stage company with no history of commercial operations, product sales, or proven market demand. We have not demonstrated the ability to manufacture at scale, sell products commercially, generate revenue, or achieve profitability. There is no assurance we will ever generate revenue or achieve profitability.
Our business model depends on physician practices adopting in-office HBOT — a new paradigm. Market adoption risks include:
We rely on Electroimpact and other third-party suppliers for manufacturing. Disruptions in manufacturing, quality control issues, supply chain delays, or termination of manufacturing relationships could prevent us from delivering products to customers. We have no backup manufacturing capacity.
We face competition from established hyperbaric chamber manufacturers (Sechrist, Perry Baromedical, ETC BioMedical, etc.) with decades of market presence, established distribution networks, and significant financial resources. These competitors may develop competing compact chambers, reducing our competitive advantage.
Funding requirements and financial sustainability
We will require substantial additional capital to fund FDA clearance, manufacturing scale-up, commercialization, and ongoing operations. There is no guarantee we will be able to raise additional capital on acceptable terms or at all. Failure to secure adequate financing would force us to delay, reduce, or eliminate operations, potentially resulting in business failure.
The $632M valuation is based on a Discounted Cash Flow (DCF) analysis that relies on numerous assumptions about future market penetration, revenue growth, margins, and market conditions. As a pre-revenue company, this valuation is highly speculative. The actual value of the company may be materially lower than the valuation suggests, and there is no guarantee that investors will realize any return on investment.
Future equity financing rounds will dilute existing shareholders' ownership percentages. We may also issue additional shares for acquisitions, employee compensation, or other corporate purposes. Significant dilution could materially reduce the value of your investment.
We have never declared or paid cash dividends and do not anticipate paying dividends in the foreseeable future. Any return on investment will depend entirely on appreciation in share value and the ability to sell shares, which is highly uncertain.
OTC Pink market trading and liquidity limitations
OTC Pink securities are highly illiquid. Even if trading begins, there is no guarantee of:
Investors should expect to hold shares for an indefinite period and may not be able to liquidate their investment.
OTC Pink stocks are subject to extreme price volatility. Share prices can fluctuate dramatically based on low trading volumes, market sentiment, news events, or factors unrelated to company fundamentals. Investors may experience significant losses from price volatility.
While we have filed Form 211 with Glendale Securities, FINRA approval is not guaranteed. FINRA may deny the application, request additional information, or indefinitely delay approval. Without FINRA approval, our shares cannot trade on the OTC markets, making the investment completely illiquid.
Approximately 90% of outstanding shares are restricted securities subject to Rule 144 holding periods and resale restrictions. Even when OTC trading begins, these shares cannot be immediately sold, creating additional selling pressure once restrictions lift.
Patent protection and IP enforcement challenges
While we have patent protection for our compact chamber design, our IP portfolio is limited. Competitors may design around our patents, challenge patent validity, or develop alternative approaches that do not infringe our patents. Patent litigation is expensive and uncertain, potentially consuming significant capital without guaranteed success.
We rely on trade secrets and proprietary know-how which may be difficult to protect. Employee departures, inadequate confidentiality protections, or reverse engineering could result in loss of competitive advantages.
Reliance on leadership and ability to attract talent
Our success depends heavily on the continued service of our CEO and key executives. Loss of key personnel could severely disrupt operations, delay FDA clearance, and harm business prospects. We do not maintain key person life insurance.
We will need to hire additional personnel for manufacturing, sales, regulatory affairs, and operations. Competition for qualified personnel is intense, and our pre-revenue status and limited resources may make it difficult to attract and retain top talent.
An investment in RxAir360 is suitable ONLY for investors who:
IF YOU DO NOT MEET THESE CRITERIA, YOU SHOULD NOT INVEST IN RXAIR360. This is not a suitable investment for retirement accounts, college savings, emergency funds, or any capital you cannot afford to lose completely.
Important legal information governing the use of this disclosure statement
This Information and Disclosure Statement contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding our expectations, beliefs, intentions, plans, objectives, goals, strategies, future events, future revenues, future results and performance, projected financial results, business prospects, anticipated FDA clearance timelines, anticipated market opportunities, and other statements that are not historical facts.
Words or phrases such as "anticipate," "believe," "continue," "estimate," "expect," "intend," "may," "ongoing," "plan," "potential," "predict," "project," "will," or similar words or phrases, or the negatives of those words or phrases, may identify forward-looking statements, but the absence of these words does not necessarily mean that a statement is not forward-looking.
⚠️ Important: Forward-looking statements are based on management's current expectations and assumptions regarding our business, the economy, and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks, and changes in circumstances that are difficult to predict. Our actual results may differ materially from those contemplated by the forward-looking statements.
Important factors that could cause actual results to differ materially from those in forward-looking statements include, but are not limited to: delays in or failure to obtain FDA clearance; inability to manufacture at scale; failure to achieve market adoption; competitive pressures; inability to raise additional capital; macroeconomic conditions; and the risks described in the "Risk Factors" section of this document.
We undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law. You should not rely upon forward-looking statements as predictions of future events.
THIS DOCUMENT DOES NOT CONSTITUTE AN OFFER TO SELL OR A SOLICITATION OF AN OFFER TO BUY ANY SECURITIES.
This voluntary Information and Disclosure Statement is provided for informational purposes only to assist current and prospective investors in understanding RxAir360 Inc.'s business, operations, and financial condition. Nothing contained in this document should be construed as an offer to sell or a solicitation to purchase securities of RxAir360 Inc.
Any offers or sales of securities will be made exclusively through a confidential Private Placement Memorandum (PPM) and related subscription documents provided only to qualified accredited investors (as defined under Rule 501 of Regulation D of the Securities Act of 1933, as amended) who have a pre-existing substantive relationship with the company or its authorized representatives, and only in jurisdictions where such offers and sales are permitted by applicable securities laws.
State Securities Law Notice: The securities described in this document have not been registered under the Securities Act of 1933 or any state securities laws. Offers and sales of such securities may only be made in compliance with applicable federal and state securities laws, including Regulation D exemptions.
ALL FINANCIAL INFORMATION CONTAINED IN THIS DOCUMENT IS UNAUDITED AND PROVIDED FOR INFORMATIONAL PURPOSES ONLY.
The financial information, valuations, market size estimates, revenue projections, and other financial data presented in this document have not been audited, reviewed, or verified by independent certified public accountants. This information should not be relied upon as a basis for investment decisions.
RxAir360 is a pre-revenue, development-stage company with no operating history. Financial projections are based on management assumptions and estimates that are inherently uncertain and subject to significant business, economic, and competitive uncertainties and contingencies, many of which are beyond our control.
Prospective investors should conduct their own due diligence, consult with their own financial, legal, and tax advisors, and should not rely solely on the information contained in this document.
This document contains market data and industry statistics, including market size estimates, industry growth rates, and competitive positioning information. Such information has been derived from publicly available sources, industry publications, government data (including Medicare data), and company analysis.
While management believes these sources to be reliable, we have not independently verified third-party data and cannot guarantee its accuracy or completeness. Industry publications and market research reports often contain forward-looking projections that are subject to significant uncertainties.
Market size estimates for the hyperbaric oxygen therapy market are based on management's analysis of Medicare billing data, published HBOT utilization statistics, and market research. Actual addressable market may differ materially from estimates provided.
THIS DOCUMENT DOES NOT CONSTITUTE LEGAL, TAX, ACCOUNTING, OR INVESTMENT ADVICE.
The information in this document is not intended to provide, and should not be relied upon for, legal, tax, accounting, or investment advice. You should consult your own advisors regarding the legal, tax, accounting, and financial implications of any investment in RxAir360 securities.
Document Date: January 2026
This document represents a point-in-time disclosure and may not reflect the most current information about RxAir360 Inc. The company reserves the right to update, amend, or supplement this disclosure at any time without notice.
Material changes to the company's business, financial condition, regulatory status, or other significant developments will be disclosed through:
Investors should regularly check this page and the company's OTC Markets profile for updated information. Past statements may no longer be accurate or complete.
This document is directed solely at persons in the United States. This document does not constitute an offer or solicitation in any jurisdiction where such offer or solicitation is unlawful or to any person to whom it is unlawful to make such offer or solicitation.
International investors should be aware that:
International investors must consult with legal counsel in their home jurisdiction before investing and ensure compliance with all applicable laws.
By accessing and using this Information and Disclosure Statement, you acknowledge and agree that:
If you do not agree to these terms, you should not rely on this document and should exit this page immediately.
© 2026 RxAir360 Inc. All rights reserved.
Questions about this disclosure? Contact: [email protected]
Document Version 1.0 | January 2026 | For Investor Information Purposes Only