RxAir360 Inc. is redefining hyperbaric oxygen therapy (HBOT) by engineering the first monoplace chamber designed to fit within a physician's office — making HBOT as accessible as an X-ray machine in private physician offices for patients with FDA-approved conditions.
Device pending FDA 510(k) clearance — anticipated early 2026
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Access to HBOT is limited by space and logistics. Many patients never receive the therapy their doctors recommend due to scheduling delays or lack of availability.
Most HBOT centers are hospital-based or located in larger clinics, making access difficult for many patients
Device shown for demonstration purposes only; not yet available for sale
10' × 12'
Footprint
Our patented design fits comfortably within a typical physician exam room (10x10 or 10x12) and arrives via standard elevator, making it ideal for multi-story office buildings and medical complexes.
It enables clinicians to integrate HBOT directly into their workflow — no hospital referral, no patient transfer, just efficient, accessible care.
Fits in standard exam rooms without renovation
Seamlessly integrates into clinical workflow
No hospital visits, no transfers, just accessible care
Built to meet FDA 510(k) standards and international medical device regulations
Pressure Vessel for Human Occupancy
Electrical Safety & EMC
Quality Management Systems
Risk Management
Integrated control panel design
Our regulatory strategy focuses on proving substantial equivalence to established predicate devices—significantly reducing time, cost, and regulatory risk compared to the PMA pathway.
Sechrist Industries
FDA-cleared monoplace hyperbaric chambers with established safety profile
OxyHealth
Commercially available hyperbaric oxygen therapy systems
ASME PVHO-1 Certification
Independent validation of pressure vessel safety and design integrity
Eurofins E&E Testing
Electrical safety, EMC compliance, and performance verification
With predicate device comparisons documented, ASME PVHO-1 signatures secured, and Eurofins E&E testing underway, RxAir360 is positioned to achieve FDA 510(k) clearance in early 2026—unlocking immediate commercial deployment.
Primary Design & Manufacturing Partner
Prototype development, engineering design, and manufacturing excellence
Regulatory Testing & Compliance
Electrical, electromagnetic components, and safety testing for FDA clearance
World-class partners ensuring every system meets the highest standards for patient and operator safety
Real Patient Outcome: Diabetic Foot Ulcer
From imminent amputation to dramatic improvement after 26 HBOT treatments, then fully healed in just 52 total sessions. HBOT saved this patient's limb and restored their quality of life.
Individual results may vary. Consult with a healthcare professional.
HBOT has been shown to enhance wound healing, reduce inflammation, reduce post-surgical infections, and promote neuroregeneration by delivering oxygen at higher pressures — helping patients recover faster from chronic wounds, injuries, and neurological conditions.
Accelerated tissue repair
Reduced swelling & pain
Brain tissue regeneration
Enhanced tissue delivery
Based on current Medicare reimbursement data, the limited footprint of existing HBOT centers leaves an estimated millions without access. RxAir360 is designed to bridge this gap, empowering physicians to treat patients in-office.
U.S. Market Size
Estimated annual value (Medicare data)
Estimated Potential Patients
With FDA-approved conditions, estimated underserved annually
Estimated Office Compatibility
Based on standard medical office dimensions
Diabetic ulcers, surgical wounds, radiation injuries
Post-surgical, athletic, neurological
Crushed bones, fractures, compromised grafts & flaps
Burn care, carbon monoxide exposure
Late radiation effects, tissue necrosis
Market Validation
Prior to commercial launch, we have already engaged over 50 practicing physicians as seed-round investors — creating unprecedented early market validation from the exact practitioners who will use this technology
Physician Investors
Physicians Who Invested
Over 50 practicing physicians invested their own capital into RxAir360 during early seed rounds — creating dual validation as both investors and prospective future customers
Additional hundreds of physicians have expressed interest in bringing RxAir360 to their practices post-FDA clearance
These physicians want RxAir360 in their own practices. They're investing in their future clinical capabilities.
Day-one market penetration with physician partners who are evangelists, not just customers.
Pre-FDA interest validates market need and creates immediate revenue pipeline post-clearance.
No need to convince skeptical physicians. We have 50+ who have already invested and several hundred more who understand the value and want it in their practice.
Physician investors will promote to their networks. Each becomes a sales channel and brand advocate.
50+ physicians putting capital at risk before they can even buy the product. That's conviction in market need.
Company Information
For qualified accredited investor inquiries regarding company information
RxAir360 provides information to qualified accredited investors who have an existing relationship with the company or its representatives.
FDA submission in final preparation — 510(k) documentation compiled, predicate devices established
Patented technology (18+ years protection) — proprietary vertical design creates sustainable competitive moat
50+ physician investors & built-in network — immediate market access with evangelists ready to deploy
Estimated ~$13B+ addressable market — estimated total addressable market with demonstrated demand for HBOT services
Production-ready engineering — full CAD design complete, manufacturing partnerships established
OTC filing completed — positioned for enhanced liquidity and public market visibility
For information regarding investment opportunities
Diallo M. Watts, Sr.
CEO & Founder
[email protected]
No Public Offering: This website does not constitute an offer to sell or a solicitation of an offer to buy any securities. Any such offer or solicitation will be made only by means of a confidential private placement memorandum and related documents and only in jurisdictions where permitted by law.
Accredited Investors Only: Any investment opportunity is available only to accredited investors as defined by Rule 501 of Regulation D under the Securities Act of 1933. Interested parties must have a pre-existing relationship with RxAir360 Inc. or its representatives.
Forward-Looking Statements: This presentation contains forward-looking statements regarding future events, financial projections, and market opportunities. Actual results may differ materially. Investment in early-stage medical device companies involves significant risk, including the risk of total loss of capital.
SEC Compliant
SAFE Instrument
Accredited Only
OTC Filing Completed
Confidential
Please read these disclosures carefully before proceeding. This information is critical for understanding our current status and regulatory position.
Required notices pursuant to federal securities and medical device regulations
The RxAir360 device has NOT received FDA clearance and is NOT available for sale or clinical use. The device is currently in the pre-submission phase of the FDA 510(k) clearance process. FDA clearance is anticipated in early 2026, but there is no guarantee that clearance will be granted or that the timeline will be met.
All images, specifications, and descriptions of the device shown on this website are for informational purposes only and do not represent a cleared or commercially available product. The FDA has not evaluated any claims regarding the safety or effectiveness of this device.
Nothing on this website constitutes an offer to sell or a solicitation of an offer to buy any securities. This website is for informational purposes only. Any offer or solicitation of securities will be made exclusively through a confidential private placement memorandum (PPM) and related subscription documents, and only in jurisdictions where such offer or solicitation is permitted by law.
Investment opportunities, if available, are limited to accredited investors (as defined in Rule 501 of Regulation D under the Securities Act of 1933) who have a pre-existing substantive relationship with RxAir360 Inc. or its authorized representatives.
This website contains forward-looking statements regarding RxAir360's future performance, market opportunities, regulatory timelines, and financial projections. These statements are not guarantees of future performance and involve substantial risks and uncertainties.
Actual results may differ materially from projected outcomes due to numerous factors including but not limited to: FDA regulatory decisions, manufacturing challenges, market adoption rates, competitive dynamics, capital availability, macroeconomic conditions, and unforeseen technical or operational issues.
All market size estimates, patient population figures, and financial projections are based on company analysis, third-party research, and management assumptions. These figures have not been independently verified and should not be relied upon as guarantees of future performance.
Investment in early-stage medical device companies involves substantial risk and is suitable only for investors who can afford a complete loss of their investment. RxAir360 is a pre-revenue company with no operating history. Potential risks include:
RxAir360 has filed Form 211 for OTC market qualification. This filing does NOT constitute a public offering and does NOT change the private nature of current investment opportunities. All existing investment restrictions, including accredited investor requirements and Regulation D compliance, remain in effect. OTC qualification, if granted, may provide limited liquidity options for existing shareholders but does not guarantee market liquidity or trading activity.
The information on this website does not constitute legal, financial, tax, or investment advice. Prospective investors should consult with their own legal, financial, and tax advisors before making any investment decision.
By accessing this website, you acknowledge that you have read and understood these disclaimers and agree to their terms. RxAir360 Inc. reserves the right to update these disclosures at any time without notice.
Questions about these disclosures? Contact us at [email protected]
Public Market Positioning
RxAir360 Inc. has filed Form 211 for the OTC market, positioning for enhanced liquidity and investor accessibility
We have filed our Form 211 with our market maker Glendale Securities and transfer agent Dynamic Stock Transfer for entry into the OTC market.
Market Maker: Glendale Securities
Experienced market maker facilitating OTC trading
Transfer Agent: Dynamic Stock Transfer
Trusted transfer agent managing shareholder records
Filing Status: Complete
Form 211 submitted for OTC market qualification
OTC trading provides shareholders with potential liquidity options prior to traditional exit events
Public market presence enhances company profile and credibility with institutional investors
Expands potential investor base beyond private placement constraints
Filing for OTC market qualification demonstrates RxAir360's commitment to providing liquidity pathways and transparency for shareholders. This strategic step positions the company for enhanced market accessibility while we continue our path toward FDA clearance and commercial launch.
Note: OTC filing does not constitute a public offering. All current investment opportunities remain subject to accredited investor requirements and Regulation D restrictions.
Investment Timing
Strategic timing + reduced risk + massive opportunity = the pre-Series B sweet spot
510(k) documentation compiled, final testing underway
Predicate devices established (lower regulatory risk)
ASME PVHO-1 compliant design and engineering
Full engineering design completed in SolidWorks
Manufacturing partnerships established and vetted
Supply chain mapped and ready for scale
50+ physician investors with several hundred more expressing interest
Built-in distribution network from day one
Clear unmet need in $13B+ addressable market
Early entry before FDA clearance and commercial launch drive valuation up
Get in before FDA clearance milestone
FDA clearance drives significant valuation increase
Positioned for immediate Texas deployment
SAFE investors benefit from pre-Series B pricing
Proprietary vertical design creates multi-year competitive moat (18+ years of patent protection remaining, issued 2023)
First truly office-friendly chamber creates category leadership
Physician investors become evangelists, accelerating adoption
RxAir Capital eliminates financing barriers for physician buyers
Business Model
RxAir360's planned diversified business model combines equipment sales with recurring revenue streams, targeting a high-margin, scalable medical device business profile
Primary revenue from RxAir360 unit sales to physician practices
Revenue Type
One-Time
Annual maintenance and service agreements for installed base
Revenue Type
Recurring
Physician and clinical staff certification and training services
Revenue Type
Per-Customer
Planned integrated leasing solutions with bundled service contracts
Revenue Type
Recurring
RxAir360 targets performance metrics consistent with established medical device sector fundamentals
Typical Industry Gross Margins
Established medical device companies in comparable categories typically achieve gross margins of 50-60% (industry benchmark data)
High-margin profile reflects specialized technology and clinical value delivery
Industry Avg. PE Ratio (3-Year)
Medical device sector has averaged PE ratios exceeding 55x over the past 3 years (based on publicly traded comparables)
Premium valuations reflect strong investor appetite for innovative medical technology
Industry benchmarks provided for educational context only to illustrate sector characteristics. RxAir360 is a pre-revenue company. Actual company performance may vary materially from industry averages and there is no guarantee RxAir360 will achieve comparable results. Past industry performance is not indicative of future results or RxAir360's future performance.
Planned integrated financing designed to eliminate a key barrier to physician adoption while creating potential predictable recurring revenue streams
Physicians don't need large capital outlays. Lease payments match patient revenue flow.
Monthly lease payments + bundled service contracts = predictable, long-term revenue streams.
Accelerates sales cycle and market penetration vs. cash-only competitors.
Independent Third-Party Validation
Independent third-party valuation provides objective assessment of RxAir360's enterprise value
Independent DCF Valuation
Discounted Cash Flow Analysis
Valuation Firm
Eqvista
Valuation Date
February 2025
Methodology
DCF Model
Eqvista, a recognized equity management and valuation platform, conducted an independent Discounted Cash Flow (DCF) analysis in February 2025, resulting in an enterprise valuation of $632 million. This third-party assessment provides objective validation of RxAir360's business model, market opportunity, and growth potential.
Objective Analysis: Independent firm with no financial interest in outcome
DCF Methodology: Industry-standard valuation approach for growth companies
Recent Assessment: Valuation reflects current market conditions and company progress
Pre-FDA Clearance: Valuation completed before final regulatory milestone
Leading equity management platform
Eqvista is a recognized equity management and valuation platform specializing in startup and growth company valuations, including 409A compliance and DCF analysis. Their independent valuations are used by companies, investors, and financial institutions to establish fair market value.
Specialized in private company valuations
409A compliance expertise
Industry-standard DCF methodologies
Understanding the $632M assessment
The $632M valuation was established in February 2025, before final FDA clearance preparations were complete. Key estimated value drivers considered in the DCF model include:
Estimated ~$13B+ addressable market opportunity
Patented technology and IP protection
Estimated high-margin business model (projected 50-60%)
Multiple recurring revenue streams
50+ physician seed investors; hundreds more expressing interest post-FDA clearance
Historical Information: The $632 million valuation was conducted by Eqvista in February 2025 based on information, assumptions, and market conditions as of that date. Valuations are point-in-time assessments and may not reflect current or future value.
No Guarantee of Value: This valuation does not constitute a guarantee, projection, or promise of actual enterprise value, exit value, or investment returns. Actual value may be materially higher or lower depending on numerous factors including FDA clearance outcomes, market acceptance, competitive dynamics, execution, and economic conditions.
Not Investment Advice: The disclosure of this third-party valuation is for informational purposes only and does not constitute investment advice, an offer to sell, or a solicitation of an offer to buy any securities. Any investment decision should be based on a complete review of offering documents and consultation with financial, legal, and tax advisors.
Forward-Looking Nature: DCF valuations incorporate assumptions about future performance, growth rates, and market conditions. Actual results may differ materially from assumptions used in the valuation model. Past valuations are not indicative of future value or investment performance.
Independent Assessment: Eqvista conducted this valuation independently. RxAir360 Inc. did not influence the methodology or outcome. The valuation reflects Eqvista's professional judgment based on their analysis of available information.
Illustrative Market Scenario
A hypothetical 1% market penetration scenario over 5 years demonstrates the estimated scale of addressable revenue potential — not a forecast or projection
Total B2B Customer Base
Physician Practices in the United States
Private physician practices represent RxAir360's primary B2B customer segment — physicians who own their practices and can make capital equipment decisions (estimated based on AMA data)
Hypothetical 5-year scenario
of 500,000+ practices
Hypothetical chambers deployed
RxAir360 units installed
Hypothetical revenue range (equipment only)
estimated equipment sales potential
Illustrative Calculation
Annual service contracts, RxAir Capital lease payments, and training programs create additional recurring revenue streams beyond equipment sales
50+ physician seed investors representing early adopters provides potential initial launch traction toward this hypothetical penetration scenario
Initial deployment with physician partners, establish operations, prove market fit
Scale to second major market, refine go-to-market strategy, build case studies
Full US market penetration, leverage physician network effects, approach 1% market capture milestone
Hypothetical Illustrative Scenario Only: The figures presented represent a purely hypothetical market penetration scenario for educational and illustrative purposes only. These are NOT projections, forecasts, predictions, or guarantees of actual future performance or results. Actual results will depend on numerous factors including but not limited to: FDA clearance timing and outcome, market acceptance rates, competitive dynamics, manufacturing scale-up, capital availability, execution capabilities, sales effectiveness, and macroeconomic conditions. Market penetration and revenue could be materially higher or lower than this scenario, or may not occur at all. This information does not constitute an offer to sell or solicitation to buy securities. Past hypothetical scenarios are not indicative of future results.
Capital Strategy
Pre-Series B capital will be deployed strategically to achieve FDA clearance, scale manufacturing, and execute market launch
Final testing & submission
Production ramp & inventory
Sales, marketing & infrastructure
Operations & contingency
This allocation prioritizes rapid manufacturing scale-up and market launch infrastructure (80% combined) to capitalize immediately on FDA clearance. With regulatory documentation already compiled and final testing underway, only 10% is allocated to clearance completion, maximizing capital efficiency.
The 40% manufacturing allocation ensures we can fulfill initial demand from our 50+ physician investor network, while the 40% market launch investment builds the infrastructure to scale beyond early adopters into broader market penetration.
Final testing complete, submission filed, clearance obtained
Production begins, initial inventory built, quality systems operational
First commercial units delivered to physician partners, revenue generation begins
Florida expansion initiated, nationwide rollout planning, Series A positioned
The RxAir360 leadership and Medical Advisory Board combine decades of expertise in hyperbaric medicine, wound care, and medical device innovation — turning vision into verified execution.
Founder & CEO
Visionary Leadership
Medical Advisor
Wound Care Expert
Medical Advisor
Hyperbaric Medicine
Clinical Experts
Multi-Specialty Guidance
Operational Excellence
Our core operational team brings deep industry expertise in hyperbaric manufacturing, service, and sales—with key hires positioned to scale as we deploy capital
VP of Infrastructure
20+ years in hyperbaric manufacturing, maintenance, and technical service operations
Director of Operations
20+ years of hands-on experience in hyperbaric operations and clinical dive protocols
Chief Sales Officer
Current Chief Marketing Officer at an insurance company, previously led a team of 100+ agents with proven sales leadership
Code Compliance & Safety Officer
Decades of fire department experience ensuring safety codes and regulatory compliance
While Richard Farmer, Kevin Dye, Tony Brown, and Keith Burch form our operational core, pre-Series B capital will enable strategic key hires across manufacturing, sales, and operations to scale our Texas market deployment and beyond.
Capital deployment includes talent acquisition for sales team expansion, manufacturing ramp, and service infrastructure
Through our RxAir Cares initiative, we will donate chambers to children's hospitals and athletic recovery programs — ensuring equitable access to life-changing HBOT treatment for those who need it most.
Providing care for pediatric patients in need
Supporting athletes in healing and performance
Breaking down barriers to life-changing treatment
Committed to donating hyperbaric chambers to underserved communities, ensuring healing reaches everyone.
Following FDA clearance, RxAir360 will launch a strategic deployment beginning in Texas, expanding to Florida, and then rolling out nationwide. Our mission: making HBOT as accessible as an X-ray machine in private physician offices treating FDA-approved conditions.
Texas Launch
Initial market deployment and physician partnerships
Florida Expansion
Strategic regional growth in high-demand markets
Nationwide Rollout
Full U.S. market penetration and scale
"Making HBOT as accessible as an X-ray machine in private physician offices treating FDA-approved conditions."
Learn more about our technology, mission, and how we're transforming access to hyperbaric oxygen therapy.
www.RxAir360Inc.com
Device Status: Images and descriptions shown in this presentation are for educational and illustrative purposes only. RxAir360 hyperbaric chambers are pending FDA 510(k) clearance and are not yet available for commercial sale or use in the United States.
Securities Notice: This presentation is for informational purposes only and does not constitute an offer to sell or a solicitation to buy securities. Any investment opportunities are available only to accredited investors through private placement memoranda and subscription agreements in compliance with applicable securities laws.
Forward-Looking Statements: This presentation contains forward-looking statements regarding RxAir360's business plans, market opportunities, regulatory pathway, and financial projections. These statements involve risks and uncertainties, and actual results may differ materially from those expressed or implied. Factors that could cause differences include regulatory delays, market acceptance, competitive pressures, and other business risks.
Medical Information: Nothing in this presentation should be construed as medical advice. HBOT treatments should only be administered under the supervision of qualified healthcare professionals. Individual patient results may vary.
© 2025 RxAir360 Inc. All rights reserved. For more information, visit www.RxAir360Inc.com