Patented Technology · FDA 510(k) Submission: Q2 2026
Form 211 Filed · OTC Markets
Hyperbaric oxygen therapy has been clinically validated for decades across 15 FDA-recognized indications — yet treatment remains confined to fewer than 1,400 specialized facilities nationwide.
Like dialysis, imaging, and urgent care before it, hyperbaric medicine is entering a critical transition: from hospital-centered to physician-integrated outpatient care. RxAir360 is building the physician-integrated hyperbaric systems and clinical infrastructure to make this expansion possible.
500,000+ physician practices. Fewer than 1,400 hyperbaric facilities.
The access gap represents an infrastructure transformation opportunity.
Prototype of the RxAir360 Vertical Monoplace Hyperbaric Chamber — currently in premarket testing and pending FDA 510(k) clearance.
Millions of patients are treated in physician offices every day, yet hyperbaric oxygen therapy remains concentrated in fewer than 1,400 facilities nationwide. Expanding physician-integrated infrastructure could significantly increase access.
Dialysis
Once hospital-based
7,500+ outpatient centers
Imaging
Once hospital radiology
6,900+ freestanding facilities
Surgery
Once hospital ORs
6,300+ ambulatory surgery centers
Hyperbaric Medicine
Still largely hospital-based
Fewer than 1,400 facilities
When healthcare infrastructure moves closer to patients, access expands and markets grow. Hyperbaric medicine is now entering that same transition — and RxAir360 is building the platform to enable it.
Estimated potential as outpatient adoption increases
Potential long-term infrastructure comparable to other outpatient services
When healthcare infrastructure moves closer to patients, adoption accelerates. Dialysis expanded to more than 7,500 outpatient centers. Imaging expanded to over 6,900 facilities. Urgent care expanded to more than 10,000 clinics. Hyperbaric medicine may be entering the same transition.
Market Infrastructure Potential
Based on comparisons to outpatient dialysis, imaging, and urgent care infrastructure expansion.
"If hyperbaric oxygen therapy has been clinically recognized for decades, why does the United States still lack the infrastructure needed to make it broadly accessible?"
— Diallo M. Watts, Sr., Founder & CEO
Hyperbaric oxygen therapy has traditionally been delivered in hospitals and specialized treatment centers due to infrastructure requirements and large chamber systems — a pattern common to many medical technologies in their early stages.
Phase 1: Discovery & Clinical Validation — HBOT gained FDA recognition for 15 indications over decades of clinical use in hospital settings.
Phase 2: Hospital-Based Adoption — Treatment remained concentrated in fewer than 1,400 specialized facilities due to infrastructure requirements.
Phase 3: Expansion to Physician-Integrated Care — New physician-integrated systems are enabling the transition of hyperbaric therapy from hospital-centered to outpatient physician practice environments — mirroring the evolution of dialysis, imaging, and ambulatory surgery.
Hyperbaric oxygen therapy is often delivered as a series of scheduled outpatient treatments. By integrating HBOT into the physician office environment, practices can expand treatment capabilities while providing patients with convenient access to therapy within their existing care setting.
Many hyperbaric treatment protocols involve multiple sessions prescribed over several weeks — making HBOT a structured therapy that integrates naturally into outpatient clinical workflows.
For practices treating chronic wound patients, hyperbaric oxygen therapy can become an important extension of comprehensive wound care.
RxAir360 is building the physician-integrated clinical infrastructure to expand access to hyperbaric oxygen therapy. By enabling deployment in physician offices where patients already receive care, we are helping transform hyperbaric medicine from a hospital-centered specialty into an accessible outpatient treatment option.
RxAir360 Inc. | Pending FDA 510(k) Clearance — Not Yet Cleared for Sale or Clinical Use
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RxAir360 brings hyperbaric oxygen therapy into physician offices and outpatient clinical settings—making advanced healing accessible to more patients in familiar, convenient settings.
Revolutionary vertical chamber is designed to fit within the footprint of a standard physician exam room (approximately 100–120 square feet)—perfect for multi-story office buildings. No facility remodel or expansion required.
Comfortable, non-intimidating chamber design increases patient acceptance and treatment adherence.
RxAir Capital Solutions offers turnkey leasing options—no large upfront investment needed to get started.
Currently completing FDA 510(k) submission with established regulatory pathway for market entry.
Partnered with proven manufacturers; tooling and scale-up processes already in progress.
Clear ROI path that supports practice growth while expanding patient access to advanced care.
RxAir360 creates value for everyone in the healthcare ecosystem—from physicians building their practice to patients seeking better outcomes to investors seeking meaningful returns.
Dr. Jeffrey Niezgoda – former president APWCA/ACHM
Dr. Tyler Sexton – President, American College of Hyperbaric Medicine
Electroimpact – precision engineering partner supporting Boeing and Airbus commercial aircraft programs
Two issued U.S. patents covering the vertical monoplace hyperbaric chamber design
FDA 510(k) submission targeted Q2 2026
Designed to ASME PVHO-1, IEC 60601-1, and NFPA 99 standards
Our Journey
From engineering breakthrough to market launch—engineered to improve accessibility and transform how physicians deliver hyperbaric therapy.
2023–2026
2026
2026
2027–2028
For informational and investor awareness purposes only. The RxAir360 chamber is not yet cleared for clinical use.
Prototype — currently in premarket testing, pending FDA 510(k) clearance.
Market Opportunity
The global hyperbaric oxygen therapy market is projected to grow from approximately $4 billion to more than $6.7 billion by 2030, driven by increasing demand for advanced wound care, expanded outpatient care delivery, and growing awareness of HBOT's clinical applications. (Source: Grand View Research)
The United States outpatient physician market — more than 500,000 practices without current HBOT access — represents a significant underserved segment within this expanding market.
Hyperbaric oxygen therapy is typically delivered as a prescribed series of outpatient treatments over several weeks. Many treatment protocols involve multiple sessions as part of comprehensive wound care or recovery strategies. Treatment courses for certain indications — such as diabetic foot ulcers — often involve 20 to 40 sessions per patient.
500,000+
Potential Practice Sites
Millions
Underserved Patients
HBOT is FDA-cleared for wound healing, diabetic ulcers, radiation injury, and other indications
Aging population and rise in chronic conditions driving increased need
Established CPT codes and insurance coverage pathways
The RxAir360 system is a patented vertical monoplace hyperbaric oxygen therapy system engineered to integrate into outpatient medical practices while maintaining the safety standards expected in clinical hyperbaric facilities.
Unlike traditional horizontal systems that require large dedicated treatment suites, the RxAir360 is designed to fit within the footprint of a standard physician exam room — approximately 100 to 120 square feet — with no facility renovation required beyond standard utility connections.
Engineered for outpatient clinical environments
~100–120 sq ft — fits in a standard exam room
Designed to integrate seamlessly into existing clinical workflows
ASME PVHO-1, IEC 60601-1, and NFPA 99 compliant
Built by Electroimpact, precision engineers for Boeing and Airbus commercial programs
Note: The RxAir360 system is pending FDA 510(k) clearance and is not yet cleared for sale or clinical use.