Pre-Revenue · FDA 510(k) Pending

Expanding Access to Clinical Hyperbaric Oxygen Therapy

A physician-integrated system designed for outpatient clinical environments.

Important Notice: The RxAir360 Hyperbaric Chamber is currently in development and has not received FDA 510(k) clearance. It is not available for commercial sale or clinical use. Hyperbaric oxygen therapy (HBOT) is FDA-cleared for certain indications; this device is not cleared for any specific use at this time. This website is for informational purposes only and does not constitute an offer to sell or solicitation of interest in securities.

Find Your Path

How Would You Like to Explore RxAir360?

Select the role that best describes you. Each path is built around your specific questions.

Two healthcare workers stand in a medical room next to a large blue hyperbaric oxygen chamber.

For Physicians

Integrate HBOT Into Your Practice

A practical overview of clinical integration, workflow design, and what implementation actually looks like.

Fits standard exam rooms — no renovation required
Designed for outpatient clinical workflows
Physician-led protocols with trained staff support
Pending FDA 510(k) clearance

Schedule a Workflow Consultation

See how this fits into your existing practice

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For Investors

Opportunity in Physician-Office HBOT

Addressing the hyperbaric oxygen therapy access gap—contingent upon FDA clearance.

Large, underserved U.S. market
Two issued U.S. patents
Scalable physician adoption model
OTC Markets: Form 211 filed

Request Business Overview

Not an offer to buy or sell securities

Happy mature man communicating with a doctor in waiting room at the clinic

For Patients & Families

Learn About Hyperbaric Oxygen Therapy

Understand how HBOT works, what conditions it addresses, and how to talk to your doctor about it.

14 FDA-cleared indications
95+ areas of clinical research
Administered in a physician's office
Non-invasive, no surgery required

Explore HBOT Basics

Always consult your physician for personalized medical advice

The Physician Access Gap

U.S. Physician Practices 500,000+

Hyperbaric Treatment Facilities Fewer than 1,400

Fewer than 1,400 hyperbaric facilities currently serve 500,000+ physician practices in the U.S. This access gap represents a significant infrastructure opportunity.

Contingent upon FDA clearance.

Market data reflects current U.S. healthcare infrastructure. RxAir360 is pursuing FDA 510(k) clearance; no determination has been made regarding safety or efficacy.

A Pattern Repeating Across Healthcare

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 entering that same transition.

Not All Hyperbaric Systems Are Designed for Clinical Use

Hyperbaric therapy is delivered across a range of environments. Understanding the differences is essential when evaluating clinical integration.

Navy blue cylindrical hyperbaric oxygen chamber with control panel and circular porthole windows

Non-Clinical Use

Consumer / Wellness Systems

Non-clinical environments
General-use applications
Varying design standards

Modern medical imaging room with CT scanners and equipment in a clinical hospital setting

Hospital-Based

Hospital-Based Systems

Facility-dependent infrastructure
Centralized deployment
Limited outpatient accessibility

Physician-Integrated

Large blue industrial machine with circular ports and control panel mounted on wooden pallet in laboratory setting

RxAir360 Clinical System

Designed for physician offices
Built within established clinical frameworks
Integrated into outpatient workflows

A Question That Led to a Platform

"If hyperbaric oxygen therapy has been clinically recognized for decades, why does access still depend on where you live?"

— Diallo M. Watts, Sr., Founder & CEO

The Story Behind RxAir360

A father's diagnosis. A research journey.
A treatment out of reach for millions.

Diallo M. Watts, Sr., Founder & CEO — on the personal experience that led to RxAir360

Built With Clinical and Engineering Leadership

Clinical Leadership

Dr. Jeffrey Niezgoda – former president APWCA/ACHM

Dr. Tyler Sexton – President, American College of Hyperbaric Medicine

Manufacturing

Electroimpact – precision engineering partner supporting Boeing and Airbus commercial aircraft programs

Intellectual Property

Two issued U.S. patents covering the vertical monoplace hyperbaric chamber design

Regulatory Pathway

FDA 510(k) submission targeted Q2 2026

Designed to ASME PVHO-1, IEC 60601-1, and NFPA 99 standards

Our Journey

Innovation in Progress

2023–2026

Engineering & Regulatory Development

Patent secured for vertical chamber design
Prototype development completed
Premarket testing underway

2026

510(k) Clearance Submission

FDA 510(k) submission in progress
Manufacturing scale-up preparation
Leasing infrastructure development