Established therapy. New access model. Where the patients already are.
We redesigned where HBOT can live. Vertical chamber. Seated patient. Designed for the physician office.
Important Notice: The RxAir360 chamber is fully functional and has passed electromagnetic compatibility and electrical safety testing. FDA 510(k) submission next. Device not yet cleared for sale or clinical use. Hyperbaric oxygen therapy (HBOT) is an established medical therapy with FDA-recognized 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.
As Seen In
RxAir360 is being recognized for its mission to expand access to Hyperbaric Oxygen Therapy through physician-integrated innovation.
Independent media coverage reflects growing attention to the access gap in Hyperbaric Oxygen Therapy and RxAir360's physician-integrated approach to closing it.
Find Your Path
Select the role that best describes you. Each path is built around your specific questions.
A practical overview of clinical integration, workflow design, and what implementation actually looks like.
See how this fits into your existing practice
Addressing the hyperbaric oxygen therapy access gap—contingent upon FDA clearance.
Not an offer to buy or sell securities
Understand how HBOT works, what conditions it addresses, and how to talk to your doctor about it.
Always consult your physician for personalized medical advice
Fewer than 1,400 hyperbaric facilities currently serve 300,000+ physician practices in the U.S. This access gap represents a significant infrastructure opportunity.
FDA 510(k) submission next. Device not yet cleared for sale or clinical use.
Market data reflects current U.S. healthcare infrastructure. The 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. FDA 510(k) submission next; no determination has been made regarding safety or efficacy.
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.
Hyperbaric therapy is delivered across a range of environments. Understanding the differences is essential when evaluating clinical integration.
It started with a simple question.
"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
A father's diagnosis led our founder to research hyperbaric oxygen
therapy — and to a larger problem: access.
A diagnosis became a design problem.
Diallo M. Watts, Sr., Founder & CEO — on the personal experience that led to RxAir360
The personal journey that led Diallo M. Watts, Sr. to found RxAir360 is now the subject of his new book, Locked Out of Healing: Why Patients Are Denied Care That Could Change Their Lives.
From his father's diagnosis to the questions about healthcare access that eventually inspired RxAir360, Locked Out of Healing tells the story behind the mission.
“I wasn’t trying to become an expert on healthcare access, build a medical device company, or spend years thinking about why some forms of care are available to patients while others remain practically out of reach.
I was trying to help my father.”
Book Status
NOW AVAILABLE
Locked Out of Healing
Available now in paperback and Kindle
Medical Advisory Board co-chaired by Tyler Sexton, MD and Jeffrey A. Niezgoda, MD — current and past Presidents, respectively, of the American College of Hyperbaric Medicine.
Clinical Advisory Board chaired by Amy E. Stokes, DPT, CSCS.
Electroimpact – advanced engineering and manufacturing partner with aerospace automation experience supporting Boeing, Airbus, Northrop Grumman, Bombardier and other major programs.
ABW Technologies – pressure-vessel fabrication partner with decades of ASME pressure-vessel experience, U/U2 authorization, and aerospace, defense and nuclear capabilities.
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.
Testing passed. FDA 510(k) submission next.
Designed to ASME PVHO-1, IEC 60601-1, and NFPA 99 standards
Execution
The engineering, regulatory, clinical and operating foundation is already in place. A fully functional chamber has been built with partners who bring aerospace-level precision and certified pressure-vessel fabrication.
Advanced engineering and manufacturing partner with aerospace automation experience supporting Boeing, Airbus, Northrop Grumman, Bombardier and other major programs.
Pressure-vessel fabrication partner with decades of ASME pressure-vessel experience, U/U2 authorization, and aerospace, defense and nuclear capabilities.
Refers to the fully functional chamber already built and the engineering and manufacturing foundation already established. Commercial-scale production has not yet begun. FDA 510(k) submission next; device not yet cleared for sale or clinical use.
Our Progress
The engineering, regulatory, clinical and operating foundation is already in place.
Patent issued
U.S. Patent No. 11,648,164 B2, issued May 16, 2023
Fully functional chamber built
Vertical monoplace chamber. Upright seated patient. Walk-in entry.
EMC testing passed
Electromagnetic compatibility testing passed — final report received.
Electrical Safety testing passed
Electrical safety testing passed — final Eurofins report awaiting delivery.
FDA 510(k) submission
NEXT — Testing passed. FDA 510(k) submission is next.
For informational purposes only. FDA 510(k) submission next. Device not yet cleared for sale or clinical use.
