Randomized U.S. Trial Finds Autonomous System Improves Precision of Hospital Oxygen Therapy
JAMA Internal Medicine study finds O2matic’s autonomous oxygen system significantly increased time within the target range from 63% to 85%, representing a 35% relative improvement, while reducing both under-oxygenation and over-oxygenation compared to manual oxygen therapy
Copenhagen, Denmark, Aug. 03, 2026 (GLOBE NEWSWIRE) -- — O2matic ApS today announced results from a randomized, multicenter U.S. clinical trial showing that hospitalized patients receiving autonomous oxygen titration with the O2matic PRO 100 spent significantly more time within the prescribed oxygen range than patients receiving standard clinician-managed oxygen therapy.
The SAVE-O2 AI trial, led by investigators at the University of Colorado Anschutz School of Medicine, enrolled 300 adults at four U.S. hospitals. The results were published today in JAMA Internal Medicine and presented simultaneously at the Military Health System Research Symposium. The study is funded by the U.S. Department of War.
The study found that patients treated with the O2matic system spent 85% of their time within their prescribed oxygen range, compared with 63% among patients receiving standard clinician-managed oxygen therapy (a 35% relative increase). Patients also spent less time with oxygen levels that were too low or too high, received a lower overall volume of supplemental oxygen and required fewer manual oxygen adjustments. There was no increase in serious adverse events.
Medical Oxygen’s Global Scale—and Persistent Manual Burden
Oxygen is among the most frequently used treatments in hospital and emergency care. A 2025 Lancet Global Health Commission on medical oxygen security estimated 374 million people worldwide need oxygen therapy each year, including 364 million patients with acute medical or surgical needs. Despite that scale, oxygen delivery remains largely dependent on intermittent manual management by nurses or respiratory therapists during periodic patient checks.
Maintaining patients within prescribed oxygen ranges is important because both insufficient and excessive oxygen exposure have been associated with adverse clinical outcomes and a patient’s oxygen needs can change rapidly between assessments. The O2matic PRO100 continuously monitors blood oxygen saturation through pulse oximetry and automatically adjusts oxygen flow in real time to help keep patients within a clinician-defined target range.
“Oxygen is one of the most widely used therapies in medicine, yet it is still managed largely through repeated manual adjustments by clinicians,” said Adit Ginde, MD, MPH, senior associate dean for clinical research and professor of emergency medicine at the University of Colorado Anschutz School of Medicine and principal investigator of the study. “Our findings show that autonomous oxygen titration with the O2matic PRO100 helped patients remain in their target oxygen range more consistently while reducing exposure to both under- and over-oxygenation. These results suggest that O2matic’s technology could meaningfully improve how supplemental oxygen is delivered in civilian hospitals and military medicine.”
“This study provides rigorous U.S. evidence that autonomous oxygen titration can maintain prescribed oxygen levels substantially more consistently than conventional manual management,” said Marie-Louise Little, CEO of O2matic. “The results suggest an opportunity to improve the precision of one of medicine’s most widely used therapies while reducing the need for clinicians to make repetitive manual adjustments.”
The study included hospitalized adults with acute respiratory illness, traumatic injuries, burns and patients recovering from surgery who had recently begun receiving supplemental oxygen. Participants were randomly assigned to standard oxygen management or autonomous titration using the O2matic PRO100 targeting a normoxemia range of SpO₂ 90–96%.
Compared with standard care, patients receiving autonomous oxygen titration:
- Spent 85% vs 63% of monitored time within the target oxygen range.
- Had 45% less time in hypoxemia, i.e., excessively low oxygen levels.
- Had 68% less time in hyperoxemia, i.e., excessively high oxygen levels.
- Received a lower overall volume of supplemental oxygen, with approximately 23% less daily oxygen use.
- Required fewer manual adjustments by clinical staff.
- Experienced no increase in serious adverse events.
The trial was conducted at UCHealth University of Colorado Hospital, Vanderbilt University Medical Center, Oregon Health & Science University and Wake Forest University School of Medicine.
The SAVE-O2 AI study is part of a broader CU Anschutz research program to modernize oxygen delivery. The next phase, the two-year AURORA program, will continue the collaboration with O2matic and evaluate its technology in ambulances, medical helicopters and military settings, where clinicians must manage critically ill or injured patients with limited time, attention and oxygen supplies.
“We are grateful for the trust and partnership from Professor Ginde, Associate Professor David J. Douin, and the broader SAVE‑O2 AI investigator group at CU Anschutz, as well as the researchers at Vanderbilt University Medical Center, Oregon Health & Science University and Wake Forest University School of Medicine” said Farzad Saber, Chief Business Development Officer at O2matic. “We look forward to continuing our collaboration through the AURORA project as we evaluate autonomous oxygen therapy in patient transport. This study’s findings show how autonomous oxygen titration can improve precision in oxygen delivery and reduce the burden of routine manual adjustments, especially in emergency and transport settings where staff time and oxygen supplies are limited.”
Regulatory status, funding and disclosures
The O2matic PRO100 used in the trial is a CE-marked Class IIb medical device under the European Union Medical Device Regulation (MDR). In the United States the PRO100 remains investigational and has not been cleared or approved by the U.S. Food and Drug Administration for commercial use. The trial was conducted under an FDA Investigational Device Exemption sponsored by IDTS Medical, Inc.
The study was sponsored by the U.S. Department of War’s Defense Health Agency Research and Engineering Directorate, Combat Casualty Care Portfolio, through the Medical Technology Enterprise Consortium under Other Transaction Number W81XWH-15-9-0001. Additional support was provided by the National Center for Advancing Translational Sciences.
The PRO100 systems used in the study were rented from O2matic for research purposes. O2matic had no role in study design, data collection, analysis or publication decisions.
The views and conclusions described are those of the study authors and should not be interpreted as representing official policies or endorsements of the U.S. government.
About O2matic
O2matic is a Danish ISO 13485-certified medical-technology company developing automated and digital respiratory-care systems. Founded in Copenhagen in 2017, the company develops CE-marked, patent-protected closed-loop systems that continuously monitor patients and automatically titrate supplemental oxygen in hospital and home-care settings.
O2matic is currently engaging with prospective strategic and financial investors regarding an additional closing of its Series A financing. The funding would support U.S. regulatory activities, continued clinical development and preparations for commercial expansion.
Study Contacts:
• Dr. Adit Ginde, University of Colorado Anschutz – adit.ginde@cuanschutz.edu
• Farzad Saber, Chief Business Development Officer, O2matic – fas@o2matic.com
Press Contacts:
Marie-Louise Little, CEO
O2matic
Funding and Disclosures
This study was sponsored by the U.S. Department of War’s Defense Health Agency, Combat Casualty Care Portfolio via the Medical Technology Enterprise Consortium under Other Transaction Number W81XWH-15-9-0001. Additional support was provided by the National Center for Advancing Translational Sciences, NCATS. The PRO100 oxygen delivery system used in the study was rented for research purposes from O2matic of Denmark. The PRO100 was investigational in the United States and had not been FDA cleared or approved for commercial use. O2matic had no role in study design, data collection, analysis, or publication decisions. The trial was conducted under a U.S. Food and Drug Administration Investigational Device Exemption (IDE). IDTS Medical, Inc. served as the sponsor of the IDE under which the trial was conducted.
Disclaimer: The views and conclusions contained herein are those of the authors and should not be interpreted as necessarily representing the official policies or endorsements, either expressed or implied, of the U.S. Government.
Attachments
Marie-Louise Little O2matic mll@o2matic.com
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