Categories: Clinical TrialNews

O2matic’s Proprietary Technology to be Evaluated by the University of Colorado, Funded by the U.S. Department of Defense

COPENHAGEN, Denmark & AURORA, Colo.–(BUSINESS WIRE)–#SAVEO2O2matic, a Danish medical device company focused on developing next-generation oxygen therapy and monitoring technologies, has announced that its proprietary technology is the subject of research led by Adit Ginde, MD, Professor of Emergency Medicine and Anesthesiology at the University of Colorado School of Medicine.

Dr. Ginde and his team’s work has paved the way for the SAVE-O2 trial, a multicenter randomized clinical trial funded by the U.S. Department of Defense. The SAVE-O2 trial focuses on redefining oxygen requirements in critically ill trauma patients through targeting normoxemia.

Preliminary results from analyzing data from approximately 12,000 randomized patients have unveiled promising outcomes. Manually targeting normoxemia successfully reduces hyperoxemia without increasing hypoxemia, resulting in lower mortality rates, shortened hospital stays, and decreased supplemental oxygen requirements.

Dr. Ginde presented initial results at the Military Health System Research Symposium in 2023, earning his team the distinguished recognition of Outstanding Research Accomplishment. Their advancements in oxygen therapy protocols have already begun to influence guidelines, with updates to 10 relevant Joint Trauma System guidelines.

Dr. Ginde and his team are now evaluating the efficacy of automatic oxygen therapy technology, with O2matic’s proprietary technology chosen for a multi-center study involving 300 patients. This study, named SAVE-O2 AI, and initiated in May 2024, aims to publish results by early 2026.

“We at O2matic are deeply honored to be part of this significant study and eagerly anticipate the potential impact of our technology on acute and trauma patients,” said Arnt Lund, O2matic’s CEO. “We are also grateful to the IDE sponsor for this study, IDTS Medical, Inc. and its CEO, Mario Nozzarella, who guided us through the U.S. Food and Drug Administration Investigational Device Exemption (US FDA IDE) process and received our final (non-conditional) letter regarding the submission G230325/A001 with a strong sense of urgency.”

The award is funded by the U.S. Department of Defense through the Medical Technology Enterprise Consortium (MTEC) to further oxygen research using autonomous solutions.

Disclaimer Note:

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.

Contacts

Media Contact: Paul Williams, MediaLine Communications, paul@medialinecommunications.com, 310/569-0023

Study Contacts:
Adit Ginde, MD, MPH, (Principal Investigator), University of Colorado, adit.ginde@cuanschutz.edu

Farzad Saber, Chief Business Development Officer, O2matic, fas@O2matic.com

Anja Rode Lave, Global Product Manager, O2matic, aro@o2matic.com

Mario Nozzarella, (Clinical Trial Sponsor), Chief Executive Officer, IDTS Medical, Inc, mario.nozzarella@idtsmedical.com

Staff

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