IDTS Medical serves as IDE sponsor as researchers evaluate automated oxygen therapy technology in critically ill trauma patients.
AURORA, CO & COPENHAGEN, DENMARK - May 21, 2024 - O2matic, a Danish medical device company focused on next-generation oxygen therapy and monitoring technologies, announced that its proprietary technology was selected for evaluation in a multicenter clinical study led by researchers at the University of Colorado School of Medicine and funded by the U.S. Department of Defense.
The research is led by Adit Ginde, MD, Professor of Emergency Medicine and Anesthesiology at the University of Colorado School of Medicine. The work builds on previous research examining how oxygen therapy can be better managed in critically ill and trauma patients.
IDTS Medical's Role in the Study
This research also represents an important milestone for IDTS Medical, Inc. and its CEO, Mario Nozzarella, who served as the clinical trial sponsor and helped guide O2matic through the U.S. Food and Drug Administration's Investigational Device Exemption (FDA IDE) process.
As the IDE sponsor, IDTS Medical supported the regulatory process necessary for O2matic's technology to be evaluated in the United States.
O2matic CEO Arnt Lund recognized IDTS Medical and Nozzarella for their role in helping the company navigate the FDA submission process.
"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."
Research Into Better Oxygen Management
The study builds upon the work of Dr. Ginde and his research team through the SAVE-O2 trial, a multicenter randomized clinical trial focused on redefining oxygen requirements in critically ill trauma patients.
The research focuses on targeting normoxemia, or maintaining blood oxygen levels within an appropriate range, rather than routinely providing more supplemental oxygen than necessary.
Preliminary analysis involving approximately 12,000 randomized patients found that manually targeting normoxemia reduced hyperoxemia without increasing hypoxemia. The researchers reported associations with lower mortality rates, shorter hospital stays, and reduced supplemental oxygen requirements.
Dr. Ginde presented initial results from the research at the Military Health System Research Symposium in 2023, where his team received recognition for Outstanding Research Accomplishment.
The research has also contributed to updates to 10 relevant Joint Trauma System guidelines.
Evaluating Automated Oxygen Therapy
Building on the findings from the SAVE-O2 trial, researchers are now evaluating whether automated oxygen therapy technology can help achieve more precise oxygen management in critically ill patients.
O2matic's proprietary technology was selected for evaluation in a multicenter study involving approximately 300 patients.
The study, known as SAVE-O2 AI, began in May 2024 and is designed to evaluate the efficacy of automated oxygen therapy technology in an acute and trauma care setting.
O2matic's technology is designed to automatically adjust supplemental oxygen based on a patient's oxygen saturation levels. The goal of automated oxygen therapy is to help clinicians maintain appropriate oxygen levels while reducing unnecessary exposure to excessively high or low oxygen levels.
Funded by the U.S. Department of Defense
The research is funded by the U.S. Department of Defense through the Medical Technology Enterprise Consortium (MTEC).
The funding supports continued research into oxygen therapy and autonomous solutions that may have applications in trauma and critical care environments.
For IDTS Medical, participation in the regulatory and clinical trial process represents an opportunity to support the evaluation of emerging respiratory technology in a U.S. healthcare setting.
Advancing Respiratory Technology
IDTS Medical has a strong focus on respiratory care and medical technology, making its involvement in the O2matic project a significant development for the organization.
Through its role as IDE sponsor, IDTS Medical helped support the regulatory pathway for O2matic's technology to enter clinical evaluation in the United States.
Mario Nozzarella's involvement also reflects IDTS Medical's broader interest in supporting innovative respiratory technologies and expanding access to solutions that may improve patient care.
The research conducted by the University of Colorado and supported by the Department of Defense will help determine the potential role of automated oxygen therapy in critically ill and trauma patients.
About O2matic
O2matic is a Danish medical device company focused on developing next-generation oxygen therapy and monitoring technologies. The company's technology is designed to support automated oxygen delivery and help maintain patients within targeted oxygen saturation ranges.
About IDTS Medical
IDTS Medical, Inc. is a Minnesota-based healthcare organization focused on respiratory care, home medical equipment, and innovative healthcare solutions.
The organization provides respiratory services and medical equipment while also supporting the development and evaluation of emerging healthcare technologies.
Through its work with medical device companies, clinical researchers, and healthcare organizations, IDTS Medical supports efforts to bring innovative respiratory solutions into the U.S. healthcare market.
About the SAVE-O2 AI Study
The SAVE-O2 AI study is a multicenter clinical study led by researchers at the University of Colorado School of Medicine. The study evaluates automated oxygen therapy technology in critically ill and trauma patients and is funded by the U.S. Department of Defense through the Medical Technology Enterprise Consortium.
The study builds upon previous research investigating the benefits of targeting normoxemia in critically ill patients.
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.
