A novel device could enable early detection of a deadly condition

Each year, at least 1.7 million adults in the United States and millions more around the world develop sepsis, a life-threatening condition that occurs when the body’s immune system reacts unusually violently to an infection. The condition, which can be difficult to detect and treat, quickly damages tissues and vital organs and is one of the leading causes of death in hospitals.

To help doctors detect the development of the disease, health technology company Opticyte has developed a novel, non-invasive device that can send alerts when a patient has low levels of oxygen in their cells, an early sign of sepsis. The doctor can then treat the patient, often with antibiotics and intravenous fluids, to prevent the most serious symptoms of the rapidly evolving disease.

Dr. Lori Arakaki, inventor of a technology called VitalO2 and founder and CEO of Opticyte, called the device a potential breakthrough, and with good reason: it is the first and only cellular oxygen monitor that can measure low oxygen levels inside cells in real time.

“The VitalO2 device is easy to use and can provide clinicians with the definitive, real-time information needed to prevent multi-organ failure,” said Arakaki, a bioengineer by training.

The device consists of a monitor, a fiber-optic cable for light transmission and a skin patch attached to the patient’s hand. The monitor shines light through a cable into the skin and measures the reflected light. A machine learning algorithm analyzes reflected light to measure oxygen in the patient’s muscle tissue cells in real time. Low oxygen levels in muscle tissue correlate with low oxygen levels in the cells of vital organs when oxygen deficiency is systemic or occurs in the bloodstream.

Currently, the device is also showing promise in monitoring low oxygen levels during trauma, heart failure and other conditions.

“In the future, I anticipate that VitalO2 will be widely used in emergency departments, intensive care units, surgical suites, nursing homes, ambulances and other settings where there is a need for rapid and accurate cellular oxygen measurements,” Arakaki said.

So far, the prototype device has been tested in the first human observational study of sepsis, involving about 150 patients at two medical centers in Seattle. Further studies using the VitalO2 device to predict organ dysfunction and death in patients with sepsis are likely next. Opticyte is also under investigation, with preliminary results showing encouraging results in improving decisions regarding red blood cell transfusions in cancer patients and the recognition of shock in patients undergoing cardiac surgery.

Blood oxygen levels are currently measured using a device called a pulse oximeter, which is placed on the end of the finger and works using beams of light. However, this technology, known for several decades, only measures arterial blood oxygen saturation, not at the cellular or tissue level. The problem is that in the case of sepsis and other severe conditions, patients often show normal blood oxygen levels on pulse oximeter readings, even though there is not enough oxygen in the cells and tissues. As a result, pulse oximeters can easily miss early signs of systemic oxygen deprivation associated with sepsis, hemorrhage, and heart failure – all situations that can quickly lead to organ failure and death.

Studies have shown that pulse oximeters have a greater error in measuring blood oxygen levels in black patients. Importantly, the Opticyte VitalO2 device has been designed and tested from the outset to be accurate in people with a variety of skin tones and pigmentation levels, from light to dark, which reduces the risk of measurement errors in patients, Arakaki said. The device’s algorithm has also been designed to be sensitive to different genders and body weights.

“This device will meet long-term medical needs, especially in emergency medicine and intensive care services,” Arakaki said. “There are many ways in which people can develop systemic oxygenation deficiency leading to organ failure.”

In 2023, Opticyte received Breakthrough Device Designation from the U.S. Food and Drug Administration. Arakaki believes this will speed up the review process and lead to FDA approval within the next one to two years.

Dr. Stephanie M. Davis, coordinator of the NHLBI’s small business program, said in the meantime that her team is looking forward to the results of further testing.

“This is an innovative device that can save lives,” she said. “This could one day help reduce the high number of sepsis deaths in hospitals and help monitor oxygen deficiency in other serious conditions, including heart disease.”