Opticyte Gets Breakthrough Nod for Cell O2 Patient Monitor for Organ Failure

Medical device start-up Opticyte has gained breakthrough status from the U.S. Food and Drug Administration (FDA) for its Cell O₂ patient monitor, which provides real-time, continuous monitoring of those at risk for organ failure.
 
Cell O₂ leverages noninvasive optical spectroscopy tech to measure and spot systemic low oxygen levels inside cells. The device aims to reduce organ failure via immediate and continuous monitoring of cellular oxygen levels during hospitalization for sepsis, trauma, and myocardial infarction.
 
“We’re pleased the FDA recognized the strength of our data and the promise of our technology to deliver reliable and actionable cellular oxygenation readings for medical staff–often working in emergency medicine–to more effectively prevent organ failure and save lives,” Lori Arakaki, Ph.D., Opticyte co-founder and CEO told the press. “This new designation will allow us to more quickly reach sepsis, trauma, and cardiac surgery patients with organ dysfunction who are on the verge of organ failure.”
 
Opticyte was used in a recent first-in-human observational study of almost 150 patients that documented real-time readings of low cell O₂ in patients with sepsis, a potential precursor to organ failure, shock, and death. The company is currently organizing further studies to investigate the prognostic value of cell oxygenation for organ dysfunction and mortality.
 
“In the emergency department, we’re always racing against time. Opticyte’s technology offers the potential to see continuous, real-time data indicating systemic low cellular oxygenation and allow those of us on the frontlines of care to respond with effective countermeasures to course correct potential organ dysfunction and ideally save more lives,” said Dr. Eileen Bulger, Chief of Trauma at Harborview Medical Center.
 
Opticyte evaluated over 130 healthy people with a variety of physical characteristics, including lighter and darker skin tones, to build training and testing data for its machine learning algorithm.
 
“Opticyte’s commitment to ensuring people with different skin tones and pigmentation are included in the foundation of their technology, dramatically improving the standard of care and saving lives for the hundreds of thousands of people suffering from organ dysfunction, makes us especially proud to support their efforts,” said Nate Doran, a Seattle-based micro VC.