- FDA awarded breakthrough designation to Colorado Springs, Colorado-based Med-botics' Oxalert Enhanced Pulse Oximeter (EPOTM) device to be used in post-operative inpatients and home users receiving opioid therapy, the company said Tuesday.
- The device is designed to be worn on the wrist and to prevent respiratory arrest and death from opioid overdose.
- Oxalert continuously monitors blood oxygen levels in post-operative inpatients and home users receiving opioids and prompts them to breathe if the oxygen levels dip below 90% using electrical stimulus and audio prompts.
Between 1999 and 2017, nearly 218,000 people have died in the United States from prescription opioid-related overdoses, according to the Centers for Disease Control and Prevention. And according to Med-botics, almost all of the deaths from opioid overdose occur in home settings when opioids are continued post-surgery.
Yet only approximately 10% of the 40 million post-operative patients receiving opioids in the U.S. are continuously monitored, Med-botics said, even though opioid use after surgery usually continues at home after hospital discharge.
Without continuous monitoring, hypoxemia (lower than normal oxygen levels in the blood), often goes undetected in those patients. In severe cases, hypoxemia can interfere with heart and brain function.
Med-botics said its device, which rouses overly sedated patients to resume conscious control over their breathing, aims to make opioids safer both in the hospital and at home.
Commercial availability of the Oxalert device will be an "important step in the effort to eradicate 'dead-in-bed' adverse events," Richard Dutton, former executive director of the Anesthesia Quality Institute, said in the Med-botics press release.
According to Med-botics, plans for a clinical trial of the device are underway.
The breakthrough designation means the company can receive additional input from FDA and accelerated review at the filing stage. Designated devices that later receive marketing authorization may also benefit from a CMS reimbursement model allowing products to receive payment even without initially demonstrating a substantial clinical improvement standard.
Another breakthrough designation was awarded to Shreis Scalene Sciences (Shreis) for its Cytotron device to treat breast, liver and pancreatic cancers, the company announced Thursday. Gaithersburg, Maryland-based Shreis said it also intends to submit a request for breakthrough designation in other solid tumors such as adult and pediatric brain tumors and lung cancer.