Technology startups are stepping up their efforts to meet the needs of 60 million people worldwide who use opioids. about 1 percent of the world’s adult populationIn the United States, deaths related to synthetic opioids have increased 1,040 percent from 2013 to 2019The COVID-19 pandemic and the continued spread of fentanyl have since increased the death toll even further. 81,083 fatal overdoses in 2023 alone.
Innovations include biometric monitoring systems that help doctors determine the correct drug dosage, nerve stimulators that ease withdrawal symptoms, wearable and ingestible systems that monitor for signs of overdose, and autonomous drug delivery systems that could prevent overdose deaths.
This is how patients receive the dose they need
For decades, opioid blockers and other craving suppressant medications have been the primary treatment tool for opioid addiction. However, despite its clinical dominance, this approach remains underused. In the United States about 22 percent of the 2.5 million adults with opioid use disorder receive medication-assisted therapy such as methadone, Suboxone, and similar medications.
Determining the ideal dosage for patients in the early stages of treatment is critical to keeping them in recovery programs. The shift from heroin to potent synthetic opioids such as fentanyl has complicated this process, as the typical recommended drug doses may be too low for people with high fentanyl tolerance.
A North Carolina-based startup is developing a predictive algorithm to help clinicians adapt these protocols and track progress in real time using biometric data. OpiAID, which is currently working with 1,000 patients across three clinical sites, recently launched a research pilot project with virtual treatment provider Bicycle Health. Patients taking Suboxone wear a Samsung Galaxy Watch6 to measure their heart rate, body movements and skin temperature. OpiAID CEO David Reeser says doctors can use this data to derive unique stress indicators, especially during withdrawal. (He declined to share details about how the algorithm works.)
“Biometric detection of stress plays a role in how resilient someone will be,” Reeser adds. “For example, poor heart rate variability during sleep could indicate that a patient may be more vulnerable that day. If withdrawal symptoms are measurable, the risk of relapse may be higher for illicit drugs.”
Nerve stimulators relieve opioid withdrawal
While OpiAID’s software solution relies on patient monitoring, electrical nerve stimulation devices intervene directly. These behind-the-ear devices place electrodes on nerve endings around the ear and send electrical impulses to block pain signals and relieve withdrawal symptoms such as anxiety and nausea.
The US Food and Drug Administration (FDA) has approved several nerve stimulation devices, including DyAnsys’ Drug reliefwhich delivers weak electrical impulses to the cranial nerves of the ear at regular intervals. Others include the Sparrow system from Spark Biomedical and the NETNeuro device from NET Recovery.
Masimo’s Bridge behind-the-ear device costs $595 to care providers.Masimo
Similarly, Masimo’s Bridge relieves withdrawal symptoms by stimulating the brain and spinal cord via electrodes. The device is designed to help patients start, begin or gradually wean themselves off medication-assisted treatment. In a clinical studyBridge reduced the severity of symptoms by 85 percent in the first hour and by 97 percent on the fifth day.A Masimo spokesman said the company’s typical customers are healthcare providers and correctional facilities, but there is also interest from emergency physicians.
Devices monitor blood oxygen to prevent overdose deaths
In 2023, the FDA approved Masimo’s halo Device for monitoring blood oxygen levels and alerting emergency contacts when it detects respiratory depression caused by opioids, which Main cause of overdose deaths. The product includes a pulse oximeter cable and disposable sensors connected to a mobile app.
Halo uses Masimo’s signal extraction technology, developed in the 1990swhich improves traditional oxygen monitoring techniques by filtering out artifacts caused by blood movement. Masimo uses four signal processing engines to distinguish the real signal from noise that can cause false alarms; for example, they distinguish between arterial blood and deoxygenated venous blood.
The Masimo Halo system is available without a prescription. Masimo
Halo is available without a prescription for 250 US dollarsA spokesman said sales continued to be promising as more healthcare providers recommended the drug to high-risk patients.
An ingestible sensor for monitoring patients
Last year in a first clinical study on humansDoctors used an ingestible sensor to monitor the vital functions of the patients’ stomach. Researchers analyzed the breathing patterns and heart rate of 10 patients in a sleep study at West Virginia University. Some participants had episodes of central sleep apnea, which can be an indication of opioid-induced respiratory depression. The capsule transmitted this data wirelessly to external devices connected to the cloud.
Celero’s Rescue Rx capsule remains in the user’s stomach for one week.Benjamin Pless/Celero Systems
“To our knowledge, this is the first time anyone has demonstrated the ability to accurately monitor human heart and respiratory signals using an ingestible device,” says Benjamin Pless, one of the study’s co-authors. “It uses very low-power circuitry, including a radio, a microprocessor and an accelerometer, as well as software to distinguish between different physiological signals.”
Pless and colleagues from MIT and Harvard Medical School began Celero Systems to launch a modified version of that capsule that also releases an opioid antagonist after detecting respiratory depression. Pless, CEO of Celero, says the team has successfully demonstrated that administering nalmefene, an opioid antagonist similar to Narcan, can rapidly reverse overdoses.
Celero’s next step is to integrate vital sign monitoring functionality for human trials. The company’s final device, Rescue-Rx, is designed to remain in the stomach for a week and then be excreted naturally. Pless says Rescue-Rx’s ingestible form will make the therapy cheaper and more accessible than portable auto-injectors or implants.
Celero’s capsule can detect vital functions inside the stomach. youtube.com
Autonomous administration of overdose medication
Rescue-Rx is not the only autonomous drug delivery project currently in development. IEEE Transactions on Biomedical Circuits and Systems The article introduced a wrist-worn near-infrared spectroscopy sensor designed to detect low blood oxygen levels due to an overdose.
Hugh Lee, a professor of biomedical engineering at Purdue University, and Juan Mesa, a doctoral student and co-author of the study, say that while more experiments on humans are needed, the results provide a valuable tool in combating the epidemic. “Our wearable device has consistently detected cases of oxygen deprivation, raised alarms, and activated the circuits designed to release the antidote through the implantable capsule,” they wrote in an email.
Lee and Purdue colleagues founded Rescue Biomedicine to commercialize the A2D2 system, which consists of a wristband and an implanted naloxone capsule that releases the drug when oxygen levels fall below 90 percent. Next, the team will test the closed system in mice.
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