As an emergency physician for over 15 years in the Pacific Northwest, Dr. Desislava Hite frequently encountered drug overdoses. And according to Hite, what's important to understand about overdose is that it's very reversible -- if the patient makes it to the emergency room in time.
"You can reposition the patient, give oxygen, give medications like Naloxone, you can really prevent complications like heart attacks, brain damage, and ultimately death," Hite said in an interview. "But oftentimes, we would see people come in and they are just a little too late, so it's been minutes, sometimes hours before they were found, and so they end up in the ICU. Some have permanent brain damage, and of course, many don't even make it to us."
Hite and her husband Michael Hite wanted to build something to prevent these deaths and complications. So in 2019, they founded Ayuda Medical, which offers a wearable device that can detect an overdose and call for help. The company has since been backed by the National Institutes of Health and the National Institute on Drug Abuse and is seeking to secure FDA approval. And its services could be life-saving as the U.S. battles a major overdose crisis. The CDC estimates that in 2023, more than 107,000 overdose deaths occurred.
Ayuda Medical's wearable device is called ARMband. It is worn on the upper arm to be discreet and monitors for lack of motion, changes in breathing patterns and drops in oxygen levels. If it detects that the user is unresponsive and has overdosed, then it activates an alarm and announces, "This is an overdose. Get help, give Naloxone now." This is supposed to alert people nearby who may be able to help. An accompanying app also provides alerts to Emergency Medical Services, overdose response teams or a network of community responders. In addition, it can send alerts to preselected contacts.
To help build the device, the company is relying on people with lived experience of substance use disorders. It is working with people in different regions as different places have different needs. For example, people in Alaska have to bundle up more because of the colder weather, so Ayuda Medical is trying to understand how additional layers may affect the device.
But there are some similarities between different communities, Hite noted.
"One of the things that we learned is that the device is very much needed and wanted," she said. "One of the comments we heard is, 'Regardless of the choices we make in life, we're not suicidal,' and so this tool would be of significant benefit."
The company has received support from the NIH and NIDA (which is part of the NIH) via the Small Business Innovation Research program. Through the SBIR program, companies can get up to $2.8 million to build technologies that can have an effect on substance use disorders, according to the website. This funding is helping Ayuda Medical conduct clinical studies in order to secure clearance from the Food and Drug Administration.
Once it gets clearance from the FDA, the company hopes to receive reimbursement from Medicaid for its device. It also plans on offering it via cash pay.
In addition to the SBIR grant, Ayuda Medical was selected for NIH's company showcase, in which companies are matched to a certain event and receive paid registration and an opportunity to network with investors and strategic partners. In Ayuda Medical's case, it was matched with the HLTH conference that was held in Las Vegas in October.
Several other companies are addressing substance use disorder in the U.S., including digital health companies Bicycle Health, Pelago and Boulder Care. When it comes to overdose specifically, there are very few companies that exist, however, according to Hite.
Looking ahead, Ayuda Medical aims to secure additional funding, including from venture capital firms. In the long term, Ayuda Medical hopes to effectively move the needle on drug overdoses.
"Our ultimate goal is to look at that graph of the rising opioid overdoses and see it start to go down," Hite said. "I've already seen it plateau at least, with an impressive effort of naloxone distribution, harm reduction, just general education that you can get online. So I'm starting to see that change [but] I do think there's still a need for more."