San Diego-based startup secures non-dilutive funding to conduct clinical studies and prepare for regulatory pathway with FDA for its novel wearable medication monitor

SAN DIEGO–()–Digital health startup CARI Health was awarded an SBIR Fast Track grant from the National Institute on Drug Abuse (NIDA), an agency of the National Institutes of Health (NIH), to help it bring the world’s first wearable medication monitor to market. CARI Health is eligible for up to $2.8M over three years as project milestones are successfully completed within Phase I and Phase II portions of the grant. The award funding will go toward supporting product development and conducting human clinical studies for CARI Health’s wearable remote medication monitoring device.

“Wearable remote monitoring is a convenient and patient-friendly way to demonstrate methadone treatment compliance remotely. Under today’s standard of care, especially in the beginning of methadone treatment, patients have to show up almost daily for clinic visits, which creates a significant barrier to begin and remain in treatment.”

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Over the past several years, CARI Health has received funding from the San Diego Angel Conference (SDAC), NuFund Venture Group, Cove Fund, Chemical Angel Fund, Device of Tomorrow Capital, and several individual angel investors. More recently, it received investments from the Cedars Sinai Accelerator and the Rady Venture Fund (UCSD).

“As the national opioid crisis continues to escalate amid growing illicit fentanyl use, the discovery of new and innovative solutions is urgent,” says CARI Health Founder and CEO Patrik Schmidle. “Wearable remote monitoring is a convenient and patient-friendly way to demonstrate methadone treatment compliance remotely. Under today’s standard of care, especially in the beginning of methadone treatment, patients have to show up almost daily for clinic visits, which creates a significant barrier to begin and remain in treatment.”

Schmidle originally launched CARI Health after a close family member struggled with opioid use disorder.

By participating in programs like the Institute for the Global Entrepreneur MedTech Accelerator at University of California San Diego, MedTech Innovator, the world’s largest MedTech accelerator, and the Cedars Sinai Accelerator, CARI Health has benefitted from best-in-class mentorship and expert guidance. It was also selected as one of Connect San Diego’s 2022 Cool Companies and was honored again in 2023. In addition, CARI is part of San Diego-based EvoNexus, which has an average 2% admittance rate.

“This NIDA grant will support CARI Health’s product development as we build on the success of our efforts to date,” said Schmidle. “And once our product is ready to be deployed in human studies, the funds will help us conduct those human trials.”

Research reported in this press release was supported by the National Institute on Drug Abuse of the National Institutes of Health under award number R44DA059523-01. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

About CARI Health

CARI Health is focused on the future of wearable remote medication monitoring, enabling clinicians to view patient medication levels in real time, and keep them on life-saving medications. www.CARIHealth.com, LinkedIn.

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Hilary McCarthy
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