EvoNexus Portfolio Company, CARI Health Nabs $2.8M NIDA Grant
MED TECH: Funding for Medication Monitors to Combat Opioid Addiction
CARI Health’s wearable remote medication monitoring device is getting closer to preparing for human testing and a regulatory pathway with the Food and Drug Administration. Photo courtesy CARI Health
SAN DIEGO, CA / SAN DIEGO BUSINESS JOURNAL / NOVEMBER 1ST, 2023 / Drug overdose deaths, opioid addiction and drug overdoses related to opioids continue to be crises in America, putting companies that tackle those issues in a place of growing importance and need.
According to the National Institutes on Drug Abuse (NIDA), part of the National Institute of Health, drug overdose deaths rose from 2019 to 2021, with more than 106,000 drug overdose deaths in 2021. Deaths involving synthetic opioids other than methadone, primarily fentanyl, also rose, with more than 70,000 OD deaths reported in 2021.
CARI Health, developer of remote medication monitors that allow clinicians to prescribe medications and get real-time reports on medication levels, is closing in on bringing the first wearable medication monitor to market.
CARI Health’s work was recently awarded a Small Business Innovation Research Fast Track grant from NIDA to help it bring its wearable medication monitoring device to market.
CARI Health will be eligible for up to $2.8 million over three years as project milestones are successfully completed, said company CEO Patrik Schmidle, who founded the company in 2015 as a response to a family member who struggled with a substance use disorder.
Schmidle said the award funding will go toward supporting product development and conducting the company’s long-sought human clinical studies for the device. The company will also need to gain regulatory approval by the Food and Drug Administration.
Hope for Addicted
CARI Health initially began with hope to provide better care for those with addictions, said CARI Health advisor Carla Marienfeld, Clinical Professor of Psychiatry at UCSD and 13-year member of the American Academy of Addiction Psychiatry, and it has grown to include academic expertise in engineering, medicine and biochemistry combined with business knowledge and vision to offer products and services to do just that.
The sensor technology CARI Health is developing allows patients more freedom from many of the restrictions currently limiting ease of using life-saving medications like methadone.
“It uses new technology to address important barriers that prevent people from fully utilizing the treatment that is available,” she said.
“While current medications for opioid use disorder are life-saving and critical, we still have a lot of work to do to make accessing and using these medications as easy and beneficial as any other medication for any other chronic disease.”
Schmidle said that as the national opioid crisis continues to escalate amid growing illicit fentanyl use, “the discovery of new and innovative solutions is urgent.”
Wearable remote monitoring is a convenient and patient-friendly way to demonstrate methadone treatment compliance remotely, he said.
“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 said.
Adi Mandapaka, CARI Health’s chief technology officer, has been with the company for two years. He said nothing has changed during his tenure in the company as far as CARI Health’s passion or in the way it executes.
“What has significantly changed is the systematic nature with which we approach the space, looking at ourselves as a true medical device manufacturer,” Mandapaka said. “You don’t make one or two of anything and call it a success. You have to think about hundreds of thousands of people using something and how we structure the company and the discipline we bring, in order to be sure everybody gets the same level of performance.”
Investor, Institution Interest
Schmidle said the company closed its initial seed round of funding on Dec. 31 and has started its second seed round. CARI Health has already raised more than $7 million in grant funding and $2.5 million in angel investor funding.
Over the past several years, CARI Health has received funding from San Diego Angel Conference, NuFund Venture Group, Cove Fund, Chemical Angel Fund, Device of Tomorrow Capital, and several individual angel investors. The company has recently received investment from the Rady Venture Fund at UC San Diego.
In a bit of a surprise, CARI Health also recently found an interested party in the Cedars-Sinai Accelerator.
Schmidle said that while Cedars-Sinai is known for its care for patients with heart conditions, organ transplant and chronic diseases like diabetes, and don’t often treat patients with methadone treatments, those with the program told him they want to better understand the clinical demand for other indications.
Schmidle said he talked to 60 clinicians who were interested in what the device might do beyond opioid-related needs and how they might use it as part of their tools in treatment of other conditions.
About CARI Health
FOUNDER AND CEO: Patrik Schmidle
HEADQUARTERS: San Diego
BUSINESS: Sensor enabled digital health company
FUNDING: $9.5 million (grant and seed funding)
SOCIAL IMPACT: Schmidle says that the opioid crisis is a trillion-dollar crisis and that health parity and health equity in the population is disproportionate to persons of color
NOTABLE: Company is a resident of EvoNexus, which has an average 2% admittance rate
EvoNexus is California’s leading nonprofit technology startup incubator located in San Diego. EvoNexus has successfully incubated over 260 startups with a survival rate of over 85%. Since the incubator’s formation in 2010, EvoNexus companies have secured over $1.6B in venture funding, $10B in pre-exit valuation, and had 51 acquisitions valued at over $2.1B. EvoNexus is supported by corporate partners, including some of the largest multinational corporations in the world. Learn more at evonexus.org.