Battelle and Spark Biomedical, Inc. Join Forces to Advance Bioelectric Treatment Solutions for Opioid Use Disorder

The jointly run pilot clinical study is the first step in pioneering closed-loop opioid withdrawal detection and treatment

Battelle, the largest independent nonprofit applied science and technology organization in the world, and Spark Biomedical, Inc., a leading developer of wearable neurostimulation solutions, entered into a collaborative agreement to jointly run a pilot clinical study to advance remote detection and treatment of opioid use disorder (OUD).

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The study's primary objective is to collect physiological data via biosensors from patients experiencing opioid withdrawal symptoms, cravings, and addiction-related psychological stressors using the Battelle NeuroHub System. From the data, the team will develop an artificial intelligence (AI) algorithm to detect withdrawal using objective physiological biomarkers.

After study completion, Spark and Battelle plan to use the resulting opioid withdrawal algorithm to:

• Develop a new, more objective physiological assessment tool for opioid withdrawal measurement
• Develop AI and machine learning algorithms to better understand mental health states
• Move towards the development of a closed-loop neurostimulation solution for opioid withdrawal

Currently, opioid withdrawal measurement is clinically managed using the Clinical Opioid Withdrawal Scale (COWS) which subjectively pairs measurements across 11 withdrawal-related symptoms to assess the severity and trajectory of opioid withdrawal. With subjective data, various symptom weighting, and more than one measurement scale in the assessment, COWS can provide variable results.

Healthcare trends continue to shift toward wearable technology, self-assessment, and telemedicine to provide patients consistent, reliable, and in-the-moment treatment options. With the opioid epidemic continuing to grow and treatment options remaining scarce in high-impacted rural populations, inserting AI machine learning and wearable solutions into the opioid use disorder treatment lifecycle may introduce much-needed accuracy, availability, and portability for both providers and patients.

Dr. Navid Khodaparast, co-founder and Chief Science Officer of Spark Biomedical, Inc., stated, "As we enter a new world where telehealth medicine is gaining momentum, we need more efficient methods to help patients alleviate their opioid withdrawal symptoms at home or in an outpatient setting. Better, more accurate remote assessment of withdrawal symptoms is an important first step. Ultimately, a closed-loop neurostimulation treatment solution will allow a doctor and patient to accurately monitor and efficiently treat their symptoms. That kind of targeted precision could significantly improve relapse and OUD treatment outcomes."

"Battelle is eager to further develop our neurotechnology solutions, in this exciting new collaboration with Spark Biomedical, to help assess and solve such a huge societal problem such as opioid addiction and withdrawal," said Battelle Fellow Justin Sanchez who is working on the project with Battelle bioengineer Michael Darrow.

The jointly run pilot clinical study is estimated to begin in the summer of 2022 and run through the year. Once complete, the teams will start work to leverage the data and the companies' respective technology solutions to create a new, holistic closed-loop opioid withdrawal assessment and treatment solution.

About Spark Biomedical

Spark Biomedical, Inc. is a leading U.S.-based wearable neurostimulation solutions developer devoted to the life-saving work of helping 36.3 million people worldwide overcome withdrawal, heal from addiction, and achieve the better quality of life they deserve. With opioid-related misuse and overdose deaths on the rise, the company's mission is to eliminate opioid addiction by working to address the full opioid addiction lifecycle, including withdrawal management, opioid-sparing, relapse prevention, and PTSD/trauma abatement.

Spark Biomedical is helping patients take the first step of overcoming acute opioid withdrawal with its FDA-cleared wearable technology, the Sparrow Therapy System — Transcutaneous Auricular Neurostimulation (tAN®) for Opioid Withdrawal Relief. Sparrow™ Therapy provides an easy, safe, and effective drug-free treatment option supported by clinical evidence. Next steps are underway with the launch of two NIDA-funded clinical trials to improve adult relapse rates and help infants suffering from Neonatal Opioid Withdrawal Syndrome (NOWS).

Learn more at sparkbiomedical.com or on LinkedIn.

About Battelle

Every day, the people of Battelle apply science and technology to solving what matters most. At major technology centers and national laboratories around the world, Battelle conducts research and development, designs and manufactures products, and delivers critical services for government and commercial customers. Headquartered in Columbus, Ohio since its founding in 1929, Battelle serves the national security, health and life sciences, and energy and environmental industries. For more information, visit www.battelle.org.

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