Spark Biomedical

Spark Biomedical is a leading US-based company that develops wearable neurostimulation solutions to help individuals overcome withdrawal, heal from addiction, and achieve a better quality of life. Its FDA-cleared flagship product, the Sparrow Therapy System, utilizes transcutaneous auricular neurostimulation (tAN) technology to provide a safe, comfortable, and drug-free treatment option for opioid withdrawal relief. The device, worn on and around the ear, delivers mild electrical stimulation to cranial nerve branches, triggering the brain to produce its own endorphins and alleviate withdrawal symptoms within 30 to 60 minutes.

Spark Biomedical's Sparrow Therapy System has demonstrated remarkable clinical success, with 84% of participants experiencing mild to no withdrawal symptoms within an hour of therapy initiation in a Level one clinical trial. By day three, 100% of participants sustained a clinically meaningful reduction in opioid withdrawal symptoms. Furthermore, the company is exploring the potential of tAN therapy in managing relapse rates and treating Neonatal Opioid Withdrawal Syndrome (NOWS) through ongoing NIDA-funded clinical trials.

In July 2023, Spark Biomedical received FDA clearance for its next-generation device, Sparrow Ascent, designed for more versatile patient use, including in-patient, out-patient, or via telehealth. With ergonomic enhancements, longer battery life, and 28 lightweight earpieces, Sparrow Ascent aims to provide patients with greater control over their opioid withdrawal therapy.

Key customers and partnerships

Spark Biomedical has partnered with AcuityMD, a commercial platform for medical technology companies, to accelerate the expansion of its novel treatment for opioid withdrawal. The Sparrow Therapy System is already in use at more than two dozen rehabilitation facilities nationwide, and the company aspires to increase market penetration with AcuityMD's data-driven software, enabling strategic patient access to its innovative device.

Moreover, Spark Biomedical has collaborated with renowned institutions such as the Medical University of South Carolina (MUSC) and UT Southwestern Medical Center to conduct clinical trials and explore the applications of tAN therapy in managing NOWS. The company has also joined forces with the Feinstein Institutes for Medical Research at Northwell Health to commercialize a wearable neurostimulation solution focused on reducing excessive blood loss, leveraging the Feinstein Institutes' patented vagus nerve stimulation (VNS) concept and Spark Biomedical's expertise in clinical trials, FDA submissions, and commercialization.