Spark Biomedical

About Spark Biomedical

Spark Biomedical, established in 2018, is a medical device company focused on developing wearable neurostimulation solutions to address the opioid crisis and other neurological conditions. The company was co-founded by Daniel Powell (CEO), Dr. Alejandro Covalin (CTO), and Dr. Navid Khodaparast (CSO). Powell has over 25 years of experience in developing and marketing technical solutions, with a specific passion for neurostimulation, having previously launched products for deep brain stimulation and vagus nerve stimulation. Dr. Covalin, a UCLA alumnus with over 25 years of experience and 18 patents, leads the company's research, development, and intellectual property strategy. Dr. Khodaparast, with a background in applying neuroplasticity concepts to stroke recovery, directs the company's clinical trials and scientific endeavors.

The company's core technology is Transcutaneous Auricular Neurostimulation (tAN), a non-invasive method that stimulates branches of the vagus and trigeminal nerves on and around the ear. This stimulation triggers the brain to release endorphins, the body's natural pain relievers, which helps to alleviate the symptoms of opioid withdrawal. Spark Biomedical's business model centers on the sale of its FDA-cleared devices to healthcare providers, addiction treatment centers, and directly to patients via telehealth partnerships. The company primarily serves individuals suffering from opioid use disorder, providing a drug-free alternative or supplement to traditional medication-assisted treatments.

Spark Biomedical's flagship product is the Sparrow Ascent, the second generation of its Sparrow Therapy System. The original Sparrow system received FDA 510(k) clearance in January 2021 for use in clinical settings. Building on user feedback, the Sparrow Ascent, cleared by the FDA in July 2023, features a longer battery life and an ergonomic design suitable for both in-patient and at-home use. The system includes a patient controller and disposable hydrogel earpieces that deliver mild electrical pulses. A key benefit is its ability to provide relief from withdrawal symptoms like anxiety, nausea, and muscle aches without the side effects of medication, allowing patients to detox more comfortably. The company is also exploring the application of its tAN technology for other conditions, including heavy menstrual bleeding, neonatal opioid withdrawal syndrome (NOWS), and reducing stress for military personnel.