Dallas, TX, January 4, 2021 — Spark Biomedical, Inc. announced today that the U.S. Food and Drug Administration (FDA) granted 510(k) clearance to The Sparrow Therapy System, a wearable neurostimulation device for opioid withdrawal relief. The Sparrow Therapy System is the first-ever drug-free, needle-free, wearable neurostimulation solution for opioid withdrawal to receive FDA clearance. The Sparrow is also the only opioid withdrawal solution offering patients a personalized, systemic-side-effect-free therapy option that enables detox while going about normal activities of daily living.

The Sparrow Therapy System has the potential to help over 11.5 million Americans who suffer from opioid dependence or addiction — giving them a safe, easy, and effective path through withdrawal. Sparrow is an essential first step in eliminating the withdrawal roadblock that two out of five adults cannot overcome.1

Daniel Powell, co-founder and CEO of Spark Biomedical, Inc, stated, “We saw an enormous unmet need in the opioid epidemic — making that first step through opioid withdrawal easier and more comfortable while at the same time giving patients more control over their therapy.”

Daniel further noted, “We felt the need was so urgent that in under two and half years, we conceptualized, designed, tested, and manufactured a proprietary medical device, backed by Level 1 clinical evidence and an FDA clearance — all in the middle of a pandemic. This achievement would certainly not have been possible without the incredibly dedicated Spark Biomedical team and the investors who believed in us.”

To complete Level 1 clinical evidence, over a twelve-month period, 26 participants were enrolled in a prospective, randomized, controlled trial to determine the effectiveness of Transcutaneous Auricular Neurostimulation (tAN) therapy using the Sparrow Therapy System. Therapy effectiveness was measured using the 11-point Clinical Opioid Withdrawal Scale (COWS). The study’s primary endpoint was achieved by demonstrating a clinically meaningful reduction in COWS (greater than 15%) within the first 60 minutes of therapy. Participants received tAN therapy for up to five days, and on days two through five, all participants sustained a meaningful reduction in withdrawal symptoms (i.e., tremor, gooseflesh skin, gastric distress). The study will be completed in early 2021, and full study results will be published in a peer-reviewed scientific journal.

Navid Khodaparast, PhD., co-founder and Chief Science Officer, commented, “These achievements highlight the potential of tAN as a new treatment approach for neurological and psychiatric disease. From the beginning, our objective was to design a clinical trial that would demonstrate a meaningful treatment effect and promote confidence in patients and families suffering from OUD. We are grateful for the FDA’s decision. In alignment with our company values, we are already looking beyond to expand our understanding of tAN in larger clinical trials.”

In addition to FDA clearance, the Sparrow Therapy System was issued a U.S. Patent (Patent No. US 10,695,568 B1) in June of 2020 for its novel use of neurostimulation in treating substance use disorder.

Spark co-founder and Chief Technology Officer Alejandro Covalin, Ph.D. noted, This FDA clearance brings us a step closer to a world of non-invasive devices in which medical problems can be solved with targeted neuromodulation as opposed to systemic medicine.

With FDA clearance, The Sparrow Therapy System is now available to physicians in the U.S. to help patients overcome the opioid withdrawal barrier. Key locations throughout the country have already been identified to help launch The Sparrow Therapy System. Other industry-leading facilities will follow shortly to provide a broad footprint of locations available to patients.

Both physicians and their patients can learn more about the Sparrow Therapy System at www.sparkbiomedical.com.

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Indication for Use

The Sparrow Therapy System is a transcutaneous nerve field stimulator intended to be used in patients experiencing opioid withdrawal in conjunction with standard symptomatic medications and other therapies for opioid withdrawal symptoms under the supervision of trained clinical personnel.

About Spark Biomedical

Spark Biomedical, Inc. is a Texas-based medical device company and developer of the first drug-free, needle-free, wearable solution for opioid withdrawal relief backed by evidence from a double-blind, randomized controlled clinical trial targeting patients with opioid use disorder.

The Sparrow Therapy System uses Transcutaneous Auricular Neurostimulation (tAN) to treat withdrawal symptoms by stimulating nerves on and around the ear. The wearable earpiece is designed to be worn up to 24 hours a day throughout opioid reduction or as prescribed to aid in the reduction of withdrawal symptoms.

The company’s vision to ignite a brighter future for those struggling with opioid addiction is fueled by its unique blend of scientific expertise, technical innovation, and deep medical device industry experience. For more information, schedule a consultation or visit www.sparkbiomedical.com.

1Centers for Disease Control and Prevention. 2018 Annual Surveillance Report of Drug-Related Risks and Outcomes — United States. Surveillance Special Report 2pdf icon. Centers for Disease Control and Prevention, U.S. Department of Health and Human Services. Published August 31, 2018