DALLAS, Texas, Aug. 29, 2023 — Spark Biomedical, Inc., a Dallas-based pioneer in wearable neurostimulation technology, was awarded a $1.15M Phase II grant to develop a Transcutaneous Auricular Neurostimulation (tAN®) device, Sparrow® Hawk, to address the adverse effects of acute stress reaction (ASR). In partnership with Battelle, Sparrow Hawk development brings a rapidly deployable, non-invasive, wearable approach to ASR prevention and treatment into the battlefield setting.

Exposure to traumatic events, such as those found on the battlefield or during military maneuvers, may not only result in physical injury but also affect a soldier’s psychological or mental well-being. ASR can result in anxiety, nausea, irritability, dysregulated emotions, poor sleep, poor concentration, cognitive fatigue, and headaches. According to the Armed Forces Health Surveillance Branch, mental health issues cause more military medical evacuations than any other condition.¹ Left untreated, ASR has also been linked to a 10-fold increase in completed suicide risk and can lead to the development of post-traumatic stress disorder (PTSD) symptoms, often resulting in substance abuse issues.²

Current ASR treatment efforts within military settings primarily involve frontline psychiatry and combat operational stress control. However, the effectiveness of these treatments is often constrained by the proximity and immediacy of care, with trained personnel required to administer therapy promptly. In many battlefield scenarios, the affected individuals may not have access to such immediate care, exacerbating the potential adverse outcomes of ASR.

Phase I:

During Phase I, the team at Spark Biomedical successfully completed critical benchmarks by developing performance parameters and form factors for a revolutionary compact, disposable, cable-free, “all-in-one” wearable tAN device.

Phase II

In Phase II Spark Biomedical and Battelle will focus on:

• Developing a functional Sparrow Hawk device that can be used in a clinical trial
• Testing the device in a clinical setting to evaluate its efficacy in restoring performance on operationally relevant tasks within a meticulously crafted clinical model of laboratory stress.

"We are deeply committed to exploring the positive impact of tAN therapy on alleviating acute stress reaction and the potential long-term effects related to PTSD. Our wearable technology has the capacity to provide timely and non-invasive neurostimulation, making it a game-changer for various neuropsychiatric conditions. Particularly, in supporting the brave men and women serving our country, this device could be invaluable in military far-forward environments, and civilian use for patients experiencing ASR in the emergency department," stated Dr. Navid Khodaparast, study co-Principal Investigator, and Chief Science Officer of Spark Biomedical.

“Spark is proud to continue our partnership with the team at Battelle to conduct the first randomized controlled clinical trial assessing the use of tAN therapy to treat and prevent symptoms of acute stress reaction. Once healthy participant recruitment begins, participants will be randomized to receive active or sham tAN therapy either prior to or during the acute stressor while undertaking tasks relevant to military operational environments. The results of this trial will be critical to optimizing the use of this therapy and lay the groundwork for future trials in real-world settings.” Dr. Melanie McWade, co-Principal Investigator, and Senior Director of Clinical Operations at Spark Biomedical.

The Sparrow Hawk tAN system holds significant promise for diverse applications, including:

• Military Use: The compact form factor of the Sparrow Hawk tAN device is designed to fit comfortably under a military helmet, making it suitable for far-forward environments where immediate access to care may be limited.
• Healthcare and First Responders: Frontline health workers, firefighters, police officers, and first responders exposed to acute stress can benefit from the Sparrow Hawk tAN system, aiding in the reduction of stress-related neurological events.
• ‍Emergency Department: Patients seeking care in a hospital due to experiencing or witnessing a traumatic event.

After the recent FDA clearance of Sparrow Ascent, Spark’s next generation of wearable neurostimulation for opioid withdrawal relief, the development of Sparrow Hawk showcases Spark Biomedical's continued commitment to pushing the boundaries of wearable neurostimulation technology to support a safe, comfortable, drug-free path to improved mental health.

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 use disorder by working to address the full 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 Ascent— Transcutaneous Auricular Neurostimulation (tAN®) for Opioid Withdrawal Relief. Sparrow Ascent provides a safe, comfortable, 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. sparrowrx.com on LinkedIn, Twitter, Instagram and Facebook.

About this research

The Phase I and Phase II Small Business Technology Transfer Research (STTR) is supported by the Department of Defense, U.S. Army Medical Research Acquisition Activity under Topic Number: A21C-T024 (“Non-invasive device for prevention or treatment of Acute Stress Reaction”). The content is solely the responsibility of the authors and does not necessarily represent the official views of the Department of Defense.

Citations

1. Armed Forces Health Surveillance Branch. Update: Medical evacuations, active and reserve components, U.S. Armed Forces, 2017. MSMR 25, 17–22 (2018).
2. Gradus, J. L. et al. Acute stress reaction and completed suicide. Int. J. Epidemiol. 39, 1478–1484 (2010).

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