A Better Way Forward for Neonatal Opioid Withdrawal Syndrome (NOWS)

A Solution for the Most Vulnerable Patients, Powered by Transcutaneous Auricular Neurostimulation (tAN®)

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Providing safe, effective, and non-invasive care for Neonatal Opioid Withdrawal

Every 25 minutes a baby in the U.S. is born into Neonatal Opioid Withdrawal Syndrome (NOWS). This equates to thousands of NOWS newborns who need special care entering the healthcare system each year. These infants are born with painful symptoms like:

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Tremors

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Irritability

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Feeding difficulties

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Seizures

Current treatment options often involve prolonged hospital stays and pharmacologic interventions, which can have long-term impacts on the infant and family.

Sparrow® Fledgling: A Breakthrough in Neonatal Care

At Spark Biomedical, we’re pioneering a groundbreaking approach to treating NOWS with transcutaneous auricular neurostimulation (tAN). The Sparrow Fledgling™, our wearable neurostimulation device based on our FDA-cleared Sparrow Ascent technology, is designed specifically for the unique needs of neonates experiencing withdrawal.

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Non-invasive Treatment

Gentle electrical stimulation applied to the auricular branch of the vagus and trigeminal nerves.

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Regulation of Withdrawal Symptoms

Modulates the brain’s response to withdrawal, reducing symptom severity.

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Ease of Use

A compact, wearable solution that supports Neonatal Intensive Care Unit (NICU)

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FDA Breakthrough Status - What It Means for Physicians and Patients

The Sparrow Fledgling™ is currently in clinical trials to validate its safety and efficacy in neonates. As part of Spark Biomedical’s commitment to bring innovation treatments to market, we have applied for and secured FDA Breakthrough Device Designation, which means:

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Expedited FDA Communication
Accelerated collaboration with the FDA during the pre-submission and review process.

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Faster Path to Market
Streamlined development and regulatory pathways for promising technologies.

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Potential for Earlier Access
Aims to provide an effective solution to physicians and families sooner.

Publications & Clinical Trials

We are proud to collaborate with top institutions and researchers to explore the full potential of tAN for neonatal care.

Clinical Trials

Transcutaneous Auricular Neurostimulation for ICU Patients with Traumatic Brain Injury (tAN-TBI)

Status:

Not Yet Recruiting
Understanding the Effects of Transcutaneous Auricular Neurostimulation for Treatment of Chronic Pain

Status:

Recruiting
Understanding the Effects of Transcutaneous Auricular Neurostimulation for Treatment of Chronic Pain

Status:

Recruiting
Determining the Independent and Synergistic Effects of Transcutaneous Auricular Neurostimulation (tAN) on Direct Brain Activation in Healthy Individuals

Status:

Recruiting
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Publications

Spark Biomedical is at the forefront of research on NOWS. Our work has been recognized in the following leading scientific journal:

Frontiers

Transcutaneous Auricular Neurostimulation (tAN): A Novel Adjuvant Treatment in Neonatal Opioid Withdrawal Syndrome

Our Clinical Trial Partners

Podcasts & Video Blogs

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Our Origin Story

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Our Clinical Story

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The Vision for Sparrow

Together, we can transform care for the most vulnerable patients. Let’s give every baby a chance to thrive, starting from day one.

Want to follow our progress?

Stay up to date on Spark Biomedical’s advancements in neonatal neurostimulation—fill out the form to receive the latest updates.

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