Spark Biomedical, Inc.


Spark Biomedical is dedicated to transforming healthcare through innovative, drug-free, wearable neurostimulation technology. Their mission is to develop science-backed solutions that address critical needs in mental health, women’s health, hemostasis, and pediatrics, aiming to improve patient outcomes and build a healthier future. They focus on providing safe, effective, non-invasive bioelectronic medicine that fills treatment gaps and offers new treatment paths.

Industries

health-care
medical-device
therapeutics

Nr. of Employees

small (1-50)

Spark Biomedical, Inc.

18208 Preston Road, Suite D9 531, Dallas, Texas 75252


Patents

Device and method for the treatment of substance use disorders

US-10695568-B1

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Products

FDA‑cleared wearable auricular neurostimulation system for opioid withdrawal

A market‑cleared wearable auricular neurostimulation system intended to provide non‑pharmacologic symptom relief for patients experiencing opioid withdrawal.

Wearable neonatal auricular neurostimulation device (in clinical evaluation)

A compact, gentle wearable neurostimulation device designed for neonatal use to reduce symptoms associated with neonatal opioid withdrawal; currently under clinical evaluation and subject to regulatory breakthrough designation processes.


Services

Partnership and operational support for investigator‑led and sponsor trials deploying wearable neurostimulation, including trial design, site partnerships, and device provisioning.

Provision of investigator‑facing tools and services to integrate wearable neurostimulation devices into clinical research workflows.

Expertise Areas

  • Wearable neurostimulation development
  • Clinical trial management and design (including decentralized and sham‑controlled trials)
  • Hemostasis therapy research and development
  • Neonatal neuromodulation for withdrawal syndromes
  • Show More (4)

Key Technologies

  • Transcutaneous auricular neurostimulation (tAN)
  • Vagus nerve stimulation (VNS)
  • Trigeminal nerve stimulation
  • Wearable medical device design
  • Show More (4)

News & Updates

The investment will support the company’s core areas of bioelectronic medicine, including neurological health, hemostasis, and women’s health.

Clinical enrollment concludes for Spark Biomedical’s pivotal trial investigating a non-invasive, drug-free neurostimulation treatment for newborns born with NOWS.

New Health Canada Approval Allows Spark Biomedical to Offer Drug-Free Opioid Withdrawal Relief Across Canada.

Details not provided in the source.

Details not provided in the source.

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