Spark Biomedical Inc. Company Profile

Background

Spark Biomedical Inc., founded in 2018 and headquartered in Dallas, Texas, is a medical device company specializing in wearable neurostimulation solutions. The company's mission is to eliminate opioid addiction by addressing the full addiction lifecycle, including withdrawal management, opioid sparing, relapse prevention, and PTSD/trauma abatement. Spark Biomedical is recognized for its innovative, drug-free therapies that leverage bioelectronic medicine to provide non-invasive treatment options for various health conditions.

Key Strategic Focus

Spark Biomedical's strategic focus centers on developing and commercializing non-invasive neurostimulation devices targeting critical areas such as:

Neurological Health: Addressing conditions like opioid withdrawal and addiction.

Women's Health: Developing solutions for menstrual health and related issues.

Hemostasis: Innovating treatments to control bleeding.

Pediatrics: Providing therapies for neonatal opioid withdrawal syndrome (NOWS).

The company's core objectives include advancing bioelectronic medicine through pioneering wearable neurostimulation solutions, offering safe and effective alternatives to traditional therapies, and improving patient outcomes across these domains.

Financials and Funding

As of April 2025, Spark Biomedical secured a $15 million Series A funding round led by WAVE Ventures and supported by Pathway to Cures. This investment aims to accelerate the development of the company's bioelectronic treatments across its core business areas. Additionally, Spark Biomedical has received substantial non-dilutive funding from federal institutions, including the National Institutes of Health (NIH) and the Department of Defense (DoD), totaling approximately $22 million.

Pipeline Development

Spark Biomedical's product pipeline includes:

Sparrow Therapy System: An FDA-cleared wearable neurostimulation device designed for opioid withdrawal relief. Clinical trials demonstrated that 84% of participants experienced mild to no withdrawal symptoms within an hour of therapy initiation.

Sparrow Ascent: A next-generation device cleared by the FDA in July 2023, offering enhanced features such as ergonomic design, longer battery life, and increased patient control over therapy.

Sparrow Fledgling: A device targeting neonatal opioid withdrawal syndrome (NOWS). Phase II clinical trials are underway to evaluate its efficacy in reducing withdrawal symptoms in infants.

Sparrow Hawk: A wearable device under development aimed at treating acute stress reactions (ASR), particularly for military and emergency use. In collaboration with Battelle, this project is supported by a $1.15 million DoD grant.

Technological Platform and Innovation

Spark Biomedical's technological platform is centered on Transcutaneous Auricular Neurostimulation (tAN®), which involves delivering mild electrical pulses to stimulate the vagus and trigeminal nerves through the skin around the ear. This stimulation activates the central nervous system to modulate pathways, reduce discomfort, and support physiological balance, resulting in non-invasive, drug-free support for a range of conditions.

The company's proprietary technologies include:

tAN® Therapy: Utilizing precise, mild electrical pulses to stimulate cranial nerves, offering a non-invasive alternative to traditional treatments.

Wearable Devices: Developing user-friendly, portable devices that enable patients to manage their conditions discreetly and effectively.

Significant scientific methods employed by Spark Biomedical encompass:

Clinical Trials: Conducting rigorous studies to validate the safety and efficacy of their devices across various indications.

Collaborative Research: Partnering with academic and research institutions to advance the understanding and application of neurostimulation therapies.

Leadership Team

Spark Biomedical's leadership team comprises experienced professionals dedicated to advancing the company's mission:

Daniel Powell: President & Chief Executive Officer.

Alejandro Covalin, PhD: Chief Technology Officer.

Navid Khodaparast, PhD: Chief Science Officer.

Karl Pawlik: Chief Financial Officer.

Jackie Powell: Chief Marketing Officer.

Brent Croft: Senior Vice President of Quality & Regulatory.

Amy Gaston: Vice President of Strategic Growth, Women's Wellness.

Chris Czura, PhD: Senior Director of Scientific Affairs.

Jared Wettenstein: Director of Program Development.

Lyndsie Olson: Director of Clinical Operations.

Melanie McWade, PhD: Director of Clinical Operations.

Michael Darrow, PhD: Director of Research Innovations.

Tricia Ericson: Director of Sales Operations.

Heather Vanderpool: Senior Product Manager.

Caroline Benner: Clinical Project Manager.

Josh Galante: Account Manager.

Udim Obot: Public Relations & Social Media Specialist.

Meghan Luellen: Product Development Engineer I.

Kelly Jackson: Office Manager.

Brooke Le: Clinical Research Associate.

Kimiko Harada: Clinical Research Coordinator.

Faith Powell: Design Intern.

Leadership Changes

As of the latest available information, there have been no recent significant changes or appointments within Spark Biomedical's leadership team.

Competitor Profile

Market Insights and Dynamics

The wearable neurostimulation market is experiencing significant growth, driven by increasing demand for non-invasive, drug-free treatment options for various medical conditions. The opioid crisis has further amplified the need for effective withdrawal management solutions, positioning companies like Spark Biomedical at the forefront of addressing this public health challenge.

Competitor Analysis

Key competitors in the neurostimulation space include:

Biosense Webster: Specializes in the diagnosis and treatment of cardiac arrhythmias.

Otto Bock HealthCare: A medical technology company focusing on prosthetics and orthotics.

STERIS USA: Provides infection prevention and other procedural products for healthcare markets.

MED-EL: Offers hearing loss solutions through implantable devices.

While these companies operate in the broader medical device industry, Spark Biomedical's unique focus on wearable neurostimulation for addiction treatment and related conditions differentiates it within the market.

Strategic Collaborations and Partnerships

Spark Biomedical has established several strategic collaborations to enhance its market position and innovation capacity:

Battelle Memorial Institute: Collaborating on the development of the Sparrow Hawk device for treating acute stress reactions, supported by a $1.15 million DoD grant.

ElectroCore, Inc.: Partnered to distribute the Sparrow Ascent device within certain Department of Veterans Affairs facilities, expanding access to opioid withdrawal treatment for veterans.

Medical University of South Carolina (MUSC) and UT Southwestern Medical Center: Collaborated on Phase II clinical trials for the Sparrow Fledgling device targeting neonatal opioid withdrawal syndrome.

Operational Insights

Spark Biomedical's strategic considerations include:

Market Position: Leveraging its FDA-cleared devices and ongoing clinical trials to establish a strong foothold in the neurostimulation market.

Competitive Advantages: Offering non-invasive, drug-free treatment options with demonstrated clinical efficacy, addressing unmet needs in addiction treatment and related health conditions.

Regulatory Compliance: Achieving ISO 13485 and MDSAP certifications, positioning the company for international expansion into markets such as Canada.