Spark Biomedical

Medical Device for Opioid Withdrawal and Addiction
Founded 2019-07-26 Dallas, TX

Problem statement

The opioid epidemic continues to grow out of control throughout the COVID Pandemic - experts predict there will be over 100,000 opioid overdose deaths in 2022, up over 100% in the last 3 years. The major barrier to beating an opioid addiction is getting through the debilitating physical withdrawals. Furthermore, over 40,000 babies are born every year into opioid dependence and face a brutal first 3-4 weeks of life in the NICU as they are weened off opioids, with an average cost of over $70,000 per child.

About company

Spark Biomedical is a medical device company focused on solutions to address addiction, withdrawal, and overall mental health. Spark's flagship product, the Sparrow therapy system, is a non-invasive wearable neurostimulator that alleviates nearly all withdrawal symptoms in as little as 30-60 minutes. The device sends electrical signals to the brain, driving endogenous endorphin production and calming the fight-or-flight instincts that create a near primal urge to use again. The Sparrow for adults is backed tier 1 clinical evidence and FDA cleared. The Sparrow Fledgling, for neonates, has undergone is first proof-of-concept trial with great success - and is now entering an NIH funded pivotal trial to obtain FDA approval.

Traction information

Spark is a commercial stage medical device company that has traversed full product development, clinical trials, regulatory submission with the FDA and acquisition of unique reimbursement codes. • Generation 1 product FDA cleared • Generation 2 product complete and in FDA review • Neonatal indication expansion submitted to the FDA • Long-term addiction indication expansion clinical trial NIH funded and started • DOD contract awarded for additional indication expansion • Q2, 2022 revenue on track for $70K • 2022 revenue on track for $500K • Custom CPT code obtained • Three U.S. patents issued with international protection filed

Product images


Spark Biomedical just completed a joint venture agreement with Northwell Health and the Feinstein Institute to bring a new novel neuromodulation therapy to market. The new subsidiary, 5 Liters, will take over a decade of preclinical work lead by Kevin Tracey and his team at the Feinstein institute using neurostimulation of the Vagus nerve to activate platelets in order to reduce blood loss and stop bleeding. This novel approach to blood management has applications on the battlefield, in the OR, emergency room, and around the world where expensive hemostatic agents aren't available. 5 Liters will translate the preclinical work to humans and bring this novel, potentially life saving blood management solution to market.

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In the last week, Spark was awarded 1) Edison Awards - Bronze for innovation in Healthcare 2) 3 Platinum, 4 Gold, and 1 honorable mention Hermes Awards for creative design 3) Fast Company Most Innovative Company - Honorable Mention.

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Series AMental Health & WellnessMedical Devices


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Daniel Powell
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