Spark Biomedical

The opioid epidemic continues to take over 100,000 American lives every year. 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. For Women's health, we have a global opportunity to empower women with the only non-hormonal, not pharmaceutical solution to improve menstrual health. This starts with our initial launch in the US to the 29 million American women who miss an average of 7 days of work a year due to menstrual burden.

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. • 2 generations of products FDA Cleared • $22 million in non-dilutive funding from both the NIH and DoD • FDA granted Breakthrough Designation for Neonatal Opioid Withdrawal Syndrome (NOWS) • 8 US patents issued, 6 pending, strong freedom to operate • ISO 13485 and MDSAP certified • 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

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  Spark Biomedical Completes Enrollment in a Neurostimulation Pivotal Trial for Opioid Use Disorder

  Yahoo Finance

  Final enrollment concludes for Spark Biomedical's pivotal study investigating a non-invasive, drug-free neurostimulation therapy aimed at improving treatment retention for adults with opioid use disorder.Dallas, TX, June 12, 2025 (GLOBE NEWSWIRE) -- Spark Biomedical, a leader in wearable neurostimulation technology, has completed enrollment for its pivotal clinical trial, which aims to improve treatment retention for adults with opioid use disorder. Funded by the National Institute on Drug Abuse

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  Spark Biomedical Secures $15M Series A To Advance Drug-Free Wearable Neurostimulation Therapies

  GlobeNewswire News Room

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