Spark Biomedical

Spark Biomedical has developed a novel wearable neurostimulation platform with multiple applications. We are FDA cleared and on market to treat opioid withdrawal and addiction. We have concluded a study for neonatal opioid withdrawal syndrome and will be submitting that to the FDA next quarter. Lastly we are launching a wellness brand for Women's Menstrual health after demonstrating a 55% reduction in blood loss, 50% reduction in cramp pain, and significant improvements in mood and quality of life.

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