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Spark Biomedical

Wearable Neurostimulation Platform
Dallas

About 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.

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Problem statement

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.

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.
• 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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Milestones

June 2024

Government Grant Received

Spark Biomedical received $575,086.00 from DHA

July 2023

Government Grant Received

Spark Biomedical received $574,689.19 from DHA

March 2022

Government Grant Received

Spark Biomedical received $171,429.00 from Army

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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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Spark Biomedical is a part of

Funding

Not raising capital right now

$11,300,000
committed
$15,000,000
round goal
Total raised to date:$24,000,000

Government grants

AgencyTotal Amount
Army$171,429.00
DHA$1,149,775.19
Total$1,321,204.19
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