Mar 30, 2020

Daniel Powell is the CEO of Spark Biomedical, a medical device company based in Texas whose mission is to develop effective, wearable neurostimulation devices. In this episode, he discusses an auricular nerve stimulator to aid in the relief of opioid withdrawal both in adults and newborn infants.

Top three takeaways:

1. This auricular, transcutaneous nerve stimulator device works to alleviate opioid withdrawal by stimulating the necessary nerves to kickstart endogenous endorphin release in the brain.
2. A major part of opioid addiction is avoiding withdrawals; opioids chemically replace endorphins and bind to opioid receptors, and the brain no longer produces endogenous endorphins, so that when the user no longer takes the drugs, they no longer have the necessary chemicals to deal with anxiety and pain. This is what makes opioid withdrawals unique and is why opioid addicts try so hard to avoid them.
3. When starting a project, it is highly beneficial to have a diverse team of people with different skill sets that can contribute to every aspect of the project.

[0:00] Powell explains his job  – Spark Biomedical is currently developing an auricular, transcutaneous nerve stimulator designed to stimulate specific cranial nerve branches and is designed to relieve opioid withdrawal

[3:45] There is some evidence to support the efficacy of acupuncture-based stimulation for treating opioid withdrawal in adults, which is the basis for the creation of the non-invasive auricular nerve stimulator

[7:15] The ear pieces are easy to apply and disposable – since there are no needles, it is easy to replace the ear pieces as needed

[9:15] When observing withdrawal symptoms in adults using this device, one can observe that the common symptoms – shaking, sweating, etc. – approach a normal level over a 60-minute window

[10:45] So far, there have not been issues with the FDA, as Spark Biomedical has completed their pre-submission process, where they write down the questions to be answered by the FDA

[13:30] This is Spark Biomedical’s first main project; the company was formed specifically for this project at the end of 2018, and there was a good network of people to call on for both scientific and financial applications

[16:45] When someone is addicted to opioids, they are not simply chasing euphoria, but are also trying to run away from withdrawals

[20:45] During acute withdrawal, the stimulator helps to jump-start the brain to produce the endogenous endorphins necessary to occupy opioid receptors, which helps to alleviate withdrawal

[23:45] A good dose of endogenous endorphins can alleviate withdrawal symptoms for a long time; one subject who used the stimulator device for an hour felt no withdrawal symptoms for six hours after removing the device

[25:15] The project is currently in clinical trials for adults, and Spark Biomedical is currently partnered with MUSC to run the trials for infants; the hope is that the product is on market for adults in the second half of 2020

[28:15] A good piece of entrepreneurial advice is to have a diverse team with different educational backgrounds and skill sets to be able to contribute to every aspect of the project

[31:30] A challenge when building the company is that it was built remotely, and does not convene in a single office

[34:00] The company was built on people who were tired of corporate life, and pays based on results rather than hours