2023 was an active year of change at Kernel. Since Bryan handed over the CEO torch to me nearly a year ago, we have been honing our focus and making a push to have an impact with Flow. In the last year we launched Kernel Flow2, shipped our first systems to researchers, published validation work from Flow1, started to build brain-based biomarkers for depression and mild cognitive impairment, completed a number of partnerships to help companies developing products for the brain (not just pharmaceuticals), and refreshed our brand.

The rest of this newsletter is a detailed recap of some of this work! Set your devices in focus mode, get comfy and enjoy the updates.

Ryan

CEO, Kernel

www.kernel.com

Clinical Research

Depression pilot

Mild cognitive

impairment pilot

Flow2 Launch

Flow1 Study Results

Up Next

Last summer, we began work to apply our Kernel Flow neuroimaging technology to two clinical areas - depression and dementia. In the second half of 2023, we worked hard to build partnerships with clinicians and researchers in these spaces to get observational studies up and running in both areas.

As we kicked-off our efforts in these first two areas, we’ve had many conversations with patients, family members, clinicians, and payers about the need for these types of capabilities. We’re incredibly excited about what a future with Kernel Flow in primary care settings could look like!

DEPRESSION PILOT

We have set out to determine if Kernel Flow could be used to predict who will respond to a depression treatment. This could have a huge impact on how depression treatments are selected and administered. We launched our aptly-named Prediction of REsponse to Depression Interventions Using Clinical and TD-fNIRS Measurements (PREDICT) study to evaluate what predictive signals we can identify. After a short 3 months of planning, we measured our first patient last July and are currently enrolling patients beginning new treatments at several sites throughout the US.

MILD COGNITIVE IMPAIRMENT PILOT

Annual check-ups do not currently have any evaluation of brain function - what if an inexpensive, easy, and direct measure of brain function were a routine part of an annual health exam? Imagine a world where you know something is changing with your cognition with the same ease that you can screen for atrial fibrillation using an Apple Watch. To start to realize this future, we started to explore if Kernel Flow could be used to distinguish between a ‘healthy’ brain and the brain of a patient that’s been diagnosed with Mild Cognitive Impairment (MCI). Last summer, we also launched our Investigating Mild Cognitive Impairment in Patients And Controls With TD-fNIRS (IMPACT) study. At the end of 2023, we reached the midpoint of this study and saw promising preliminary results on an individual-level from our interim readout. We’re extremely energized by the rapid progress we’ve made in this space.

Amongst all of the excitement around our new clinical directions, we also managed to release our second generation Kernel Flow system - Flow2. This system improves on many areas from Flow1. In particular, we have a much denser and more uniform measure of the whole cortical layer of the brain. We’ve lowered power, increased our signal-to-noise ratio, and further streamlined the measurement process. The first systems have begun shipping to our early partners and customers on our waiting list. The system sells for $99,200 and is available for use in research settings. The system specifications are available here and you can email sales@kernel.com to find out more.

Finally, we had a big summer sharing results from our first-generation Flow1 system. We first announced results from our ketamine (psychedelic) work that was sponsored by Cybin and published in Scientific Reports. In this study we demonstrated the ability to measure the acute impact of a drug on brain function. We showed some nice correlations between the subjective mystical experiences that participants reported and changes in brain connectivity. This work is a foundational example not only for psychedelics but for any fast-acting intervention for the brain.

Second, we released results from our study of alcohol’s effect on the brain, again published in Scientific Reports. In this study we gave volunteers a mixed drink on 3 different days each with a different amount of alcohol (or none!) and then measured their brain function while they performed a computer task. One of the most interesting findings from this study was that we were able to observe changes in brain activity due to alcohol before we could detect changes in the volunteers’ ability to perform the task. We could also see that the brain activity we measured clearly changed based on how much alcohol the volunteer was given. This work demonstrated our fundamental ability to measure dose-dependent functional responses in the brain, whether the drug is alcohol or something else altogether.

The next quarter should be filled with action. We have a number of active partnerships with other companies. Our IMPACT MCI study should finish enrollment, and we’ll be submitting two additional publications on the characterization of Flow2 and the reliability of our measurements. We’re making great strides toward our goal of making neuroimaging accessible, reliable, and actionable so that the promise of precision neuromedicine can be realized.