Key Points
- The device, called DIADEM, measures and compensates for the attenuation of ultrasound caused by the human head and hair.
- Results from clinical trials support its effective and safe deployment in patients with treatment-resistant depression and chronic pain.
SPIRE, an early-stage company spun out from the University of Utah, was established to produce controlled deep brain neuromodulation for chronic pain and depression. Its primary device, DIADEM, delivers low-intensity focused ultrasound (LIFU) neuromodulation to selectively and controllably modulate the deep brain circuits involved in these disorders.
DIADEM’s technology overcomes the key barrier for transcranial ultrasound: the human head and hair. The device directly measures and compensates for the attenuation of ultrasound by these obstacles. Results from clinical trials support its effective and safe deployment in patients, as validated in the following peer-reviewed publications:
- In “Device for Multifocal Delivery of Ultrasound into Deep Brain Regions in Humans,” which was featured on the cover of IEEE Transactions in Biomedical Engineering, the research team conducted in vivo validation of the modulation capabilities of the DIADEM device and its mechanical registration targeting method. They enrolled two participants with treatment-resistant depression in a clinical trial targeting the subcallosal cingulate. The stimulation modulated mood states and was well tolerated with no adverse events.
- A clinical case report on the first person treated in the follow-up treatment-resistant depression clinical trial, “Durable Effects of Deep Brain Ultrasonic Neuromodulation on Major Depression: A Case Report,” was published in the Journal of Medical Case Reports. This participant’s symptoms of depression were relieved for more than 44 days.
- Another small clinical trial that enrolled three participants with essential tremor was published in the Journal of Neural Engineering. In this study, titled “Noninvasive Modulation of Essential Tremor with Focused Ultrasonic Waves,” the researchers used the DIADEM device to apply LIFU to the ventral intermediate nucleus. The team noted that this “was the first demonstration that DIADEM could modulate overt motor behavior in humans with LIFU neuromodulation.”
“We’ve been blown away by the positive results so far,” said Dr. Riis, a postdoctoral researcher in the Department of Biomedical Engineering, in the University of Utah’s press release. “After just a single 40-minute stimulation session, patients are showing immediate, clinically substantial improvements in symptoms.”
SPIRE has completed Phase 2 clinical studies for chronic pain and depression. The company is now conducting Phase 3 trials for these indications with the goal of obtaining regulatory approval and providing the treatments to the large number of patients who are currently in need of new treatment options.
Read SPIRE’s April 2024 Company Profile
See the University of Utah’s Press Release
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