The University of Utah, one of the nation’s leading research universities, announces the launch of a clinical study evaluating Diadem, a noninvasive ultrasound-based neuromodulation device developed by Spire Therapeutics under the support of the U.

Scientists at the U and Spire Therapeutics, a spinoff company based on research at the university, created Diadem to provide effective, noninvasive treatment options for individuals suffering from chronic pain, depression and other neurological conditions.

Diadem uses low-intensity focused ultrasound to deliver precise pulses of sound energy to deep regions of the brain. These ultrasonic waves gently modulate overactive neural circuits linked to chronic pain, depression, addiction and other indications—without surgery, implants or medication. Unlike traditional neuromodulation techniques that rely on electrical currents or magnetic fields, Diadem provides both a noninvasive and a targeted approach to restoring healthy brain function with minimal risk.

To make this technology possible, several important long-standing barriers had to be overcome using novel engineering designs and approaches. Spire holds exclusive rights to a growing portfolio of patent applications covering the core technology behind Diadem, ensuring strong protection of intellectual property as the company advances toward FDA approval. The technology is the subject of pending patent applications in jurisdictions around the world, underscoring Spire’s commitment to securing rights to the foundational innovations behind Diadem.

The upcoming clinical trials mark critical steps for evaluating Diadem’s safety and effectiveness in patients. Early stage research and feasibility data have shown encouraging outcomes, supporting the move into pivotal trials.

“The ability to noninvasively target deep brain circuits could reshape how we treat mental and neurological disorders,” said Jan Kubanek, faculty member in biomedical engineering at the U and founder of Spire Therapeutics. “This is a major milestone toward that goal.”

The trial will be conducted in collaboration with the U’s Data Coordinating Center, one of the largest academic research organizations in the country, ensuring rigorous study design and adherence to FDA standards.

“This is what it looks like when university research moves beyond the lab and starts changing lives,” said Jim Hotaling, associate vice president for research innovation and translation at the U. “Helping technologies like Diadem reach patients is exactly why we invest in innovation—and why it matters.”

“Our mission is to bring effective, noninvasive treatment options to patients who have exhausted existing therapies,” added Kubanek. “With Diadem, we are one step closer to achieving that goal.”