Official Website: Spire Therapeutics
source confidence: Medium status: Useful updated 2026-08-11
Summary
SPIRE's official website describes Diadem, a low-intensity focused ultrasound (LIFU) device for surgery-free, drug-free treatment of chronic pain and depression by noninvasively modulating hyperactive deep brain circuits, with patient-specific compensation for skull and hair acoustic distortions.
Useful Claims
- SPIRE positions Diadem as an ultrasonic device that noninvasively and precisely resets deep brain circuits hyperactive in chronic pain and depression.
- The site states Diadem compensates for ultrasound distortions caused by the head and hair to deliver controlled, practical therapy.
- The site gives the addressable populations it is aiming at as headline statistics:
20Mpeople in the United States with treatment-resistant chronic pain and6Mwith treatment-resistant depression. These are the company's own framing of the market, not epidemiological estimates it sources. - The site claims clinical studies have shown rapid, immediate improvements in pain intensity and depressive symptoms.
- SPIRE lists funders and partners including the National Institutes of Health, National Science Foundation, Focused Ultrasound Foundation, University of Utah Health, Wellcome Trust, and private investors.
- The site is recruiting: it invites people whose chronic pain or depression has not responded to existing treatments to sign up for its respective clinical studies. That places the studies as open and enrolling at capture time, and says nothing about their registration, phase, or results.
- The capture includes the dates October 3 and August 27, 2024 without the associated pitch-competition text, so what those dates mark cannot be read from this document.
Verbatim
"An ultrasonic device called Diadem noninvasively and precisely resets the deep brain circuits that are hyperactive in chronic pain and depression. Diadem is unique in that it compensates for the ultrasound distortions by the head and hair, and thus provides a controlled and practical therapy." — Home page, Diadem description
"Because Diadem resets the hyperactive deep brain regions directly using focused ultrasonic waves, clinical studies have shown rapid, immediate improvements in pain intensity and depressive symptoms." — Home page, clinical-study description
"We are currently funded by the National Institutes of Health, the National Science Foundation, the Focused Ultrasound Foundation, University of Utah Health, the Wellcome Trust, and private investors." — Home page, funders
"20M People in the United States suffer from treatment-resistant chronic pain" — Home page, statistics band (the figure and its caption are separate lines in the layout)
"6M People in the United States suffer from treatment-resistant depression" — Home page, statistics band
"pain or depression and existing treatments are not helpful, sign up for the respective clinical study." — Home page, recruitment call to action
"SPIRE wins the Altitude Lab DEMO day pitch competition" — Home page, media coverage (October 3, 2024)
"SPIRE wins the Wilson Sonsini Entrepreneur & Investor Life Science Summit competition" — Home page, media coverage (August 27, 2024)
"If you're suffering from chronic pain or depression and existing treatments are not helpful, sign up for the respective clinical study." — Home page, clinical studies call-to-action
Reliability Notes
The 20M and 6M population figures sit in a statistics band where each number and caption are separate elements, so text extraction places them on separate lines. Both figures and the study-recruitment invitation are present in the capture and quoted above; the source renders the first figure as 20M, not "approximately 20 million."
This is an official company source. Epidemiology figures, clinical-outcome claims, and mechanism-of-action statements on a company site are leads, not independent verification. Trial enrollment status, regulatory pathway, and comparative efficacy versus TMS, ECT, or DBS should be confirmed against clinical-trial registries, peer-reviewed publications, and FDA device databases before high-confidence use.