Spire Therapeutics

Executive Summary

Spire Therapeutics, based in San Diego, is developing Diadem, a novel ultrasonic device that noninvasively resets hyperactive deep brain circuits implicated in chronic pain and depression. By compensating for ultrasound distortions caused by the skull and hair, Diadem delivers precise, controlled therapy without surgery or implants. Founded in 2018, the company is privately held and operates at the intersection of respiratory and medical devices, with potential to transform neuromodulation for millions of patients. Early-stage clinical data will be critical to validate safety and efficacy, and the company is expected to advance toward pivotal studies or regulatory clearance. With a differentiated technology and a large addressable market, Spire represents a high-risk, high-reward opportunity in non-invasive brain stimulation.

Upcoming Catalysts (preview)

• H1 2027Initiation of First-In-Human Clinical Trial for Diadem50% success
• H2 2026FDA Breakthrough Device Designation or IDE Approval70% success
• Q4 2026Series A/B Funding Round to Support Clinical Development65% success