Under the amended protocol, the Company is enrolling an additional 15 patients receiving less than 90 mg per day in morphine equivalents to further characterize safety and efficacy in patients with ongoing opioid use associated with the treatment of chronic lower back pain.

The new cohort is already more than 85% enrolled and leverages the Company’s newly implemented, patient-centric AI pain medication monitoring system to capture rapid, accurate patient-reported outcome measures and analgesic-use patterns in real time.

This expansion follows previously reported completion of enrollment in the original ADAPT study population and positive interim 180-day data demonstrating statistically significant, clinically meaningful improvements in functional disability (ODI%) and pain, together with an excellent safety profile.

The trial remains supported by a favorable independent Data Safety Monitoring Board (DSMB) review, which reported no significant adverse events and recommended continued advancement of the program.