Spectral Medical (EDT) Status update summary

Tigris trial enrollment and timeline

• Enrollment reached 138 patients, with robust activity until a slowdown in October due to a nationwide saline shortage caused by Hurricane Helene.

• Full enrollment is now projected by the end of Q1 2025, with top-line data expected about 120 days after last patient enrollment, targeting early Q3 2025.

• FDA submission is anticipated around the end of Q3 2025, with a complete review expected by Q1 2026.

• The saline shortage reduced enrollment by approximately a dozen patients, but screening activity remains strong and is improving.

• Enrollment requires 150 evaluable patients, but due to some patients not receiving intervention, total enrollment will be slightly higher (157-160).

Sub-studies and data updates

• The PrisMax sub-study has enrolled 12 patients and is on track to reach its target of at least 15.

• The EDEN sub-study data are locked and undergoing analysis, with abstracts to be presented in February and manuscript submission targeted for January.

Site performance and operational dynamics

• High-performing sites continue to drive the majority of enrollments, with little change in site performance patterns.

• External factors such as staff turnover and leaves have impacted some sites, but overall site engagement remains strong.