Spectral Medical Inc. provided a business update focusing on Tigris, the Company's follow-on study designed to build on knowledge gained from the earlier EUPHRATES trial, which evaluated the use of Polymyxin B Hemoperfusion (‘PMX') in a randomized controlled trial of adults treated for endotoxemia and septic shock. The Tigris trial end point is a reduction in the 28-day mortality in subjects with septic shock using the PMX hemoperfusion cartridge versus standard of care. Corporate Highlights: Tigris Trial: Patient Enrollment: Total of 50 patients randomized to-date out of the 150 total to be enrolled in Tigris, with preliminary topline data continuing to exceed expectations: Specifically, Company added approximately 30% of our total enrollment target in the second half of 2022 alone; Company are also nearing our interim enrollment target of 90 patients (‘Interim Enrollment'); at Interim Enrollment, Baxter has the right to view the trial data, and subsequently the option to make the second milestone payment to Spectral to maintain its exclusive distribution rights.

Tigris Clinical Trial Sites: There are currently 15 Tigris sites onboarded and actively enrolling patients. Company have actively removed underperforming sites while aggressively pursuing the onboarding process of additional sites: January 11, 2023, onboarded the Medical University of South Carolina and is open for enrollment; Anticipate Tigris site no.16, a premier northern California health science center, to be onboarded in the next 1-2 weeks; There are 6 potential Tigris trial sites that are at various stages of our clinical team's vetting process; and Company expect to have 18-20 clinical trial sites onboarded by the end of the first quarter of 2023. Timing: Company continue to focus on finalizing the Tigris trial within the reasonably shortest timelines.

To meet final trial enrollment in 2023, Company estimate the need for approximately 20 productive trial sites. Observational Studies: EUPHAS-2 is a Spectral-sponsored observational study in Italy using EAA-guided PMX, which is now complete have reviewed the topline results, which strongly support the preliminary data received from the Tigris trial. These data strengthen confidence in ability to achieve a successful trial outcome as well as potential FDA approval; EDEN is the Company's ancillary observational study, in which data is collected on patients with sepsis even if ineligible for Tigris.

EDEN will capture much needed data on the full range of septic shock and its relation to organ failure and endotoxin activity. These data will inform subsequent discussions with the FDA on labelling for PMX, and provide important data on potential expanded indications for PMX. The Company has onboarded 5 EDEN sites and enrolled 30 patients into the observational study.