From GlobeNewswire: 2024-11-08 08:00:00

Spectral Medical Inc. has enrolled 135 patients out of the 150 total target for its Tigris trial. Despite disruptions in October due to Hurricane Helene’s impact on the medical supply chain, the company remains focused on completing the trial and potentially achieving FDA approval.

With a strengthened balance sheet and expected funds, Spectral aims to complete Tigris trial enrollment by early 2025. The company has received approximately $11 million in gross proceeds since April to support this goal.

In anticipation of positive trial outcomes, Spectral is collaborating with Baxter on post-approval marketing plans for PMX commercialization. A sub-study with Baxter aims to obtain FDA clearance for hemoperfusion for the Prismax device.

Financially, Spectral reported increased revenue and operating expenses for the third quarter of 2024. The company’s loss for the period was $9,995,000, an increase from $3,804,000 in the same period last year.

Spectral is a Phase 3 company seeking FDA approval for its product, Toraymyxin™, which treats septic shock. The Tigris Trial is a key study for this product, aiming to improve outcomes for patients with endotoxic septic shock.

Overall, Spectral has made significant progress in patient enrollment for the Tigris trial and is on track to complete enrollment in early 2025. The company’s financial results reflect its ongoing commitment to advancing therapeutic options for sepsis and septic shock.



Read more at GlobeNewswire:: Spectral Medical Announces Third Quarter Results and