Spectral Medical (EDT) Status update summary

Key regulatory and clinical milestones

• Achieved full enrollment of the Tigris study with 157 patients, marking a major step in sepsis clinical research.

• Data monitoring and cleaning are underway, with data lock expected by end of July and top-line results anticipated by mid-August.

• Primary endpoint is 28-day all-cause mortality, with Bayesian analysis combining new and prior data; 90-day outcomes will also be reported.

• FDA submission is targeted for October, with regulatory review expected to take about nine months.

• Extensive safety and effectiveness data from other jurisdictions and retrospective studies will support the FDA application.

Financing and commercialization update

• Secured a $10 million debt facility from Vantive, structured in four tranches tied to clinical and regulatory milestones.

• The financing features a 9% annual interest rate, four-year term, and no dilution or conversion features.

• Vantive remains a committed commercialization partner, with the recent financing reflecting strong alignment.

• Commercialization strategy leverages Vantive’s acute therapy distribution network, with potential for sales force scaling.

Market opportunity and adoption outlook

• Estimated addressable market is 120,000–130,000 patients annually in the U.S. and Canada, based on conservative analysis.

• Adoption in ICUs is expected to be driven by survival benefit and health economic value, such as reduced ICU days and costs.

• If clinical outcomes are robust, the therapy could become the de facto standard of care for its target population.

• No competing technologies are currently available or on the immediate horizon for this patient subset.