Mr. Chris Seto reports
SPECTRAL MEDICAL RECEIVES US$3 MILLION FROM VANTIVE
Spectral Medical Inc. has received the $3-million (U.S.) Tranche B advance from Vantive US Healthcare LLC pursuant to the previously disclosed senior secured promissory note entered into in May, 2025.
The Tranche B advance further strengthens Spectral's balance sheet and will be used to support continuing regulatory and commercialization preparations, as well as general working capital requirements. Spectral does not anticipate requiring any additional funding -- beyond the fully drawn senior secured promissory note as previously disclosed -- to meet its upcoming key milestones, including United States Food and Drug Administration submission, and through to PMX commercialization.
"We appreciate Vantive's continued support and are pleased to have closed the Tranche B advance," said Chris Seto, chief executive officer of Spectral Medical. "This non-dilutive capital enhances our liquidity and provides additional flexibility as we execute on our regulatory pathway and commercialization plans. With this funding in place, we remain focused on operational priorities."
Under the terms of the promissory note, Vantive may advance funds up to $10-million (U.S.) to Spectral in up to four separate tranches to support Spectral's continued evidence generation strategy and path to commercialization of Toraymyxin (PMX). With the $3-million (U.S.) Tranche B advance, together with the initial $4-million (U.S.) Tranche A advance, the current cumulative draw of the promissory note is $7-million (U.S.).
A copy of the agreement has been filed under Spectral's profile on SEDAR+.
About Spectral
Medical Inc.
Spectral is a phase 3 company seeking U.S. FDA approval for its unique product for the treatment of patients with septic shock, Toraymyxin (PMX). PMX is a therapeutic hemoperfusion device that removes endotoxin, which can cause sepsis, from the bloodstream and is guided by the company's FDA-cleared Endotoxin Activity Assay (EAA), the clinically available test for endotoxin in blood.
PMX is approved for therapeutic use in Japan and Europe, licensed by Health Canada, and has been used safely and effectively with over 360,000 units sold worldwide to date. In March, 2009, Spectral obtained the exclusive development and commercial rights in the U.S. for PMX, and in November, 2010, signed an exclusive distribution agreement for this product in Canada. In July, 2022, the U.S. FDA granted breakthrough device designation for PMX for the treatment of endotoxic septic shock. Approximately 330,000 patients are diagnosed with septic shock in North America each year.
The Tigris trial is a confirmatory study of PMX in addition to standard care versus standard care alone and is designed as a 2:1 randomized trial of 150 patients using Bayesian statistics. Endotoxic septic shock is a malignant form of sepsis.
The trial methods are detailed in "Bayesian methods: a potential path forward for sepsis trials."
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