TORONTO, Aug. 25, 2025 (GLOBE NEWSWIRE) -- Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late-stage theranostic company advancing therapeutic options for sepsis and septic shock, today announced that it has received the US$3 million Tranche B advance from Vantive US Healthcare LLC (“Vantive”) 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 ongoing r ...

Core Insights - Spectral Medical Inc. reported significant clinical and operational progress in Q2 2025, particularly with the Tigris trial, which is pivotal for the PMA submission to the FDA [3][4][7] - The company achieved a revenue increase of 73% year-over-year for Q2 2025, driven by product sales and non-dilutive funding from Vantive [8][12] - Operating expenses decreased by 47% in Q2 2025 compared to the previous year, contributing to a reduced loss for the quarter [9][13] Clinical Development - The Tigris trial, a Phase III study evaluating PMX for endotoxic septic shock, completed patient enrollment in April 2025 and is on track to report topline results by mid-August 2025 [3][6] - The company has submitted all non-clinical studies to the FDA and plans to submit clinical results by the end of October 2025 [6][8] - The EDEN study, completed in Q4 2023, provided critical data on septic shock, indicating a significantly higher mortality rate for patients with endotoxic septic shock [6][11] Financial Performance - Revenue for Q2 2025 was $813,000, up from $471,000 in Q2 2024, marking a 73% increase [8] - Product revenue for Q2 2025 reached $403,000, an 86% increase from $217,000 in the same period last year [8] - Operating expenses for Q2 2025 were $2,514,000, down from $4,702,000 in Q2 2024, primarily due to finance income from a promissory note [9][10] Balance Sheet and Funding - The company ended Q2 2025 with cash of $3,100,000, a slight increase from $2,988,000 at the end of 2024 [15] - Spectral entered into a promissory note agreement with Vantive for up to $10 million, providing financial flexibility for regulatory processes and commercialization planning [5][12] - Total liabilities increased to $45,672,000 as of June 30, 2025, compared to $32,865,000 at the end of 2024 [21] Market Position and Product Development - PMX, the company's therapeutic hemoperfusion device, is already approved for use in Japan and Europe and has been used over 360,000 times [17] - The Tigris trial is designed as a 2:1 randomized study of 150 patients, utilizing Bayesian statistics to evaluate PMX's effectiveness [18] - The company is collaborating with Vantive on post-approval commercialization planning, aligning efforts with potential FDA approval timelines [6][12]

Core Points - Spectral Medical Inc. held its Annual Meeting of shareholders on June 5, 2025, where all resolutions in the Management Information Circular were approved [1][2] Group 1: Election of Directors - Seven director nominees were elected with high approval rates, including Jan D'Alvise (99.78%), Jun Hayakawa (99.79%), and David W. Feigal, Jr. (99.67%) [3] Group 2: Appointment of Auditors - MNP LLP was re-appointed as the auditor of Spectral with 99.95% votes in favor [4] Group 3: Company Overview - Spectral is a Phase 3 company seeking U.S. FDA approval for its product Toraymyxin™ (PMX), a therapeutic hemoperfusion device for treating septic shock [4][5] - PMX has been approved for use in Japan and Europe, with over 360,000 applications to date [5] - The U.S. FDA granted Breakthrough Device Designation for PMX in July 2022 for endotoxic septic shock treatment [5] Group 4: Clinical Trials - The Tigris Trial is a confirmatory study comparing PMX in addition to standard care versus standard care alone, designed as a 2:1 randomized trial of 150 patients [6]

Company Overview - Spectral Medical Inc. is a late-stage theranostic company focused on advancing therapeutic options for sepsis and septic shock [1] - The company is seeking U.S. FDA approval for its product Toraymyxin™ (PMX), a therapeutic hemoperfusion device designed to remove endotoxin from the bloodstream [4][5] - PMX has been approved for therapeutic use in Japan and Europe, with over 360,000 applications to date [5] Clinical Trials and Regulatory Status - The Tigris Trial is a confirmatory study comparing PMX in addition to standard care versus standard care alone, involving 150 patients in a 2:1 randomized trial [6] - The U.S. FDA granted Breakthrough Device Designation for PMX for the treatment of endotoxic septic shock in July 2022 [5] Upcoming Events - Management will participate in a fireside chat at the 3rd Annual H.C. Wainwright BioConnect Investor Conference on May 20, 2025, at Nasdaq headquarters in New York City [1][3] - Investors interested in meeting with the management team can contact their H.C. Wainwright representative [2]

Core Insights - Spectral Medical Inc. has completed enrollment for its Tigris trial, a Phase III clinical trial evaluating PMX for endotoxic septic shock, with topline results expected in August 2025 [1][2][3] - The company has entered into a promissory note agreement with Vantive for up to US$10 million to support PMX commercialization [1][9] Clinical Development - The Tigris trial has enrolled a total of 157 patients, with 151 evaluable patients and 100 treated with PMX [6] - The data lock for the trial is expected to be completed in approximately 90 days, with topline results anticipated two weeks post-data lock [6] - The company is on track to submit clinical results to the FDA by the end of October 2025 [6] Financial Performance - Revenue for Q1 2025 was $572,000, a decrease of 14% from $668,000 in Q1 2024 [10] - Operating expenses increased significantly to $13,174,000, up 173% from $4,825,000 in the prior year, primarily due to non-cash fair value adjustments [11] - The company reported a loss of $12,605,000 for Q1 2025, compared to a loss of $4,160,000 in Q1 2024 [13] Balance Sheet and Financing - As of March 31, 2025, the company had cash of $1,670,000, down from $2,988,000 at the end of 2024 [14] - The promissory note with Vantive includes a four-year maturity and a payment-in-kind interest rate of 9% [15] Commercialization Activities - The company is collaborating with Vantive on post-approval marketing plans for PMX commercialization [15] - Vantive intends to submit a 510(k) application for its PrisMax System, which is expected to be the primary device used for PMX treatments upon commercial launch [15] Regulatory and Clinical Study Insights - The EDEN study, completed in Q4 2023, showed that patients with endotoxic septic shock had a significantly higher mortality rate of 60% compared to 14.1% for other septic shock patients [6] - The results from the EDEN study will inform discussions with the FDA regarding PMX labeling and the addressable population in the U.S. [6]

Core Viewpoint - Spectral Medical Inc. has secured a non-dilutive financing agreement with Vantive US Healthcare LLC for up to US$10 million to support the commercialization of its blood filtration therapy, Toraymyxin™ (PMX) [2][4][5]. Financing Details - The financing consists of a senior secured promissory note with a total principal amount of up to US$10 million, which can be drawn in up to four tranches [2][3]. - The first tranche of US$4 million was triggered on May 6, 2025, upon the execution of the agreement [4]. - The remaining tranches are contingent upon specific milestones outlined in the agreement [4]. Company Strategy and Milestones - The funds will support Spectral's evidence generation strategy and the path to commercialization of PMX, which is designed to remove endotoxin from the bloodstream in patients with sepsis [3][4]. - The company does not anticipate needing additional funding to meet key upcoming milestones, including the release of topline results and U.S. FDA submission [4]. Management Commentary - The CEO of Spectral expressed gratitude for the partnership with Vantive, emphasizing the non-dilutive nature of the funding and the alignment between the two companies [5]. Product Overview - PMX is a therapeutic hemoperfusion device that has been approved for use in Japan and Europe and has been utilized over 360,000 times [11]. - The device is currently seeking U.S. FDA approval and has received Breakthrough Device Designation for the treatment of endotoxic septic shock [11]. Clinical Trial Information - The Tigris Trial is a confirmatory study comparing PMX in addition to standard care versus standard care alone, designed as a 2:1 randomized trial involving 150 patients [12].

Core Insights - Spectral Medical Inc. is advancing its Tigris trial, a Phase 3 study evaluating Polymyxin B Hemoperfusion (PMX) for treating endotoxemia and septic shock [2][4] - The company aims to finalize full enrollment of 150 evaluable patients by the end of March 2025, with 152 patients already enrolled [8] Enrollment Update - As of now, 152 patients have been enrolled in the Tigris trial, with six patients enrolled in February [8] - The trial is designed to randomize 150 patients in a 2:1 ratio, with 100 patients receiving PMX and 50 receiving standard care [6][8] - The company estimates that an additional four to seven patients are needed to reach the target of 150 evaluable patients [8] Product and Market Context - PMX is already approved for therapeutic use in Japan and Europe, having been safely used on over 340,000 patients [5] - Approximately 330,000 patients are diagnosed with septic shock annually in North America, highlighting the market potential for PMX [5]