Spectral Medical Inc.
Other OTCCapital Structure
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in mil. unless spec.- CEO
- Christopher Seto
- Full Time Employees
- 29
- Sector
- Healthcare
- Industry
- Medical - Diagnostics & Research
- Address
- 135 The West Mall Toronto ON Canada M9C 1C2
- IPO Date
- Dec 18, 2009
- Website
- spectraldx.com
- Similar Companies
- Business
- Spectral Medical Inc. is a late-stage theranostic company specializing in therapeutic solutions for sepsis and septic shock. The company’s core products include the EAA™ Endotoxin Activity Assay, a rapid diagnostic test that measures endotoxin activity in human whole blood, and the Toraymyxin™ PMX extracorporeal hemoadsorption therapy, designed to remove endotoxins from the bloodstream. These products are used to diagnose and treat endotoxic septic shock and are approved or licensed in regions including the United States, Canada, Japan, and Europe. The company targets healthcare providers and institutions dealing with septic shock patients and operates primarily in North America, Europe, and parts of Asia. Founded in 1988 and headquartered in Toronto, Canada, Spectral Medical holds exclusive development and commercial rights for Toraymyxin™ in the U.S. and Canada with established partnerships, notably an exclusive supply and distribution agreement with Baxter Healthcare Corporation extended through 2034. Recent significant developments include the company’s advancement in its Phase III Tigris clinical trial evaluating Toraymyxin™ for endotoxic septic shock treatment, with patient enrollment surpassing 150 and topline positive results announced in 2025 that show a clinically meaningful survival benefit. These results underpin Spectral Medical’s planned Premarket Approval (PMA) submission to the U.S. Food and Drug Administration (FDA), now targeted for the first quarter of 2026. Additionally, Spectral Medical strengthened its commercialization strategy through collaboration with Vantive US Healthcare LLC, aligning for market approval and distribution in North America. In 2024, Baxter Healthcare exercised its right to maintain exclusive distribution of PMX products in the U.S. and Canada, affirming a decade-long partnership. The company also filed a base shelf prospectus to support future financing needs as it progresses through regulatory milestones. Spectral Medical operates within the healthcare and medical device industry, focusing on critical care segments addressing severe systemic infections. Its precision diagnostic and therapeutic products cater to hospitals and intensive care units managing septic shock cases, an area with significant unmet medical need given the high morbidity and mortality rates associated with sepsis. Spectral Medical’s strategy emphasizes innovation in targeted therapies and diagnostics, leveraging its proprietary technology and regulatory designations such as Breakthrough Device Designation by the FDA in 2022 to expedite product approval and adoption. The company’s geographic reach includes the United States, Canada, Europe, and Japan, with ongoing efforts to expand market access following regulatory approvals and clinical validation. Overall, Spectral Medical Inc. is positioned as a specialized developer and commercializer of advanced theranostic solutions for septic shock, with recent clinical and regulatory progress marking key milestones towards broader market introduction and commercial growth. The company’s headquarters remain in Toronto, Canada, and it continues to advance its product pipeline and strategic partnerships to address critical care needs globally.
Spectral Medical Announces PMA Submission to U.S. FDA for PMX
Spectral Medical Announces First Quarter 2026 Financial Results and Provides Corporate Update
Spectral Medical Inc. Announces Participation in the 2026 Bloom Burton & Co. Healthcare Investor Conference
Spectral Medical Announces Fourth Quarter and Fiscal 2025 Results and Provides Corporate Update
Spectral Medical and Vantive Announce Publication of Complete Results from Spectral's Tigris Trial in the Lancet Respiratory Medicine
Spectral Medical Provides Update on PMA Submission Timing for PMX-20R
Spectral Medical Inc. (EDT:CA) Discusses Year-End Update: FDA Filing Timeline, Tigris Trial Results, and Commercialization Readiness Transcript
Reviewing SiBone (NASDAQ:SIBN) & Spectral Diagnostics (OTCMKTS:EDTXF)
Spectral Medical Inc. Files Base Shelf Prospectus and Revised AIF
Spectral Medical Announces Publication of EDEN Observational Study
Spectral Medical Receives US$3 Million From Vantive
Spectral Medical and Vantive Announce Topline Results from Spectral's Tigris Trial Evaluating PMX Hemoadsorption Therapy for Endotoxic Septic Shock
Spectral Medical Announces Second Quarter and Provides Corporate Update
Spectral Medical Inc. Announces Filing of Base Shelf Prospectus
Spectral Medical Inc. Announces Results of Annual Meeting of Shareholders
Spectral Medical to Present at the 3rd Annual H.C. Wainwright BioConnect Investor Conference
Spectral Medical Announces First Quarter and Provides Corporate Update
Spectral Medical Announces Non-Dilutive Financing of Up to $10 Million with Vantive
Spectral Medical Announces Fourth Quarter and Fiscal 2024 Results and Provides Corporate Update
Spectral Medical Provides November Tigris Trial Update