Spectral Medical

What Spectral Medical does

Spectral Medical Inc. is a Toronto-based, publicly-traded late-stage theranostics company (TSX: EDT, founded 1991) developing a combined diagnostic and therapeutic platform for endotoxic septic shock. Its core product pairing consists of EAA™, the only FDA-cleared, CE-marked, and Health Canada-licensed rapid diagnostic measuring endotoxin activity in whole blood (results in approximately 30 minutes), and Toraymyxin™ PMX, a Polymyxin B extracorporeal direct hemoadsorption column that removes endotoxin from the bloodstream in septic shock patients. Spectral holds exclusive US development and commercial rights to PMX from Toray Industries (since 2009) and Canadian rights (since 2010), with EAA guiding patient selection at endotoxin activity levels of 0.60-0.90.

The Tigris Phase 3 trial (157 patients enrolled, April 2025) met its primary endpoint with 95.3% posterior probability of benefit at 28 days and >99% at 90 days, with full results published in Lancet Respiratory Medicine in May 2026; the company submitted its PMA application to FDA in May 2026 with formal filing confirmation in June 2026. Revenue (FY2024: $2.29M; Q1 2026: $891K, up 56% YoY) is generated from EAA test sales, proprietary cardiac biomarker reagents (Single-Chain Troponin I-C fusion proteins and NT-proBNP) sold to IVD manufacturers, and licensing royalties. Vantive (Carlyle-owned, ex-Baxter Kidney Care) is the exclusive distributor for PMX in the US and Canada and provided a non-dilutive US$10M promissory note in May 2025 to bridge to commercialization. The company also operates subsidiary Dialco Medical, commercializing SAMI (acute CRRT) and DIMI (home hemodialysis) devices with FDA clearances and Health Canada licenses.

Name

Spectral Medical

Legal name

Spectral Medical Inc.

Website

https://spectraldx.com

Company type

Public

Founded year

1991

Operating status

Operating

Headcount range

11–50 employees

Short description

Spectral Medical Inc. is a late-stage theranostics company developing EAA™, an FDA-cleared endotoxin diagnostic, and Toraymyxin™ PMX, a hemoadsorption therapy, to treat endotoxic septic shock in hospital ICU patients, with US FDA PMA review pending.

Ownership category

akta.pro rank

Product category

Sepsis Theranostics / Critical Care Medical Devices

NAICS

Electromedical and Electrotherapeutic Apparatus Manufacturing (334510), Medical and Diagnostic Laboratories (6215)

SIC

Surgical & Medical Instruments & Apparatus (3841), Electromedical & Electrotherapeutic Apparatus (3845), In Vitro & In Vivo Diagnostic Substances (2835)

akta.pro primary industry

Renal Replacement Therapy Consumables (Bloodlines, Filters, Cartridges) (HLAHAKAH)

akta.pro secondary industries

Clinical Chemistry & Hematology Diagnostics (automated analyzers, blood testing) (HLAAALAH), Specialty & Biomarker Laboratory Services (Immunoassays/Flow/Cytometry) (HLAGAEAB)

Keywords

• Endotoxin diagnostics
• Septic shock therapy
• Hemoadsorption devices
• Theranostic platforms
• Cardiac biomarker reagents

Headquarters

HQ city

Toronto

HQ country

Canada

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales, Supply Chain, Infrastructure

Revenue model

1. Product Sales (EAA and Reagents): Revenue from sales of EAA Endotoxin Activity Assay tests and cardiac reagent products including Single-Chain Troponin I-C proteins and NT-proBNP. Q1 2026 revenue was $891,000, up 56% from $572,000 in Q1 2025.
2. Royalty Revenue: Royalty revenue earned from license arrangements for proprietary Troponin I and other reagent technologies with industry leaders. Royalty revenue for nine months ended September 30, 2024 was $135,000 compared to $126,000 for same period prior year.
3. PMX (Pending FDA Approval): PMX is approved for therapeutic use in Japan and Europe, licensed by Health Canada. Once FDA approves the PMA application, PMX will be commercialized in US through Vantive as exclusive distributor. Over 360,000 units have been sold worldwide to date.

Go-to-market motion2 records

Distribution channels2 records

Marketing channels5 records

Core offering

Spectral Medical develops and commercializes a theranostic platform for endotoxic septic shock, pairing the FDA-cleared EAA Endotoxin Activity Assay (a rapid chemiluminescent blood diagnostic) with the Toraymyxin PMX-20R hemoadsorption column (extracorporeal Polymyxin B therapy that removes endotoxin from the bloodstream). The company also sells recombinant cardiac biomarker reference reagents (Single-Chain Troponin I-C, NT-proBNP) to IVD manufacturers and, through its Dialco Medical subsidiary, offers dialysis devices (SAMI for acute CRRT, DIMI for home hemodialysis).

Product overview

Spectral Medical is a late-stage theranostic company offering a dual-product approach combining diagnostics with targeted therapy. The core portfolio consists of EAA™ Endotoxin Activity Assay (FDA-cleared diagnostic for measuring endotoxin activity in blood) and Toraymyxin™ PMX-20R (Polymyxin B hemoadsorption therapy for endotoxin removal). These products work together as a theranostic pair—the EAA™ identifies patients with elevated endotoxin activity (EAA ≥0.60) who may benefit from PMX treatment. Additionally, the company offers cardiac reagent products (RP-3500, RP-3700, RP-8100) for IVD assay development through its reagents line, and operates subsidiary Dialco Medical Inc. which commercializes SAMI (acute CRRT device) and DIMI (home hemodialysis device).

Differentiator

Problem solved

Functional benefit

Products and services

• EAA Endotoxin Activity Assay The only FDA-cleared, Health Canada licensed, and CE marked rapid diagnostic test for measuring endotoxin activity in human whole blood, providing results in approximately 30 minutes for risk stratification of sepsis patients. Uses a chemiluminescent bioassay with a highly specific IgM antibody targeting the Lipid-A portion of endotoxin.
• Toraymyxin PMX-20R Polymyxin B extracorporeal direct hemoadsorption column that removes endotoxin from the bloodstream, used for treatment of patients with sepsis and endotoxemia. Single-use therapeutic device. Patient selection guided by EAA levels between 0.60 and 0.90. Over 360,000 treatments performed worldwide.
• Cardiac Reagents

Quantifiable outcome

• 28-day mortality: 38.7% with PMX vs 45.1% standard of care (6.4% absolute risk reduction, 95.3% probability of benefit)
• +3 more outcomes

Named customers5 records

Segments3 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Four partnerships are on record, tiered core.

• VantivecoreStrategic or Co-development Partner · 1 February 2025Collaboration on PrisMax sub-study completed February 2025. Vantive intends to submit 510(k) application for PrisMax System to be used with PMX treatments. PrisMax has leading installed base in US ICUs and will be primary ICU device for PMX on commercial launch. Joint commercialization planning for post-approval marketing.
• VantivecoreChannel Partner/ Reseller/ Distributor · 31 January 2025Vantive is Spectral's exclusive distributor of PMX in the US and Canada and has non-exclusive rights to distribute EAA globally. Vantive acquired Baxter's Kidney Care segment from Carlyle Group in January 2025. Spectral's PMX distribution agreement was assigned to Vantive upon closing. Vantive plans to commercialize both EAA and PMX beginning in US upon FDA approval.
• Baxter Healthcare CorporationcoreChannel Partner/ Reseller/ Distributor · 21 February 2024Baxter was original exclusive distribution partner for PMX in US and Canada. Announced amendment and extension of exclusive supply and distribution agreement for 10 years following PMX FDA approval. Distribution agreement subsequently assigned to Vantive upon Carlyle Group acquisition.
• Toray IndustriescoreOEM/ Whitelabel/ Licensing Partner · 1 March 2009Toray Industries developed and originally marketed PMX (Toraymyxin) in Europe (since 1994) and Japan (since 2002). Spectral obtained exclusive development and commercial rights in US in March 2009. Over 360,000 PMX units sold worldwide under Toraymyxin brand.

Scale indicators7 records

Recent moves8 records

Expansion highlights5 records

Market position

Competitive moat5 records

Key risks6 records

Key highlights6 records

Customer concentration

• Xtwitter.com/spectralmedical
• LinkedInlinkedin.com/company/spectralmedical

Compliance5 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 records

Subsidiaries2 records

Funding overview

Funding rounds10 records

Investors5 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Spectral Medical