By Melane Sampson
Closely held illumiSonics is addressing a significant unmet medical need by redefining tissue imaging with its proprietary multi-laser imaging (MLI) platform, an advanced modality designed for life sciences research, digital pathology, retinal imaging, and more.
“We are poised to drive real clinical impact because we are able to generate multiple diagnoses from a single tissue sample without staining—dramatically simplifying workflows, preserving scarce tissue, reducing costs, and improving patient outcomes,” John Mackey, MD, FRCPC, FCAHS, CEO of illumiSonics, says in an interview with BioTuesdays.
Dr. Mackey recalls that MLI emerged from novel physics discovered at the University of Alberta and represents a fundamentally new way of analyzing tissue. Unlike conventional imaging, which relies heavily on dyes and indirect visualization, MLI captures the full interaction between light and matter without contact. “MLI is analogous to magnetic resonance imaging, but at the tissue level—it’s one scan with multiple outputs, built on a new set of physical measurements.”
He explains that the system integrates three distinct signals: light scattering, hyperspectral autofluorescence, and a proprietary absorption-based signal that detects pressure waves generated when light interacts with tissue. This final component, which forms the basis for the company’s patent portfolio, enables measurement of entirely new physical variables. The result is an eight-dimensional dataset that extends far beyond the limited color spectrum visible to the human eye.
While the MLI platform has broad potential, illumiSonics is initially targeting three verticals: pathology, surgical imaging, and ophthalmology. Its first commercial product, the Advanced Imaging Device (AID), is already entering the market and focuses on formalin-fixed, paraffin-embedded tissue—the standard in pathology. Designed for simplicity, the system reduces a complex workflow to a single step. “You place the slide in the device, press a button, and the system captures everything,” Dr. Mackey says. “But the real value is what you can do with the data.”
Traditional pathology workflows are slow, labor-intensive, and constrained by limited tissue samples. MLI replaces chemical staining with a fully digital, non-destructive process, preserving tissue for additional downstream analyses, such as mass spectrometry, spatial transcriptomics, and gene sequencing. At the same time, it replicates the outputs clinicians rely on.
The company has published numerous articles demonstrating that pathologists can assess tumor margins, grade disease, and make clinical determinations using MLI-generated images. Dr. Mackey points out that this validation is critical for adoption, but the broader opportunity lies beyond replication. MLI enables virtual immunohistochemistry (IHC), a complex and variable process key to oncology. “We can generate virtual IHC for key drug targets like HER2, TROP-2, and FOLR1—and we can do it on the same tiny biopsy sample all at once.”
He emphasizes that this capability has direct implications for pharmaceutical development, particularly in the area of antibody-drug conjugates, where identifying precise cellular targets is essential. “Tissue scarcity remains a persistent bottleneck, but with MLI, one sample can yield the full panel. That is something that is not possible today.” The platform also supports retrospective analysis of archived samples, enabling the development of predictive diagnostics that identify which patients are most likely to respond to specific therapies.
The company has structured its business model to capture value across multiple segments of the tissue diagnostics market, which exceeds $20 billion globally. Revenue streams include slide scanning services, hardware leasing and sales, virtual IHC offerings for pharmaceutical partners, and the development of novel in vitro diagnostics. “We are already generating revenue from scanning services and hardware orders,” Dr. Mackey says, noting that a single AID system can process more than 4,000 slides annually, with revenue potential of approximately $3 million per device. “We’re not trying to replace existing standards—we’re monetizing the data in new ways.”
Beyond pathology, illumiSonics sees near-term commercialization in dermatology through its Surgical Imaging Device (SID), designed for use in Mohs surgery. Mohs procedures require precise, real-time margin assessment, yet current workflows are time-intensive, often requiring 30 to 60 minutes per sample and multiple iterations while the patient waits. MLI has the potential to reduce this process to under five minutes. “The surgeon can assess margins immediately, without freezing or staining—it fundamentally changes the workflow and delivers unprecedented patient outcomes,” Dr. Mackey says.
He highlights that the impact on clinic efficiency could be significant, as many dermatologists perform a limited number of procedures per day with waitlists of several months. By accelerating margin assessment, MLI could increase patient throughput by approximately 25% while reducing reliance on reagents and specialized staff. Because the process is non-destructive, tissue can also be preserved for future analysis, adding clinical and research value. “The Mohs surgery market alone represents an estimated $500 million opportunity, and we have very strong early demand from clinicians,” he says.
The company’s third vertical, ophthalmology, represents both its most ambitious and potentially most transformative application. The MLI Retinal Imaging Device (RID), still in preclinical development, aims to address key limitations in current eye care—the ability to detect disease early enough to prevent progression. Existing tools, such as optical coherence tomography, provide structural information. RID adds molecular and functional insight. “We can measure metabolic activity, oxygenation, and vascular changes before structural damage occurs,” Dr. Mackey says.
This capability could significantly improve the detection and management of diseases such as macular degeneration, diabetic retinopathy, and glaucoma. It may also extend beyond ophthalmology, offering insights into systemic and neurological health. “The retina is part of the brain,” Dr. Mackey notes. “If we can measure oxygen delivery and metabolism there, we may have a new way to monitor brain health.”
He clarifies that the initial commercialization strategy for RID focuses on optometry clinics, where the device would function as a screening tool within existing reimbursement frameworks. By flagging potential issues rather than making primary diagnoses, the company expects to reduce regulatory barriers while enabling widespread adoption. “The retinal imaging market is more than $6.5 billion and continues to grow as the demand for earlier, more personalized diagnostics increases,” he says.
illumiSonics has spent eight years developing its MLI platform, supported by more than 40 peer-reviewed publications, numerous academic theses, and a robust patent portfolio with dozens of issued patents. The company is working with leading institutions, including Sunnybrook Research Institute, where clinical trials are launching for its dermatology application. To date, Dr. Mackey says funding has come primarily from grants and early investors, providing substantial non-dilutive capital.
He adds that a $5 million Series A round is planned for mid-2026, with proceeds allocated toward accelerating development across its core products, expanding clinical validation, and advancing the retinal imaging program into human trials. “We know we can execute in pathology and dermatology,” Dr. Mackey says. “Ophthalmology is further out, but it has the greatest long-term potential.”
In conclusion, he re-emphasizes that MLI is a platform technology with applications that extend far beyond its initial markets although the company’s near-term focus remains on demonstrating commercial value in its three targeted verticals. “Our broader ambition is to reshape how biological data is captured and used.”
With growing clinical validation, increasing industry interest, and multiple revenue pathways, illumiSonics is positioning itself at the forefront of a shift toward data-driven diagnostics. “MLI is new and novel but we have gained credibility—we are seeing increased acceptance and enthusiasm,” Dr. Mackey says. “This is important technology. We believe the time is right to go to market and help millions of people worldwide.”
Editor’s Note: This article does not constitute an offer to sell or the solicitation of an offer to buy any securities of illumiSonics, and shall not constitute an offer, solicitation or sale of any security in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
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