illumiSonics and Sunnybrook Launch INOVAIT Focus Fund–Backed Clinical Trial Bringing Label-Free Laser Histology to Mohs Skin Cancer Surgery

First prospective study to validate Multi-Laser Imaging (MLI™) virtual histology against the frozen-section gold standard in a live surgical setting

WATERLOO, Ontario & TORONTO--(BUSINESS WIRE)--illumiSonics Inc., a medical technology company commercializing label-free tissue imaging, today announced the launch of a prospective clinical validation study at Sunnybrook Health Sciences Centre evaluating its Multi-Laser Imaging (MLI™) platform for skin cancer margin assessment during Mohs micrographic surgery. The study is led by Principal Investigators Dr. Deepak Dinakaran (radiation oncology) and Dr. Robert Bobotsis (dermatology).

The single-centre, prospective, observational study will enroll up to 200 patients undergoing Mohs surgery at Sunnybrook’s multidisciplinary dermatology clinic between July 2026 and December 2028. It is the first prospective clinical evaluation of MLI virtual histology, building on retrospective work in which the technique showed greater than 95% agreement with conventional histology for cancer type and 92% agreement for margin assessment, with pathologists unable to reliably distinguish MLI virtual slides from conventional chemically stained slides.

This study is supported in part by the INOVAIT Focus Fund. With financial contributions from the Government of Canada’s Strategic Response Fund, the Focus Fund accelerates the development and clinical translation of image-guided therapy and artificial intelligence technologies, helping Canadian innovations advance toward patient and clinical care.

Addressing a Bottleneck in Mohs Surgery

Mohs micrographic surgery is the gold standard for treating skin cancers in cosmetically and functionally sensitive areas such as the face, ears, nose, and hands. The procedure is performed in stages: tissue is removed, frozen, sectioned, stained, and examined under a microscope while the patient waits, with the cycle repeating until margins are confirmed clear. Each cycle of freezing, sectioning, staining, and review typically takes up to 60 minutes, and a multi-stage case can occupy most of a clinical day, contributing to throughput constraints and patient waitlists that in some centres extend to several months.

MLI is illumiSonics’ proprietary imaging platform based on Photon Absorption Remote Sensing (PARS®), a non-contact optical modality that captures high-resolution, label-free images of unstained tissue. In a single scan, MLI integrates six co-registered signals — four channels of hyperspectral autofluorescence, light scattering, and the PARS absorption signal — into a multi-dimensional dataset, from which machine learning can generate virtual H&E and other stains. Because the workflow is entirely digital and non-destructive, the tissue is preserved for any downstream testing that may be clinically indicated.

Study Design

The study’s primary objective is to evaluate the diagnostic concordance of MLI-based virtual histology against standard-of-care frozen-section histology for skin cancer margin assessment. The primary endpoint is diagnostic agreement, measured by Cohen’s kappa, between MLI-based and standard-of-care interpretation by six masked board-certified pathologists. Secondary objectives include inter-rater reliability of margin assessment and the feasibility of integrating MLI into real-world clinical workflows.

The work will proceed in two sequential phases using only excess tissue that would otherwise be archived and discarded: Phase 1 images frozen tissue samples, and Phase 2 images fresh tissue prior to freezing. The study introduces no additional procedures for patients and does not affect their standard clinical care or treatment.

Quotes

“This trial validates moving MLI from a promising laboratory result to a prospective test in the real clinical environment where it would ultimately be used,” said Dr. Deepak Dinakaran, Principal Investigator at Sunnybrook. “If virtual histology can match the accuracy of frozen-section standard during Mohs surgery, but at much faster speeds, it points toward a faster, more efficient path to margin assessment.”

“Mohs is a setting where speed and normal tissue preservation both matter enormously to patients,” said Dr. Robert Bobotsis, co-Principal Investigator and Mohs surgeon at Sunnybrook. “Validating a fully digital, rapid workflow here is an important step toward reducing the time patients spend waiting between stages of frozen section analysis.”

“We are grateful for the support of the INOVAIT Focus Fund and for the partnership with the Sunnybrook team,” said Dr. John Mackey, CEO and Co-Founder of illumiSonics. “Prospective clinical validation is the threshold every imaging technology must cross before it can change practice, and this study is designed to test MLI against the most demanding real-world benchmark.”

“We are pleased to see illumiSonics’s Focus Fund project progressing towards the clinical environment,” said Raphael Ronen, Co-Executive Director of INOVAIT. “With their observational study underway, we’re looking forward to learning the results from this study and are proud to support this meaningful step forward towards commercialization.”

About INOVAIT

INOVAIT is Canada’s image-guided therapy (IGT) and artificial intelligence (AI) network. As a pan-Canadian network, INOVAIT supports companies and academic institutions from coast to coast to commercialize cutting-edge medical technologies that positively impact the healthcare system and create high-quality jobs. The network brings together companies, research institutes, post-secondary institutions, and not-for-profit organizations to collaborate on game-changing projects to transform healthcare. INOVAIT strengthens the Canadian medtech ecosystem by fuelling continuous innovation that revolutionizes healthcare. INOVAIT was established in 2020 by Sunnybrook Research Institute in Toronto and supported by the Government of Canada’s Strategic Response Fund. To learn more, visit www.INOVAIT.ca.

About Sunnybrook Health Sciences Centre

Sunnybrook Health Sciences Centre is inventing the future of health care with over 1.1 million patient visits each year and more than 16,000 dedicated staff, learners and volunteers. An internationally recognized leader in research and education and a full affiliation with the University of Toronto distinguishes Sunnybrook as one of Canada’s premier academic health sciences centres. Sunnybrook specializes in caring for high-risk pregnancies, critically ill newborns and adults, offering specialized rehabilitation and treating and preventing cancer, cardiovascular disease, neurological and psychiatric disorders, orthopaedic and arthritic conditions and traumatic injuries. The Hospital also has a unique and leading national program for the care of Canada’s war veterans. To learn more, visit www.Sunnybrook.ca.

About illumiSonics Inc.

illumiSonics Inc. (Waterloo, ON) is a medical technology company commercializing Multi-Laser Imaging (MLI™/PARS®) for label-free, non-destructive tissue diagnostics. The platform is being developed across applications spanning pathology imaging, surgical margin assessment, and retinal imaging. More information is available at www.illumisonics.com