Mr. Adrian Mendes reports

PERIMETER B-SERIES OCT WITH IMGASSIST AI 2.0 DEMONSTRATES SUPER-SUPERIORITY COMPARED TO STANDARD-OF-CARE IN PIVOTAL CLINICAL TRIAL

Perimeter Medical Imaging AI Inc. today released positive top-line results from the pivotal study designed to support its planned premarket approval application (PMA) submission to the United States Food and Drug Administration (FDA) for approval to market the company's next-generation Perimeter B-Series OCT system, which combines proprietary artificial intelligence (AI) technology with optical coherence tomography (OCT), for use during breast-conserving surgeries (BCS) in the United States.

In this prospective, multicentre, randomized, clinical trial, 206 breast cancer patients undergoing BCS for the treatment of stage 0 to III invasive ductal carcinoma and/or ductal carcinoma in situ were evaluated to measure the effectiveness of the combined B-Series OCT imaging system with ImgAssist AI 2.0 as compared with lumpectomy current standard methods including palpation, specimen radiograph, intraoperative pathology and ultrasound in addressing positive margins. Participants were recruited from multiple clinical sites across the United States.

The B-Series OCT with ImgAssist AI 2.0 enabled surgeons to more effectively address residual cancer at the surgical margin during surgery as compared with current standard methods. The pivotal trial met its primary endpoint, achieving a statistically significant (p value equals 0.0050) reduction in patients with residual cancer during surgery. These results demonstrate super-superiority (lower bound of confidence interval for treatment effect greater than a predetermined minimal clinically meaningful difference) of the Perimeter B-Series OCT with ImgAssist AI 2.0 system's ability to aid surgeons in achieving clear surgical margins during surgery, potentially lowering the need for reoperation.

"These positive top-line pivotal trial results are very encouraging for this patient population undergoing BCS," said Dr. Sarah Butler, Perimeter's vice-president, clinical and medical affairs. "The trial easily met its primary end point, demonstrating that intraoperative margin assessment using OCT combined with Perimeter's AI technology may be able to help lower re-excision rates by identifying regions of interest and guiding real-time decisions by surgeons on margin status in the OR. We are looking forward to submitting our FDA PMA for B-Series OCT with ImgAssist AI 2.0 in early 2025."

"Surgeons have worked for years to innovate every step in the diagnosis and treatment plan for their cancer patients, with the ultimate goal of improving survivability and quality of life," commented Adrian Mendes, Perimeter's chief executive officer. "The promise of B-Series OCT with ImgAssist AI 2.0 is greater peace of mind. Both for the surgeon who -- no matter how skilled -- currently faces nearly one in five odds of needing to perform repeat surgery due to positive margins; and for their patient, who under the current paradigm, typically has to wait (and worry) for up to seven days for their surgeon to receive a postoperative pathology report which will determine whether they will have to go through the emotional and physical trauma of a second surgery due to cancer left behind. We believe that, based on these positive top-line pivotal trial results, we are well positioned to make a real difference in the treatment of cancer patients; and should the FDA approve the PMA, B-Series OCT with ImgAssist AI 2.0 has the potential for rapid acceptance and adoption by BCS surgeons in the United States."

In addition to the primary end-point analysis reported today, the company is conducting additional analyses, including secondary end points and additional reporting. Perimeter anticipates that detailed results from the pivotal trial evaluating the use of its next-generation B-Series OCT with ImgAssist AI 2.0 during BCS will be presented at an upcoming medical conference.

Conference call

Perimeter is pleased to invite all interested parties to participate in a conference call and live audio webcast today at 5 p.m. Eastern Time, during which the pivotal trial top-line results will be discussed. To participate in the call, please dial 1-800-717-1738 or 1-646-307-1865. The conference call will also be broadcast live on-line through a listen-only webcast, which will be posted on the investors section of the company's website and archived for approximately 90 days.

About Perimeter Medical Imaging AI Inc.

Based in Toronto, Canada, and Dallas, Tex., Perimeter Medical Imaging AI is a medical technology company driven to transform cancer surgery with ultrahigh-resolution, real-time, advanced imaging tools to address areas of high unmet medical need. Available across the United States, the company's FDA-cleared (U.S. Food and Drug Administration) Perimeter S-Series OCT (optical coherence tomography) system provides real-time, cross-sectional visualization of excised tissues at the cellular level. The breakthrough-device-designated investigational Perimeter B-Series OCT with ImgAssist AI represents the company's next-generation artificial intelligence technology that is currently being evaluated in a pivotal clinical trial, with support from a grant of up to $7.4-million (U.S.) awarded by the Cancer Prevention and Research Institute of Texas. The company's ticker symbol PINK is a reference to the pink ribbons used during Breast Cancer Awareness Month.

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