Registry aims to collect thousands of images and data from surgeries performed nationwide

TORONTO and DALLAS, June 4, 2025 /CNW/ - Perimeter Medical Imaging AI, Inc. (TSXV: PINK) (OTCQX: PYNKF) ("Perimeter" or the "Company") announced today that it has launched the OCT-Tissue Surveillance Registry, a database that aims to collect thousands of images and data from surgical procedures performed using the company's imaging technology. Perimeter will use the registry to inform future product development and continually enhance the artificial intelligence ("AI") deep-learning model for its investigational next-generation technology.

"I have used Perimeter's OCT technology in more than 120 surgeries, and it has become an invaluable tool," said Dr. Jennifer Tittensor, a general surgeon for Timpanogos Regional Hospital and the first contributor to the OCT-Tissue Registry. "In my practice, it helps me assess margins in real-time and decide whether I need to remove more tissue - potentially avoiding the need for a second surgery. Being a part of the registry allows me to track and analyze patient outcomes and help shape future improvements in the technology. I am excited to be involved." 

Perimeter's S-Series OCT utilizes the company's patented wide-field optical coherence tomography ("OCT") technology to enable surgeons to visualize tissue specimens in real-time, with ultra-high resolution, during surgery. Building on this foundation, the investigational next-generation B-Series OCT with ImgAssist AI 2.0, under premarket approval review by the U.S. Food and Drug Administration, integrates AI and is intended to help surgeons more efficiently detect suspicious tissue during breast-conserving surgery.

"The launch of this registry provides an opportunity to patients and surgeons to help future patients have better clinical care," said Perimeter CEO Adrian Mendes. "We look forward to collaborating with physicians to collect high-quality data and images from a broad and diverse patient population. The more images we can gather from the widest range of patients, the better we can train our AI algorithm to detect patterns in various tissue types. This registry could potentially help physicians provide more personalized care, achieve clean margins more frequently, and reduce the need for second surgeries due to residual cancer."

One of the biggest challenges with developing non-generative AI for medical applications is acquiring a large, diverse dataset that reflects a full range of patient characteristics, such as age, ethnicity, tissue density, and body mass. To develop the ImgAssist AI algorithm, Perimeter trained its deep learning models using several million proprietary OCT images of cancerous and healthy tissue. These models, created by the company's AI team, were designed for real-time use.

The launch of the OCT-Tissue Registry enables Perimeter to use real-world images and clinical data to make its AI model even more sophisticated. The registry also allows surgeons to contribute retrospective data and track patient outcomes to evaluate surgical results over time.

To learn more or inquire about participation in OCT-Tissue Registry, please contact Perimeter Medical Imaging AI Clinical Affairs at clinical@perimetermed.com.

About Perimeter Medical Imaging AI, Inc.

Based in Toronto, Canada and Dallas, Texas, Perimeter Medical Imaging AI (TSXV: PINK) (OTCQX: PYNKF) is a medical technology company driven to transform cancer surgery with ultra-high-resolution, real-time, advanced imaging tools to address areas of high unmet medical need. Available across the U.S., our FDA-cleared Perimeter S-Series OCT 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 our next-generation artificial intelligence technology that was evaluated in a pivotal clinical trial, with support from a grant of up to US$7.4 million awarded by the Cancer Prevention and Research Institute of Texas. Patient enrollment completed in September 2024, with expected FDA submission in 2025. The company's ticker symbol "PINK" is a reference to the pink ribbons used during Breast Cancer Awareness Month.

S-Series Intended Use

The S-Series OCT is indicated for use as an imaging tool in the evaluation of excised human tissue microstructure, by providing two-dimensional, cross-sectional, real-time depth visualization, with image review manipulation software for identifying and annotating regions of interest.

S-Series Unapproved Uses

The S-Series OCT has 510(k) clearance under a general indication and has not been evaluated by FDA specifically for use in breast tissue, breast cancer, other types of cancer, margin evaluation, and reducing re-excision rates. The safety and effectiveness of these uses has not been established. Clinical evidence related to these uses can be found in the clinical evidence listed below. Contraindications, limitations, warnings and precautions, and how to obtain a full copy of the FDA-required instructions for use are also provided on this page.

For more information on unapproved/off-label uses, contact medicalaffairs@perimetermed.com.  

B-Series Intended Use

B-Series OCT is an adjunctive three-dimensional imaging tool which provides volumetric cross-sectional, real-time depth visualization, coupled with an artificial intelligence computer aided detection algorithm which identifies and marks focal areas suspicious for breast cancer and is used concurrently with physician interpretation of the images. The device is intended for use in conjunction with other standard methods for evaluation of the margins of an excised lumpectomy specimen during surgical procedures in patients with a biopsy-confirmed diagnosis of breast cancer.

CAUTION: Perimeter B-Series OCT is limited by U.S. law to investigational use and not available for sale in the United States. The safety and effectiveness of this device has not yet been evaluated by the U.S. FDA. For more information, please contact medicalaffairs@perimetermed.com. 

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Forward-Looking Statements

This news release contains statements that constitute "forward-looking information" within the meaning of applicable Canadian securities legislation. In this news release, words such as "may," "would," "could," "will," "likely," "believe," "expect," "anticipate," "intend," "plan," "estimate," and similar words and the negative form thereof are used to identify forward-looking statements. Forward-looking information may relate to management's future outlook and anticipated events or results and may include statements or information regarding the future financial position, business strategy and strategic goals, competitive conditions, research and development activities, projected costs and capital expenditures, research and clinical testing outcomes, taxes and plans and objectives of, or involving, Perimeter. Without limitation, information regarding the potential benefits of Perimeter S-Series OCT and Perimeter B-Series OCT, the expected benefits of Perimeter's updated version of its ImgAssist AI, and Perimeter's expectations regarding the PMA submission to the FDA are forward-looking information. Forward-looking statements should not be read as guarantees of future performance or results, and will not necessarily be accurate indications of whether, or the times at or by which, any particular result will be achieved. No assurance can be given that any events anticipated by the forward-looking information will transpire or occur. Forward-looking information is based on information available at the time and/or management's good-faith belief with respect to future events and are subject to known or unknown risks, uncertainties, assumptions, and other unpredictable factors, many of which are beyond Perimeter's control. Such forward-looking statements reflect Perimeter's current view with respect to future events, but are inherently subject to significant medical, scientific, business, economic, competitive, political, and social uncertainties and contingencies. In making forward-looking statements, Perimeter may make various material assumptions, including but not limited to (i) the accuracy of Perimeter's financial projections; (ii) obtaining positive results from trials; (iii) obtaining necessary regulatory approvals; and (iv) general business, market, and economic conditions. Further risks, uncertainties and assumptions include, but are not limited to, those applicable to Perimeter and described in Perimeter's Management Discussion and Analysis for the year ended December 31, 2023, which is available on Perimeter's SEDAR+ profile at https://www.sedarplus.ca, and could cause actual events or results to differ materially from those projected in any forward-looking statements. Perimeter does not intend, nor does Perimeter undertake any obligation, to update or revise any forward-looking information contained in this news release to reflect subsequent information, events, or circumstances or otherwise, except if required by applicable laws.

CONTACTS:

Stephen Kilmer
Investor Relations
Direct: 647-872-4849
Email: skilmer@perimetermed.com 

Susan Thomas
Media Relations
Direct: 619-540-9195 
Email: susan@endpointcommunications.net 

Adrian Mendes
Chief Executive Officer
Toll-free: 888-988-7465 (PINK)
Email: investors@perimetermed.com 

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SOURCE Perimeter Medical Imaging AI Inc.