Perimeter Announces B-Series OCT with ImgAssist AI 2.0 Pivotal Trial Accepted for Presentation at the 2025 Annual Meeting of the American Society of Breast Surgeons

Rhea-AI Summary

Perimeter Medical Imaging AI (TSXV: PINK, OTCQX: PYNKF) announced that its pivotal trial results for the B-Series OCT with ImgAssist AI 2.0 will be presented at the 2025 American Society of Breast Surgeons Annual Meeting. The trial, focused on breast-conserving surgeries, met its primary endpoint with a statistically significant reduction in patients with residual cancer during surgery (p-value = 0.0050).

The detailed results are under embargo until May 1, 2025, 1:00 pm PST, and will be presented by Dr. Alastair Thompson, the trial's Primary Principal Investigator from Baylor College of Medicine. The full abstract will be published in the Annals of Surgical Oncology.

Following positive topline results reported in November 2024, Perimeter plans to submit its FDA premarket approval (PMA) application in early 2025 to market the AI-enabled OCT system in the United States. The technology provides real-time, high-resolution visualization of margins in the operating room.

Positive

• Pivotal trial met primary endpoint with statistical significance (p=0.0050)
• FDA PMA submission planned for early 2025
• Results to be published in leading oncology journal
• Presentation at major industry conference increases visibility

Negative

• FDA approval still pending
• Detailed trial results remain under embargo

– Pivotal trial met its primary endpoint with statistically significant reduction in patients with residual cancer during surgery (p-value = 0.0050) –

– Presentation will highlight both previously reported positive topline results and new additional analyses, including secondary endpoints and additional reporting –

TORONTO and DALLAS, March 5, 2025 /PRNewswire/ - Perimeter Medical Imaging AI, Inc. (TSXV: PINK) (OTCQX: PYNKF) ("Perimeter" or the "Company"), a commercial-stage medical technology company, is pleased to announce that detailed results from the pivotal trial evaluating the use of its next-generation B-Series OCT with ImgAssist AI 2.0 ("Perimeter B-Series") during breast-conserving surgeries ("BCS") will be presented during the scientific session of the 26^th Annual Meeting of the American Society of Breast Surgeons ("ASBrS") taking place in Las Vegas, NV, April 30-May 4, 2025.

ASBrS is the primary leadership organization for general surgeons who treat patients with breast disease and is committed to continually improving the practice of breast surgery by serving as an advocate for surgeons who seek excellence in the care of breast patients.

The detailed results of the Perimeter B-Series pivotal trial are subject to an embargo policy, pursuant to which all scientific abstracts accepted for oral or poster presentations during the ASBrS 26th Annual Meeting, press releases, and the Society's Official Proceedings are embargoed until 1:00 pm PST on May 1, 2025. The full abstract will be published by the Annals of Surgical Oncology and released following the oral presentation by Dr. Alastair Thompson, the trial's Primary Principal Investigator, Surgeon and Professor, Section Chief of Breast Surgery, Olga Keith Wiess Chair of Surgery at Baylor College of Medicine, Breast Cancer Program Leader at the Dan L Duncan Comprehensive Cancer Center. The Annals of Surgical Oncology is one of the leading journals in oncology and surgery, and features original articles on the latest advances in oncology for surgeons from all specialties.

"It is a great honor to be selected by the ASBrS to present the detailed results of our pivotal trial for the first time at its prestigious annual meeting, and we are pleased this comes as we continue to work toward obtaining regulatory approval to market our next-generation, AI-enabled OCT system in the United States," said Perimeter's Chief Executive Officer, Adrian Mendes. "Adding an AI assistant will help surgeons more easily utilize our ground-breaking wide-field OCT technology, which provides high-resolution clarity to visualize margins in real-time in the operating room. We believe increasing breast cancer surgeon awareness of this important innovation through participation in important forums like ASBrS 2025 will go a long way towards advancing the technology's future adoption."

In November 2024, Perimeter reported positive topline results from the pivotal study designed to support the Company's planned U.S. Food and Drug Administration ("FDA") premarket approval ("PMA") submission to market the Perimeter B-Series for use during BCS in the United States. The Company plans to submit its FDA PMA for the Perimeter B-Series in early 2025.

About Perimeter Medical Imaging AI, Inc.

Based in Toronto, Canada and Dallas, Texas, Perimeter Medical Imaging AI (TSX-V: 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 is currently being 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. The company's ticker symbol "PINK" is a reference to the pink ribbons used during Breast Cancer Awareness Month.

Perimeter B-Series OCT is limited by U.S. law to investigational use and not available for sale in the United States. Perimeter S-Series OCT has 510(k) clearance under a general indication and has not been evaluated by the U.S. 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. For more information, please visit www.perimetermed.com/disclosures.

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 outcomes of the clinical trial and future 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

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.

FAQ

What were the key results of Perimeter's B-Series OCT with ImgAssist AI 2.0 pivotal trial?

The trial met its primary endpoint, showing statistically significant reduction in patients with residual cancer during surgery, with a p-value of 0.0050.

When will PYNKF submit its FDA premarket approval application for the B-Series device?

Perimeter plans to submit its FDA PMA application in early 2025.

When will the detailed results of PYNKF's pivotal trial be presented?

The detailed results will be presented at the ASBrS Annual Meeting, with embargo lifting on May 1, 2025, at 1:00 pm PST.

What is the main benefit of Perimeter's B-Series OCT technology for breast cancer surgery?

The technology provides high-resolution visualization of margins in real-time during breast-conserving surgeries, with AI assistance to help surgeons utilize the system.