Perimeter B-Series OCT with ImgAssist AI 2.0 Demonstrates Super-Superiority Compared to Standard-of-Care in Pivotal Clinical Trial

Rhea-AI Summary

Perimeter Medical Imaging AI announced positive topline results from its pivotal study for the B-Series OCT system with ImgAssist AI 2.0. The trial, involving 206 breast cancer patients, demonstrated super-superiority in detecting residual cancer during breast-conserving surgeries compared to standard methods. The study met its primary endpoint with statistical significance (p-value = 0.0050). The technology aims to reduce the need for reoperation by helping surgeons achieve clear surgical margins during initial surgery. The company plans to submit an FDA PMA application in early 2025.

Positive

• Met primary endpoint with statistical significance (p=0.0050)
• Demonstrated super-superiority over current standard methods
• Technology shows potential to reduce reoperation rates
• Clear pathway to FDA submission in early 2025

Negative

• FDA approval still pending and not guaranteed
• Commercial launch timeline dependent on regulatory approval

– Intraoperative margin assessment during BCS using Perimeter B-Series OCT with ImgAssist AI 2.0 enabled surgeons to more effectively address residual cancer at the surgical margin as compared to current standard methods –

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

– B-series super-superiority based on predefined clinical and statistical significance parameters  –

– FDA PMA application for B-Series OCT system with ImgAssist AI expected to be submitted in early 2025 –

– Perimeter Medical Imaging AI to host conference call/webcast today at 5 pm ET –

TORONTO and DALLAS, Nov. 20, 2024 /PRNewswire/ - Perimeter Medical Imaging AI, Inc. (TSXV: PINK) (OTC: PYNKF) ("Perimeter" or the "Company"), a commercial-stage medical technology company, today announced positive topline results from the pivotal study designed to support its planned Premarket Approval Application ("PMA") submission to the U.S. 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, multi-center, randomized, clinical trial, 206 breast cancer patients undergoing BCS for the treatment of Stage 0-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 to 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 to current standard methods. The pivotal trial met its primary endpoint, achieving a statistically significant (p-value = 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 topline 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 endpoint, 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 1-in-5 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 post-operative 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 topline 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 endpoint analysis reported today, the Company is conducting additional analyses, including secondary endpoints 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 5:00 pm Eastern Time, during which the pivotal trial topline 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 online 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, Texas, Perimeter Medical Imaging AI (TSXV: PINK) (OTC: 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.

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SOURCE Perimeter Medical Imaging AI Inc.

FAQ

What were the results of Perimeter Medical's (PYNKF) pivotal trial for B-Series OCT?

The trial met its primary endpoint with statistical significance (p=0.0050), demonstrating super-superiority in detecting residual cancer during breast-conserving surgeries compared to standard methods.

When will Perimeter Medical (PYNKF) submit FDA PMA for B-Series OCT with ImgAssist AI 2.0?

Perimeter Medical plans to submit the FDA PMA application in early 2025.

How many patients were included in Perimeter Medical's (PYNKF) B-Series OCT pivotal trial?

The trial included 206 breast cancer patients undergoing breast-conserving surgeries for Stage 0-III invasive ductal carcinoma and/or ductal carcinoma in situ.