Perimeter Medical Imaging AI to Begin Trading on OTCQX on February 27, 2025

Rhea-AI Summary

Perimeter Medical Imaging AI (TSXV: PINK) (OTC: PYNKF) announced that its common shares will begin trading on the OTCQX® Best Market under the symbol "PYNKF" on February 27, 2025. This upgrade from the Pink® market aims to increase visibility and broaden the company's U.S. shareholder base.

CEO Adrian Mendes noted this move aligns with their U.S.-focused business strategy, as many shareholders are based there and it's the primary target market for their S-Series OCT system and upcoming AI-enabled B-Series product.

In November 2024, Perimeter reported positive topline results from a pivotal study supporting their planned FDA premarket approval submission. The trial met its primary endpoint with a statistically significant reduction (p-value = 0.0050) in patients with residual cancer during surgery, demonstrating super-superiority of their B-Series OCT with ImgAssist AI 2.0 system. The company plans to submit its FDA PMA in early 2025.

Positive

• Upgrade to OTCQX Best Market from Pink market should increase visibility to U.S. investors
• Pivotal trial for B-Series with ImgAssist AI 2.0 met primary endpoint with statistical significance (p=0.0050)
• Trial demonstrated super-superiority in reducing residual cancer during breast-conserving surgeries
• FDA PMA submission for B-Series OCT with ImgAssist AI 2.0 planned for early 2025

Negative

• None.

TORONTO and DALLAS, Feb. 25, 2025 /PRNewswire/ - Perimeter Medical Imaging AI, Inc. (TSXV: PINK) (OTC: PYNKF) ("Perimeter" or the "Company"), a commercial-stage medical technology company, is pleased to announce that its common shares will begin trading on the OTCQX® Best Market under the symbol "PYNKF", effective with the open of business on February 27, 2025.

"Many of our shareholders are based in the United States and the U.S. is the primary target market for our current S-Series OCT system, as well as our upcoming AI-enabled B-Series product," said Perimeter's Chief Executive Officer, Adrian Mendes. "Accordingly, this upgrade to OTCQX from the Pink® market is a natural evolution for Perimeter, which should increase our visibility and complement our efforts to broaden our U.S. shareholder base."

In November 2024, Perimeter reported positive topline results from a pivotal study designed to support the Company's planned U.S. Food and Drug Administration ("FDA") premarket approval ("PMA") submission to market its next-generation B-Series with ImgAssist AI 2.0 for use during breast-conserving surgeries in the United States. 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 demonstrated 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. The company plans to submit its FDA PMA for B-Series OCT with ImgAssist AI 2.0 in early 2025.

Perimeter's common shares will continue to trade on the TSX Venture Exchange under its existing symbol "PINK". 

About Perimeter Medical Imaging AI, Inc.

Based in Toronto, Canada and Dallas, Texas, Perimeter Medical Imaging AI (TSX-V: PINK) (OTC: PYNKF) is a 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 has recently been 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, statements regarding the timing of the annual meeting, 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 

Glen Akselrod
Bristol Capital
Telephone: 905-326-1888 ext 1
Email: glen@bristolir.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

When will Perimeter Medical (PYNKF) begin trading on the OTCQX Best Market?

Perimeter Medical's common shares will begin trading on the OTCQX Best Market under the symbol 'PYNKF' on February 27, 2025.

What were the results of Perimeter Medical's (PYNKF) pivotal study for its B-Series product?

The pivotal trial met its primary endpoint with a statistically significant (p-value = 0.0050) reduction in patients with residual cancer during surgery, demonstrating super-superiority of the B-Series OCT with ImgAssist AI 2.0 system.

When does Perimeter Medical (PYNKF) plan to submit its FDA premarket approval for the B-Series product?

Perimeter Medical plans to submit its FDA premarket approval (PMA) for the B-Series OCT with ImgAssist AI 2.0 in early 2025.

Will Perimeter Medical (PYNKF) continue trading on the TSX Venture Exchange?

Yes, Perimeter Medical's common shares will continue to trade on the TSX Venture Exchange under its existing symbol 'PINK'.

What is the potential clinical benefit of Perimeter Medical's (PYNKF) B-Series with ImgAssist AI 2.0?

The system aids surgeons in achieving clear surgical margins during breast-conserving surgeries, potentially lowering the need for reoperation by reducing residual cancer.