Medical City Dallas Hospital Adopts Perimeter's Innovative OCT Imaging Technology for Surgery

Rhea-AI Summary

Perimeter Medical Imaging AI (OTCQX:PYNKF) announced that Medical City Dallas Hospital, an 899-bed acute care facility, has adopted their S-Series OCT imaging technology for surgical procedures. This adoption follows the hospital's participation in a pivotal trial of Perimeter's next-generation B-Series device, which combines OCT with AI technology for breast-conserving surgeries.

The S-Series OCT technology, FDA-cleared in 2021, provides high-resolution visualization of tissue microstructures at the cellular level, offering superior imaging capabilities compared to traditional methods like X-ray, MRI, or ultrasound. The system is optimized to identify regions of interest in tissue microstructures down to 2mm, making it particularly effective for visualizing surgical margins.

Positive

• FDA-cleared S-Series OCT technology adoption by major 899-bed hospital
• Technology provides unique cellular-level visualization capabilities
• Ongoing clinical trial for next-generation B-Series device with AI integration
• Expanding nationwide deployment of S-Series OCT technology

Negative

• None.

News Market Reaction – PYNKF

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+2.87% News Effect

On the day this news was published, PYNKF gained 2.87%, reflecting a moderate positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

Deployment follows participation in pivotal trial of Perimeter's next-gen technology with AI for breast-conserving surgeries

TORONTO and DALLAS, July 2, 2025 /PRNewswire/ - Perimeter Medical Imaging AI, Inc. (TSXV: PINK) (OTCQX: PYNKF) ("Perimeter" or the "Company"), a commercial-stage medical technology company, announced today that Medical City Dallas Hospital, an award-winning 899-bed acute care hospital in the Dallas-Fort Worth area, has adopted the company's current S-Series OCT (optical coherence tomography) technology for high-resolution visualization of tissue microstructures during surgery. The move comes on the heels of the hospital's participation in the pivotal, randomized controlled trial of Perimeter's next-generation B-Series device, which combines proprietary artificial intelligence ("AI") technology with OCT, and is being evaluated by the U.S. Food and Drug Administration for use during breast-conserving surgeries in the United States.

"We are incredibly proud to partner with Medical City Dallas Hospital and its team of surgeons, who are truly innovators in their field," said Perimeter CEO Adrian Mendes. "Working with Dr. DiPasquale and Dr. Anderson and the Medical City Dallas team, who used our B-Series in the randomized controlled pivotal trial, has been invaluable to advancing our next-generation product and we are pleased that they are adopting our commercially approved S-Series to potentially enhance margin visualization in the OR."

Medical City Dallas Hospital is the latest U.S. hospital to adopt the S-Series OCT, as Perimeter continues to deploy the technology nationwide. Cleared by the U.S. Food and Drug Administration (FDA) in 2021 for a general tissue indication, S-Series OCT is a high-resolution technology that, unlike X-ray, magnetic resonance imaging (MRI), or ultrasound, can 'see' disease at the cellular level. It is optimized down to 2mm for identifying regions of interest in tissue microstructures, and features such as blood vessels, ducts, and glands, making it ideal for visualizing surgical margins.

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 was recently 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.

S-Series OCT Intended Use and Unapproved Uses

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.  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 anticipated terms and jurisdictions of the Offering; securities offered thereunder; the timing of the Offering, including the anticipated Closing Date; use of proceeds from the Offering; fees anticipated to be paid to the Agent and terms thereof; regulatory and exchange approvals, including the listing of the common shares offered pursuant to the Offering on the TSXV, 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 Annual Information Form for the year ended December 31, 2024, 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.

FAQ

What is Perimeter Medical's (PYNKF) S-Series OCT technology used for?

The S-Series OCT technology is used for high-resolution visualization of tissue microstructures during surgery, capable of seeing disease at the cellular level and optimized to identify regions of interest down to 2mm.

When did the FDA clear Perimeter Medical's S-Series OCT technology?

The FDA cleared Perimeter Medical's S-Series OCT technology in 2021 for general tissue indication.

How does Perimeter's OCT technology differ from traditional imaging methods?

Unlike X-ray, MRI, or ultrasound, Perimeter's OCT technology can visualize disease at the cellular level, specifically optimized for identifying features such as blood vessels, ducts, and glands down to 2mm.

What is Perimeter Medical's next-generation B-Series device?

The B-Series is Perimeter's next-generation device that combines OCT imaging with artificial intelligence technology, currently being evaluated by the FDA for use during breast-conserving surgeries.

Which hospital has recently adopted Perimeter Medical's OCT technology?

Medical City Dallas Hospital, an 899-bed acute care hospital in the Dallas-Fort Worth area, has adopted Perimeter's S-Series OCT technology.