Intermountain Health Brings Perimeter's Claire™ to the Operating Room, a Landmark in Breast Cancer Surgery Using AI
Rhea-AI Summary
Perimeter Medical Imaging AI (OTCQX:PYNKF) announced that Intermountain Health has become the first U.S. health system to commercially deploy Perimeter's Claire OCT System™, described as the only FDA-approved, AI-enabled imaging device for intraoperative margin assessment during breast-conserving breast cancer surgery.
Claire uses optical coherence tomography to provide real-time, cellular-level visualization of excised tissue, while integrated AI highlights areas of concern to support surgeons' decisions in the operating room. According to Perimeter, the system is now in clinical use at Intermountain’s LDS Hospital and American Fork Hospital under a systemwide agreement, marking Claire’s transition from clinical trial use into routine clinical practice.
Positive
- First commercial deployment of Claire OCT System at Intermountain Health in the U.S.
- Only FDA-approved AI-enabled imaging device for breast-conserving surgery margin assessment in the U.S.
- Systemwide agreement with Intermountain Health; initial deployment at LDS and American Fork hospitals
- Transition of Claire from clinical trial setting into clinical practice
Negative
- None.
AI-generated analysis. How Rhea-AI works. Not financial advice.
Health system is first to commercially deploy Claire, the only FDA-approved, AI-enabled imaging device for margin assessment during breast-conserving surgery in the
Claire is designed to enhance surgeons' ability to detect difficult-to-see cancer - far beyond what's visible to the naked eye - in real-time in the OR
"Every breast surgeon wants to give their patient the best possible chance of completing treatment in a single surgery, but microscopic cancer can be difficult to identify in the operating room," said Dr. Teresa Reading, a breast surgeon at Intermountain Health LDS Hospital in
Surgeons performing breast-conserving surgery have long faced a difficult challenge: remove too little tissue and risk leaving undetected cancer behind, or remove too much and potentially affect cosmetic results. Claire addresses that challenge through real-time visualization of tissue suspicious for disease, with AI identifying areas of concern in the operating room to help surgeons make more informed decisions while the patient is still in surgery.
Claire builds on Perimeter's legacy S-Series OCT platform, which was cleared by the FDA for general tissue imaging and uses optical coherence tomography, a light-based imaging technology used in ophthalmology and cardiology. The OCT provides real-time, cellular-level visualization of tissue, while the AI available in Claire sifts through the images generated during surgery to flag areas of concern.
"Reducing unnecessary repeat surgeries is a priority for Intermountain Health because every additional procedure places a burden on patients, families, surgeons, and the healthcare system overall," said Phillip Wood, Executive Program Director, Intermountain Ventures, Intermountain Health. "Claire gives our surgical teams new information at the point of care, when it has the greatest potential to influence the course of treatment. As the first health system to commercially deploy this technology, we look forward to building on our partnership with Perimeter and to demonstrate how AI can be responsibly integrated into surgical care."
For Perimeter, the Intermountain milestone marks the movement of Claire from clinical trial to clinical practice. Claire is currently deployed at LDS Hospital and American Fork Hospital as part of Intermountain Health's systemwide agreement with Perimeter.
"The first deployment of Claire is a defining moment for Perimeter and for the use of AI in cancer surgery as a whole," said Perimeter CEO Adrian Mendes. "For the first time, a
Source
1 Kim Y, Ganduglia-Cazaban C, Tamirisa N, et al. Contemporary analysis of reexcision and conversion to mastectomy rates and associated healthcare costs for women undergoing breast-conserving surgery. Ann Surg Oncol. 2024;31(1):318-327.
About Intermountain Health
Headquartered in
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. Claire™, recently approved by the FDA, is our next-generation AI-enabled device. The Company's ticker symbol "PINK" is a reference to the pink ribbons used during Breast Cancer Awareness Month.
Claire Indications for Use: The Claire OCT System is an adjunctive three-dimensional imaging tool, providing 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. It is used concurrently with a physician's interpretation of the images. The Claire OCT System is intended for use in conjunction with other standard methods for evaluation of the margins of excised lumpectomy tissue during surgical procedures in patients with a biopsy-confirmed diagnosis of breast cancer.
The Claire OCT System should not be used to replace standard tissue histopathology assessment and should not be used for diagnosis. The device is not intended for use in any of the following individuals: under the age of 18, male, have metastatic cancer (Stage IV), have lobular carcinoma as their primary diagnosis, have had previous ipsilateral breast surgery for benign or malignant disease within two years (including implants and breast augmentation), patients with multi-centric disease (histologically diagnosed cancer in two different quadrants of the breast), unless resected in a single specimen, patients with bilateral disease (diagnosed cancer in both breasts), patients who are currently lactating, patients who are currently pregnant, or concurrent use in surgeries with cryo-assisted localization. Refer to prescriber labeling for full safety information.
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 and the commercialization of Claire, including the potential market size for the device and building the next layer of Claire's AI infrastructure, 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, 2025, which is available on Perimeter's SEDAR+ profile at https://www.sedarplus.com, 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
Sara Batchelder
Email: sbatchelder@ampublicrelations.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.