Mr. Adrian Mendes reports

PERIMETER MEDICAL IMAGING AI'S 'CLAIRE' BECOMES FIRST FDA-APPROVED AI-ENABLED IMAGING DEVICE FOR BREAST CANCER SURGERY

Perimeter Medical Imaging AI Inc. has received U.S. Food and Drug Administration premarket approval for Claire (formerly the Perimeter OCT B-Series with ImgAssist AI 2.0), the first artificial-intelligence-enabled imaging device approved in the United States for intraoperative breast cancer margin assessment. The technology received breakthrough device designation from the FDA and is designed to enhance surgeons' ability to detect difficult-to-see cancer during breast-conserving surgery and potentially reduce the need for reoperations.

"Repeat breast cancer surgeries due to residual disease remain a significant clinical, health and economic burden," said Perimeter chief executive officer Adrian Mendes. "Claire's FDA approval marks a major milestone in breast cancer care as we advance our goal of reducing repeat surgeries so that no patient has to be told, 'We didn't get it all.' We plan to begin a nationwide launch in the coming weeks so that surgeons can rapidly adopt the industry's first FDA-approved real-time AI-powered imaging technology for breast cancer surgery."

Innovating the standard of care

Claire combines Perimeter's proprietary AI with its patented wide-field OCT imaging to enable high-resolution, real-time evaluation of excised tumour margins. The system delivers 10 times higher resolution than standard X-ray and ultrasound at two-millimetre imaging depth -- the clinically relevant margin width for breast cancer margin assessment. Claire's innovative AI technology was trained on Perimeter's proprietary and growing OCT image library of over two million breast tissue images.

Today, surgeons use a combination of physical examination and, in limited cases, intraoperative pathology to assess margins before sending specimens to pathology for final evaluation. As a result, patients may wait up to a week or more to learn whether margins are clear or additional surgery is required. Claire is designed to identify areas of concern during surgery, helping surgeons determine whether to remove more tissue before completing the procedure. Today, national averages indicate repeat surgeries occur in about 20 per cent of breast-conserving surgeries in the United States.

"Despite progress in breast cancer treatment, intraoperative margin assessment remains challenging, often leading to excess removal of healthy tissue, reoperations and anxiety for patients as they await pathology results," said Dr. Alastair Thompson, 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, and the primary principal investigator of the pivotal trial that supported Claire's PMA application. "Claire has the potential to become a new standard in breast surgical care, helping reduce re-excisions while improving patient outcomes."

Claire's trial demonstrated statistically significant improvement

The pivotal trial of Claire demonstrated an 88.1-per-cent margin accuracy and a statistically significant reduction in patients with residual cancer postsurgery compared with the standard of care alone. As presented by Dr. Thompson at the 26th annual meeting of the American Society of Breast Surgeons, these results demonstrated supersuperiority (lower bound of confidence interval for treatment effect greater than a predetermined minimal clinically meaningful difference) of its ability to aid surgeons in achieving clear surgical margins. This large-scale pivotal clinical trial would not have been possible without the generous grant of $7.4-million (U.S.) from the Cancer Prevention and Research Institute of Texas.

A critical innovation behind Claire is its AI engine, trained on millions of proprietary OCT images of cancerous and healthy tissue. This image library can only be generated using Perimeter's patented OCT imaging engine and represents a unique advantage, as every surgical procedure performed with Claire generates new data that can be used to improve the AI product, helping to create better outcomes for future patients. Claire has been designed and developed on a diverse data set spanning a multitude of patient characteristics to help surgeons assess areas of interest during surgery. This use of AI is what makes Claire one of the few AI-enabled Class 3 devices on the U.S. market today. A predetermined change control plan was authorized as part of the PMA approval and includes planned AI enhancements that can be implemented without additional FDA interaction.

"Developing AI for clinical use is incredibly challenging, requiring large, high-quality data sets that reflect real-life patient diversity," said Perimeter's chief innovation officer and co-founder, Andrew Berkeley. "This approval reflects years of hard work with our clinical partners, integrating AI directly into surgical decision making and advancing its role from operational support to real-time patient care."

Platform opportunity

Claire's FDA approval positions Perimeter at the forefront of AI-enabled intraoperative imaging and marks the first commercialization of its proprietary OCT-AI platform. The company's patented wide-field OCT technology, proprietary data set and integrated AI capabilities target an estimated 300,000 annual U.S. breast cancer surgeries while providing a scalable foundation for expansion into additional cancer indications over time.

Management believes this innovative, patented platform represents the initial step toward addressing a significantly larger global opportunity across additional cancer surgeries, biopsy procedures and pathology applications.

Renowned Silicon Valley venture capitalist, entrepreneur and former Facebook executive Chamath Palihapitiya commented: "I've been a major investor in Perimeter for several years, and it's been the incredible clinical and commercial potential of Claire that has driven my excitement all along. After rigorous development, clinical and regulatory engagement, and collaboration with the medical community, I believe Perimeter is at the starting line of something truly transformational."

Mr. Palihapitiya continued: "Claire delivers greater peace of mind. Both for the surgeon who currently faces nearly one in five odds of needing to perform repeat surgery due to positive margins, and, for the breast cancer patient, who, under the current paradigm, typically has to wait (and worry) for up to 10 days to learn whether an additional surgery is required. A second surgery is an emotional and physical journey that we are trying to prevent. This is exactly the kind of AI-driven innovation that can improve the standard of care by delivering measurable, real-world medical impacts. I'm excited to see what Perimeter can accomplish as it commercializes the first AI-enabled imaging device for breast cancer surgery."

About Perimeter Medical Imaging AI Inc.

Based in Toronto, Canada, and Dallas, Tex., Perimeter Medical Imaging AI is a medical technology company driven to transform cancer surgery with ultrahigh-resolution, real-time, advanced imaging tools to address areas of high unmet medical need. Claire, recently approved by the Food and Drug Administration, is its next-generation AI-enabled device. The company's ticker symbol PINK is a reference to the pink ribbons used during breast cancer awareness month.

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