Perimeter Medical Imaging AI (TSX-V:PINK; OTCQX:PYNKF) is an early stage commercial growth company that is pioneering a breakthrough, ultra-high-res, AI-driven intraoperative margin visualization technology called B-Series Optical Coherence Tomography (OCT) with ImgAssist AI 2.0. B-Series would allow surgeons real-time insights during breast conserving surgeries (BCS), supporting critical decisions on margin status and potentially reducing re-excisions, minimizing patient trauma, and lowering healthcare costs. Perimeter’s B-Series OCT has Breakthrough Device Designation, is currently under FDA review, and Premarket Approval (PMA) is anticipated early next year. The company’s current FDA cleared device, S-Series OCT, is currently being commercialised having placed over 21 devices in market, representative of a high margin, recurring razor-razorblade revenue model. The company has imaged over 3,000 patients to date, and in the first half of 2025 has accomplished over $1mm in revenue.
“While our S-Series OCT, now in market, is highly effective at margin visualization, the next-gen B-Series OCT aims to offer even greater intraoperative support—driven by rapidly evolving AI that is intended to assist surgeons in improving patient outcomes,” Adrian Mendes, CEO of Perimeter, says in an interview with BioTuesdays.
“It’s an exciting time for Perimeter. As we continue collecting data from S-Series users, our performance metrics are trending sharply upward,” he adds.
OCT is a non-invasive optical imaging technique that generates ultra-high-resolution images of sub-surface tissue structures. Like ultrasound but using light instead of sound, it produces cross-sectional, 3D images—offering 10 times the resolution of ultrasound or X-ray, and 100 times that of MRI. A focused beam of light rapidly scans the tissue specimen, and the reflected light—penetrating up to two-millimeters—is transformed into detailed images.
Mr. Mendes explains that Perimeter has amassed a proprietary dataset of several million images of both healthy and cancerous tissue, captured using its OCT technology. The company’s in-house AI team is leveraging this vast image library to train real-time AI models purpose-built for clinical settings.
By layering the widely adopted first-generation, FDA 510(k)-cleared S-Series OCT system with its proprietary ImgAssist software, Perimeter developed the next-gen, investigational-use B-Series OCT.
“Often when a device receives FDA approval, it can take a year or more before it is commercially deployed—but it’s not going to be like that for us,” Mr. Mendes contends. “Traction for the S-Series OCT continues to build, with growing adoption reflected in both new system placements and increased utilization by existing users.”
Mr. Mendes points out that in the past few months alone, Providence Saint Joseph Medical Center, a nationally recognized, 383-bed, not-for-profit hospital in Burbank California, and Medical City Dallas Hospital, an award-winning 899-bed acute care hospital in the Dallas-Fort Worth area, have adopted the S-Series OCT technology for high-resolution visualization of tissue microstructures during surgery.
In August, Perimeter reported Q2 2025 revenue of approximately $500,000, representing ~100% year-over-year growth. The company also projects 35% procedure growth, leading to more than 50% growth in recurring revenue compared to Q1 2025. Additionally, in the first half of 2025, the company accomplished over $1mm in revenue, 25% higher than total revenue for all of 2024.
“Primarily driven by stronger utilization of existing S-Series systems, we saw significantly more intraoperative OCT imaging procedures performed at a higher per-procedure pricing,” Mr. Mendes notes.
He suggests that this momentum bodes well for B-Series OCT with ImgAssist AI 2.0, which the company believes will see rapid acceptance and adoption following FDA approval anticipated in approximately six months.
In March, Perimeter submitted its PMA to the FDA, which included results from a multi-center pivotal study led by Dr. Alastair Thompson at Baylor College of Medicine. The trial evaluated the B-Series OCT with ImgAssist AI 2.0 during BCS.
“The study showed that [addition of] the B-Series OCT system [with standard methods] enabled surgeons to more effectively identify and address residual cancer at the surgical margin—compared to current standard methods [alone],” Mr. Mendes emphasizes.
“We easily met the primary endpoint with a statistically significant (p-value = 0.0050) reduction in patients with residual cancer during surgery. This confirms the potential of our technology to help surgeons achieve clearer margins during surgery, potentially lowering the need for reoperation,” he adds.
The reoperation rate for cancer patients is high—specifically for breast cancer where nearly one in four women require repeat surgery after initial lumpectomy, largely because residual cancer cells often cannot be detected by sight, touch, or conventional imaging methods.
“Patients often wait up to a week or more for post-operative pathology results, only to learn they need a second surgery due to cancer left behind,” Mr. Mendes says. “These reoperations are not just traumatic for the patient—they strain healthcare resources and delay urgently needed care for others.”
Each year in the US, approximately 200,000 breast lumpectomies are performed, with 23% resulting in re-excisions. At an average of $17,000 per repeat surgery, the cost burden is significant. Across the top eight cancers, including breast, colorectal, lung, prostate, and others, re-excisions contribute to $1.2 billion in annual costs to the healthcare system.
Looking ahead as AI becomes smarter and more scalable, Perimeter is already developing ImgAssist AI 3.0—designed to deliver even more precise localization of suspicious tissue within the scanned image. According to Mr. Mendes, this next iteration will enhance specificity, sensitivity, and increase surgeon confidence.
“ImgAssist AI 3.0 aims to give surgeons greater peace of mind, with tighter visual focus, fewer errors, and a step-function improvement in usability,” he adds.
While version 3.0 will still require regulatory oversight, Mr. Mendes highlights that the process should be less burdensome than with 2.0 thanks to the FDA’s Pre-determined Change Control Process (PCCP). This pathway allows Perimeter to pre-submit software changes for future versions, facilitating faster rollouts without the need for full regulatory re-review each time.
Although Perimeter is well positioned to make a real difference in the treatment of breast cancer, Mr. Mendes envisions a multi-cancer future, arguing that the underlying technology has a much broader potential.
“We already have surgeons using the Series-S OCT system in other cancers—lung, melanoma, head and neck—and the data are very promising,” Mr. Mendes shares. “Ultimately, we believe Perimeter will evolve into a multi-cancer imaging company, because the technology works far beyond breast cancer.”
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