Leede Financial analyst Douglas Loe reiterated his “Speculative Buy” rating and $3.00 target price on Perimeter Medical Imaging (Perimeter Medical Imaging Stock Quote, Chart, News, Analysts, Financials TSXV:PINK) after the company received U.S. regulatory approval for its AI-enabled B-Series optical coherence tomography (OCT) platform.
The Ontario-based developer of breast tumor imaging systems announced that the U.S. Food and Drug Administration granted approval for its B-Series platform, which integrates artificial intelligence with OCT technology to help surgeons visualize tumor margins during breast cancer surgery.
Loe said the approval was broadly expected and already incorporated into his financial model.
“We long believed that B-Series clinical performance merited positive regulatory regard and so FDA approval is largely infused into our model already,” he said in a March 4 note.
The approval follows a 206-patient clinical study completed last year that evaluated the platform’s ability to assess margins of excised breast tumors during lumpectomy procedures. The study showed the system could identify residual tumor margins in real time with an accuracy rate of 88.1%, helping surgeons determine when additional tissue removal was required and potentially reducing the need for follow-up surgeries.
According to trial data, B-Series identified 56 residual disease margins across 35 patients, with additional tissue removal ultimately clearing residual disease in several cases. The study also suggested improved surgical precision: approximately 19.9% of patients assessed using standard-of-care techniques required additional tissue shaving, compared with 3.8% of those assessed using the B-Series platform.
Loe said the results build on the company’s earlier FDA-approved S-Series OCT system and further support the commercial outlook for the platform.
He forecasts Perimeter Medical Imaging will generate $3.4-million in Adjusted EBITDA on revenue of $29.8-million in fiscal 2028, improving to $20.5-million in Adjusted EBITDA on revenue of $53.2-million in fiscal 2029.
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