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Perimeter Medical Imaging AI receives FDA Breakthrough Device Designation for OCT Imaging System with ImgAssist AI

Press releases may be edited for formatting or style | April 15, 2021 Artificial Intelligence CT Operating Room X-Ray

Jeremy Sobotta, Perimeter’s Chief Executive Officer stated, “Achieving a Breakthrough Device Designation from the FDA further validates our strong belief that Perimeter’s novel OCT Imaging System combined with AI has the potential to be a transformative, disruptive new technology aimed at helping surgeons treat breast cancer. This Breakthrough Designation, combined with the Centers for Medicare & Medicaid Services’ (CMS) initiatives around MCIT, have the potential to provide a pathway to expediting adoption of this innovative technology. We are committed to providing physicians with ultra-high-resolution images of excised breast tissue ‘real-time’ during a surgical procedure combined with added artificial intelligence tools to help them interpret areas suspicious for cancer, with the goal of improving patient outcomes and lowering healthcare costs.”


About Perimeter Medical Imaging AI, Inc.
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Perimeter Medical Imaging AI (TSX-V:PINK)(OTC:PYNKF)(FSE:4PC) is a Toronto-based company with U.S. headquarters in Dallas, Texas that is developing and commercializing advanced imaging tools that allow surgeons, radiologists, and pathologists to visualize microscopic tissue structures during a clinical procedure. Perimeter’s Optical Coherence Tomography (OCT) Imaging System provides clinicians with real-time, ultra-high-resolution, sub-surface image volumes of the margin (1-2 mm below the surface) of an excised tissue specimen. The ability to visualize microscopic tissue structures during a clinical procedure in addition to standard of care tissue assessment for decision making during the procedure has the potential to result in better long-term outcomes for patients and lower costs to the healthcare system. Perimeter’s OCT Imaging System is cleared by the FDA 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. In addition, Perimeter is advancing its proprietary, next-gen artificial intelligence technology and machine learning tools through clinical development under its ATLAS AI project, which is made possible, in part, by a $7.4 million grant awarded by the Cancer Prevention and Research Institute of Texas (CPRIT). Perimeter’s ticker symbol “PINK” is a reference to the pink ribbons used during Breast Cancer Awareness Month by the Canadian Cancer Society and the American Cancer Society, driving home the company’s dedication to helping surgeons, radiologists and pathologists use Perimeter’s imaging technology and AI in the fight against breast cancer, which is estimated to account for 30% of all female cancer diagnoses this year.

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