Perimeter Medical Imaging AI Reports Third Quarter 2021 Financial Results and Provides Corporate Update

Perimeter Medical Imaging AI, Inc. (TSX-V:PINK) (OTC:PYNKF) (FSE:4PC) (“Perimeter” or the “Company”), a medical technology company driven to transform cancer surgery with ultra-high-resolution, real-time, advanced imaging tools to address high unmet medical needs, today reported financial results for its third quarter ended September 30, 2021 and provided a corporate update.

Company Highlights

• Perimeter Medical Imaging AI Announces Important Milestone in ATLAS AI Project with FDA Investigational Device Exemption (IDE) Approval to Launch Clinical Trial Using Perimeter B-Series OCT with ImgAssist AI in Breast Conservation Surgery

Jeremy Sobotta, Perimeter’s Chief Executive Officer stated, “Our sales and marketing team continues to expand its market development activities to support the adoption of our flagship, commercially available Perimeter S-Series OCT technology by oncoplastic surgeons who recognize that our innovative medical imaging technology could potentially represent the next ‘game changer’ in margin visualization. As we reach out to physicians, we consistently hear about the great medical need for tools in the OR to help surgeons identify if they have adequately removed cancerous tissue ‘real time’ during a procedure. Perimeter S-Series delivers 2mm subsurface imaging of excised tissue margins, allowing surgeons to identify and annotate microscopic tissue structures and make more informed decisions during a tissue excision procedure.”

Mr. Sobotta continued, “We also made great strides in our ATLAS AI project as we advance the clinical development of the ‘next-gen’ Perimeter B-Series OCT with our proprietary ImgAssist AI. With FDA approval of our IDE application received just after quarter-end, activities are currently underway to support a randomized, multi-site, pivotal study to assess the impact on re-operation rates when surgeons use OCT combined with AI during breast conservation surgery and evaluate our technology against the current standard of care. We expect that the first patient in this study will be randomized before year-end.”

Quarterly Updates

• Subsequent to quarter end, on November 2, 2021, Perimeter announced that the U.S. Food and Drug Administration (FDA) approved an investigational device exemption (IDE) application for the Perimeter B-Series OCT with ImgAssist AI technology, enabling its use in the upcoming pivotal study as part of the ATLAS AI Project. It is anticipated that over 300 patients across 8 U.S. clinical sites will participate in the pivotal study to be led by Principal Investigator, Dr. Alastair Thompson at Baylor College of Medicine.
• On August 25, 2021, Perimeter provided a corporate update on the ramp-up of its commercial organization. Under the leadership of Steve Sapot, Perimeter’s Chief Commercial Officer, the Company continues to build the infrastructure to support and expand its sales and marketing team, including key market development managers tasked with launching Perimeter’s novel S-Series OCT medical imaging technology in the U.S. market.
• On August 10, 2021, Perimeter announced that its common shares are now eligible for electronic clearing and settlement through The Depository Trust Company (“DTC”) in the United States. This electronic method of clearing securities speeds up the receipt of stock and cash and thus can accelerate the settlement process for investors and brokers, enabling the stock to be traded over a wider selection of brokerage firms.
• Perimeter also continued to strengthen its team through key leadership appointments and significant expansion of the Company’s commercial infrastructure. On July 13, 2021, Perimeter announced the appointment of Dr. Sarah Butler as VP, Clinical and Medical Affairs.

Summary of Third Quarter 2021 Financial Results