Mr. Adrian Mendes reports

PERIMETER MEDICAL IMAGING AI ANNOUNCES ALIGNMENT WITH FDA ON KEY ELEMENTS OF ONGOING CLINICAL TRIAL EVALUATING AI-ENABLED B-SERIES OCT MEDICAL IMAGING TECHNOLOGY

Perimeter Medical Imaging AI Inc. today provided an update on the clinical development of its continuing clinical trial evaluating the use of Perimeter B-Series OCT combined with its proprietary ImgAssist AI software during breast conservation surgery. Based on feedback from the U.S. Food and Drug Administration (FDA), the company has reached alignment on key elements of the continuing clinical trial, including the introduction of an interim analysis, which is expected in the second quarter of 2024.

Adrian Mendes, Perimeter's chief executive officer, stated: "This positive interaction with the FDA marks an important milestone in our clinical development program. As a first step, we received regulatory approval to implement our substantially enhanced AI algorithm in the ongoing pivotal clinical trial under the existing study protocol and we have now aligned on other key elements in order to chart a clear path forward for the development of our B-Series OCT with ImgAssist AI."

Mr. Mendes continued: "Importantly, we will have a planned interim analysis in the trial, which will provide us with an early readout of results based on the use of the newest algorithm. If key end points are met at the time of the interim analysis, we may opt to conclude the trial and begin preparing regulatory submissions supporting market clearance. Alternatively, the interim analysis could support continuing the trial to build a stronger submission package from additional subjects. Ultimately, our goal is to expedite the development of our next-gen AI technology and deliver it to our surgeon customers to improve clinical and economic outcomes in breast surgical oncology."

Dr. Alastair Thompson, principal investigator and professor, section chief of breast surgery, and Olga Keith Wiess, chair of surgery at Baylor College of Medicine and co-associate director for clinical research at the Dan L. Duncan Comprehensive Cancer Center, stated: "Having participated in earlier stages of its development, and, as principal investigator of the study, I am excited that the clinical trial continues to advance and gather additional clinical data using the updated AI software. There is a strong need for new tools to assist surgeons with 'real-time' margin assessment in the operating room. I believe combining AI with high-resolution imaging has the potential to become a new standard of care during breast conservation surgery."

Summary of clinical trial updates:

• Clearance to introduce enhanced AI algorithm:
  • Perimeter received approval from the FDA to introduce an enhanced AI algorithm in the continuing clinical trial under the existing study protocol. As a result, all clinical trial sites will use the updated AI as patients continue to enroll in the continuing study.
• Enrolment of additional subjects:
  • In order to obtain statistically significant findings based on the use of the new AI algorithm, Perimeter is permitted to enroll up to 531 subjects.
• Introduction of interim analysis within study protocol:
  • Perimeter intends to conduct a planned interim analysis in the second quarter of 2024. If statistically significant positive interim results are obtained, the company may opt to conclude the trial and begin preparing regulatory submissions supporting market clearance. If it is determined that more data are needed, the company may continue with its clinical trial and anticipates study completion by the end of 2024.
• Additional clinical trial sites permitted:
  • To further support and expedite patient enrolment, Perimeter has received clearance to increase the number of clinical trial sites, most recently adding Mayo Clinic and Baptist MD Anderson in Florida.
• Summary of anticipated AI improvements:
  • The new enhanced AI takes advantage of additional training data and Perimeter's latest AI advancements that demonstrate improved sensitivity, specificity, precision and recall. It is expected that this updated version of ImgAssist AI will contribute to more accurate classification, as well as fewer false positives and negatives.

About Perimeter Medical Imaging AI Inc.

Based in Toronto, Canada, and Dallas, Tex., Perimeter 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. Available across the United States, the company's FDA-cleared Perimeter S-Series OCT system provides real-time, cross-sectional visualization of excised tissues at the cellular level. The breakthrough-device-designated investigational Perimeter B-Series OCT with ImgAssist AI represents the company's next-generation artificial intelligence technology that is currently being evaluated in a pivotal clinical trial, with support from a grant of up to $7.4-million (U.S.) awarded by the Cancer Prevention and Research Institute of Texas. The ticker symbol PINK is a reference to the pink ribbons used during breast cancer awareness month.

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