Perimeter Medical Imaging AI (PINK) investor relations material

Platform and clinical evidence

• Claire received FDA PMA approval in Mar 2026 as the first AI-enabled imaging device cleared for U.S. breast-conserving surgery.

• OCT and AI highlight suspicious tissue regions, providing intraoperative margin insight in as little as 10 min; AI trained on 2M+ breast tissue images.

• Pivotal trial showed a statistically significant reduction in positive margins vs standard of care alone.

• Reported 88.1% margin accuracy; improved tumor excision completeness without meaningful increase in excised volume, with a clinically demonstrated safety profile.

• Claire is an adjunctive tool and does not replace standard histopathology or serve as a diagnostic device; 6 patents issued and 6 pending or provisional.

Market and differentiation

• ~300,000 U.S. breast-conserving surgeries occur annually; ~21% require repeat procedures due to positive margins under current standard of care.

• Estimated opportunity includes ~$17B global TAM, ~$650M U.S. breast market and ~$4B long-term platform opportunity across cancers, biopsy, surgery and pathology.

• Adjacent U.S. markets estimated at ~$100M for lung cancer and ~$200M for head and neck cancer.

• Claire provides real-time images of the whole margin and additional shaves with AI interpretation; alternatives cited rely on point readings or cavity fluorescence.

• Estimated hospital value is ~$21,100 per re-excision avoided; U.S. hospital re-excision burden estimated at $417M annually.

Commercial momentum

• First Claire placements began in Q2 2026; Intermountain Health became the first U.S. health system to commercially deploy the system, with 50+ procedures in Aug-Sep 2026.

• Procedures grew 17% QoQ and recurring revenue grew 31% QoQ; initial Claire conversions at existing customer sites are performing procedures.

• 22 placements and more than 4,000 patients imaged to date; the legacy S-Series has been commercialized since 2022.

• Commercial strategy centers on converting the installed base, adding new system placements and increasing utilization.

• 2027 priorities include expanding sales and clinical application specialist teams, growing utilization, advancing reimbursement and entering new hospital systems.