Perimeter Medical Imaging AI (PINK) Investor presentation summary

Investment highlights

• First FDA-approved AI imaging device for breast cancer surgery, Claire, received PMA approval in March 2026, establishing a unique AI-enabled surgical imaging platform.

• Clinical trials showed Claire significantly reduced positive surgical margins compared to standard care, lowering the need for repeat surgeries.

• Large market opportunity with approximately 300,000 U.S. breast-conserving surgeries annually and expansion potential across other cancers and procedures.

• High-margin, recurring revenue model with hardware placements driving multiple revenue streams and a target gross margin of ~70%.

• Commercial launch began in Q2 2026, leveraging first-mover advantage and a strong competitive moat through regulatory approval, patents, and proprietary datasets.

Technology and clinical impact

• Claire combines patented OCT imaging with AI to provide real-time, intraoperative margin assessment, delivering results in as little as 10 minutes.

• The system is trained on a proprietary library of over 2 million breast tissue images, enhancing AI accuracy and clinical confidence.

• Clinical data shows 88.1% margin accuracy and improved completeness of tumor excision without increasing excised tissue volume.

• FDA approval was achieved through a rigorous PMA pathway, with a predetermined change control plan allowing ongoing AI improvements.

• Claire’s adoption is supported by testimonials from surgeons and patients, highlighting improved surgical decision-making and patient outcomes.

Market opportunity and growth strategy

• Initial focus is on breast cancer surgery, with plans to expand into lung, head & neck, and other oncological, biopsy, and pathology applications.

• U.S. addressable market estimated at $650M, with a global TAM of ~$17B based on 2028 surgical volumes.

• Current customer base includes 22 hospital placements and over 4,000 procedures, with significant untapped market potential in major U.S. cities.

• Commercial strategy centers on converting legacy users, expanding system placements, and driving consistent intraoperative utilization.

• Revenue model includes hardware, consumables, service contracts, and AI software upgrades, supporting recurring revenue streams.