Perimeter Medical Imaging AI (PINK) Q4 2024 earnings summary

Executive summary

• Achieved significant progress in 2024, including strong revenue growth, expanded user base, and positive pivotal trial results for next-generation AI-enabled imaging system.

• Achieved strong commercial traction with nine new S-Series OCT system placements in 2024, up from three in 2023, and 303% Q4 revenue growth year-over-year.

• Advanced B-Series OCT with proprietary AI technology; pivotal trial met primary endpoint, showing significant reduction in residual cancer during surgery.

• Submitted pre-market approval (PMA) application to the FDA for B-Series OCT with ImgAssist AI 2.0, following successful pivotal trial.

Financial highlights

• Q4 2024 revenue was $293,000, a 303% increase over Q4 2023, driven by consumables, system leases, and warranty programs.

• Full-year 2024 revenue was $846,000, a 110% increase year-over-year.

• Q4 2024 net loss was $3.4 million ($0.06/share), a 35% decrease from Q4 2023.

• Full-year 2024 net loss was $13.4 million ($0.19/share), compared to $14.0 million ($0.22/share) in 2023.

• Operating expenses for Q4 2024 were $4.7 million, down 6% year-over-year; full-year 2024 operating expenses were $19.4 million, up from $16.7 million in 2023.

Outlook and guidance

• Anticipates FDA approval for B-Series within approximately one year, with potential for acceleration due to breakthrough device designation.

• Preparing for commercial launch of B-Series, balancing investment timing with regulatory progress.

• Plans to expand sales and clinical support teams, especially post-approval, to increase U.S. coverage.

• Plans to present pivotal trial results at the ASBrS Annual Meeting and submit for peer-reviewed publication.

• Focused on maintaining and growing a core base of early adopters to support rapid B-Series adoption.