Perimeter Medical Imaging AI (PINK) investor relations material

Product and clinical evidence

• Claire is a Class III, FDA-approved AI imaging device for breast cancer surgery; it combines wide-field OCT with AI to help surgeons assess tissue margins in real time.

• Wide-field OCT expands the imaging view to 10 cm, provides ~10 μm resolution, and images a few millimeters into tissue without touching the patient or using dyes.

• ImgAssist AI flags suspicious areas across thousands of images, narrowing the surgeon’s review to roughly half a dozen or a dozen images; AI accuracy was cited at 88%.

• A trial across 10 hospitals enrolled over 300 patients; among 200 patients who received imaging, 26 had clinical benefit, and the trial showed less tissue removal than standard care.

• U.S. breast cancer surgeries exceed 300,000 annually, with a cited reoperation rate of 20%-25%; research and papers also cover head and neck, bladder, and lung cancers.

Commercial strategy and market access

• Commercialization began in late 2022 with the earlier device; Claire launched in 2026, and the strategy is to convert installed S-Series customers to Claire and increase utilization per machine.

• Claire carries a 2x-3x higher ASP than S-Series; current growth is constrained by sales-team capacity, with expansion planned in Florida, the Northeast, and Midwest.

• Reimbursement is being pursued through an expedited pathway enabled by Breakthrough Device Designation, with management expecting progress in early 2027; reimbursement was identified as a major catalyst.

• Management expects 2027 to bring accelerated growth with reimbursement and FDA approval; expansion to other cancer indications would require evidence to support stronger indication-specific claims.

• The device supplements rather than replaces pathology: surgeons make purchase decisions for OR-based use, while pathology continues its standard tissue review.

Business model and financial position

• Revenue streams include system sales at a few hundred thousand dollars with ~50% gross margin, consumables with over 90% gross margin, and service contracts at ~$25,000 annually.

• Consumables and service can support breakeven within a year when a device is placed at no charge; management cited over $2 million in annual revenue without reimbursement.

• Management estimated ~$20,000 in savings per avoided reoperation, including avoided procedure costs, OR efficiency, reduced treatment delays, and quality or reputational benefits.

• Cash was expected to last beyond mid-2027, with no material debt apart from a convertible note; management described the balance sheet as solid.