Company Announcements

Conference Call/Webcast Today at 5 pm ET

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TORONTO and DALLAS, May 13, 2025 /CNW/ - Perimeter Medical Imaging AI, Inc. (TSXV: PINK) (OTCQX: PYNKF) ("Perimeter" or the "Company"), a commercial-stage medical technology company, today reported financial results for its first quarter ended March 31, 2025 and provided a corporate update. Unless specified otherwise, all amounts in this press release are expressed in U.S. dollars and are presented in accordance with International Financial Reporting Standards as issued by the International Accounting Standards Board.

Business Highlights 

Current Perimeter S-Series OCT ("Perimeter S-Series") Device

• The Company continues to gain significant positive commercial market traction with its first U.S. Food and Drug Administration ("FDA")-cleared product, Perimeter S-Series:
  • Q1-2025 revenue of $550,269, up 460% year-over-year and 89% sequentially.
  • Q1-2025 first-time capital OCT unit sale.
  • Q1-2025 case volumes increased 160% year-over-year and 15% sequentially.
• In April 2025, Perimeter also achieved several commercial milestones: record number of patient cases were supported by Perimeter S-Series; highest-ever number of consumables were shipped; 88% of eligible devices were covered by paid ESP warranty programs; and Perimeter's 2025 billings (purchase orders for consumables, new devices and ESP warranty programs) surpassed $1 million.
• Since the start of 2025, Perimeter announced that CHRISTUS St. Vincent was the first hospital in New Mexico, Covenant Health Fort Sanders Regional was the first hospital in Tennessee, and HonorHealth, a leading healthcare system serving more than 5 million people in the greater Phoenix and Scottsdale areas, was the first in Arizona, to deploy the Perimeter S-Series technology.

Upcoming Perimeter B-Series OCT with ImgAssist AI ("Perimeter B-Series") Device

• The Company is also advancing the development of its next-generation Perimeter B-Series, which combines proprietary AI technology with OCT, toward potential commercialization.
• In March 2025, the Company submitted a Premarket Approval ("PMA") application to the FDA for the Perimeter B-Series for use during breast-conserving surgeries ("BCS") in the United States. The FDA PMA submission represents the achievement of a major milestone – Perimeter's first pre-market regulatory submission for its AI-enabled wide-field OCT technology, as well as for a specific indication label. The PMA is currently under review with the FDA.
• In May 2025, detailed results from the pivotal trial evaluating the use of Perimeter B-Series for intraoperative margin assessment during BCS were presented during the scientific session of the 26th Annual Meeting of the American Society of Breast Surgeons ("ASBrS") by the trial's Primary Principal Investigator, Dr. Alastair Thompson. As previously announced, the pivotal trial met its primary endpoint with statistically significant reduction in patients with residual cancer during surgery (p-value = 0.0050) and demonstrated super-superiority compared to standard-of-care alone. Among other positive findings, Dr. Thompson's ASBrS presentation highlighted that use of Perimeter B-Series has the potential to change the current paradigm by empowering surgeons to identify regions of interest, enhance real-time intraoperative decision-making, and reduce the incidence of re-excision due to unaddressed residual disease following lumpectomy.
• Perimeter also plans to submit detailed pivotal trial results for publication in one or more peer-reviewed journals.

Corporate

• Effective with the open of business on February 27, 2025, Perimeter's common shares began trading on the OTCQX® Best Market under the symbol "PYNKF". Perimeter's common shares also continue to trade on the TSX Venture Exchange under the symbol "PINK".
• In March 2025, Perimeter announced that it had filed a preliminary short form prospectus with the securities regulatory authorities in the Provinces of British Columbia, Alberta and Ontario in connection with an offering of units of the Company ("Units"), with each Unit consisting of one common share and one common share purchase warrant (the "Offering"). The Offering remains ongoing.

"This has been a pivotal start of the year for Perimeter, marked by record revenue from sales of our current S-Series system, the presentation of positive pivotal trial results for our next-generation AI-enabled B-Series product at ASBrS, the world's premier breast cancer surgical conference, and of course, the filing of the FDA PMA application for the upcoming B-Series," commented Adrian Mendes, Perimeter's Chief Executive Officer. "That positive momentum has continued into the current second quarter, as demonstrated by the achievement of several commercial milestones in April. We look forward to updating investors as we progress."

Summary First Quarter 2025 Financial Results

Perimeter reported first quarter 2025 revenues of approximately $550,000, which consisted of recurring sales of S-Series consumables, one-time sale of capital equipment, and sales of ESP warranty programs. First quarter 2025 revenues increased 460% over Q1-2024.

Operating expenses for the three months ended March 31, 2025 were approximately $4.6 million, essentially unchanged from the same period in 2024.

First quarter 2025 net loss was approximately $4.3 million, or $0.05 per common share, compared to approximately $2.1 million, or $0.03 per common share, in the three months ended March 31, 2024.

Cash used in operating activities in the three months ended March 31, 2025, was approximately $3.8 million, an increase of 6% from the comparable period in 2024.

As of March 31, 2025, cash was approximately $2.4 million. This amount does not include a Cancer Prevention and Research Institute of Texas (CPRIT) grant receivable of approximately $931,000, which is related to the reimbursement of pivotal clinical trial project costs, as of the end of the first quarter.

For detailed financial results, please refer to Perimeter's filings on SEDAR+ and the Company's website.

This press release is not an offer to sell or the solicitation of an offer to buy the securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to qualification or registration under the securities laws of such jurisdiction. The securities being offered under the Offering have not been, nor will they be, registered under the United States Securities Act of 1933, as amended (the "U.S. Securities Act"), and such securities may not be offered or sold to, or for the account or benefit of, persons in the United States or U.S. persons absent registration or an applicable exemption from U.S. registration requirements. "United States" and "U.S. persons" have the meanings ascribed to them in Regulation S under the U.S. Securities Act.

Conference Call

The Company will host a conference call and live audio webcast today at 5:00 pm Eastern Time to discuss its first quarter 2025 results and provide a corporate update. To participate in the call, please dial 1-800-717-1738 or 1-646-307-1865. The conference call will also be broadcast live online through a listen-only webcast, which will be posted on the Investors section of the Company's website and archived for approximately 90 days.

About Perimeter Medical Imaging AI, Inc.

Based in Toronto, Canada and Dallas, Texas, Perimeter Medical Imaging AI (TSX-V: PINK) (OTCQX: PYNKF) is a medical technology company driven to transform cancer surgery with ultra-high-resolution, real-time, advanced imaging tools to address areas of high unmet medical need. Available across the U.S., our 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 our next-generation artificial intelligence technology that has recently been evaluated in a pivotal clinical trial, with support from a grant of up to US$7.4 million awarded by the Cancer Prevention and Research Institute of Texas. The company's ticker symbol "PINK" is a reference to the pink ribbons used during Breast Cancer Awareness Month.

Perimeter B-Series OCT is limited by U.S. law to investigational use and not available for sale in the United States. Perimeter S-Series OCT has 510(k) clearance under a general indication and has not been evaluated by the U.S. FDA specifically for use in breast tissue, breast cancer, other types of cancer, margin evaluation, and reducing re-excision rates. The safety and effectiveness of these uses has not been established. For more information, please visit www.perimetermed.com/disclosures.

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Forward-Looking Statements

This news release contains statements that constitute "forward-looking information" within the meaning of applicable Canadian securities legislation. In this news release, words such as "may," "would," "could," "will," "likely," "believe," "expect," "anticipate," "intend," "plan," "estimate," and similar words and the negative form thereof are used to identify forward-looking statements. Forward-looking information may relate to management's future outlook and anticipated events or results and may include statements or information regarding the future financial position, business strategy and strategic goals, competitive conditions, research and development activities, projected costs and capital expenditures, research and clinical testing outcomes, taxes and plans and objectives of, or involving, Perimeter. Without limitation, information regarding management's views regarding the second quarter, the potential benefits of Perimeter S-Series OCT and Perimeter B-Series OCT and the expected benefits of Perimeter's updated version of its ImgAssist AI are forward-looking information. Forward-looking statements should not be read as guarantees of future performance or results, and will not necessarily be accurate indications of whether, or the times at or by which, any particular result will be achieved. No assurance can be given that any events anticipated by the forward-looking information will transpire or occur. Forward-looking information is based on information available at the time and/or management's good-faith belief with respect to future events and are subject to known or unknown risks, uncertainties, assumptions, and other unpredictable factors, many of which are beyond Perimeter's control. Such forward-looking statements reflect Perimeter's current view with respect to future events, but are inherently subject to significant medical, scientific, business, economic, competitive, political, and social uncertainties and contingencies. In making forward-looking statements, Perimeter may make various material assumptions, including but not limited to (i) the accuracy of Perimeter's financial projections; (ii) obtaining positive results from trials; (iii) obtaining necessary regulatory approvals; and (iv) general business, market, and economic conditions. Further risks, uncertainties and assumptions include, but are not limited to, those applicable to Perimeter and described in Perimeter's Management Discussion and Analysis and Annual Information Form for the year ended December 31, 2024, which are available on Perimeter's SEDAR+ profile at https://www.sedarplus.ca, and could cause actual events or results to differ materially from those projected in any forward-looking statements. Perimeter does not intend, nor does Perimeter undertake any obligation, to update or revise any forward-looking information contained in this news release to reflect subsequent information, events, or circumstances or otherwise, except if required by applicable laws.

CONTACTS: 

Stephen Kilmer
Investor Relations
Direct: 647-872-4849
Email: skilmer@perimetermed.com

Adrian Mendes
Chief Executive Officer
Toll-free: 888-988-7465 (PINK)
Email: investors@perimetermed.com 

SOURCE Perimeter Medical Imaging AI Inc.