PINK Perimeter Medical Imaging AI Inc

Conference Call/Webcast Today at 5 pm ET

TORONTO and DALLAS, May 14, 2024 /CNW/ - Perimeter Medical Imaging AI, Inc. (TSXV: PINK) (OTC: PYNKF) (FSE: 4PC) ("Perimeter" or the "Company") – a commercial-stage medical technology company – today reported financial results for its first quarter ended March 31, 2024 and provided a corporate update.

Adrian Mendes, Perimeter's Chief Executive Officer stated, "This past quarter we saw significant momentum in the clinical development side of our business. We are enrolling patients at a much higher rate than anticipated in our ongoing pivotal clinical trial, which is evaluating the use of our proprietary B-Series OCT with ImgAssist AI during breast-conserving surgeries. Due to the speed of enrollment, we have opted to forego the interim analysis, pending regulatory approval, and will focus our efforts on expediting full enrollment in the study, now anticipated in early Q4. We have a high degree of confidence that this pathway not only allows for the strongest data package for regulatory submissions to support potential commercial approval, but it is also the most capital- and resource-efficient option."

Mr. Mendes continued, "Our commercial team is also seeing growing market traction as they work to establish Perimeter S-Series OCT as a preferred technology for margin visualization in the OR.  We successfully completed three S-Series placements year to date, including two additional previously unannounced placements, one within a current national healthcare network customer and one within a new healthcare network, showing our ability to expand our customer footprint. We fielded substantial interest from our demos and interactions at the recent ASBrS conference. In addition, we are seeing the power of peer-based recommendations, as current surgeon champions, who are already using Perimeter's technology in their operating rooms, are referring their colleagues to our sales team."

• Perimeter continues its commercial expansion efforts and, year to date, has completed placements of its flagship Perimeter S-Series OCT system at three new hospital sites, including two additional follow-on placements in North Texas within a leading national healthcare system, and one placement within a new healthcare network.
• In February 2024, researchers from the University of Texas Health Science Center and The University of Texas MD Anderson Cancer Center published results from a new study in the Annals of Surgical Oncology. The study data demonstrated that high reoperation rates after breast-conserving surgery persist (ranging from 15% to 21%, and as high as 40% in some cohorts) and are correlated with elevated risks and adverse outcomes for patients and underscore the need for new approaches to address high operation rates and better methods of margin assessment for surgeons. Funding to support this research was provided, in part, by Perimeter.
• In February 2024, Perimeter announced results demonstrating its proprietary AI algorithm combined with OCT identified 96.8% of pathology-positive margins in a peer reviewed retrospective study. These results highlight the clinical viability of AI-enhanced margin visualization using OCT in breast cancer surgery and its potential to decrease reoperation rates due to residual tumors.
• Perimeter exceeded its goal of reaching sufficient patient enrollment numbers to conduct an interim analysis by the second quarter of this year within its ongoing pivotal clinical trial, which is evaluating the use of its proprietary AI technology combined with OCT during breast-conserving surgeries. With patient enrollment tracking significantly ahead of modeled expectations and now anticipated to be complete in early Q4, the Company has opted to forego an interim analysis, pending regulatory approval, and focus its efforts on expediting full enrollment in the study. Perimeter has a high degree of confidence that this pathway not only allows for the strongest data package to support regulatory submissions for commercial approval but is the most capital- and resource-efficient option.

All of the amounts are expressed in U.S. dollars unless otherwise indicated and are presented in accordance with International Financial Reporting Standards ("IFRS") as issued by the International Accounting Standards Board.

Operating expenses for the three months ended March 31, 2024 were $4,704,125 compared to $3,833,017 for the same period in 2023.

For the three months ended March 31, 2024, net loss decreased to $2,121,701 compared to $3,259,459 for the same period in 2023.

For the three months ended March 31, 2024, cash used in operating activities was $3,566,489.

As of March 31, 2024, cash and cash equivalents were $10,625,034. This amount does not include a Cancer Prevention and Research Institute of Texas (CPRIT) grant receivable of  $1,407,555 as of  March 31, 2024, which is related to the reimbursement of pivotal clinical trial project costs.

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

The Company will host a conference call and live audio webcast today at 5:00 pm Eastern Time to discuss its first quarter 2024 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. A telephonic playback of the conference call will be available for 14 days after the event by calling 1-844-512-2921 or 1-412-317-6671 and referencing conference ID 1166195. The above listed dates and times are subject to change.

Based in Toronto, Canada and Dallas, Texas, Perimeter Medical Imaging AI (TSXV: PINK) (OTC: PYNKF) (FSE: 4PC) 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 is currently being 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.

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 the potential benefits of Perimeter S-Series OCT and Perimeter B-Series OCT, the expected benefits of Perimeter's updated version of its ImgAssist AI, the expected timing of the completion of full enrollment in Perimeter's clinical trial, Perimeter's expectations regarding the outcomes of the clinical trial, and the timing of Perimeter's earnings call, 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 for the year ended December 31, 2023, which is 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.

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SOURCE Perimeter Medical Imaging AI, Inc.