Perimeter Medical Imaging AI Reports Report First Quarter 2024 Financial Results and Provides Corporate Update
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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."
Quarterly Highlights
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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.
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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.
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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.
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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.
