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Perimeter Medical Imaging AI Reports Second Quarter 2024 Financial Results and Provides Corporate Update
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TORONTO and DALLAS, Aug. 14, 2024 /PRNewswire/ - 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 second quarter ended June 30, 2024 and provided a corporate update.
Business Highlights
The Company continues to gain positive commercial market traction with its first U.S. Food and Drug Administration ("FDA")-cleared product, Perimeter S-Series OCT. It has already achieved six (6) new S-Series OCT system placements year-to-date, compared to a total of three (3) for all of 2023, and Q2-2024 revenues grew 83% over Q2-2023. In addition, the Company is advancing the development of its next-generation Perimeter B-Series OCT system, which combines proprietary AI technology with OCT, toward potential commercialization.
In May 2024, Perimeter provided an update on the ongoing pivotal clinical trial evaluating the use of its B-Series OCT system during breast-conserving surgeries ("BCS"). Today, based on current trends, the Company is pleased to announce that it now expects patient enrollment in the study to be completed in Q3-2024 rather than later in the 2024 fourth quarter. If successful, the trial is expected to support the Company's submission to the FDA for authorization to market Perimeter B-Series OCT in the United States in 2025.
In June 2024, a white paper authored by Amelia A. Gunter, M.D. from the Center for Cancer and Blood Disorders, Weatherford, TX, reported results from a retrospective, quantitative assessment of reoperation rates among 72 patients in her practice who underwent OCT imaging during BCS in order to gain insight into the potential benefits and limitations of OCT for patient outcomes.1 While not designed to guide clinical practice, the research demonstrated that:
Dr. Gunter's reoperation rate with OCT was 5.6%, compared to the national rate of 19.9% as determined from a national claims database study conducted by MD Anderson and University of Texas researchers that included 24,106 patients;
While the national reoperation rate in commercial insurance patients with ductal carcinoma in situ ("DCIS") was 30.8%, the Perimeter S-Series OCT reoperation rate in patients with DCIS was 13.3%; and
In commercial insurance patients with invasive ductal carcinoma ("IDC"), the national rate of reoperation was shown to be 18.0%, while Perimeter's S-Series OCT reoperation rate in patients with IDC was 0.0%.1, 2, 3
In July 2024, the 1,000th paid Perimeter S-Series OCT patient scan was performed, representing an important clinical and commercial milestone achievement by the Company.
In July 2024, Perimeter's product innovation team completed the first-of-its-kind installation of the recently developed "ImgClear" AI image enhancement algorithm with a commercial Perimeter S-Series OCT system. Internal testing has demonstrated ImgClear enables users to achieve better quality images (up to 441% signal-to-noise ratio increase) and ...