Perimeter Medical Imaging AI Announces Patient Randomization Underway at Clinical Trial Site at Mayo Clinic in Florida
DALLAS and TORONTO, Oct. 11, 2023 /CNW/ - Perimeter Medical Imaging AI, Inc. (TSXV: PINK) (OTC: PYNKF) (FSE: 4PC) ("Perimeter" or the "Company") – a commercial-stage medical technology company – announced that patient randomization is underway at Mayo Clinic in Florida, the most recent clinical site to be initiated as part of an ongoing multi-center, randomized two-arm pivotal clinical trial evaluating the investigational Perimeter B-Series OCT combined with its proprietary ImgAssist AI software.
Dr. Sarah Butler, Perimeter's Vice President, Clinical and Medical Affairs stated, "Patient recruitment and randomization is underway at the Mayo Clinic in Florida, which is one of the sites where we are studying the combination of the Perimeter B-Series medical imaging platform with artificial intelligence software. Combining high-resolution optical coherence tomography with AI algorithms can potentially help surgeons better identify regions of interest during breast conserving surgeries, with the aim of improving patient outcomes and reducing healthcare costs."
Adrian Mendes, Perimeter's Chief Executive Officer stated, "We are pleased that we continue to advance our ongoing pivotal clinical trial, supporting our goal to expedite the development of our next-gen AI technology. With its potential to become the new standard for specimen imaging technology during breast conservation surgery, our hope is that the data generated from this study will support the commercialization of Perimeter B-Series."
Based in Toronto, Canada and Dallas, Texas, Perimeter Medical Imaging AI (TSX-V: 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.
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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, Perimeter B-Series OCT, and Perimeter ImgAssist; details regarding Perimeter's ongoing clinical trials; and the anticipated completion date of Perimeter's clinical trials, 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, 2022, which is available on Perimeter's SEDAR profile at www.sedar.com, 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.
SOURCE Perimeter Medical Imaging, Inc.
Released October 11, 2023