CA Market News
1月前
Perimeter Selected for INOVAIT Pilot Fund to Advance AI for Breast Cancer SurgeryJune 9, 2026 9:05 AM
PR Newswire (US) Canadian government-backed contribution supports next-generation AI
development for Claire™, Perimeter's flagship intraoperative imaging platformTORONTO, June 9, 2026 /PRNewswire/ - Perimeter Medical Imaging AI, Inc. (TSXV: PINK) (OTCQX: PYNKF) ("Perimeter" or the "Company") today announced it has been selected to receive a contribution from the INOVAIT Pilot Fund to advance next-generation AI capabilities for its flagship product Claire™, which received U.S. Food and Drug Administration approval earlier this year as the first AI-enabled imaging device for use during breast cancer surgery. The project was one of 10 selected for funding in the latest round of the INOVAIT Pilot Fund call for applications.Today, approximately one in four women undergoing breast-conserving surgery requires a follow-on surgical procedure.1 For decades, the possibility of needing additional surgery has been accepted as an unfortunate reality, in part because surgeons have had no way to visualize tissue at the microscopic level during the procedure.2 Claire addresses that problem, combining wide-field OCT imaging with proprietary AI to help surgeons see microscopic cancer in the operating room, guiding them to areas that warrant a closer look, particularly in the critical margin zone where cancer is most likely to be missed. Claire works alongside other intraoperative margin assessment techniques, giving surgeons additional intelligence that combines real-time imaging with AI detection support before post-operative pathology evaluation."We're grateful for INOVAIT's support of this work. While advances in breast cancer treatment have accelerated over the past decade, surgeons still have limited tools in the operating room to assess microscopic disease," said Perimeter CEO Adrian Mendes. "This project helps to advance what Claire's AI can do in the operating room. Better tools lead to better decisions. And better decisions can change what's possible for patients on the day of their surgery."The project will focus on building more robust and scalable AI to support continued improvement of Perimeter's OCT+AI platform. The Company expects to receive up to nearly $148,000 in INOVAIT contributions. An additional $100,000 Mitacs Business Strategy Internship award will support graduate student participation through the university collaboration. The project is conducted in partnership with Dr. Ervin Sejdic, Professor in the Edward S. Rogers Sr. Department of Electrical and Computer Engineering at the University of Toronto."This project goes beyond a single model update - it's about building the next layer of Claire's AI infrastructure. By improving how we label data, characterize performance, and deploy AI on operating-room hardware, we can aim to make future enhancements faster, more robust, and more directly connected to the surgical workflow. The goal is to give surgeons increasingly precise intelligence at the moment it matters most," said David Rempel, Co-founder and INOVAIT Project Lead at Perimeter. The work supported by this contribution will target four specific areas: developing tools to reduce the burden of manual expert labeling required to train AI models; building a clearer understanding of how the AI performs across different tissue types and disease presentations; designing a two-tier AI architecture that combines fast initial screening with more detailed follow-up analysis; and optimizing the system for efficient performance on the hardware used in operating room environments. The future deployment of these capabilities will proceed in accordance with standard FDA review processes for class III devices."Perimeter represents exactly the kind of company the INOVAIT Pilot Fund is designed to support - one that has demonstrated real clinical impact and is now building on that foundation to go further," said Raphael Ronen, Co-Executive Director of INOVAIT. "Pilot Fund projects have the potential to transform patient outcomes, and we are proud to support Perimeter's work at this important stage."INOVAIT is a pan-Canadian network funded by the Government of Canada and hosted at the Sunnybrook Research Institute with the objective of building a truly integrated image-guided therapy and artificial intelligence (AI) ecosystem, fueling continuous innovation that revolutionizes healthcare globally. Funding for this project was provided in part by INOVAIT through the Government of Canada's Strategic Response Fund.Ce projet a été financé en partie par INOVAIT dans le cadre du Fonds de réponse stratégique du gouvernement du Canada.Sources1 Metcalfe LN, Ziska AM, Yamal KS, Jacobs LK, Oker EE, Underwood HR, Thompson AM. Beyond the Margins-Economic Costs and Complications Associated With Repeated Breast-Conserving Surgeries. JAMA Surg. 2017 Nov 1;152(11):1084-1086. doi: 10.1001/jamasurg.2017.2661. PMID: 28768303; PMCID: PMC5831419.2 Levy Y, Rempel D, Nguyen M, Yassine A, Sanati-Burns M, Salgia P, Lim B, Butler SL, Berkeley A, Bayram E. The Fusion of Wide Field Optical Coherence Tomography and AI: Advancing Breast Cancer Surgical Margin Visualization. Life. 2023; 13(12):2340. https://doi.org/10.3390/life13122340.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. Claire™, recently approved by the U.S. Food and Drug Administration (FDA), is our next-generation AI-enabled device. The Company's ticker symbol "PINK" is a reference to the pink ribbons used during Breast Cancer Awareness Month.For more information, please visit www.perimetermed.com.Indications for Use: The Claire OCT System is an adjunctive three-dimensional imaging tool which provides volumetric cross-sectional, real-time depth visualization, coupled with an artificial intelligence computer-aided detection algorithm which identifies and marks focal areas suspicious for breast cancer. It is used concurrently with physician interpretation of the images. The Claire OCT System is intended for use in conjunction with other standard methods for evaluation of the margins of excised lumpectomy tissue during surgical procedures in patients with a biopsy-confirmed diagnosis of breast cancer.The Claire OCT System should not be used to replace standard tissue histopathology assessment and should not be used for diagnosis. The device is not intended for use in any of the following individuals: under the age of 18, male, have metastatic cancer (Stage IV), have lobular carcinoma as their primary diagnosis, have had previous ipsilateral breast surgery for benign or malignant disease within two years (including implants and breast augmentation), patients with multi-centric disease (histologically diagnosed cancer in two different quadrants of the breast), unless resected in a single specimen, patients with bilateral disease (diagnosed cancer in both breasts), patients who are currently lactating, patients who are currently pregnant, or concurrent use in surgeries with cryo-assisted localization. Refer to prescriber labeling for full safety information.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 StatementsThis 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 and the commercialization of Claire, including the potential market size for the device and building the next layer of Claire's AI infrastructure, 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, 2025, which is available on Perimeter's SEDAR+ profile at https://www.sedarplus.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.ContactsStephen Kilmer
Investor Relations
Direct: 647-872-4849
Email: skilmer @Hofheimer-9195
Email: susan@endpointcommunications.net Adrian Mendes
Chief Executive Officer
Toll-free: 888-988-7465 (PINK)
Email: investors@perimetermed.com View original content to download multimedia:https://www.prnewswire.com/news-releases/perimeter-selected-for-inovait-pilot-fund-to-advance-ai-for-breast-cancer-surgery-302795289.htmlSOURCE Perimeter Medical Imaging AI Inc. Original: Perimeter Selected for INOVAIT Pilot Fund to Advance AI for Breast Cancer Surgery
CA Market News
1月前
Perimeter Announces First Quarter 2026 Financial ResultsMay 28, 2026 4:40 PM
PR Newswire (Canada) Conference call/webcast today at 5:00 pm ETTORONTO and DALLAS, May 28, 2026 /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, 2026, 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."We continued to execute well across our business in the first quarter of 2026, delivering strong recurring revenue growth via sales to our legacy S-Series OCT users, along with significantly improved operating performance," commented Adrian Mendes, Perimeter's Chief Executive Officer. "Moving forward, buoyed by the first two placements of our next-generation, FDA PMA-approved, AI-enabled Claire™ OCT device, and supported by our recently completed LIFE financing, which was led by healthcare-dedicated institutional investors alongside new and existing investors, we are poised to begin expanding the presence of OCT+AI with additional leading healthcare institutions across the United States. We look forward to updating all of our stakeholders as we progress."Business HighlightsLegacy S-Series OCT to Commercial Launch of Claire OCT+AIThe positive commercial momentum built throughout 2025 for the Company's legacy S-Series OCT continued in Q1-2026, with recurring revenues increasing 14% year-over-year.In March 2026, Perimeter received U.S. Food and Drug Administration ("FDA") premarket approval ("PMA") for Claire, the first AI-enabled imaging device approved in the United States for intraoperative breast cancer margin assessment. The technology, which previously received Breakthrough Device designation from the FDA, is designed to enhance surgeons' ability to detect difficult-to-see cancer during breast-conserving surgery and potentially reduce the need for re-operations.In April, the Company formally unveiled Claire OCT+AI at the 27th Annual Meeting of the American Society of Breast Surgeons (ASBrS) in Seattle, WA.Today, Perimeter is pleased to announce the first two commercial placements of the Claire device – consisting of legacy replacements of Perimeter S-Series systems by two top-tier hospitals – marking a critical step as the Company works to establish its proprietary technology as a standard of care in breast-conserving surgery.The Company's sales funnel for Claire has grown rapidly, and already stands at close to 50 qualified leads. Of those, more than a dozen are currently classified by Perimeter as being within one of the "Prospecting, Developing, Validating, and Contracting" stages.CorporateIn February 2026, Perimeter entered into cancellation agreements with certain employees and consultants of the Company, pursuant to which it cancelled 1,935,553 previously issued stock options (the "Original Options"), exercisable at prices ranging from C$0.38 to C$2.85, and replaced the same number of Original Options with new stock options, exercisable at a price of C$0.30 per common share. No directors or officers of the Company have entered or will enter into cancellation agreements, have had Original Options cancelled or received Replacement Options.In March 2026, Perimeter entered into a warrant cancellation agreement with SC Master Holdings LLC ("Social Capital"), pursuant to which Social Capital agreed to surrender 14,466,667 common share purchase warrants of the Company for cancellation, for no consideration.In April 2026, the Company closed the first tranche of its previously announced non-brokered private placement (the "Debenture Offering") of convertible debentures of the Company (the "Convertible Debentures"). Under the first tranche of the Debenture Offering, the Company issued C$2,760,000 (approximately US$2.0 million) principal amount of Convertible Debentures to Mr. Mendes. The Company continues to expect to complete additional closings of the Debenture Offering of up to US$3.0 million for aggregate gross proceeds of up to US$5.0 million (inclusive of the first tranche).In May 2026, Perimeter announced the successful closing of its previously announced "best efforts" offering, pursuant to the listed issuer financing exemption (the "Life Offering"), of 21,489,000 units of the Company (the "Units") at a price of C$0.35 per Unit for aggregate gross proceeds of C$7,521,150 (approximately US$5,516,729). Paradigm Capital Inc. acted as lead agent and sole bookrunner, together with Brookline Capital Markets, a division of Arcadia Securities, LLC, in connection with the Life Offering.Summary First Quarter 2026 Financial ResultsRevenue was approximately $385,000 for the first quarter of 2026, with the full amount coming from recurring revenue, which consisted of the sale of S-Series consumables and system leases, as well as from the sale of ESP warranty programs. First quarter 2026 revenues compared to approximately $550,000 in Q1-2025, which consisted of approximately $320,000 in recurring revenue, in addition to approximately $230,000 from one-time sale of legacy S-Series capital equipment.Operating expenses for the three months ended March 31, 2026 were approximately $3.2 million, down 30% from $4.6 million in the same period in 2025.First quarter 2026 net loss was approximately $3.0 million, or $0.02 per common share, a 31% improvement compared to approximately $4.3 million, or $0.05 per common share, in the three months ended March 31, 2025.Cash used in operating activities in the three months ended March 31, 2026, was approximately $2.2 million, a 41% decrease from the comparable period in 2025.As of March 31, 2026, cash was approximately $421,000. This amount does not include any of the approximate $7.5 million in gross proceeds that the Company raised from the April 2026 first tranche closing of the (still to be fully completed) Debenture Offering nor from the successful May 2026 completion of the Life Offering.Conference CallThe Company will host a conference call and live audio webcast today at 5:00 pm Eastern Time to discuss its first quarter 2026 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. Claire™, recently approved by the U.S. Food and Drug Administration (FDA), is our next-generation AI-enabled device. The Company's ticker symbol "PINK" is a reference to the pink ribbons used during Breast Cancer Awareness Month.Indications for Use: The Claire OCT System is an adjunctive three-dimensional imaging tool which provides volumetric cross-sectional, real-time depth visualization, coupled with an artificial intelligence computer-aided detection algorithm which identifies and marks focal areas suspicious for breast cancer. It is used concurrently with physician interpretation of the images. The Claire OCT System is intended for use in conjunction with other standard methods for evaluation of the margins of excised lumpectomy tissue during surgical procedures in patients with a biopsy-confirmed diagnosis of breast cancer.The Claire OCT System should not be used to replace standard tissue histopathology assessment and should not be used for diagnosis. The device is not intended for use in any of the following individuals: under the age of 18, male, have metastatic cancer (Stage IV), have lobular carcinoma as their primary diagnosis, have had previous ipsilateral breast surgery for benign or malignant disease within two years (including implants and breast augmentation), patients with multi-centric disease (histologically diagnosed cancer in two different quadrants of the breast), unless resected in a single specimen, patients with bilateral disease (diagnosed cancer in both breasts), patients who are currently lactating, patients who are currently pregnant, or concurrent use in surgeries with cryo-assisted localization. Refer to prescriber labeling for full safety information.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 StatementsThis 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 Company's commercial launch of Claire OCT, expansion of its presence with leading healthcare institutions across the United States, ability to meaningfully improve patient outcomes, ability to drive sustained revenue growth and create long-term value, 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 and the commercialization of Claire and potential future market size and opportunity 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, 2025, which are available on Perimeter's SEDAR+ profile at https://www.sedarplus.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.ContactsStephen 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 View original content to download multimedia:https://www.prnewswire.com/news-releases/perimeter-announces-first-quarter-2026-financial-results-302785009.htmlSOURCE Perimeter Medical Imaging AI Inc. Original: Perimeter Announces First Quarter 2026 Financial Results
CA Market News
2月前
PERIMETER MEDICAL IMAGING AI CLOSES LIFE OFFERINGMay 5, 2026 3:55 PM
PR Newswire (Canada) /NOT FOR DISTRIBUTION TO UNITED STATES NEWS WIRE SERVICES OR FOR DISSEMINATION IN THE UNITED STATES/TORONTO, May 5, 2026 /CNW/ - Perimeter Medical Imaging AI, Inc. (TSXV: PINK) (OTCQX: PYNKF) ("Perimeter" or the "Company"), a commercial-stage medical technology company, is pleased to announce the successful closing of its previously announced "best efforts" offering, pursuant to the listed issuer financing exemption (the "Life Offering"), of 19,533,500 units of the Company (the "Units") at a price of $0.35 per Unit (the "Issue Price") for aggregate gross proceeds of approximately C$6,836,725. The Company expects to issue an additional 1,955,500 Units, for additional gross proceeds of C$684,425, in a final tranche of the Life Offering on or about May 6, 2026, to bring the total offering up to the maximum offering size of 21,489,000 Units (C$7,521,150).Each Unit is comprised of one common share in the capital of the Company (each, a "Common Share") and one Common Share purchase warrant (each, a "Warrant"). Each Warrant entitles the holder to acquire one Common Share until May 5, 2031 at an exercise price of C$0.50 per Common Share. Paradigm Capital Inc. acted as lead agent and sole bookrunner, together with Brookline Capital Markets, a division of Arcadia Securities, LLC (collectively, the "Agents"), in connection with the Life Offering.The Company also expects to complete additional closings of its previously announced concurrent non-brokered private placement (the "Concurrent Debenture Offering") of convertible debentures of the Company of up to US$3.0 million for aggregate gross proceeds of up to US$5.0 million (inclusive of the previously closed tranche as announced on April 28, 2026). The Company expects to raise aggregate proceeds of up to approximately C$14.42 million from the Life Offering together with the Concurrent Debenture Offering."We are excited to have completed this Life Offering, which was led by healthcare-dedicated institutional investors alongside new and existing investors that share our vision of transforming cancer surgery with next-generation imaging technology," said Adrian Mendes, Chief Executive Officer of Perimeter. "This financing significantly strengthens our balance sheet and positions us to execute the U.S. commercial launch of our FDA PMA-approved, AI-enabled Claire™ device for intraoperative breast cancer margin assessment. We are excited to advance the standard of care by helping reduce breast cancer re-excision rates, while improving patient outcomes."In connection with the Life Offering, the Company paid the Agents an aggregate cash commission of approximately C$468,955 and issued the Agents an aggregate of 1,339,870 broker warrants (the "Broker Warrants"), representing 7.0% of the gross proceeds raised and 7.0% of the aggregate number of Units issued under the Life Offering, respectively (in each case, reduced to 3.5% in respect of sales to certain president's list purchasers). The Company expects to pay an additional cash commission of approximately C$47,910 and issue an additional 136,885 Broker Warrants in connection with the closing of the final tranche of the Life Offering. Each Broker Warrant entitles the Agents to acquire one Common Share at a price of C$0.35 per Common Share for a period of 24 months following the closing of the Life Offering. The Company intends to use the net proceeds of the Life Offering for working capital and general corporate purposes, as described in the offering document for the Life Offering.The Life Offering was made pursuant to the listed issuer financing exemption available under Part 5A of National Instrument 45-106 – Prospectus Exemptions, as amended and supplemented by Coordinated Blanket Order 45-935 - Exemptions from Certain Conditions of the Listed Issuer Financing Exemption, in each of the provinces and territories of Canada other than Québec. The Units were also offered for sale in the United States on a private placement basis pursuant to available exemptions from the registration requirements under the United States Securities Act of 1933, as amended, and applicable state securities laws, and in other offshore jurisdictions provided that no prospectus filing or comparable obligation arose. The securities issued under the Life Offering are not subject to a statutory hold period under applicable Canadian securities laws.This press release does not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein in the United States. The securities described herein have not been and will not be registered under the United States Securities Act of 1933, as amended (the "U.S. Securities Act"), or any state securities laws, and may not be offered or sold within the United States unless registered under the U.S. Securities Act and applicable state securities laws or an exemption from such registration requirements is available.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. Claire™, recently approved by the U.S. Food and Drug Administration (FDA), is our next-generation AI-enabled device. The Company's ticker symbol "PINK" is a reference to the pink ribbons used during Breast Cancer Awareness Month.Indications for Use: The Claire OCT System is an adjunctive three-dimensional imaging tool which provides volumetric cross-sectional, real-time depth visualization, coupled with an artificial intelligence computer-aided detection algorithm which identifies and marks focal areas suspicious for breast cancer. It is used concurrently with physician interpretation of the images. The Claire OCT System is intended for use in conjunction with other standard methods for evaluation of the margins of excised lumpectomy tissue during surgical procedures in patients with a biopsy-confirmed diagnosis of breast cancer.The Claire OCT System should not be used to replace standard tissue histopathology assessment and should not be used for diagnosis. The device is not intended for use in any of the following individuals: under the age of 18, male, have metastatic cancer (Stage IV), have lobular carcinoma as their primary diagnosis, have had previous ipsilateral breast surgery for benign or malignant disease within two years (including implants and breast augmentation), patients with multi-centric disease (histologically diagnosed cancer in two different quadrants of the breast), unless resected in a single specimen, patients with bilateral disease (diagnosed cancer in both breasts), patients who are currently lactating, patients who are currently pregnant, or concurrent use in surgeries with cryo-assisted localization. Refer to prescriber labeling for full safety information.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 StatementsThis 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, statements regarding the expected use of proceeds of the Life Offering, the closing of additional tranches of the Life Offering and expected proceeds from and closing of the Concurrent Debenture Offering 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 Annual Information form for the year ended December 31, 2025, which is available on Perimeter's SEDAR+ profile at https://www.sedarplus.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.ContactsStephen Kilmer
Investor Relations
Direct: 647-872-4849
Email: skilmer@perimetermed.comAdrian Mendes
Chief Executive Officer
Toll-free: 888-988-7465 (PINK)
Email: investors@perimetermed.com SOURCE Perimeter Medical Imaging AI Inc. Original: PERIMETER MEDICAL IMAGING AI CLOSES LIFE OFFERING
CA Market News
2月前
Perimeter Medical Imaging AI Closes First Tranche of Non-Brokered Private PlacementApril 28, 2026 8:15 AM
PR Newswire (Canada)
/NOT FOR RELEASE OR DISTRIBUTION IN THE UNITED STATES OR FOR DISSEMINATION TO U.S. NEWS WIRE SERVICES/TORONTO and DALLAS, April 28, 2026 /CNW/ - Perimeter Medical Imaging AI, Inc. (TSXV: PINK) (OTC: PYNKF) ("Perimeter" or the "Company"), a commercial-stage medical technology company, is pleased to announce that, further to its press release dated April 21, 2026, it has closed the first tranche of its previously announced non-brokered private placement (the "Debenture Offering") of convertible debentures of the Company (the "Convertible Debentures"). Under the first tranche of the Debenture Offering, the Company has issued CDN$2,760,000 (approximately US$2.0 million) principal amount of Convertible Debentures to Adrian Mendes, its Chief Executive Officer.The Company expects to complete additional closings of the Debenture Offering of up to US$3.0 million for aggregate gross proceeds of up to US$5.0 million.The Company also expects to close its previously announced brokered "best efforts" offering under the listed issuer financing exemption (the "LIFE Offering"), for aggregate gross proceeds of up to approximately CDN$7.5 million, on or about May 5, 2026.Each Convertible Debenture consists of CDN$1,000 principal amount of 3.59% convertible debentures of the Company, maturing on April 27, 2029 (the "Maturity Date"). The outstanding principal under the Convertible Debentures is (i) convertible at the option of the holder, at any time prior to the close of business on the last business day immediately preceding the Maturity Date, into units of the Company (the "Debenture Units") at the conversion price of CDN$0.415 per Debenture Unit (the "Conversion Price") or (ii) automatically converted into Debenture Units at the Conversion Price upon the occurrence of, and immediately following, any transaction that results in the Company continuing from the jurisdiction of British Columbia, Canada to the United States, any state thereof, or the District of Columbia (a "Redomiciling Transaction").Each Debenture Unit will be comprised of one common share in the capital of the Company (each, a "Common Share") and one Common Share purchase warrant (each, a "Debenture Warrant"). Each Debenture Warrant shall entitle the holder to acquire one Common Share until April 27, 2031, at an exercise price of CDN$0.59. The accrued and unpaid interest under the Convertible Debentures will be satisfied on the Maturity Date or upon the occurrence of a Redomiciling Transaction in either cash or, at the option of the Company and subject to the approval of the TSX Venture Exchange (the "TSXV"), by the issue of the equivalent value in units of the Company ("Interest Units") at a price per Interest Unit equal to the volume-weighted average price of the Common Shares on the TSXV for the five trading days preceding the applicable conversion date (provided that such price is not less than the Market Price (as such term is defined in the policies of the TSXV) of the Common Shares at the time of conversion) (the "Interest Conversion Price"). Each Interest Unit will consist of one Common Share and one Common Share purchase warrant (each, an "Interest Warrant"). Each Interest Warrant shall entitle the holder to acquire one Common Share until April 27, 2031, at an exercise price equal to a 43.0% premium to the Interest Conversion Price.The Company intends to use the proceeds of the Debenture Offering for working capital and general corporate purposes. All securities issued pursuant to the Debenture Offering will be subject to a statutory hold period of four months plus a day from the date of issuance in accordance with applicable Canadian securities laws.This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of the securities in any jurisdiction in which such offer, solicitation or sale would be unlawful. The securities being offered have not been, nor will they be, registered under the 1933 Act and may not be offered or sold in the United States or to, or for the account or benefit of, U.S. persons absent registration or an applicable exemption from the registration requirements of the 1933 Act, and applicable state securities laws.Adrian Mendes, the Chief Executive Officer of the Company, purchased a total of CDN$2,760,000 principal amount Convertible Debentures under the Debenture Offering. The placement to such person constituted a "related party transaction" within the meaning of TSXV Policy 5.9 and Multilateral Instrument 61-101 - Protection of Minority Security Holders in Special Transactions ("MI 61-101"). The Company has relied on exemptions from the formal valuation and minority shareholder approval requirements of MI 61-101 contained in sections 5.5(a) and 5.7(1)(a) of MI 61-101 in respect of related party participation in the placement as neither the fair market value (as determined under MI 61-101) of the subject matter of, nor the fair market value of the consideration for, the transaction, insofar as it involved the related party, exceeded 25% of the Company's market capitalization (as determined under MI 61-101). The Company has not filed a material change report more than 21 days before the closing of the first tranche of the Debenture Offering as the details of the Debenture Offering and the participants thereof were only finalized shortly before the closing of the first tranche of the Debenture Offering.Early Warning DisclosureIn accordance with the requirements of National Instrument 62-103 - The Early Warning System and Related Take-Over Bid and Insider Reporting Issues, Mr. Mendes is required to file an early warning report relating to his acquisition of CDN$2,760,000 principal amount of Convertible Debentures under the Debenture Offering. Prior to the Debenture Offering, Mr. Mendes owned 15,361,726 Common Shares, 14,989,976 Common Share purchase warrants ("Owned Warrants") and 2,905,908 options to purchase Common Shares ("Options"), which represented approximately 11.6% of the Common Shares outstanding on an undiluted basis and 22.2% on a partially diluted basis, assuming the exercise of the 14,989,976 Owned Warrants and 2,905,908 Options. Following the closing of the Debenture Offering, Mr. Mendes now owns 15,361,726 Common Shares, 14,989,976 Owned Warrants, 2,905,908 Options and CDN$2,760,000 principal amount of Convertible Debentures, representing approximately 11.6% of the Common Shares outstanding on an undiluted and 28.5% on a partially diluted basis, assuming the exercise of the 14,989,976 Owned Warrants, 2,905,908 Options and CDN$2,760,000 principal amount of Convertible Debentures (including the 6,650,602 Debenture Warrants underlying the Debenture Units). Mr. Mendes acquired the Convertible Debentures for investment purposes. The Convertible Debentures and certain of the Owned Warrants are subject to a blocker provision providing that Mr. Mendes shall not be entitled to convert the Convertible Debentures or exercise such Owned Warrants to the extent that, after giving effect to such conversion or exercise, as applicable, Mr. Mendes would beneficially own more than 20% of the Common Shares issued and outstanding at the time of exercise, unless the Company has first obtained shareholder approval thereof in accordance with the policies of the TSXV and the TSXV has in any case confirmed the suitability of Mr. Mendes as a new "control person" of the Company (as such term is defined in the policies of the TSXV). Therefore, Mr. Mendes was not a "control person" (as such term is defined in the policies of the TSXV) prior to the closing of the Debenture Offering and the Debenture Offering has not resulted in the creation of a new "control person" of the Company. In the future, Mr. Mendes will evaluate his investment in the Company from time to time and may, based on such evaluation, market conditions and other circumstances, increase or decrease his shareholdings as circumstances require through market transactions, private agreements, or otherwise.A copy of the early warning report to be filed by Mr. Mendes may be obtained under the Company's profile on SEDAR+ at www.sedarplus.com or may be obtained by contacting the Company at 1-888-988-7465 (PINK).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. Claire™, recently approved by the U.S. Food and Drug Administration (FDA), is our next-generation AI-enabled device. The Company's ticker symbol "PINK" is a reference to the pink ribbons used during Breast Cancer Awareness Month.Indications for Use: The Claire OCT System is an adjunctive three-dimensional imaging tool which provides volumetric cross-sectional, real-time depth visualization, coupled with an artificial intelligence computer-aided detection algorithm which identifies and marks focal areas suspicious for breast cancer. It is used concurrently with physician interpretation of the images. The Claire OCT System is intended for use in conjunction with other standard methods for evaluation of the margins of excised lumpectomy tissue during surgical procedures in patients with a biopsy-confirmed diagnosis of breast cancer.The Claire OCT System should not be used to replace standard tissue histopathology assessment and should not be used for diagnosis. The device is not intended for use in any of the following individuals: under the age of 18, male, have metastatic cancer (Stage IV), have lobular carcinoma as their primary diagnosis, have had previous ipsilateral breast surgery for benign or malignant disease within two years (including implants and breast augmentation), patients with multi-centric disease (histologically diagnosed cancer in two different quadrants of the breast), unless resected in a single specimen, patients with bilateral disease (diagnosed cancer in both breasts), patients who are currently lactating, patients who are currently pregnant, or concurrent use in surgeries with cryo-assisted localization. Refer to prescriber labeling for full safety information.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 StatementsThis 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 expected size of the Debenture Offering, the closing of additional tranches, the closing of the LIFE Offering, the use of proceeds of the Debenture Offering, the number of Convertible Debentures to be offered or sold and the timing and ability of Perimeter to complete a Redomiciling Transaction (if at all), 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 Annual Information Form for the year ended December 31, 2025, which is available on Perimeter's SEDAR+ profile at https://www.sedarplus.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.ContactsStephen 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.
Original: Perimeter Medical Imaging AI Closes First Tranche of Non-Brokered Private Placement
CA Market News
3月前
Perimeter Medical Imaging AI Announces LIFE Financing and Concurrent Private PlacementApril 21, 2026 7:15 AM
PR Newswire (Canada)
/NOT FOR RELEASE OR DISTRIBUTION IN THE UNITED STATES OR FOR DISSEMINATION TO U.S. NEWS WIRE SERVICES/TORONTO and DALLAS, April 21, 2026 /CNW/ - Perimeter Medical Imaging AI, Inc. (TSXV: PINK) (OTC: PYNKF) ("Perimeter" or the "Company"), a commercial-stage medical technology company, is pleased to announce that it has entered into an agreement with Paradigm Capital Inc., as lead agent and sole bookrunner on behalf of a syndicate of agents (collectively, the "Agents"), in connection with a "best efforts" offering under the listed issuer financing exemption (the "LIFE Offering") of up to 21,489,000 units of the Company (the "Units"), at an offering price of $0.35 per Unit, for aggregate gross proceeds of up to approximately $7.52 million, subject to a minimum offering amount of approximately $5.55 million (the "Minimum LIFE Amount"). The Company also intends to complete a concurrent non-brokered private placement of convertible debentures (the "Convertible Debentures"), for aggregate gross proceeds of up to approximately USD$5 million (the "Concurrent Offering" and, together with the LIFE Offering, the "Offerings").Each Unit will be comprised of one common share in the capital of the Company (each a "Common Share") and one Common Share purchase warrant (each, a "Warrant"). Each Warrant shall entitle the holder to acquire one Common Share for a period of 60 months from the closing of the LIFE Offering, at an exercise price of $0.50. In connection with the Concurrent Offering, the Company has entered into binding subscription agreements with Adrian Mendes, its Chief Executive Officer, and SC Master Holdings LLC ("Social Capital"), representing expected subscription proceeds totaling approximately $5.5 million.Under the Concurrent Offering, each Convertible Debenture will consist of $1,000 principal amount of 3.59% convertible debentures of the Company, maturing three years following the initial closing date of the Concurrent Offering (the "Maturity Date"). The outstanding principal under the Convertible Debentures will be (i) convertible at the option of the holder, at any time prior to the close of business on the last business day immediately preceding the Maturity Date, into units of the Company (the "Debenture Units") at the conversion price of $0.415 per Debenture Unit (the "Conversion Price") or (ii) automatically converted into Debenture Units at the Conversion Price upon the occurrence of, and immediately following, any transaction that results in the Company continuing from the jurisdiction of British Columbia, Canada to the United States, any state thereof, or the District of Columbia (a "Redomiciling Transaction") provided, however, that the conversion will be directly into Debenture Units of the Company after it has become a corporation organized under the laws of the United States, any state, or the District of Columbia in connection with the Redomiciling Transaction.Each Debenture Unit will be comprised of one Common Share and one Common Share purchase warrant (each, a "Debenture Warrant"). Each Debenture Warrant shall entitle the holder to acquire one Common Share for a period of 60 months from the initial closing of the Concurrent Offering, at an exercise price of $0.59. The accrued and unpaid interest under the Convertible Debentures will be satisfied on the Maturity Date or upon the occurrence of a Redomiciling Transaction in either cash or, at the option of the Company and subject to the approval of the TSX Venture Exchange, by the issue of the equivalent value in units of the Company ("Interest Units") at a price per Interest Unit equal to the volume-weighted average price of the Common Shares on the TSX Venture Exchange for the five trading days preceding the applicable conversion date (the "Interest Conversion Price"). Each Interest Unit will consist of one Common Share and one Common Share purchase warrant (each, an "Interest Warrant"). Each Interest Warrant shall entitle the holder to acquire one Common Share for a period of 60 months from the initial closing date of the Concurrent Offering, at an exercise price equal to a 43% premium to the Interest Conversion Price.The Company is evaluating whether or not to complete a Redomiciling Transaction, which would remain subject to the approval of its shareholders and board of directors. The Company expects that, in the case of conversion of the Convertible Debentures in connection with a Redomiciling Transaction, the securities issuable thereunder may qualify as qualified small business stock within the meaning of Section 1202 or Section 1045 of the Internal Revenue Code of the United States. Potential investors should consult with their independent tax advisors prior to making any investment decision. In the event that the Company elects to proceed with a Redomiciling Transaction, further information will be provided at such time.The Company will pay to the Agents a cash fee equal to 7% of the gross proceeds raised under the LIFE Offering (the "Cash Commission"), and issue the Agents broker warrants equal to 7% of the aggregate number of Units issued under the LIFE Offering (the "Broker Warrants"), provided however that the Cash Commission and Broker Warrants payable in connection with sales to certain president's list purchasers will be reduced to 3.5% and 3.5%, respectively. Each Broker Warrant shall entitle the Agents to buy one Common Share at a price of $0.35 per Common Share. The Broker Warrants shall be exercisable until that date which is 24 months following the Closing Date (as defined below).The LIFE Offering is conditional upon the closing of the Minimum LIFE Amount. All securities issued pursuant to the LIFE Offering will not be subject to a hold period under applicable Canadian securities laws. All securities issued pursuant to the Concurrent Offering will be subject to a statutory hold period of four months plus a day from the date of issuance in accordance with applicable Canadian securities laws. The first tranche of the LIFE Offering is expected to close on or about May 5, 2026 (the "Closing Date") and the first tranche of the Concurrent Offering is expected to close on or about April 24, 2026, both of which are subject to certain conditions including, but not limited to, the receipt of all necessary regulatory and stock exchange approvals, including the approval of the TSX Venture Exchange.The Company intends to use the proceeds of the Offerings for working capital and general corporate purposes and as described in the offering document for the LIFE Offering.The Units will be offered in all provinces and territories of Canada, except Québec, in accordance with Part 5A of National Instrument 45-106 – Prospectus Exemptions, under the listed issuer financing exemption, as amended and supplemented by Coordinated Blanket Order 45-935 Exemptions from Certain Conditions of the Listed Issuer Financing Exemption. The Units may also be offered in the United States on a private placement basis pursuant to applicable exemptions from the registration requirements of the United States Securities Act of 1933, as amended (the "1933 Act") and applicable state securities laws, and in other offshore jurisdictions provided that no prospectus filing or comparable obligation arises.The Convertible Debentures will be offered in all provinces and territories of Canada, except Québec, on a private placement basis. The Convertible Debentures may also be offered in the United States on a private placement basis pursuant to applicable exemptions from the registration requirements of the 1933 Act and applicable state securities laws, and in other offshore jurisdictions provided that no prospectus filing or comparable obligation arises.There is an offering document related to the LIFE Offering that can be accessed under the Company's profile at www.sedarplus.com and at https://perimetermed.com/. Prospective investors should read this offering document before making an investment decision.This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of the securities in any jurisdiction in which such offer, solicitation or sale would be unlawful. The securities being offered have not been, nor will they be, registered under the 1933 Act and may not be offered or sold in the United States or to, or for the account or benefit of, U.S. persons absent registration or an applicable exemption from the registration requirements of the 1933 Act, and applicable state securities laws.Adrian Mendes, the Chief Executive Officer of the Company, has entered into a binding subscription agreement to purchase a total of USD$2,000,000 (approximately CDN$2,760,000) principal amount Convertible Debentures under the Concurrent Offering and Social Capital, a control person of the Company, has entered into a binding subscription agreement to purchase a total of USD$2,000,000 (approximately CDN$2,760,000) principal amount Convertible Debentures under the Concurrent Offering. The placement to such persons will constitute a "related party transaction" within the meaning of TSX Venture Exchange Policy 5.9 and Multilateral Instrument 61-101 - Protection of Minority Security Holders in Special Transactions ("MI 61-101"). The Company has relied on exemptions from the formal valuation and minority shareholder approval requirements of MI 61-101 contained in sections 5.5(a) and 5.7(1)(a) of MI 61-101 in respect of related party participation in the placement as neither the fair market value (as determined under MI 61-101) of the subject matter of, nor the fair market value of the consideration for, the transaction, insofar as it involved the related parties, exceeded 25% of the Company's market capitalization (as determined under MI 61-101). The Company has not filed a material change report more than 21 days before the expected closing of the Offerings as the details of the Offerings and the participants thereof have not yet been finalized.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. Claire™, recently approved by the U.S. Food and Drug Administration (FDA), is our next-generation AI-enabled device. The Company's ticker symbol "PINK" is a reference to the pink ribbons used during Breast Cancer Awareness Month.Indications for Use: The Claire OCT System is an adjunctive three-dimensional imaging tool which provides volumetric cross-sectional, real-time depth visualization, coupled with an artificial intelligence computer-aided detection algorithm which identifies and marks focal areas suspicious for breast cancer. It is used concurrently with physician interpretation of the images. The Claire OCT System is intended for use in conjunction with other standard methods for evaluation of the margins of excised lumpectomy tissue during surgical procedures in patients with a biopsy-confirmed diagnosis of breast cancer.The Claire OCT System should not be used to replace standard tissue histopathology assessment and should not be used for diagnosis. The device is not intended for use in any of the following individuals: under the age of 18, male, have metastatic cancer (Stage IV), have lobular carcinoma as their primary diagnosis, have had previous ipsilateral breast surgery for benign or malignant disease within two years (including implants and breast augmentation), patients with multi-centric disease (histologically diagnosed cancer in two different quadrants of the breast), unless resected in a single specimen, patients with bilateral disease (diagnosed cancer in both breasts), patients who are currently lactating, patients who are currently pregnant, or concurrent use in surgeries with cryo-assisted localization. Refer to prescriber labeling for full safety information.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 StatementsThis 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 expected size of the Offerings, the use of proceeds of the Offerings, the jurisdictions in which the Units and Convertible Debentures will be offered or sold, the number of Units and Convertible Debentures to be offered or sold, the ability of Perimeter to close the Offerings on the terms announced (if at all), the timing and ability of Perimeter to complete a Redomiciling Transaction (if at all) and the timing and ability of Perimeter to satisfy the conditions to closing of the Offerings (if at all), 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 Annual Information form for the year ended December 31, 2025, which is available on Perimeter's SEDAR+ profile at https://www.sedarplus.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.ContactsStephen Kilmer
Investor Relations
Direct: 647-872-4849
Email: skilmer@perimetermed.comAdrian Mendes
Chief Executive Officer
Toll-free: 888-988-7465 (PINK)
Email: investors@perimetermed.com
SOURCE Perimeter Medical Imaging AI Inc.
Original: Perimeter Medical Imaging AI Announces LIFE Financing and Concurrent Private Placement
CA Market News
3月前
Perimeter Announces Preliminary Unaudited Fourth Quarter and Full Year 2025 Financial Results Marked by Record Revenues and Improved Operating PerformanceMarch 31, 2026 4:15 PM
PR Newswire (Canada)
Conference Call/Webcast Today at 5:00 pm ETTORONTO and DALLAS, March 31, 2026 /CNW/ - Perimeter Medical Imaging AI, Inc. (TSXV: PINK) (OTCQX: PYNKF) ("Perimeter" or the "Company"), a commercial-stage medical technology company, today reported preliminary unaudited financial results for its fourth quarter and full year ended December 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."2025 marked a pivotal inflection point for Perimeter as we executed against our strategic roadmap and positioned the Company for what we believe is a significant long-term growth opportunity," commented Adrian Mendes, Perimeter's Chief Executive Officer. "We made substantial progress seeding the market with our S-Series OCT platform, expanding our image dataset, and building commercial momentum, while simultaneously advancing our next-generation AI-enabled solution. The strength of our execution is underscored by the March 2026 FDA PMA approval of our Claire™ OCT device. This milestone not only validates our technology and strategy but also positions Perimeter at the forefront of innovation in breast cancer surgery, with the opportunity to meaningfully improve patient outcomes.""Building on this strong foundation, we are now squarely focused on the upcoming commercial launch of Claire OCT and on expanding our presence with leading healthcare institutions across the United States. With a growing installed base, increasing consumable sales, and a differentiated OCT + AI enabled platform, we believe Perimeter is uniquely positioned to drive sustained revenue growth and create long-term value. At the same time, we remain committed to advancing our clinical and product roadmap as we work to establish Perimeter's technology as a standard of care in breast-conserving surgery and, over time, expand our propriety, AI-enabled OCT technology into additional medical applications," Mr. Mendes concluded.Business HighlightsFirst FDA 510(k)-Cleared Device: Perimeter S-Series OCT While the U.S. Food and Drug Administration ("FDA") continued to review the Company's Premarket Approval ("PMA") application for its next-generation system for use during breast-conserving surgeries in the United States, commercial market traction with the Company's first FDA-cleared product under a general indication, the Perimeter S-Series OCT system, continued to grow:Q4-2025 revenue of $711,000, up 143% year-over-year compared to Q4-2024, and up 33% sequentially from Q3-2025.Full year 2025 revenue of $2.3 million was 172% higher than revenue for 2024.In November 2025, Dr. Kayla Griffith, Breast Surgical Oncologist, and HCA HealthONE Rose, part of the HCA HealthONE network of 9 hospitals and 17 surgery centers in the Rocky Mountain region and one of the largest health systems in the Denver area, were the first in Colorado to adopt the Company's S-Series OCT for tissue visualization in the operating room.In January 2026, Perimeter entered into an agreement with Intermountain Health, the largest nonprofit healthcare system in the Intermountain West region, to enable the deployment of S-Series OCT for tissue visualization in the operating rooms at Intermountain Health LDS Hospital in Salt Lake City and Intermountain Health American Fork Hospital in American Fork, Utah.Introducing Claire™, the First AI-enabled Imaging Device to Receive FDA PMA Approval for Intraoperative Breast Cancer Margin AssessmentIn early March 2026, Claire, which combines Perimeter's proprietary artificial intelligence ("AI") with its patented wide-field OCT imaging to enable high-resolution, real-time evaluation of excised tumor margins, received FDA PMA approval.Claire delivers 10 times higher resolution than standard X-ray and ultrasound at 2mm imaging depth - the clinically relevant margin width for breast cancer margin assessment. Claire's innovative AI technology was trained on Perimeter's proprietary and growing OCT image library of over 2 million breast tissue images.The technology, which previously received Breakthrough Device designation from the FDA, is designed to enhance surgeons' ability to detect difficult-to-see cancer during breast-conserving surgery and potentially reduce the need for re-operations.Perimeter is making final preparations for the U.S. commercial launch of Claire, which it expects to begin in Q2-2026.CorporateIn December 2025, Perimeter announced the closing of a non-brokered private placement where the Company issued an aggregate of 19,757,306 Units at a price of C$0.18 per Unit for aggregate gross proceeds of C$3,556,315.In February 2026, Perimeter entered into cancellation agreements with certain employees and consultants of the Company, pursuant to which it cancelled 2,175,619 previously issued stock options (the "Original Options"), exercisable at prices ranging from C$0.38 to C$2.85, and replaced the same number of Original Options with new stock options, exercisable at a price of C$0.30 per common share. No directors or officers of the Company have entered or will enter into cancellation agreements, have had Original Options cancelled or received Replacement Options.In March 2026, Perimeter entered into a warrant cancellation agreement with SC Master Holdings LLC ("Social Capital"), pursuant to which Social Capital agreed to surrender 14,466,667 common share purchase warrants of the Company for cancellation, for no consideration.Summary Preliminary Unaudited Fourth Quarter 2025 Financial Results1Revenue was approximately $711,000 for the fourth quarter of 2025, which consisted of the sale of consumables and system leases, as well as from the sale of ESP warranty programs. Fourth quarter 2025 revenues increased 143% over approximately $293,000 in Q4-2024.Operating expenses for the three months ended December 31, 2025 were approximately $2.5 million, down 46% from $4.7 million in the same period in 2024.Fourth quarter 2025 net loss was approximately $2.0 million, or $0.02 per common share, a 42% improvement compared to approximately $3.4 million, or $0.06 per common share, in the three months ended December 31, 2024.Summary Preliminary Unaudited Full Year 2025 Financial Results1For the year ended December 31, 2025, revenue was approximately $2.3 million, a 172% increase compared to approximately $846,000 in the prior year. Throughout 2025, revenue growth was driven by commercial adoption of Perimeter S-Series OCT, both in terms of existing system utilization and installed base growth.Perimeter's full year 2025 operating expenses were approximately $14.4 million compared to approximately $19.4 million in 2024.Full year 2025 net loss was approximately $12.9 million, or $0.16 per common share, compared to a net loss of approximately $13.4 million, or $0.19 per common share, in 2024.Cash used in operating activities in the 12 months ended December 31, 2025, was approximately $9.3 million, a 36% improvement from approximately $14.7 million the comparable period in 2024.As of December 31, 2025, cash was approximately $2.5 million.Perimeter currently anticipates that it will file its annual audited consolidated financial statements, its annual management's discussion and analysis, and its certification of annual filings for the year ended December 31, 2025 on SEDAR+ and the Company's website on or about April 2, 2026.1 Preliminary and unaudited financial results are subject to customary financial statement procedures by the Company and its auditors. Actual results could be affected by subsequent events or determinations. While the Company believes there is a reasonable basis for these preliminary financial results, the results involve known and unknown risks and uncertainties that may cause actual results to differ materially. Preliminary fiscal results represent forward-looking information. See "Cautionary Note Regarding Forward-Looking Information and Statements" and "Financial Outlook". The audit of the consolidated financial statements for the year and three months ended December 31, 2025, is currently in process. All financial information contained in this press release is qualified in its entirety with reference to such financial statements.Conference CallThe Company will host a conference call and live audio webcast today at 5:00 pm Eastern Time to discuss its preliminary unaudited fourth quarter and full year 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. Claire, recently approved by the FDA, is our next-generation AI-enabled device. The Company's ticker symbol "PINK" is a reference to the pink ribbons used during Breast Cancer Awareness Month.Indications for Use: The Claire OCT System is an adjunctive three-dimensional imaging tool which provides volumetric cross-sectional, real-time depth visualization, coupled with an artificial intelligence computer-aided detection algorithm which identifies and marks focal areas suspicious for breast cancer. It is used concurrently with physician interpretation of the images. The Claire OCT System is intended for use in conjunction with other standard methods for evaluation of the margins of excised lumpectomy tissue during surgical procedures in patients with a biopsy-confirmed diagnosis of breast cancer.The Claire OCT System should not be used to replace standard tissue histopathology assessment and should not be used for diagnosis. The device is not intended for use in any of the following individuals: under the age of 18, male, have metastatic cancer (Stage IV), have lobular carcinoma as their primary diagnosis, have had previous ipsilateral breast surgery for benign or malignant disease within two years (including implants and breast augmentation), patients with multi-centric disease (histologically diagnosed cancer in two different quadrants of the breast), unless resected in a single specimen, patients with bilateral disease (diagnosed cancer in both breasts), patients who are currently lactating, patients who are currently pregnant, or concurrent use in surgeries with cryo-assisted localization. Refer to prescriber labeling for full safety information. 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 StatementsThis 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 Company's results for the three and 12 months ended December 31, 2025, commercial launch of Claire OCT, expansion of its presence with leading healthcare institutions across the United States, ability to meaningfully improve patient outcomes, ability to drive sustained revenue growth and create long-term value, 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 and the commercialization of Claire and potential future market size and opportunity 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.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.Financial OutlookThis press release contains a financial outlook within the meaning of applicable Canadian securities laws. The financial outlook has been prepared by management of the Company to provide an outlook for certain of the Company's financial results for the three and 12 months ended December 31, 2025 and may not be appropriate for any other purpose. The financial outlook has been prepared based on a number of assumptions including the assumptions discussed under the heading "Forward-Looking Statements" herein. The actual results of the Company's operations for any period will likely vary from the amounts set forth in these projections and such variations may be material. The Company and its management believe that the financial outlook has been prepared on a reasonable basis. However, because this information is highly subjective and subject to numerous risks, including the risks discussed under the heading "Forward-Looking Statements" herein, it should not be relied on as necessarily indicative of future results.ContactsStephen 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
View original content to download multimedia:https://www.prnewswire.com/news-releases/perimeter-announces-preliminary-unaudited-fourth-quarter-and-full-year-2025-financial-results-marked-by-record-revenues-and-improved-operating-performance-302730573.htmlSOURCE Perimeter Medical Imaging AI Inc.
Original: Perimeter Announces Preliminary Unaudited Fourth Quarter and Full Year 2025 Financial Results Marked by Record Revenues and Improved Operating Performance
CA Market News
4月前
Perimeter Schedules Fourth Quarter and Full Year 2025 Financial Results Conference Call for March 31st; Provides Corporate UpdateMarch 23, 2026 5:00 PM
PR Newswire (US)
TORONTO and DALLAS, March 23, 2026 /PRNewswire/ - Perimeter Medical Imaging AI, Inc. (TSXV: PINK) (OTCQX: PYNKF) ("Perimeter" or the "Company"), a commercial-stage medical technology company, announced it will report its fourth quarter and full year 2025 financial and operating results after market close on Tuesday, March 31, 2026. Following the announcement, Perimeter management will host a webcast and conference call to discuss the results and provide a corporate update.Fourth Quarter and Full Year 2025 Results Conference Call Details:Date: Tuesday, March 31, 2026
Time: 5:00 pm Eastern Time
Dial-In Numbers: 1-800-717-1738 (Canada and the United States) or 1-646-307-1865 (International)The call will also be broadcast live and archived on the Company's website here.Warrant Cancellation AgreementThe Company also announces that it has entered into a warrant cancellation agreement (the "Warrant Cancellation Agreement") with SC Master Holdings LLC ("Social Capital"), pursuant to which Social Capital has agreed to surrender 14,466,667 common share purchase warrants (the "Warrants") of the Company for cancellation, for no consideration. 80% of the Warrants had a strike price of C$3.99 and 20% of the Warrants had a strike price of C$4.50. Half of the Warrants at each strike price were subject to accelerated expiry if the 60-day volume weighted average trading price of Perimeter's Common Shares is greater than the strike price during the applicable period. The other half of the Warrants were not subject to accelerated expiry, and instead may have been exercised for cash or exercised using a cashless exercise feature at any time prior to expiry. Subject to the accelerated expiry clause described above, all Warrants had an expiration date of January 27, 2027.Early Warning Disclosure as a Result of the Warrant CancellationPrior to the cancellation of the Warrants, Social Capital owned 29,089,337 common shares and 14,581,881 Warrants representing 22.2% of Perimeter's outstanding common shares on a non-diluted basis and 30% of the outstanding Perimeter Common Shares on a partially-diluted basis, assuming exercise of the Warrants. Following the cancellation of the Warrants, Social Capital owns 29,089,337 Perimeter common shares and 115,214 Warrants representing 22.2% of the outstanding Perimeter common shares on a non-diluted basis and 22.3% of the outstanding Perimeter common shares on a partially-diluted basis, assuming exercise of the Warrants.Social Capital holds the Perimeter common shares and Warrants for investment purposes.The foregoing disclosure is being disseminated pursuant to National Instrument 62-103 – The Early Warning System and Related Take-Over Bid and Insider Reporting. A copy of the report to be filed with Canadian securities regulators in connection with the cancellation of the Warrants will be available on Perimeter's SEDAR+ profile at www.sedarplus.com and a copy may be obtained by contacting Perimeter as noted under "Contacts" below.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. Claire, recently approved by the FDA, is our next-generation AI-enabled device. The Company's ticker symbol "PINK" is a reference to the pink ribbons used during Breast Cancer Awareness Month.Indications for Use: The Claire OCT System is an adjunctive three-dimensional imaging tool which provides volumetric cross-sectional, real-time depth visualization, coupled with an artificial intelligence computer-aided detection algorithm which identifies and marks focal areas suspicious for breast cancer. It is used concurrently with physician interpretation of the images. The Claire OCT System is intended for use in conjunction with other standard methods for evaluation of the margins of excised lumpectomy tissue during surgical procedures in patients with a biopsy-confirmed diagnosis of breast cancer.The Claire OCT System should not be used to replace standard tissue histopathology assessment and should not be used for diagnosis. The device is not intended for use in any of the following individuals: under the age of 18, male, have metastatic cancer (Stage IV), have lobular carcinoma as their primary diagnosis, have had previous ipsilateral breast surgery for benign or malignant disease within two years (including implants and breast augmentation), patients with multi-centric disease (histologically diagnosed cancer in two different quadrants of the breast), unless resected in a single specimen, patients with bilateral disease (diagnosed cancer in both breasts), patients who are currently lactating, patients who are currently pregnant, or concurrent use in surgeries with cryo-assisted localization. Refer to prescriber labeling for full safety information. 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.CONTACTS:Stephen Kilmer
Investor Relations
Direct: 647-872-4849
Email: skilmer@perimetermed.comAdrian Mendes
Chief Executive Officer
Toll-free: 888-988-7465 (PINK)
Email: investors@perimetermed.com
View original content to download multimedia:https://www.prnewswire.com/news-releases/perimeter-schedules-fourth-quarter-and-full-year-2025-financial-results-conference-call-for-march-31st-provides-corporate-update-302722488.htmlSOURCE Perimeter Medical Imaging AI Inc.
Original: Perimeter Schedules Fourth Quarter and Full Year 2025 Financial Results Conference Call for March 31st; Provides Corporate Update
INV4
4月前
Thanks nowwhat2 also found this:
FDA premarket approval (PMA) is a rigorous process that evaluates the safety and effectiveness of Class III medical devices before they can be sold in the U.S. This process requires manufacturers to provide substantial scientific evidence to demonstrate that their devices are safe for patients.
PMA meaning: understanding FDA pre-market approval
• The FDA PMA process is a crucial regulatory gateway for companies bringing high-risk medical devices to the US market.
• But "what is a PMA?" is a frequently-asked question. The PMA process is complex, stringent and often misunderstood.
• This blog post maps out everything you need to know about securing FDA PMA approval for your organization.
What is PMA?
The FDA PMA process is a US regulatory pathway for the approval of high-risk medical devices before they can be marketed and sold.
The PMA process is applicable to medical devices that are considered to have a high risk to patients, such as life-sustaining or life-supporting devices.
The FDA PMA process involves a comprehensive review of scientific data and evidence submitted by the device manufacturer.
You need to provide detailed information about your device's design, manufacturing process and performance and clinical data, demonstrating safety and efficacy throughout. The FDA then assesses this information to determine whether your device meets the required standards for clearance.
The PMA process, reflecting the high-risk nature of the devices it scrutinizes, is rigorous and typically involves multiple stages of review, including a quality management system review as well as a thorough scientific and clinical evaluation, usually including clinical trials.
It also includes inspection of your manufacturing facilities. The FDA assesses the benefits and risks of your device based on the data provided, as well as the potential impact on patient health and safety.
Upon successful completion of the PMA process, the FDA clears your device for marketization, allowing it to be sold and used in the United States.
PMA definition
'PMA' simply stands for 'pre-market approval'.
The logic is clear: the FDA requires pre-market approval for high-risk medical devices to ensure their safety and effectiveness before they enter the bodies of patients.
No PMA? No legal ability to market your high-risk device.
PMA meaning
Completing a PMA means that your medical device must pass through a comprehensive safety review process.
FDA PMA approval proves that the FDA has determined your device to be safe and effective for its intended use and, although high-risk by nature, offers sufficient patient benefit alongside its controlled risk to pose a net benefit to society.
FDA medical devices classification
The FDA categorizes all medical devices marketed in the US into three broad risk categories:
As you can see, while low-risk Class I devices require only general medical device controls with no regulatory oversight, and Class II devices require Special Controls alongside a 510(k) submission, it's Class III high-risk devices that fall under the FDA PMA bracket.
Class III devices constitute around 10% of all medical devices marketed in the US.
This tripartite regulatory structure embodies the FDA's emphasis on appropriate, targeted and risk-based oversight of life science products.
The higher your risk class, the higher the burden of proof that falls on you, the manufacturer, to prove to the FDA that your device is safe and effective.
The FDA PMA approval is therefore the most difficult and complex of all medical device approval processes in the US.
Do Class II devices need PMA?
No, Class II medical devices in the US do not require completion of the FDA PMA process.
Let's look in more detail. This handy decision flowchart should help you determine your regulatory pathway:
As you can see, while there are some exceptions here to our general three-part rule, such as some Class I devices needing a 510(k) and some innovative Class II devices needing a de novo, the alignment of 'PMA' and 'Class III' is clear.
Only Class III device manufacturers need to worry about the FDA PMA approval process.
The reason, as we've touched on above, is that any devices with a lower level of risk simply don't require the same extensive level of FDA oversight that a PMA approval demands.
So before you begin your FDA PMA preparations, make absolutely sure your device falls into the Class III category. (More on that below.)
Do all Class III devices require a PMA?
Yes, all modern Class III medical devices are required by the FDA to pass through the PMA process before marketization.
But here the plot does admittedly thicken a little, because there is a potential second option.
Because the 510(k) clearance process works by proving substantial equivalence to a medical device already on the market, it is possible to pass through the 510(k) process rather than the PMA process if you can find a high-risk device that's substantially equivalent to yours.
But the catch is that it must be a device marketed before the 1976 Medical Device Amendments to the FD&C Act.
Since high-risk Class III devices like pacemakers and heart valves are most subject to innovation and update, it's unlikely you'll be bringing a device to market that's substantially equivalent to mid-'70s technology.
And at any rate, the FDA frowns on the use of predicates any older than a decade or so.
This route therefore appears increasingly (and vanishingly) unlikely as a regulatory pathway option for Class III manufacturers.
It's therefore safe to generalize and say that all modern Class III devices will require a PMA approval completion.
https://www.qualio.com/blog/fda-pma
$PYNKF 🤓
INV4
4月前
Perimeter Medical Imaging AI's 'Claire' Becomes First FDA-approved AI-Enabled Imaging Device for Breast Cancer Surgery
March 3, 2026
Claire demonstrated a statistically significant reduction in patients with residual
cancer post-surgery compared to the standard of care alone
Social Capital's Chamath Palihapitiya highlights Claire as a compelling example
of how AI innovation can drive meaningful medical impact
Company plans nationwide launch of real-time AI tool for margin assessment
designed to help surgeons reduce repeat surgeries
TORONTO and DALLAS, March 3, 2026 /CNW/ - Perimeter Medical Imaging AI, Inc. (TSXV: PINK) (OTCQX: PYNKF) ("Perimeter" or the "Company"), a commercial-stage medical technology company, announced today that it has received U.S. Food and Drug Administration ("FDA") premarket approval ("PMA") for Claire™ (formerly the Perimeter OCT B-Series with ImgAssist AI 2.0), the first AI-enabled imaging device approved in the United States for intraoperative breast cancer margin assessment. The technology received Breakthrough Device designation from the FDA and is designed to enhance surgeons' ability to detect difficult-to-see cancer during breast-conserving surgery and potentially reduce the need for re-operations.
"Repeat breast cancer surgeries due to residual disease remain a significant clinical, health, and economic burden," said Perimeter CEO, Adrian Mendes. "Claire's FDA approval marks a major milestone in breast cancer care, as we advance our goal of reducing repeat surgeries so that no patient has to be told 'we didn't get it all.' We plan to begin a nationwide launch in the coming weeks so that surgeons can rapidly adopt the industry's first FDA-approved real-time AI-powered imaging technology for breast cancer surgery."
Innovating the Standard of Care
Claire combines Perimeter's proprietary AI with its patented wide-field OCT imaging to enable high-resolution, real-time evaluation of excised tumor margins. The system delivers 10 times higher resolution than standard X-ray and ultrasound at 2mm imaging depth - the clinically relevant margin width for breast cancer margin assessment. Claire's innovative AI technology was trained on Perimeter's proprietary and growing OCT image library of over 2 million breast tissue images.
Today, surgeons use a combination of physical examination, and in limited cases intraoperative pathology to assess margins before sending specimens to pathology for final evaluation. As a result, patients may wait up to a week or more to learn whether margins are clear or additional surgery is required. Claire is designed to identify areas of concern during surgery, helping surgeons determine whether to remove more tissue before completing the procedure. Today, national averages indicate repeat surgeries occur in about 20 percent of breast-conserving surgeries in the United States.1
"Despite progress in breast cancer treatment, intra-operative margin assessment remains challenging, often leading to excess removal of healthy tissue, re-operations, and anxiety for patients as they await pathology results," said Dr. Alastair Thompson, Surgeon and Professor, Section Chief of Breast Surgery, Olga Keith Wiess Chair of Surgery at Baylor College of Medicine, Breast Cancer Program Leader at the Dan L Duncan Comprehensive Cancer Center, and the Primary Principal Investigator of the pivotal trial that supported Claire's PMA application. "Claire has the potential to become a new standard in breast surgical care helping reduce re-excisions while improving patient outcomes."
Claire's Trial Demonstrated Statistically Significant Improvement
The pivotal trial of Claire demonstrated an 88.1% margin accuracy and a statistically significant reduction in patients with residual cancer post-surgery compared to the standard of care alone. As presented by Dr. Thompson at the 26th Annual Meeting of the American Society of Breast Surgeons (ASBrS 2025), these results demonstrated super-superiority (lower bound of confidence interval for treatment effect greater than a predetermined minimal clinically meaningful difference) of its ability to aid surgeons in achieving clear surgical margins. This large-scale pivotal clinical trial would not have been possible without the generous grant of US$7.4 million from the Cancer Prevention and Research Institute of Texas (CPRIT).
A critical innovation behind Claire is its AI engine, trained on millions of proprietary OCT images of cancerous and healthy tissue. This image library can only be generated using Perimeter's patented OCT imaging engine and represents a unique advantage, as every surgical procedure performed with Claire generates new data that can be used to improve the AI product, helping to create better outcomes for future patients. Claire has been designed and developed on a diverse data set spanning a multitude of patient characteristics to help surgeons assess areas of interest during surgery. This use of AI is what makes Claire one of the few AI-enabled class III devices on the U.S. market today. A pre-determined change control plan (PCCP) was authorized as part of the PMA approval and includes planned AI enhancements that can be implemented without additional FDA interaction.
"Developing AI for clinical use is incredibly challenging, requiring large, high-quality datasets that reflect real-life patient diversity," said Perimeter's Chief Innovation Officer and co-founder, Andrew Berkeley. "This approval reflects years of hard work with our clinical partners integrating AI directly into surgical decision-making and advancing its role from operational support to real-time patient care."
Platform Opportunity
Claire's FDA approval positions Perimeter at the forefront of AI-enabled intraoperative imaging and marks the first commercialization of its proprietary OCT-AI platform. The Company's patented wide-field OCT technology, proprietary dataset, and integrated AI capabilities target an estimated 300,000 annual U.S. breast cancer surgeries, while providing a scalable foundation for expansion into additional cancer indications over time.2
Management believes this innovative, patented platform represents the initial step toward addressing a significantly larger global opportunity across additional cancer surgeries, biopsy procedures, and pathology applications.
Renowned Silicon Valley venture capitalist, entrepreneur, and former Facebook executive, Chamath Palihapitiya, commented, "I've been a major investor in Perimeter for several years, and it's been the incredible clinical and commercial potential of Claire that has driven my excitement all along. After rigorous development, clinical and regulatory engagement, and collaboration with the medical community, I believe Perimeter is at the starting line of something truly transformational."
Palihapitiya continued, "Claire delivers greater peace of mind. Both for the surgeon who currently faces nearly 1-in-5 odds of needing to perform repeat surgery due to positive margins, and for the breast cancer patient, who, under the current paradigm, typically has to wait (and worry) for up to 10 days to learn whether an additional surgery is required. A second surgery is an emotional and physical journey that we are trying to prevent. This is exactly the kind of AI-driven innovation that can improve the standard of care by delivering measurable, real-world medical impacts. I'm excited to see what Perimeter can accomplish, as it commercializes the first AI-enabled imaging device for breast cancer surgery."
Sources
1 Kim Y, Ganduglia-Cazaban C, Tamirisa N, et al. Contemporary Analysis of Reexcision and Conversion to Mastectomy Rates and Associated Healthcare Costs for Women Undergoing Breast-Conserving Surgery. Ann Surg Oncol. 2024;31:3649-3660
2 American Cancer Society, Breast Cancer Facts & Figures, 2024-2025.
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. Claire, recently approved by the FDA, is our next-generation AI-enabled device. The Company's ticker symbol "PINK" is a reference to the pink ribbons used during Breast Cancer Awareness Month.
Indications for Use: The Claire OCT System is an adjunctive three-dimensional imaging tool which provides volumetric cross-sectional, real-time depth visualization, coupled with an artificial intelligence computer-aided detection algorithm which identifies and marks focal areas suspicious for breast cancer. It is used concurrently with physician interpretation of the images. The Claire OCT System is intended for use in conjunction with other standard methods for evaluation of the margins of excised lumpectomy tissue during surgical procedures in patients with a biopsy-confirmed diagnosis of breast cancer.
The Claire OCT System should not be used to replace standard tissue histopathology assessment and should not be used for diagnosis. The device is not intended for use in any of the following individuals: under the age of 18, male, have metastatic cancer (Stage IV), have lobular carcinoma as their primary diagnosis, have had previous ipsilateral breast surgery for benign or malignant disease within two years (including implants and breast augmentation), patients with multi-centric disease (histologically diagnosed cancer in two different quadrants of the breast), unless resected in a single specimen, patients with bilateral disease (diagnosed cancer in both breasts), patients who are currently lactating, patients who are currently pregnant, or concurrent use in surgeries with cryo-assisted localization. Refer to prescriber labeling for full safety information.
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.
Link article
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