TORONTO & DALLAS--(BUSINESS WIRE)--Perimeter Medical Imaging AI, Inc. (TSX-V:PINK)(OTC:PYNKF) (FSE:4PC) (“Perimeter” or the “Company”), a medical technology company driven to transform cancer surgery with ultra-high-resolution, real-time, advanced imaging tools to address high unmet medical needs, today reported financial results for its first quarter ended March 31, 2022 and provided a corporate update.
- The Company reiterates full-year 2022 commercial installation guidance of 15-20 units, with sales and marketing activities underway building upon the first commercial S-Series OCT installation.
- B-Series OCT with ImgAssist AI reaches late-stage clinical validation phase with ongoing multi-center, randomized, two-arm pivotal clinical trial.
- Company strengthens its balance sheet with private placement completed in first quarter resulting in $48.7 million in gross proceeds to support key commercial and clinical objectives.
Jeremy Sobotta, Perimeter’s Chief Executive Officer stated, “This past quarter we have made considerable progress across both the clinical development and commercial fronts. Our sales team has been extremely active at key industry and scientific meetings, including showcasing our S-Series OCT at the annual meetings of the Society of Surgical Oncology, the National Consortium of Breast Centers, and the American Society of Breast Surgeons.”
Mr. Sobotta added, “In parallel, we continue to onboard sites to participate in the ongoing pivotal trial evaluating our B-Series OCT combined with ImgAssist AI. The financing completed in the first quarter further strengthened our balance sheet allowing us to continue to execute on our vision to bring our transformative ultra-high resolution medical imaging technology directly into the OR to assist the surgeon with real-time intraoperative margin assessment – with the aim of improving patient outcomes and reducing healthcare costs.”
- Sales and marketing activities are ongoing following Perimeter’s first commercial placement in the U.S in late 2021.
In March and April 2022, Perimeter conducted multiple clinical presentations and product demonstrations highlighting Perimeter S-Series OCT at a number of leading industry events and conferences including:
- SSO 2022, the Society of Surgical Oncology’s International Conference on Surgical Cancer Care, featuring a spotlight presentation by Dr. Beth Dupree and Dr. Amelia Tower;
- NCoBC 2022, the National Consortium of Breast Centers’ 31st Interdisciplinary Breast Center Conference; and
- ASBrS 2022, the 23rd Annual Meeting of the American Society of Breast Surgeons, including a symposium and panel discussion with Dr. Amelia Tower and Dr. Maryam Elmi moderated by Dr. Richard Fine.
- In January 2022, Perimeter closed a private placement resulting in gross proceeds of C$48.7 million to the Company, which included a C$43.4 million strategic investment in the Company by Social Capital.
- Following receipt of U.S. FDA Breakthrough Device Designation for Perimeter B-Series OCT combined with proprietary ImgAssist artificial intelligence (AI) software, Perimeter initiated a multi-center, randomized, two-arm pivotal clinical trial to evaluate its Perimeter B-Series OCT with ImgAssist AI for use during breast conservation surgery. In January 2022, Perimeter announced the expansion of the ongoing pivotal study to include Baylor College of Medicine in Houston, TX.
Summary of First Quarter 2022 Financial Results
All of the amounts are expressed in Canadian dollars unless otherwise indicated and are presented in accordance with International Financial Reporting Standards as issued by the International Accounting Standards Board applicable to the preparation of interim financial statements, including International Accounting Standard 34, Interim Financial Reporting.
Operating expenses for the three months ended March 31, 2022 were $4,848,835 compared to $3,820,245 during the same period in 2021.
For the three months ended March 31, 2022, the net loss was $6,449,068 compared to $4,015,732 during the same period in 2021.
For the three months ended March 31, 2022, cash used in operating activities was $3,643,859.
As at March 31, 2022, cash and cash equivalents were $49,682,256.
Perimeter’s sales and marketing efforts will continue to focus on placing its commercially available, flagship Perimeter S-Series OCT at leading hospitals where key opinion leaders can champion this innovative technology, with the goal of reaching an S-Series install base of 15 to 20 units by the end of 2022. In parallel, Perimeter’s clinical team will focus on the continued enrollment of patients and onboarding of healthcare institutions in the ongoing pivotal trial evaluating its next-gen investigational Perimeter B-Series OCT with ImgAssist AI when used in breast lumpectomy procedures, with the goal of gathering data from over 300 patients across eight sites and completing enrollment in 2022.
Perimeter will host a conference call and audio webcast on Wednesday, June 1, 2022 at 5:00 pm Eastern Time to discuss the year-end results and to provide a corporate update. The webcast will be broadcast live on the Investors section of the Perimeter website. To participate in the call, please dial 1-877-704-4453 or 1-201-389-0920 for international callers and provide conference ID number 13729978.
The webcast will also be archived on the Investors section of the Perimeter website for at least 90 days, and a telephonic playback of the conference call will be available for 14 days following the event by dialing (844) 512-2921 or (412) 317-6671 for international callers and referencing conference ID 13729526.
About the Clinical Development of Perimeter B-Series OCT with ImgAssist AI
Perimeter is advancing the development of its proprietary, next gen “ImgAssist” artificial intelligence (AI) technology under its ATLAS AI project, which is made possible, in part, by a US$7.4 million grant awarded by the Cancer Prevention and Research Institute of Texas (CPRIT). A multi-center, randomized, two-arm clinical trial is underway to measure the effectiveness of the breakthrough-device-designated investigational Perimeter B-Series OCT with ImgAssist AI in reducing the number of unaddressed positive margins in breast lumpectomy procedures when used in addition to standard intraoperative margin assessment.
About Perimeter Medical Imaging AI, Inc.
Based in Toronto, Canada and Dallas, Texas, Perimeter Medical Imaging AI (TSX-V:PINK) (OTC:PYNKF) (FSE:4PC) is a medical technology company driven to transform cancer surgery with ultra-high-resolution, real-time, advanced imaging tools to address areas of high unmet medical need. Available across the U.S., our FDA-cleared Perimeter S-Series OCT system provides real-time, cross-sectional visualization of excised tissues at the cellular level. The breakthrough-device-designated investigational Perimeter B-Series OCT with ImgAssist AI represents our next-generation, artificial intelligence technology that is currently under clinical development. The company’s ticker symbol “PINK” is a reference to the pink ribbons used during Breast Cancer Awareness Month.
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
This news release contains statements that constitute “forward-looking information” within the meaning of applicable Canadian securities legislation. In this news release, words such as “may,” “would,” “could,” “will,” “likely,” “believe,” “expect,” “anticipate,” “intend,” “plan,” “estimate,” and similar words and the negative form thereof are used to identify forward-looking statements. Forward-looking information may relate to management’s future outlook and anticipated events or results and may include statements or information regarding the future financial position, business strategy and strategic goals, competitive conditions, research and development activities, projected costs and capital expenditures, research and clinical testing outcomes, taxes and plans and objectives of, or involving, Perimeter. Without limitation, estimates regarding the number of Perimeter S-Series OCT instillations in 2022, information regarding the potential benefits of Perimeter S-Series OCT, Perimeter B-Series OCT, and Perimeter ImgAssist, Perimeter’s expected marketing activities and the expected details regarding Perimeter’s ongoing clinical trials are forward-looking information. Forward-looking statements should not be read as guarantees of future performance or results, and will not necessarily be accurate indications of whether, or the times at or by which, any particular result will be achieved. No assurance can be given that any events anticipated by the forward-looking information will transpire or occur. Forward-looking information is based on information available at the time and/or management’s good-faith belief with respect to future events and are subject to known or unknown risks, uncertainties, assumptions, and other unpredictable factors, many of which are beyond Perimeter’s control. Such forward-looking statements reflect Perimeter’s current view with respect to future events, but are inherently subject to significant medical, scientific, business, economic, competitive, political, and social uncertainties and contingencies. In making forward-looking statements, Perimeter may make various material assumptions, including but not limited to (i) the accuracy of Perimeter’s financial projections; (ii) obtaining positive results from trials; (iii) obtaining necessary regulatory approvals; and (iv) general business, market, and economic conditions. Further risks, uncertainties and assumptions include, but are not limited to, those applicable to Perimeter and described in Perimeter’s Management Discussion and Analysis for the year ended December 31, 2021, which is available on Perimeter’s SEDAR profile at www.sedar.com, and could cause actual events or results to differ materially from those projected in any forward-looking statements. Perimeter does not intend, nor does Perimeter undertake any obligation, to update or revise any forward-looking information contained in this news release to reflect subsequent information, events, or circumstances or otherwise, except if required by applicable laws.