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 third quarter ended September 30, 2022 and provided a corporate update.
Key Highlights
- Activated initial eight planned clinical trial sites to evaluate Perimeter’s B-Series OCT system with ImgAssist AI technology and received U.S. Food and Drug Administration (“FDA”) approval to expand the number of institutions with the goal of accelerating enrollment.
- Perimeter S-Series OCTs placed within a national healthcare provider system and at Pavilion Surgery Center, the first in the state of California.
- Data presented at the College of American Pathologists 2022 Annual Meeting supports the potential use of S-Series OCT across several tissue types.
Jeremy Sobotta, Perimeter’s Chief Executive Officer stated, “I’m proud of the progress we made over the third quarter despite continued headwinds impacting both our customers’ and clinical partners’ operations. With all eight initial pivotal clinical trial sites active and authorization to expand the number of sites, we anticipate continued improvement in patient enrollment rates. We believe the high level of engagement from our existing investigators and the significant interest we have received for expansion sites reflect the belief within our end-user community that our B-Series OCT with ImgAssist AI has the potential to be a transformative technology.”
Mr. Sobotta continued, “Commercially, we continue to execute in a challenging environment. While staffing and other macro-pressures persist for our customers, we believe the caliber of users and institutions adopting the technology are strong indicators of the validity of our stated early commercialization strategy of building future reference sites and key opinion leaders with our flagship, S-Series OCT.”
Quarterly Updates
- Perimeter is conducting a multi-center, randomized two-arm pivotal clinical trial evaluating Perimeter B-Series OCT combined with its proprietary ImgAssist AI software in approximately 330 patients. Led by Principal Investigator, Dr. Alastair Thompson at the Baylor College of Medicine in Houston, TX, the initial eight planned clinical sites have now been activated. Perimeter received FDA approval to expand the number of institutions involved in the clinical trial, and other high-potential sites are currently being evaluated to further support patient enrollment.
- Perimeter presented data to leading pathologists in the U.S. at the Annual Meeting of the College of American Pathologists 2022 (CAP22), which took place October 8 to 11, 2022 in New Orleans, LA. These data support the potential use of Perimeter’s OCT medical imaging technology in a variety of settings and across several tissue types, including the analysis of margins in head and neck surgery.
- On October 3, 2022, Perimeter announced it had graduated from a Tier 2 Issuer to a Tier 1 Issuer on the TSX Venture Exchange.
- On September 29, 2022, Perimeter announced the commercial placement of its Perimeter S-Series OCT system at a hospital that is part of a major national healthcare system and one of the largest healthcare networks in North Texas.
- On August 3, 2022, Perimeter announced its first commercial placement of an S-Series OCT device in the state of California at Pavilion Surgery Center, an affiliate of St. Joseph Hospital. The device will be used under the direction of Michele Carpenter, MD, a breast surgeon who performs breast conservation and other surgeries at Pavilion Surgery Center and marks the first commercial use of the technology in a standalone, ambulatory setting.
Summary of Third 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 September 30, 2022 were $5,936,097 compared to $3,748,590 during the same period in 2021.
Net finance income for the three months ended September 30, 2022 was $935,139 compared to finance costs of $(101,827) for the three months ended September 30, 2021.
Net loss for the three months ended September 30, 2022 was $(818,527) compared to $(3,880,172) for the same period in 2021.
For the nine months ended September 30, 2022, cash used in operating activities was $(13,097,026).
As of September 30, 2022, cash and cash equivalents were $43,200,189.
For detailed financial results, please see Perimeter’s filings at www.sedar.com and on the company’s website at https://ir.perimetermed.com/.
Company Outlook
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. In light of the continued issues facing healthcare providers which are, in turn, impacting its sales cycle, the Company withdraws its installation guidance for the fiscal year 2022. Perimeter will continue to provide updates on progress as it occurs and evaluate the outlook on an ongoing basis. 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 330 patients across a minimum of eight sites and completing enrollment in the first half of 2023.
Conference Call
The Company will host a conference call and live audio webcast today, November 15, 2022, at 5:00 pm Eastern Time to discuss its third quarter results and to provide a corporate update. To participate in the call, please dial 1-877-704-4453, or 1-201-389-0920 for international callers, and provide conference ID number 13734184. The 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. The webcast will be archived on the Company's investor relations webpage for at least 90 days. A telephonic playback of the conference call will be available for 14 days after the conference call by calling 1-844-512-2921 or 1-412-317-6671 from abroad and referencing conference ID 13734184. The above listed dates and times are subject to change.
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 being evaluated in a pivotal clinical trial, with support from a grant of up to US$7.4 million awarded by the Cancer Prevention and Research Institute of Texas. The company’s ticker symbol “PINK” is a reference to the pink ribbons used during Breast Cancer Awareness Month.
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 Statements
This news release contains statements that constitute “forward-looking information” within the meaning of applicable Canadian securities legislation. In this news release, words such as “may,” “would,” “could,” “will,” “likely,” “believe,” “expect,” “anticipate,” “intend,” “plan,” “estimate,” and similar words and the negative form thereof are used to identify forward-looking statements. Forward-looking information may relate to management’s future outlook and anticipated events or results and may include statements or information regarding the future financial position, business strategy and strategic goals, competitive conditions, research and development activities, projected costs and capital expenditures, research and clinical testing outcomes, taxes and plans and objectives of, or involving, Perimeter. Without limitation, information regarding the potential benefits of Perimeter S-Series OCT, Perimeter B-Series OCT, and Perimeter ImgAssist; Perimeter’s expected marketing and sales activities; and the expected details regarding Perimeter’s ongoing clinical trials, including anticipated improvements in patient enrollment rates and the estimated completion date of enrollment, 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.
