On May 2, 2022 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, reported financial results for the year ended December 31, 2021 and provided a corporate update (Press release, Perimeter Medical Imaging AI, MAY 2, 2022, View Source [SID1234613331]).

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Key Highlights

Perimeter officially progresses to commercial stage with its first S-Series OCT installation.
Clinical development of B-Series OCT with ImgAssist AI advances into late-stage validation activities with the initiation of a multi-center, randomized, two-arm pivotal clinical trial.
The Company issues full-year 2022 commercial installation guidance of 15-20 units.
Jeremy Sobotta, Perimeter’s Chief Executive Officer stated, "We continue to build upon the significant momentum generated in 2021, which represented a transformative year for Perimeter that was marked by the Company’s first commercial placement of its flagship Perimeter S-Series OCT imaging platform and the initiation of a pivotal trial on our FDA breakthrough-designated device for our investigational Perimeter B-Series OCT combined with ImgAssist artificial intelligence."

Mr. Sobotta continued, "We are grateful for the support from long-term shareholders, as well as Social Capital, who led a recent financing which resulted in gross proceeds of approximately $48.7 million to further strengthen our balance sheet at this critical stage. Moving forward, I believe we are well-positioned to execute on our commercial and clinical development goals. Perimeter is uniquely positioned to draw upon its industry-leading expertise in advanced medical imaging combined with the benefits of machine learning and artificial intelligence tools to support our vision of delivering truly ‘best-in-class’ medical technology solutions to our customers with the goal of improving patient outcomes and reducing healthcare costs."

Corporate and Commercial Milestones

Perimeter received 510(k) clearance for its S-Series OCT imaging platform from the U.S. Food and Drug Administration (FDA), enabling its commercial launch in the U.S. Subsequently, under the leadership of Steve Sapot, Chief Commercial Officer, Perimeter continues to build upon its sales and marketing infrastructure – including key hires of market development managers to cover regions across the U.S.
Perimeter partnered with Minnetronix Medical, a leading medical technology and operations partner to global medical device companies, to secure commercial-scale manufacturing of Perimeter S-Series OCT imaging systems.
Subsequent to year-end, 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.
Clinical and Product Development Milestones

Perimeter received U.S. FDA Breakthrough Device Designation for Perimeter B-Series OCT combined with proprietary ImgAssist artificial intelligence (AI) software – providing a potential expedited pathway for development and adoption of this innovative technology.
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.
Summary of 2021 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 ("IFRS") applicable to the preparation of interim financial statements, including International Accounting Standard ("IAS") 34, Interim Financial Reporting.

Operating expenses for the year ended 2021 were $16,153,514 compared to $10,159,444 during the previous year.

For the year ended December 31, 2021, the net loss was $16,644,231 compared to $7,885,966 in the prior year.

For the year ended December 31, 2021, cash used in operating activities was $13,912,389.

As at December 31, 2021, cash and cash equivalents were $4,720,003. Subsequent to December 31, 2021, the Company raised additional capital through a private placement resulting in gross proceeds of approximately $48.7 million.

For detailed financial results, please see Perimeter’s filings at www.sedar.com and on the company’s website at View Source

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 act as champions of 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 8 sites and completing enrollment in 2022.

Conference Call

Perimeter will host a conference call and audio webcast tomorrow (Tuesday, May 3, 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 of 1-201-389-0920 for international callers and provide conference ID number 13729526. To participate in the call, please dial (877) 407-0789 or (201) 689-8562 for international callers and provide conference ID number 13727220.

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 Perimeter B-Series OCT + ImgAssist AI in reducing the number of unaddressed positive margins in breast lumpectomy procedures when used in addition to standard intraoperative margin assessment. Approximately 300 patients undergoing breast conservation surgery across eight U.S. clinical sites will participate in the pivotal study led by Principal Investigator, Dr. Alastair Thompson at Baylor College of Medicine, with study enrollment anticipated by the end of 2022.