Perimeter Medical Imaging AI Reports 2020 Financial Results and Provides Corporate Update

Written by on April 30, 2021

Perimeter Medical Imaging AI, Inc. (TSX-V:PINK)(OTC:PYNKF) (FSE:4PC) (“Perimeter” or the “Firm”), a medical know-how firm pushed to remodel most cancers surgical procedure with ultra-high-resolution, real-time, superior imaging instruments to deal with excessive unmet medical wants, right this moment reported monetary outcomes for the 12 months ended December 31, 2020 and offered a company replace.

Jeremy Sobotta, Perimeter’s Chief Government Officer said, “In 2020, we achieved quite a few key milestones, added to our management staff, and created momentum that continues to construct in 2021. The FDA’s latest 510(ok) clearance for Perimeter S-Collection OCT permits us to carry our commercial-ready imaging platform to the U.S. market, and gross sales growth actions are underway. Importantly, we’ve a robust stability sheet that permits us to execute towards our scientific growth and commercialization plans as we try to allow physicians to create higher affected person outcomes with decrease healthcare prices.”

Mr. Sobotta added, “As well as, we’ve made important progress with our ‘next-gen’ growth work combining synthetic intelligence instruments with our OCT imaging system beneath the ATLAS AI mission, which is funded, partially, by the Most cancers Prevention and Analysis Institute of Texas. We imagine the latest Breakthrough System Designation from the FDA is additional validation that Perimeter’s know-how may present important benefits over current alternate options for intra-operative analysis of margins and has the potential to be a transformative, disruptive new know-how that helps surgeons deal with breast most cancers. Wanting forward, we goal to provoke a randomized, multi-site, pivotal examine this 12 months to judge Perimeter OCT coupled with ImgAssist AI towards the present normal of care and assess the influence on re-operation charges for sufferers present process breast conservation surgical procedure.”

Company Highlights

  • In February 2020, Perimeter was awarded a $7.Four million grant by the Most cancers Prevention and Analysis Institute of Texas (“CPRIT”), a number one state physique that funds most cancers analysis, to help the event of Perimeter’s synthetic intelligence software program beneath the ATLAS AI mission.

  • In 2020, Perimeter introduced the additions of Ian Mortimer, President and Chief Monetary Officer of Xenon Prescribed drugs Inc., and Aaron Davidson, CFO and Senior Vice President of Company Improvement of Profound Medical Inc. to its Board of Administrators. The appointees carry key experience within the areas of economic administration, public firm oversight, life sciences, and medical system know-how growth to the board.

  • In September 2020, Perimeter added to its management staff with the appointment of Steve Sapot as Chief Business Officer. A confirmed gross sales chief, Mr. Sapot led a capital gross sales staff throughout his tenure at Faxitron that achieved an set up base of 1000’s of latest radiography techniques in main hospitals and breast most cancers facilities across the globe.

  • Subsequent to 12 months finish, in March 2021, Perimeter accomplished the acceleration of sure share buy warrants issued on June 29, 2020 and, because the Firm’s third quarter outcomes ending September 30, 2020, has obtained a complete of roughly $8.three million in proceeds from the train of roughly 4.three million warrants.

Product and Scientific Improvement Updates

  • On March 1, 2021, Perimeter introduced that it had obtained 510(ok) clearance from the U.S. Meals and Drug Administration (FDA) for model 2.1 of the Perimeter S-Collection OCT, enabling Perimeter to carry its commercial-ready imaging platform to the U.S. market. Beforehand known as “OTIS,” Perimeter S-Collection OCT is indicated to be used as an imaging instrument within the analysis of excised human tissue microstructure by offering two-dimensional, cross-sectional, real-time depth visualization with picture assessment manipulation software program for figuring out and annotating areas of curiosity.

  • On March 30, 2021, Perimeter introduced that Dr. Beth DuPree, a surgeon at Northern Arizona Healthcare Verde Valley Medical Middle, initiated a scientific examine, which is able to enroll as much as 100 sufferers, that can consider the usage of Perimeter S-Collection OCT throughout breast conserving surgical procedure, with the goal of demonstrating that surgeons can successfully use Perimeter S-Collection OCT to help their selections if further tissue must be excised.

  • On April 15, 2021, Perimeter introduced that the FDA granted a Breakthrough System Designation for Perimeter OCT mixed with ImgAssist AI – to be referred to as Perimeter B-Collection OCT. This designation permits for accelerated interactions with the FDA throughout product growth and prioritized assessment of future regulatory submissions. As well as, a brand new Medicare coverage program (Medicare Protection of Progressive Know-how, or MCIT) supplies nationwide Medicare protection for as much as 4 years for FDA-designated Breakthrough Units upon market authorization, enabling extra speedy utilization of latest and modern applied sciences for the Medicare inhabitants.

ATLAS AI Mission

  • In July 2020, Perimeter initiated the primary part of its ATLAS AI mission which concerned gathering pictures of breast tumors from sufferers at main most cancers facilities in Texas – together with Baylor School of Medication, M.D. Anderson Most cancers Middle, and UT Well being San Antonio – to each prepare and take a look at its ImgAssist AI know-how.

  • On April 14, 2021, Perimeter offered an replace on its ATLAS AI Mission. Utilizing greater than 400 volumes of pictures of excised breast tissue collected within the first stage of the mission, the standalone AI algorithm achieved a key efficiency metric of 0.94 AUC (space beneath the receiver working attribute curve). The information generated so far help the continued development of Perimeter’s “ImgAssist” AI know-how to the subsequent stage of the ATLAS AI Mission. Perimeter intends to conduct a randomized, multi-site, pivotal examine to judge Perimeter OCT mixed with ImgAssist AI towards the present normal of care and assess the influence on re-operation charges for sufferers present process breast conservation surgical procedure.

Abstract 2020 Monetary Outcomes

All the quantities are expressed in Canadian {dollars} except in any other case indicated and are offered in accordance with Worldwide Monetary Reporting Requirements as issued by the Worldwide Accounting Requirements Board (“IFRS”) relevant to the preparation of interim monetary statements, together with Worldwide Accounting Customary (“IAS”) 34, Interim Monetary Reporting.

Working bills for the 12 months ended 2020 have been $10,159,444 in comparison with $8,708,853 throughout the earlier 12 months.

For the 12 months ended December 31, 2020, the online loss was $7,885,966 in comparison with $10,342,686 within the prior 12 months.

For the 12 months ended December 31, 2020, money utilized in working actions was $8,262,987.

As at December 31, 2020, money and money equivalents have been $10,025,122 and investments have been $1,674,750.

As of December 31, 2020, the Firm obtained US$1,220,666 of the US$7,446,844 out there from the CPRIT grant to fund actions associated to the primary 12 months of its ATLAS AI Mission.

For detailed monetary outcomes, please see Perimeter’s filings at www.sedar.com and on the corporate’s web site at https://ir.perimetermed.com/.

About Perimeter Medical Imaging AI, Inc.

Perimeter Medical Imaging AI (TSX-V:PINK)(OTC:PYNKF)(FSE:4PC) is a Toronto-based medical know-how firm with U.S. headquarters in Dallas, Texas that’s pushed to remodel most cancers surgical procedure with ultra-high-resolution, real-time, superior imaging instruments to deal with areas of excessive unmet medical want. Cleared by the U.S. FDA, the Perimeter S-Collection Optical Coherence Tomography (OCT) Imaging System supplies clinicians with cross-sectional, real-time margin visualization (1-2 mm beneath the floor) of an excised tissue specimen. Giving physicians the flexibility to visualise microscopic tissue constructions “actual time” within the working room has the potential to lead to higher long-term outcomes for sufferers and decrease prices to the healthcare system. Perimeter can be advancing the event of its proprietary, next-gen “ImgAssist” synthetic intelligence know-how beneath its ATLAS AI mission, which is made attainable, partially, by a $7.Four million grant awarded by the Most cancers Prevention and Analysis Institute of Texas (CPRIT). Perimeter has been granted a Breakthrough System Designation for the Perimeter B-Collection OCT coupled with ImgAssist AI, and has plans to provoke a randomized, multi-site, pivotal examine to judge it towards the present normal of care and assess the influence on re-operation charges for sufferers present process breast conservation surgical procedure. The corporate’s ticker image “PINK” is a reference to the pink ribbons used throughout Breast Most cancers Consciousness Month, underscoring the corporate’s dedication to serving to surgeons, radiologists, and pathologists use Perimeter’s imaging know-how and AI within the battle towards breast most cancers, which is estimated to account for 30% of all feminine most cancers diagnoses this 12 months.

Neither the TSX Enterprise Alternate nor its Regulation Companies Supplier (as that time period is outlined in insurance policies of the TSX Enterprise Alternate) accepts duty for the adequacy or accuracy of this launch.

Ahead-Wanting Statements

This information launch incorporates statements which will represent “forward-looking info” throughout the that means of relevant Canadian securities laws. On this information launch, phrases comparable to “could”, “would”, “may”, “will”, “doubtless”, “imagine”, “anticipate”, “anticipate”, “intend”, “plan”, “estimate” and comparable phrases and the detrimental type thereof are used to establish forward-looking statements. Ahead-looking info could relate to administration’s future outlook and anticipated occasions or outcomes, and should embody statements or info relating to the long run monetary place, enterprise technique and strategic objectives, aggressive situations, analysis and growth actions, projected prices and capital expenditures, analysis and scientific testing outcomes, taxes and plans and goals of, or involving, Perimeter. With out limitation, info relating to future gross sales and advertising and marketing actions, Perimeter’s know-how platform, together with Perimeter S-Collection OCT, Perimeter B-Collection OCT, Perimeter ImgAssist (the “Merchandise”), gross sales, placements and utilization charges, reimbursement for the assorted procedures, future revenues arising from the gross sales of the Firm’s Merchandise, future potential partnerships, analysis and growth actions, the Firm’s plans to hunt additional regulatory clearances for extra indications, in addition to the Firm’s plans for growth of the Merchandise is forward-looking info. Ahead-looking statements shouldn’t be learn as ensures of future efficiency or outcomes, and won’t essentially be correct indications of whether or not, or the instances at or by which, such future efficiency might be achieved. No assurance could be provided that any occasions anticipated by the forward-looking info will transpire or happen. Ahead-looking info relies on info out there on the time and/or administration’s good-faith perception with respect to future occasions and are topic to identified or unknown dangers, uncertainties, assumptions and different unpredictable elements, lots of that are past Perimeter’s management. Such forward-looking statements mirror Perimeter’s present view with respect to future occasions, however are inherently topic to important medical, scientific, enterprise, financial, aggressive, political, and social uncertainties and contingencies. In making forward-looking statements, Perimeter could make varied materials assumptions, together with however not restricted to (i) the accuracy of Perimeter’s monetary projections; (ii) acquiring optimistic outcomes from trials; (iii) acquiring needed regulatory approvals; and (iv) common enterprise, market and financial situations. Additional dangers, uncertainties and assumptions embody, however will not be restricted to, these relevant to Perimeter and described in Perimeter’s most up-to-date Administration Dialogue and Evaluation which is obtainable on Perimeter’s SEDAR profile at www.sedar.com, and will trigger precise occasions or outcomes to vary materially from these projected in any forward-looking statements. Particularly, we notice the danger that our know-how could not obtain the anticipated advantages by way of surgical outcomes. Perimeter doesn’t intend, nor does Perimeter undertake any obligation, to replace or revise any forward-looking info contained on this information launch to mirror subsequent info, occasions, or circumstances or in any other case, besides if required by relevant legal guidelines.

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Contacts

Jodi Regts
Company Communications / Investor Relations
Perimeter Medical Imaging AI, Inc.
+1 778-999-5634
media@perimetermed.com

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