Conference Call/Webcast Tomorrow (Tuesday,
May 3) at 5 pm ET
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 the
year ended December 31, 2021 and provided a corporate update.
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
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 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.
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.
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, 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20220502005831/en/
Shushu Feng Perimeter Medical Imaging AI, Inc. Direct:
647-339-7465 (PINK) Toll-free: 888-988-7465 (PINK)
investors@perimetermed.com
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