Live Call/Webcast Today 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, provided a corporate update today on its
progress towards achieving key corporate objectives, as well as
commercial, clinical and product development milestones.
Jeremy Sobotta, Perimeter’s Chief Executive Officer stated, “I
believe 2021 was a transformative year for Perimeter, and today’s
update summarizes the key milestones achieved across all areas of
our business. Importantly, we received 510K clearance from the FDA
enabling the commercial launch of our flagship Perimeter S-Series
OCT platform, and we have started to place this innovative
technology in the hands of influential thought leaders at leading
hospitals and healthcare institutions. In addition, we initiated a
multi-center, randomized, two-arm clinical trial of our
investigational Perimeter B-Series OCT imaging platform combined
with ImgAssist AI, which continues to enroll patients and is
expected to be completed later this year.”
Mr. Sobotta continued, “Backed by strong support from our
existing shareholders, we recently closed a successful equity
financing, which included Social Capital, that we anticipate will
fuel our commercial efforts and enable us to leverage their
expertise in technology and AI. We believe we have the capital and
expertise in place to support us in our journey to deliver
best-in-class advanced imaging technologies, with the aim of
improving health outcomes and reducing costs. This is an incredibly
exciting time for Perimeter, and we look forward to building upon
the positive momentum already generated at the beginning of this
year.”
Company Milestones
Financial Highlights
- 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.
Commercial Highlights
- 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.
Clinical and Product Development Highlights
- 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, with study
completion anticipated by the end of 2022.
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. The commercial team has an
aggressive schedule of trade shows, webinars and other targeted
industry events to showcase Perimeter S-Series OCT in the coming
months. 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 approximately 300 patients across 8 sites and completing the
study in 2022.
Conference Call
To participate in the call, please dial (877) 407-0789 or (201)
689-8562 for international callers and provide conference ID number
13727220. A listen-only audio webcast will be broadcast live on the
Investors section of the Perimeter website. 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 3727220.
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 completion 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, 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, 2020, 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220223006162/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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