Pivotal study underway to assess Perimeter’s
OCT imaging platform combined with AI technology and its impact on
positive margin rates during breast conservation surgery
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, announced the expansion of its ongoing
pivotal study to include an additional clinical trial site at
Baylor College of Medicine in Houston, TX, under the direction of
Dr. Alastair Thompson, Principal Investigator of the study.
A multi-center, randomized, two-arm clinical trial is underway
to measure the effectiveness of the Perimeter B-Series OCT imaging
platform combined with ImgAssist artificial intelligence (AI)
technology 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 are expected to participate in the pivotal trial, with study
completion anticipated by the end of 2022.
Dr. Alastair Thompson, Professor, Section Chief of Breast
Surgery, and Olga Keith Wiess Chair of Surgery at Baylor College of
Medicine and Co-associate Director for Clinical Research at the Dan
L Duncan Comprehensive Cancer Center, stated, “Failure to get clear
margins in breast cancer surgery is a critical problem that can
lead to further complications for patients due to re-operations and
higher costs to the overall healthcare system. This pioneering
technology allows surgeons to examine an excised tissue sample and
identify areas of concern to support ‘real-time’ margin assessment
during a surgery.”
Dr. Thompson continued, “Having participated in earlier stages
of Perimeter’s ATLAS AI project – including contributing to the
collection of breast tumor images in order to develop and train the
artificial intelligence algorithm – I am excited to act as
principal investigator of this pivotal study.”
Jeremy Sobotta, Perimeter’s Chief Executive Officer stated, “We
are proud to partner with leading cancer centers like Baylor to
enable the late-stage clinical development of our
breakthrough-device-designated Perimeter B-Series OCT platform that
includes AI-assisted software. We are also grateful for the grant
funding that we received from the Cancer Prevention and Research
Institute of Texas (CPRIT), which has supported our ATLAS AI
project across multiple stages, culminating in this important
pivotal study now underway. We believe our technology has the
potential to help breast cancer surgeons improve outcomes for
patients and we look forward to analyzing the data from this study,
which is expected to be completed by the end of the year.”
About the Clinical Development of Perimeter B-Series OCT with
ImgAssist AI
Perimeter is advancing the clinical 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). The U.S. FDA granted
Breakthrough Device Designation for Perimeter B-Series OCT +
ImgAssist AI, which has the potential to aid surgeons in
identifying regions of interest on scanned samples, enabling them
to make key decisions on margin status real-time intraoperatively.
Perimeter B-Series + ImgAssist AI is currently approved for
“Investigational Use Only” in the U.S., which means that at this
time, only select surgeons have access to this technology by
participating in the ongoing pivotal clinical trial.
About Perimeter S-Series OCT
Cleared by the U.S. FDA with a general tissue indication,
Perimeter S-Series Optical Coherence Tomography (OCT) is a novel
medical imaging system that provides clinicians with
cross-sectional, real-time margin visualization (1-2 mm below the
surface) of an excised tissue specimen. Giving physicians the
ability to visualize microscopic tissue structures “real time” in
the operating room has the potential to result in better long-term
outcomes for patients and lower costs to the healthcare system.
About Perimeter Medical Imaging AI, Inc.
With headquarters in Toronto, Canada and Dallas, Texas,
Perimeter Medical Imaging AI (TSX-V:PINK) (OTC:PYNKF) (FSE:4PC) is
a medical technology company that is driven to transform cancer
surgery with ultra-high-resolution, real-time, advanced imaging
tools to address areas of high unmet medical need. The company’s
ticker symbol “PINK” is a reference to the pink ribbons used during
Breast Cancer Awareness Month, underscoring the company’s
dedication to helping surgeons, radiologists, and pathologists use
Perimeter’s imaging technology and AI in the fight against breast
cancer, which is estimated to account for 30% of all female cancer
diagnoses this year.
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 (the “Products”); the estimated number of patients, U.S.
clinical sites and anticipated completion date of Perimeter’s
pivotal trial; research and development activities; as well as the
Company’s plans for development of the Products is 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, such future performance 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. In particular, we note the risk that our technology may
not achieve the anticipated benefits in terms of surgical outcomes.
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/20220111005571/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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