Pivotal study to determine the impact of
Perimeter B-Series OCT with ImgAssist AI 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 initiation of 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. The first patient procedures
were performed by Richard E. Fine, MD and Michael Berry, MD,
leading breast surgeons based out of the Margaret West
Comprehensive Breast Center in Germantown, Tennessee.
Dr. Richard E. Fine, Director of Education & Research,
Margaret West Comprehensive Breast Center, West Cancer Center &
Research Institute, stated, “We are excited to be the first site to
enroll a patient in the Perimeter pivotal trial that is evaluating
the use of Perimeter B-Series OCT imaging technology combined with
artificial intelligence. There is a strong unmet medical need to
provide breast cancer surgeons with specimen imaging tools to aid
their decisions ‘real time’ in the operating room. Through this
pivotal study, we can assess if the Perimeter B-Series with
artificial intelligence demonstrates an improvement over the
current standard of care – potentially setting a new standard for
specimen imaging technology during breast conservation
surgery.”
Dr. Michael Berry, Director of Margaret West Comprehensive
Breast Center, commented, “Approximately 15% to 20% of women who
undergo breast conservation surgery require reoperation if their
surgeon fails to get clear margins. By combining optical coherence
tomography with deep learning algorithms, this innovative
technology could assist us, as surgeons, to better identify regions
of interest on scanned samples, enabling ‘real-time’ decisions on
margin status in the OR.”
Jeremy Sobotta, Perimeter’s Chief Executive Officer stated, “The
initiation of this pivotal trial marks another milestone in our
ATLAS AI project and an important step in the clinical development
of our breakthrough-device-designated Perimeter B-Series OCT with
AI assisted software, which represents the next generation of our
commercially available flagship Perimeter S-Series OCT. Our hope is
that clinical data generated from this study will provide
supporting evidence that our technology can help breast cancer
physicians improve outcomes for patients and potentially reduce the
burden of additional costs within the healthcare system. We expect
that this study will be completed by the end of 2022.”
About West Cancer Center & Research Institute
West Cancer Center & Research Institute is a leader in adult
cancer care guided by physicians to provide the most positive
outcomes though research, novel therapies, advanced treatments, and
cancer prevention to all patients, regardless of socioeconomic
status. With over 40 years of oncology expertise, 100+ specialists,
8 locations including a breast center, and over 47,000 patients in
2020 - West is positioned as the first choice for cancer care in
the Mid-South and a national model for comprehensive care.
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). 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. A multi-center,
randomized, two-arm clinical trial is underway to measure the
effectiveness of the 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 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/20211216005378/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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