Pivotal study to determine the impact of
Perimeter’s novel OCT imaging technology combined with artificial
intelligence on positive margin rates for patients with breast
cancer
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 announced approval of its
Investigational Device Exemption (“IDE”) application by the U.S.
Food and Drug Administration (“FDA”) to conduct a multi-center,
randomized, double-arm study to evaluate the FDA
breakthrough-device-designated Perimeter B-Series OCT imaging
system that uses ImgAssist AI technology to identify regions of
interest as compared with the current standard of care for patients
undergoing breast conservation surgery. It is anticipated that over
300 patients across 8 U.S. clinical sites will participate in the
pivotal study to be led by Principal Investigator, Dr. Alastair
Thompson at Baylor College of Medicine.
Jeremy Sobotta, Perimeter’s Chief Executive Officer stated,
“This IDE approval marks another important milestone in our ATLAS
AI project, building upon the ‘Breakthrough Device Designation’
that we received in April, as we transition into clinical
validation of the AI-enabled, next generation of our commercially
available flagship OCT imaging technology. Trial start-up
activities are already underway, with world-class sites and a
number of the nation’s leading breast surgeons identified to
participate in Perimeter’s pivotal study, which we anticipate
initiating in mid-November at our first site at West Cancer
Center’s Breast Center in Germantown, Tennessee under the direction
of Dr. Richard E. Fine. Our hope is that the data generated from
this trial supports our belief that Perimeter’s innovative OCT
imaging technology will become a trusted tool for surgeons,
resulting in better patient outcomes and lower healthcare
costs.”
Dr. Alastair Thompson, Principal Investigator and Professor,
Section Chief of Breast Surgery and Olga Keith Wiess Chair of
Surgery at Baylor College of Medicine and the Dan L Duncan
Comprehensive Cancer Center said, “Currently, approximately one in
four women who undergo breast conservation surgery require
reoperation if their surgeon fails to get ‘clear’ margins. The goal
of this pivotal study is to compare the use of Perimeter B-Series
imaging technology with artificial intelligence against the
standard of care and determine if it can improve surgeon’s ability
to reduce re-operation rates for breast conservation surgery.
Importantly, Perimeter’s novel imaging technology with AI fits into
the routine surgical process with no additional imposition to the
patient as it examines a tissue sample that is already being
extracted. There is a strong medical need for tools to help
surgeons identify if we have adequately removed the cancerous
tissue real-time in the operating room and get it right the first
time.”
Dr. Richard E. Fine, Director of Education & Research,
Margaret West Comprehensive Breast Center, West Cancer Center &
Research Institute, commented, “I believe combining optical
coherence tomography with artificial intelligence could represent
the ‘next generation’ technology in specimen imaging. As breast
cancer surgeons, we understand the physical, emotional, and
financial stressors for patients that can come with needing a
second surgery. The results from this study will not only help
determine if this tool can assist physicians with improving patient
outcomes but could also provide evidence of reducing the burden of
additional costs within the overall healthcare system.”
About Perimeter S-Series OCT
Cleared by the U.S. FDA, 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 B-Series OCT with ImgAssist AI
Perimeter is advancing the development of its proprietary,
next-gen “ImgAssist” artificial intelligence 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 coupled with
ImgAssist AI, and Perimeter is conducting a randomized, multi-site,
pivotal study to evaluate it against the current standard of care
and assess the impact on re-operation rates for patients undergoing
breast conservation surgery.
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 may 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 Perimeter’s proposed IDE study on
its B-Series OTC device, the potential benefits of Perimeter’s
S-Series OCT, and the Company’s plans for the clinical development
of its B-Series OCT and ImgAssist AI 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, 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 most recent Management Discussion and Analysis 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20211102005747/en/
Shushu Feng Perimeter Medical Imaging AI, Inc. Main:
214-845-5154 Toll-free: 888-988-7465 (PINK)
media@perimetermed.com
Simplify Exchang (NYSE:PINK)
Historical Stock Chart
From Apr 2024 to May 2024
Simplify Exchang (NYSE:PINK)
Historical Stock Chart
From May 2023 to May 2024