– Intraoperative margin assessment during
BCS using Perimeter B-Series OCT with ImgAssist AI 2.0 enabled
surgeons to more effectively address residual cancer at the
surgical margin as compared to current standard methods –
– Primary endpoint met with statistically
significant reduction in patients with residual cancer during
surgery (p-value = 0.0050) –
– B-series super-superiority based on
predefined clinical and statistical significance parameters
–
– FDA PMA application for B-Series OCT system
with ImgAssist AI expected to be submitted in early 2025 –
– Perimeter Medical Imaging AI to host
conference call/webcast today at 5 pm
ET –
TORONTO and DALLAS, Nov. 20,
2024 /CNW/ - Perimeter Medical Imaging AI, Inc.
(TSXV: PINK) (OTC: PYNKF) ("Perimeter" or the "Company"),
a commercial-stage medical technology company, today announced
positive topline results from the pivotal study designed to support
its planned Premarket Approval Application ("PMA") submission to
the U.S. Food and Drug Administration ("FDA") for approval to
market the Company's next-generation Perimeter B-Series OCT system,
which combines proprietary artificial intelligence ("AI")
technology with optical coherence tomography ("OCT"), for use
during breast-conserving surgeries ("BCS") in the United States.
In this prospective, multi-center, randomized, clinical trial,
206 breast cancer patients undergoing BCS for the treatment of
Stage 0-III invasive ductal carcinoma and/or ductal carcinoma in
situ were evaluated to measure the effectiveness of the
combined B-Series OCT imaging system with ImgAssist AI 2.0 as
compared to lumpectomy current standard methods including
palpation, specimen radiograph, intraoperative pathology and
ultrasound in addressing positive margins. Participants were
recruited from multiple clinical sites across the United States.
The B-Series OCT with ImgAssist AI 2.0 enabled surgeons to more
effectively address residual cancer at the surgical margin during
surgery as compared to current standard methods. The pivotal trial
met its primary endpoint, achieving a statistically significant
(p-value = 0.0050) reduction in patients with residual cancer
during surgery. These results demonstrate super-superiority (lower
bound of confidence interval for treatment effect greater than a
predetermined minimal clinically meaningful difference) of the
Perimeter B-Series OCT with ImgAssist AI 2.0 system's ability to
aid surgeons in achieving clear surgical margins during surgery,
potentially lowering the need for reoperation.
"These positive topline pivotal trial results are very
encouraging for this patient population undergoing BCS," said Dr.
Sarah Butler, Perimeter's Vice
President, Clinical and Medical Affairs. "The trial easily met its
primary endpoint, demonstrating that intraoperative margin
assessment using OCT combined with Perimeter's AI technology may be
able to help lower re-excision rates by identifying regions of
interest and guiding real-time decisions by surgeons on margin
status in the OR. We are looking forward to submitting our FDA PMA
for B-Series OCT with ImgAssist AI 2.0 in early 2025."
"Surgeons have worked for years to innovate every step in the
diagnosis and treatment plan for their cancer patients, with the
ultimate goal of improving survivability and quality of life,"
commented Adrian Mendes, Perimeter's
Chief Executive Officer. "The promise of B-Series OCT with
ImgAssist AI 2.0 is greater peace of mind. Both for the surgeon who
– no matter how skilled – currently faces nearly
1-in-5 odds of needing to perform repeat surgery due to positive
margins; and for their patient, who under the current paradigm,
typically has to wait (and worry) for up to seven days for their
surgeon to receive a post-operative pathology report which will
determine whether they will have to go through the emotional and
physical trauma of a second surgery due to cancer left behind. We
believe that, based on these positive topline pivotal trial
results, we are well-positioned to make a real difference in the
treatment of cancer patients; and should the FDA approve the PMA,
B-Series OCT with ImgAssist AI 2.0 has the potential for rapid
acceptance and adoption by BCS surgeons in the United States."
In addition to the primary endpoint analysis reported today, the
Company is conducting additional analyses, including secondary
endpoints and additional reporting. Perimeter anticipates that
detailed results from the pivotal trial evaluating the use of its
next-generation B-Series OCT with ImgAssist AI 2.0 during BCS will
be presented at an upcoming medical conference.
Conference Call
Perimeter is pleased to invite all interested parties to
participate in a conference call and live audio webcast today at
5:00 pm Eastern Time, during which
the pivotal trial topline results will be discussed. To participate
in the call, please dial 1-800-717-1738 or 1-646-307-1865. The
conference call will also be broadcast live online through a
listen-only webcast, which will be posted on the Investors section
of the Company's website and archived for approximately 90
days.
About Perimeter Medical Imaging AI, Inc.
Based in Toronto, Canada and
Dallas, Texas, Perimeter Medical
Imaging AI (TSXV: PINK) (OTC: PYNKF) 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 being
evaluated in a pivotal clinical trial, with support from a grant of
up to US$7.4 million awarded by the
Cancer Prevention and Research Institute of Texas. The company's ticker symbol "PINK" is a
reference to the pink ribbons used during Breast Cancer Awareness
Month.
Perimeter B-Series OCT is limited by U.S. law to
investigational use and not available for sale in the United States. Perimeter S-Series OCT has
510(k) clearance under a general indication and has not been
evaluated by the U.S. FDA specifically for use in breast tissue,
breast cancer, other types of cancer, margin evaluation, and
reducing re-excision rates. The safety and effectiveness of these
uses has not been established. For more information, please visit
www.perimetermed.com/disclosures.
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 and Perimeter B-Series OCT, the expected
benefits of Perimeter's updated version of its ImgAssist AI, and
Perimeter's expectations regarding the outcomes of the clinical
trial and future submission to the FDA 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, 2023, which is
available on Perimeter's SEDAR+ profile at
https://www.sedarplus.ca, 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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SOURCE Perimeter Medical Imaging AI Inc.
