Enhanced Artificial Intelligence Software
and Interim Analysis Integrated into Current Study
TORONTO and DALLAS, Sept. 7,
2023 /CNW/ - Perimeter Medical Imaging AI, Inc.
(TSXV: PINK) (OTC: PYNKF) (FSE: 4PC) ("Perimeter" or
the "Company") – a commercial-stage medical technology company –
today provided an update on the clinical development of its ongoing
clinical trial evaluating the use of Perimeter B-Series OCT
combined with its proprietary ImgAssist AI software during breast
conservation surgery. Based on feedback from the U.S. Food and Drug
Administration ("FDA"), the Company has reached alignment on key
elements of the ongoing clinical trial, including the introduction
of an interim analysis, which is expected in the second quarter of
2024.
Adrian Mendes, Perimeter's Chief
Executive Officer stated, "This positive interaction with the FDA
marks an important milestone in our clinical development program.
As a first step, we received regulatory approval to implement our
substantially enhanced AI algorithm in the ongoing pivotal clinical
trial under the existing study protocol, and we have now aligned on
other key elements in order to chart a clear path forward for the
development of our B-Series OCT with ImgAssist AI."
Mr. Mendes continued, "Importantly, we will have a planned
interim analysis in the trial, which will provide us with an early
read-out of results based on the use of the newest algorithm. If
key endpoints are met at the time of the interim analysis, we
may opt to conclude the trial and begin preparing regulatory
submissions supporting market clearance. Alternatively, the
interim analysis could support continuing the trial to build a
stronger submission package from additional subjects. Ultimately,
our goal is to expedite the development of our next-gen AI
technology and deliver it to our surgeon customers to improve
clinical and economic outcomes in breast surgical oncology."
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 Co-associate Director for Clinical
Research at the Dan L Duncan Comprehensive Cancer Center, stated,
"Having participated in earlier stages of its development, and as
principal investigator of the study, I am excited that the clinical
trial continues to advance and gather additional clinical data
using the updated AI software. There is a strong need for new tools
to assist surgeons with 'real-time' margin assessment in the
operating room. I believe combining AI with high-resolution imaging
has the potential to become a new standard of care during breast
conservation surgery."
Summary of Clinical Trial Updates
- Clearance to introduce enhanced AI algorithm
-
- Perimeter received approval from the FDA to introduce an
enhanced AI algorithm in the ongoing clinical trial under the
existing study protocol. As a result, all clinical trial sites will
use the updated AI as patients continue to enroll in the ongoing
study.
- Enrollment of additional subjects
-
- In order to obtain statistically significant findings based on
the use of the new AI algorithm, Perimeter is permitted to enroll
up to 531 subjects.
- Introduction of interim analysis within study
protocol
-
- Perimeter intends to conduct a planned interim analysis in the
second quarter of 2024. If statistically significant positive
interim results are obtained, the Company may opt to conclude the
trial and begin preparing regulatory submissions supporting market
clearance. If it is determined that more data is needed, the
Company may continue with its clinical trial and anticipates study
completion by the end of 2024.
- Additional clinical trial sites permitted
-
- To further support and expedite patient enrollment, Perimeter
has received clearance to increase the number of clinical trial
sites, most recently adding Mayo Clinic and Baptist MD Anderson in
Florida.
- Summary of anticipated AI improvements
-
- The new enhanced AI takes advantage of additional training data
and Perimeter's latest AI advancements that demonstrate improved
sensitivity, specificity, precision, and recall. It is expected
that this updated version of ImgAssist AI will contribute to more
accurate classification, as well as fewer false positives and
negatives.
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 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.
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 the expected
details regarding Perimeter's ongoing clinical trials, including
the anticipated dates of the planned interim analysis and study
completion, 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, 2022, 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, Inc.
