– Perimeter OCT B-Series is the first system
designed to combine AI with optical coherence tomography for margin
assessment, with the aim of reducing the unacceptably high
reoperation rates associated with BCS –
– Recent study1 published in the
Annals of Surgical Oncology revealed reoperation rates of 21.1%
among commercially insured women and 14.9% among the Medicare
cohort –
– Primary endpoint results from OCT B-Series
pivotal trial expected in Q4-2024; could support submission to FDA
in 2025 –
– First-ever marketing clearance for specific
use in breast tissue, breast cancer, and margin evaluation, if
obtained, would represent a major inflection point for Perimeter's
business –
TORONTO and DALLAS, Oct. 1, 2024
/CNW/ - Perimeter Medical Imaging AI, Inc. (TSXV: PINK)
(OTC: PYNKF) ("Perimeter" or the "Company"), a
commercial-stage medical technology company, today announced the
completion of patient enrollment in a pivotal study evaluating the
use of its next-generation Perimeter B-Series OCT system, which
combines proprietary artificial intelligence ("AI") technology with
optical coherence tomography ("OCT"), during breast-conserving
surgeries ("BCS").
Unfortunately, re-excision after BCS is a common problem with
reoperation rates reported from 14 to 21%1 due to missed
margins and leaving cancer behind. If Perimeter's B-Series study is
successful, it will have demonstrated a decrease in the number of
patients where breast cancer was missed during surgery.
This prospective, multi-center, randomized, double-arm clinical
trial enrolled approximately 530 women, aged 18 years and older,
undergoing BCS for the treatment of Stage 0-III invasive ductal
carcinoma and/or ductal carcinoma in situ. Participants were
recruited from 10 clinical sites across the United States and randomized in a 2:1
ratio to the device and control arms.
Approximately 200 of these subjects will be used to evaluate the
effectiveness of the Perimeter B-Series, which integrates OCT
imaging with the ImgAssist 2.0 AI algorithm, in addressing positive
margins as compared to the standard lumpectomy procedure. A
within-subject analysis will be used to assess the primary
endpoint, which is the occurrence of at least one unaddressed
positive margin for a subject. In addition, several other analyses
will be conducted, including evaluations of safety outcomes,
cosmesis results, as well as secondary and exploratory endpoints
that examine positive cancer results at the margin and patient
levels.
"It is very exciting that the pivotal trial has completed
enrollment in such a timely manner," said Dr. Alastair Thompson, the trial's Primary Principal
Investigator, Surgeon and Professor, Section Chief of Breast
Surgery, Olga Keith Wiess Chair of Surgery at Baylor College of Medicine, Breast Cancer Program
Leader at the Dan L Duncan Comprehensive Cancer Center. "Today,
intraoperative margin assessment remains one of the most pressing
problems for both surgeons and their patients. Perimeter's AI
technology empowers surgeons with a dedicated intraoperative tool
to identify regions of interest and guide real-time decisions on
margin status in the OR. The goal is to determine whether this
technology can help lower re-excision rates – potentially setting a
new standard for specimen imaging technology during BCS. There has
been a smooth collaboration between the clinical trial sites and
Perimeter, and we all are looking forward to seeing the final
results."
"We are pleased patient enrollment has now been completed and
look forward to sharing the primary endpoint results of this
pivotal study with our stakeholders prior to the end of 2024,"
commented Adrian Mendes, Perimeter's
Chief Executive Officer. "If successful, the trial is expected to
support our submission in 2025 to the U.S. Food and Drug
Administration for authorization to market B-Series OCT with
ImgAssist AI in the United
States."
Source
1 Kim Y, Ganduglia-Cazaban C, Tamirisa N, Lucci
A, Krause TM. Contemporary Analysis of Reexcision and Conversion to
Mastectomy Rates and Associated Healthcare Costs for Women
Undergoing Breast-Conserving Surgery. Ann Surg Oncol. 2024
Feb 6. doi:
10.1245/s10434-024-14902-z. Epub ahead of print. PMID:
38319511.
About Perimeter Medical Imaging AI, Inc.
Based in Toronto, Canada and
Dallas, Texas, Perimeter Medical
Imaging AI (TSXV: 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.
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, the
expected timing of the completion of full enrollment in Perimeter's
clinical trial, Perimeter's expectations regarding the outcomes of
the clinical trial, and the expected timing of the installation of
ImgClear, 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.
CONTACTS:
Stephen Kilmer
Investor Relations
Direct: 647-872-4849
Email: skilmer@perimetermed.com
Adrian Mendes
Chief Executive Officer
Toll-free: 888-988-7465 (PINK)
Email: investors@perimetermed.com
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SOURCE Perimeter Medical Imaging AI Inc.