Conference Call/Webcast Today at
5 pm ET
TORONTO and DALLAS, Aug. 14,
2024 /CNW/ - Perimeter Medical Imaging AI, Inc.
(TSXV: PINK) (OTC: PYNKF) (FSE: 4PC) ("Perimeter" or
the "Company"), a commercial-stage medical technology company,
today reported financial results for its second quarter ended
June 30, 2024 and provided a
corporate update.
Business Highlights
- The Company continues to gain positive commercial market
traction with its first U.S. Food and Drug Administration
("FDA")-cleared product, Perimeter S-Series OCT. It has already
achieved six (6) new S-Series OCT system placements year-to-date,
compared to a total of three (3) for all of 2023, and Q2-2024
revenues grew 83% over Q2-2023. In addition, the Company is
advancing the development of its next-generation Perimeter B-Series
OCT system, which combines proprietary AI technology with OCT,
toward potential commercialization.
- In May 2024, Perimeter provided
an update on the ongoing pivotal clinical trial evaluating the use
of its B-Series OCT system during breast-conserving surgeries
("BCS"). Today, based on current trends, the Company is pleased to
announce that it now expects patient enrollment in the study to be
completed in Q3-2024 rather than later in the 2024 fourth quarter.
If successful, the trial is expected to support the Company's
submission to the FDA for authorization to market Perimeter
B-Series OCT in the United States
in 2025.
- In June 2024, a white paper
authored by Amelia A. Gunter, M.D.
from the Center for Cancer and Blood Disorders, Weatherford, TX, reported results from a
retrospective, quantitative assessment of reoperation rates among
72 patients in her practice who underwent OCT imaging during BCS in
order to gain insight into the potential benefits and limitations
of OCT for patient outcomes.1 While not designed to
guide clinical practice, the research demonstrated that:
- Dr. Gunter's reoperation rate with OCT was 5.6%, compared
to the national rate of 19.9% as determined from a national claims
database study conducted by MD Anderson and University of Texas researchers that included
24,106 patients;
- While the national reoperation rate in commercial
insurance patients with ductal carcinoma in situ ("DCIS") was
30.8%, the Perimeter S-Series OCT reoperation rate in patients with
DCIS was 13.3%; and
- In commercial insurance patients with invasive ductal carcinoma
("IDC"), the national rate of reoperation was shown to be 18.0%,
while Perimeter's S-Series OCT reoperation rate in patients with
IDC was 0.0%.1, 2, 3
- In July 2024, the 1,000th paid
Perimeter S-Series OCT patient scan was performed, representing an
important clinical and commercial milestone achievement by the
Company.
- In July 2024, Perimeter's product
innovation team completed the first-of-its-kind installation of the
recently developed "ImgClear" AI image enhancement algorithm with a
commercial Perimeter S-Series OCT system. Internal testing has
demonstrated ImgClear enables users to achieve better quality
images (up to 441% signal-to-noise ratio increase) and reduce scan
time (28% reduction). The Company expects to upgrade all installed
Perimeter S-Series OCT systems with ImgClear before the end of the
year.
"It is exciting to see the scale, scope and speed with which the
growth pillars we have been laying down since last year's
management transition are starting to produce tangible results,"
said Adrian Mendes, Perimeter's
Chief Executive Officer. "Chief among these are restructuring our
sales organization, driving both record recurring revenues and new
system placements; regimenting our real-world data collection,
facilitating the recent publication of Dr. Gunter's OCT white
paper; improving clinical trial execution, resulting in the
anticipated completion of patient enrollment in the ongoing OCT
Series-B with ImgAssist AI pivotal trial now tracking well ahead of
schedule; and finally, continuing to innovate, bringing exciting
product enhancements like our ImgClear AI image enhancement
algorithm successfully to market. With these key pillars of our new
growth strategy now firmly established, we expect that positive
momentum to continue, and we are energized by the many potential
value enhancing inflection points we see ahead."
Second Quarter 2024 Financial Results
Unless specified otherwise, all amounts in this press release
are expressed in U.S. dollars and are presented in accordance with
International Financial Reporting Standards as issued by the
International Accounting Standards Board.
The Company reported second quarter 2024 revenues of
approximately $246,000, which
consisted of the sale of consumables and system leases. Second
quarter 2024 revenues increased 83% over Q2-2023. Revenue growth
was driven by continued commercial adoption of Perimeter S-Series
OCT, both in terms of existing system utilization and installed
base growth.
Operating expenses for the three months ended June 30, 2024 were approximately $5.5 million, compared to approximately
$3.4 million for the same period in
2023. The increase was primarily due to higher stock-based
compensation, employee expenses, research and development expenses
and subcontractor expenses.
Second quarter 2024 net loss improved 35% to approximately
$3.2 million, or $0.05 per common share, compared to approximately
$4.9 million, or $0.08 per common share, in the three months ended
June 30, 2023.
Cash used in operating activities in the three months ended
June 30, 2024, was approximately
$7.5 million, compared to
approximately $7.2 million in
Q2-2023.
As of June 30, 2024, cash and cash
equivalents were approximately $6.5
million. This amount does not include a Cancer Prevention
and Research Institute of Texas
(CPRIT) grant receivable of approximately $1.8 million, which is related to the
reimbursement of pivotal clinical trial project costs, as of the
end of the 2024 second quarter.
For detailed financial results, please refer to Perimeter's
filings on SEDAR+ and the Company's website.
Conference Call
The Company will host a conference call and live audio webcast
today at 5:00 pm Eastern Time to
discuss its second quarter 2024 results and provide a corporate
update. 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.
Sources
1 Gunter, Amelia. Adjunct intraoperative optical
coherence tomography imaging and reoperation rates after
breast-conserving surgery. The Center for Cancer and Blood
Disorders, Weatherford, TX.
June 3, 2024
2 National reoperation rate calculated based on
weighted rates in Commercial and Medicare cohort in MD Anderson
study3 and overall percent of U.S. patients covered by
Commercial versus Medicare insurance in U.S. Census health
insurance coverage report.
https://www.census.gov/library/publications/2023/demo/p60-281.html
3 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; doi:
10.1245/s10434-024-14902-z
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.
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.
CONTACT:
Stephen Kilmer
Investor Relations
Direct: 647-872-4849
Email: skilmer@perimetermed.com
Adrian
Mendes
Chief Executive
Officer
Toll-free: 888-988-7465
(PINK)
Email: media@perimetermed.com
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SOURCE Perimeter Medical Imaging AI Inc.