Conference Call/Webcast Today at 5 pm
ET
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 reported financial results for its
third quarter ended September 30, 2022 and provided a corporate
update.
Key Highlights
- Activated initial eight planned clinical trial sites to
evaluate Perimeter’s B-Series OCT system with ImgAssist AI
technology and received U.S. Food and Drug Administration (“FDA”)
approval to expand the number of institutions with the goal of
accelerating enrollment.
- Perimeter S-Series OCTs placed within a national healthcare
provider system and at Pavilion Surgery Center, the first in the
state of California.
- Data presented at the College of American Pathologists 2022
Annual Meeting supports the potential use of S-Series OCT across
several tissue types.
Jeremy Sobotta, Perimeter’s Chief Executive Officer stated, “I’m
proud of the progress we made over the third quarter despite
continued headwinds impacting both our customers’ and clinical
partners’ operations. With all eight initial pivotal clinical trial
sites active and authorization to expand the number of sites, we
anticipate continued improvement in patient enrollment rates. We
believe the high level of engagement from our existing
investigators and the significant interest we have received for
expansion sites reflect the belief within our end-user community
that our B-Series OCT with ImgAssist AI has the potential to be a
transformative technology.”
Mr. Sobotta continued, “Commercially, we continue to execute in
a challenging environment. While staffing and other macro-pressures
persist for our customers, we believe the caliber of users and
institutions adopting the technology are strong indicators of the
validity of our stated early commercialization strategy of building
future reference sites and key opinion leaders with our flagship,
S-Series OCT.”
Quarterly Updates
- Perimeter is conducting a multi-center, randomized two-arm
pivotal clinical trial evaluating Perimeter B-Series OCT combined
with its proprietary ImgAssist AI software in approximately 330
patients. Led by Principal Investigator, Dr. Alastair Thompson at
the Baylor College of Medicine in Houston, TX, the initial eight
planned clinical sites have now been activated. Perimeter received
FDA approval to expand the number of institutions involved in the
clinical trial, and other high-potential sites are currently being
evaluated to further support patient enrollment.
- Perimeter presented data to leading pathologists in the U.S. at
the Annual Meeting of the College of American Pathologists 2022
(CAP22), which took place October 8 to 11, 2022 in New Orleans, LA.
These data support the potential use of Perimeter’s OCT medical
imaging technology in a variety of settings and across several
tissue types, including the analysis of margins in head and neck
surgery.
- On October 3, 2022, Perimeter announced it had graduated from a
Tier 2 Issuer to a Tier 1 Issuer on the TSX Venture Exchange.
- On September 29, 2022, Perimeter announced the commercial
placement of its Perimeter S-Series OCT system at a hospital that
is part of a major national healthcare system and one of the
largest healthcare networks in North Texas.
- On August 3, 2022, Perimeter announced its first commercial
placement of an S-Series OCT device in the state of California at
Pavilion Surgery Center, an affiliate of St. Joseph Hospital. The
device will be used under the direction of Michele Carpenter, MD, a
breast surgeon who performs breast conservation and other surgeries
at Pavilion Surgery Center and marks the first commercial use of
the technology in a standalone, ambulatory setting.
Summary of Third Quarter 2022 Financial Results
All of the amounts are expressed in Canadian dollars unless
otherwise indicated and are presented in accordance with
International Financial Reporting Standards as issued by the
International Accounting Standards Board applicable to the
preparation of interim financial statements, including
International Accounting Standard 34, Interim Financial
Reporting.
Operating expenses for the three months ended September 30, 2022
were $5,936,097 compared to $3,748,590 during the same period in
2021.
Net finance income for the three months ended September 30, 2022
was $935,139 compared to finance costs of $(101,827) for the three
months ended September 30, 2021.
Net loss for the three months ended September 30, 2022 was
$(818,527) compared to $(3,880,172) for the same period in
2021.
For the nine months ended September 30, 2022, cash used in
operating activities was $(13,097,026).
As of September 30, 2022, cash and cash equivalents were
$43,200,189.
For detailed financial results, please see Perimeter’s filings
at www.sedar.com and on the company’s website at
https://ir.perimetermed.com/.
Company Outlook
Perimeter’s sales and marketing efforts will continue to focus
on placing its commercially available, flagship Perimeter S-Series
OCT at leading hospitals where key opinion leaders can champion
this innovative technology. In light of the continued issues facing
healthcare providers which are, in turn, impacting its sales cycle,
the Company withdraws its installation guidance for the fiscal year
2022. Perimeter will continue to provide updates on progress as it
occurs and evaluate the outlook on an ongoing basis. In parallel,
Perimeter’s clinical team will focus on the continued enrollment of
patients and onboarding of healthcare institutions in the ongoing
pivotal trial evaluating its next-gen investigational Perimeter
B-Series OCT with ImgAssist AI when used in breast lumpectomy
procedures, with the goal of gathering data from over 330 patients
across a minimum of eight sites and completing enrollment in the
first half of 2023.
Conference Call
The Company will host a conference call and live audio webcast
today, November 15, 2022, at 5:00 pm Eastern Time to discuss its
third quarter results and to provide a corporate update. To
participate in the call, please dial 1-877-704-4453, or
1-201-389-0920 for international callers, and provide conference ID
number 13734184. The 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. The webcast will be
archived on the Company's investor relations webpage for at least
90 days. A telephonic playback of the conference call will be
available for 14 days after the conference call by calling
1-844-512-2921 or 1-412-317-6671 from abroad and referencing
conference ID 13734184. The above listed dates and times are
subject to change.
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, Perimeter B-Series OCT, and Perimeter
ImgAssist; Perimeter’s expected marketing and sales activities; and
the expected details regarding Perimeter’s ongoing clinical trials,
including anticipated improvements in patient enrollment rates and
the estimated completion date of enrollment, 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, 2021, 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. 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/20221115006346/en/
Chris Scott Chief Financial Officer Perimeter Medical Imaging
AI, Inc. Toll-free: 888-988-7465 (PINK) Jodi Regts Perimeter
Medical Imaging AI, Inc. Direct: 469-743-1834 Investors:
investors@perimetermed.com Media: media@perimetermed.com
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