TIDMIQAI
RNS Number : 6279Q
IQ-AI Limited
28 October 2021
28 October 2021
IQ-AI Ltd
("IQ-AI" or the "Company")
IQ-AI LIMITED ISSUES SHAREHOLDER LETTER
Company Enjoys Most Successful Year on Record
Marked Increase in Revenue and Growing Technology Portfolio
Sponsorship of a Phase I Clinical Trial
Milwaukee - 28 October 2021: IQ-AI Limited (OTCQB: IQAIF) (LSE:
IQAI) , a developer and manufacturer of medical image processing
platforms, released a letter to shareholders from Director Michael
Schmainda. The entire letter follows:
Dear Shareholders
The intent of this inaugural quarterly letter is to share our
optimism with our shareholders and to help underscore the
tremendous progress and potential of our company.
2021 has already proven to be our busiest and most successful
year on record. The marked increase in revenue, our growing
technology portfolio, our advancement of new products and
platforms, and our sponsorship of a Phase I clinical trial drive
our strategy to build upon the momentum gained during this banner
year. Our listing on the OTCQB: IQAIF, which provides direct access
for U.S. investors, is another key milestone that positions us to
achieve our goals as we head into 2022. Likewise, our Depository
Trust Company (DTC) application, which is in process, will provide
clearing and settlement efficiencies between custodian banks and
broker-dealers. We are also accelerating product development with
the expansion of our software team. A senior software engineer with
artificial intelligence (AI) experience will join us as a fulltime
employee on November 8(th) .
Year-to-date revenues have more than doubled, driven primarily
by the continued adoption of IB Clinic - container edition (IB
Clinic), and the continued funding from awarded grants from the
National Institutes of Health (NIH). IB Clinic provides seamless
integration of fully automated processing of our clinically
validated software platforms. While ideally suited for large,
high-volume brain cancer centers, IB Clinic can be easily adopted
by hospitals and diagnostic imaging chains of any size. The growing
market acceptance of our automated applications has intensified our
focus on the continued development and enhancement of IB Clinic.
Automation has the obvious benefit of off-loading busy radiologists
and technologists, and the quantitative output provides healthcare
systems with consistency that improves efficiency in study
interpretation and longitudinal comparisons. We are proud to be the
only company that can offer quantitative magnetic resonance (MR)
imaging software that answers the most frequently asked question in
neuro oncology today: "is the enhancing region tumor or is it
treatment effect?". Our pipeline is healthy, with two additional
National Cancer Institute (NCI) designated cancer centers
undergoing trial evaluations of IB Clinic.
Our flagship product, IB Neuro(TM), is at the heart of our
automated and quantitative processing. This product was the outcome
of a multi-year comparison study published in Radiology in 2008. In
this landmark study, the technology developed by the co-founder of
IQAI's subsidiary, Imaging Biometrics, LLC (IB), Professor Kathleen
Schmainda, PhD, at the Medical College of Wisconsin (MCW)
demonstrated superiority over other technologies that proclaimed to
do the same computational analysis. Specifically, the approach used
by Professor Schmainda uniquely accounts for contrast agent leakage
across the blood-brain-barrier (BBB) and was able to distinguish
between tumor and normal brain tissue more reliably than the
commonly available technologies to which it was compared. Since
then, the underlying technology has been enhanced by Professor
Schmainda and the team at IB, which has enhanced and further
differentiated IB Neuro from the competition. More recently, it has
been recognized to be consistent with the national consensus
recommended protocol for MR DSC perfusion imaging, a protocol
officially endorsed by several of the major neuro-oncology and
neuro-radiology societies.
We are acutely aware other groups offer varied and inconsistent
versions of DSC perfusion imaging platforms. These groups use their
internal versions to conduct and publish studies that may not
always shed a favorable light on the true diagnostic value of DSC
imaging. In our early days, this resulted in confounding reviews
and prolonged the sales cycle of IB Neuro. Fortunately, decades of
proven science are on our side: We have the scientific track record
and a growing body of published literature that backs up the
quality, accuracy, and robustness of our products. We continue to
invest in our core platforms, and we are grateful for Professor
Schmainda and our long-standing collaborators who continue to
translate novel technologies and ideas from the laboratories to
routine clinical use.
New products and technology development are also at an all-time
high for us. In June of this year, we were awarded a US patent for
IB Zero G(TM), our 0% gadolinium AI technology: this technology
uses only non-contrast medical images as input and generates
synthetic "with-contrast" images as output. Since receiving the
patent, and as announced in recent press releases, we have attained
and labeled over 1,000 datasets for development purposes, we have
completed the processing pipeline, and will prepare a US FDA 510(k)
application for a late Q1 2022 submission. We believe the
disruptive potential of IB Zero G to be extremely exciting on
multiple levels: institutional costs of gadolinium-based contrast
agents (GBCAs) are significant and could be avoided, administering
GBCAs is an additional step in the clinical workflow, and GBCA
administration can be prone to error if not done properly. From the
patient's perspective, GBCAs are administered intravenously.
Therefore, patients could enjoy a more comfortable scan experience
if GBCA administration is avoided. And, while still unknown, the
long-term adverse side effects of repeated GBCA dose
administrations remain a concern. IB Zero G addresses these
concerns, from both a patient risk and an institutional liability
standpoint.
The market drivers for IB Zero G are as follows:
-- People with compromised renal (kidney) function cannot
efficiently process contrast agents and are at risk of nephrogenic
systemic fibrosis (NSF), which is an untreatable condition that
gadolinium contrast can cause. Kidney patients, mostly those in
late-stage renal disease, have the highest risk. This means there
is a population of patients who would immediately benefit from this
technology.
-- If hospitals can minimize these concerns without compromising
image quality, it will be an easy decision to adopt IB Zero G.
GBCAs are expensive and administering them - via power injectors,
intravenously - can inhibit patient throughput on
capitally-intensive MR scanners. In some cases, GBCAs may not be
administered properly, thus rendering the patient scan a waste and
requiring the patient to be reschedule for a repeated scan.
-- Pediatric and neonatal patients, as well as patients who
require multiple MR contrast-enhanced scans, such as Multiple
Sclerosis (MS) and follow-up brain tumor patients, stand to benefit
as well since contrast-enhanced images provide critical diagnostic
information not available with other standard imaging technology.
Patients with understandable concerns about gadolinium retention in
the body will find IB Zero G as an attractive alternative.
In addition to IB Zero G, we are focusing development efforts on
IB Trax(TM) (metastatic tumor monitoring), IB "CAD" (AI to detect
infiltrating tumor cells not visible on standard MRI), and "dual
echo", our patented MR acquisition and post-processing technology
that generates both DSC and DCE (dynamic contrast enhanced)
parameters using a single MR acquisition and a single dose of GBCA.
IB Trax is being designed to facilitate an optimal workflow for
systematically tracking metastatic brain lesions. At its core, IB
Trax will employ IB Delta T1 (patent pending) maps to help identify
and track the locations and sizes of metastatic tumors. Metastatic
brain lesions are much more prevalent than primary tumors, and the
industry is lacking a robust and reliable platform that reduces
errors and improves efficiency for follow-up imaging and volumetric
analysis. We believe we have the core tools that can provide a
competitive advantage and, more importantly, help clinicians help
patients. IB CAD is another AI-based technology that has
demonstrated the ability to detect infiltrating cancer cells that
are not visible on standard imaging. We anticipate this having a
tremendous influence on the future management of and treatment
planning for brain tumors.
Our longstanding involvement in the brain tumor imaging sector,
and our relationship with Professor Kathleen Schmainda, PhD, led to
this year's pinnacle announcement - the sponsorship of an oral
agent that combats high-grade brain tumors. Imagine if a brain
cancer patient could take a daily pill, experience no adverse side
effects, and live much longer than they can using today's standard
of care. That is our goal and, given the highly promising results
of pre-clinical studies, we intend to follow this through to the
end. Prior Phase I clinical studies have shown that the key
ingredient, gallium, was well tolerated in human subjects. As
previously announced , we are working with the principal
investigators of the study as we qualify a new vendor for
encapsulating the agent. These things never go as fast as we like,
but progress is being made.
On October 1st we enlisted an experienced US based client
relations manager to help us market our software and sell it to
prestigious health networks. We have an established footprint in a
growing number of National Cancer Institute (NCI) designated cancer
centers that purchase annual license subscriptions to IB Clinic.
Give the large number of cases processed at these high-volume
centers, these annual subscriptions consistently range well above
$100,000 per year. We intend to focus our efforts on deploying IB
software to more NCI-designated cancer centers in 2022 and, as
mentioned previously, have active trials in two more sites.
We have not attended any medical or science conferences since
the Covid-19 pandemic began, but we plan to be active participants
once again at upcoming shows, including SNO ( Society of Neuro
Oncology ), ASNR ( American Society of Neuro Radiology ), ASFNR (
American Society of Functional Neuro Radiology ) and RSNA
(Radiological Society of North America). We continue to conduct
R&D with our collaborators at MCW, Mayo AZ, Rhode Island/Brown
University, the University of Southern California (USC), and the
Barrow Neurological Institute (BNI).
I want to emphasize we are the only dynamic susceptibility
contrast (DSC) MR perfusion platform that generates quantitative
parameter maps and the only platform validated with actual tissue
biopsy samples. Our software has been repeatedly proven to
accurately distinguish between tumor and non-tumor tissue - a basic
yet critical question challenging treatment teams each day. We are
also the only company that can generate quantitative difference
maps. The quantitative approach we use accounts for the inherent
variability within MR scans and across vendors: even if a patient
is scanned on the same day, on the same scanner, with all the same
scanner settings, by the same technologists, the maps will appear
different and are only qualitative. With our quantitative
technology, clinicians can now directly (numerically) compare MR
DSC perfusion output independent of scanner, patient, timepoint,
etc. This direct comparison between scans allows clinicians and
their patients to assess treatment response on a timelier and more
consistent basis. Our software provides this information sooner and
helps clinicians optimize treatment, extend lives, and improve
quality of life of their patients.
In closing, I want to extend our sincere appreciation to all our
shareholders. I look forward to providing you with more exciting
news and continued progress in this quarter and as we ramp up for
another milestone year in 2022.
Sincerely yours,
Michael Schmainda, CEO
Imaging Biometrics, LLC
About Imaging Biometrics, LLC
Imaging Biometrics(R), a subsidiary of IQ-AI Limited (LSE:
IQAI)(OTCQB: IQAIF), develops and provides visualization and
analytical solutions that enable clinicians to better diagnose and
treat disease with greater confidence. Through close collaboration
with top researchers and clinicians, sophisticated advancements are
translated into platform-independent and automated software
plug-ins which can extend the base functionality of workstations,
imaging systems, PACS, or medical viewers. By design, IB's advanced
visualization software seamlessly integrates into routine
workflows. For more information about Imaging Biometrics, visit the
company's website at www.imagingbiometrics.com .
Safe Harbor Statement
This press release includes statements that may constitute
forward-looking statements made pursuant to the safe harbor
provision of the Private Securities Litigation Reform Act of 1995.
These forward-looking statements can be identified by terminology
such as "will," "expects," "anticipates," "future," "intends,"
"plans," "believes," "estimates," or the negative of these words
and/or similar statements. Statements that are not historical
facts, including statements about the Company's beliefs and
expectations, are forward-looking statements. Forward-looking
statements involve inherent risks and uncertainties that could
cause actual results to differ materially from the forward-looking
statements. For example, statements about future revenues and the
Company's ability to fund its operations and contractual
obligations are forward looking and subject to risks. Several
important factors could cause actual results to differ materially
from those contained in any forward-looking statement. Potential
risks and uncertainties include, but are not limited to, the
inability to raise capital to support the Company through its
growth stage, the Company's inability to generate projected sales
and trade relations between the United States and China. The
Company does not undertake any obligation to update any
forward-looking statement, except as required under applicable
law.
Investor Relations Contact:
Michael Porter, President
Porter, LeVay & Rose, Inc.
Tel: 212-564-4700
mike@plrinvest.com
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