TIDMIQAI
RNS Number : 7623Z
IQ-AI Limited
27 January 2022
27 January 2022
IQ-AI Limited
("IQ-AI" or the "Company")
Imaging Biometrics LLC Year end 2021 Letter to shareholders
Imaging Biometrics, a subsidiary of IQ-AI Limited (OTCQB: IQAIF:
LSE: IQAI), discusses its most successful year on record.
-- Increases technology platform and expects record revenues
-- Rolls out Phase I clinical trial and prepares to file 510(K) with the FDA
Milwaukee, WI January 27, 2022, Imaging Biometrics, a subsidiary
of London-based IQ-AI Limited, develops and provides visualization
and analytical solutions that enable clinicians to better diagnose
and treat disease, today published its year end 2021 letter to
shareholders.
"Dear Shareholders:
We'd like to start by wishing you and your families good health
and a great 2022. Over the last 12 months our company, like
companies all over the world, had to manage the realities of the
ongoing pandemic. As we mentioned in previous announcements,
COVID-19 imposed a delay in sales activity as hospitals shifted
resources to deal with the influx of patients. Internally, we are
happy to report we experienced no interruptions to our operation
and the development of key technologies. Our staff are well, and we
are grateful that all our prospects re-engaged with us as the year
progressed. As a result, we saw a step-change increase in revenue
and completed our most successful year on record; more than
doubling revenue to nearly $700K. While we continue to receive
funding from the National Institutes of Health (NIH) for various
grant activities, this marked increase was driving by growth in
sales of IB Clinic-container edition (IB-ce). In addition to record
sales, we continued to receive strong activity for trial requests
of IB software. Most of these requests were for IB-ce, which
enables fully automated generation of our quantitative parameter
maps. We are the only company in the world with this capability
and, given that IB-ce was introduced only a few short years ago, we
are extremely encouraged with the initial adoption rate. The fully
automated and seamless workflow, coupled with the proven accuracy
of our quantitative maps, results in real clinical value for our
clients and the confidence they have in our ability to impact
survival and improve the quality of life in brain tumor and other
patients. The conventional imaging approaches currently used by
most hospitals and clinics remain inadequate, particularly when
assessing brain tumors. The all-too-common question, "is the
enhancing region tumor, or is it an effect due to treatment?"
continues to be asked by treatment teams around the world. That
remains our challenge; to educate and make clinicians aware of the
advanced capabilities we offer and help them understand how we can
provide the answer to that fundamental question.
Our partners, which include EnvoyAI/Terarecon, QMENTA,
Medimsight, Blackford, Arterys, Cortechs.ai, and aycan Medical
Systems, have been actively presenting our solutions to new clients
and prospects. While sales generated from our channel partners have
been slow to gain traction, we remain optimistic that our combined
efforts will gain momentum in 2022. We continue to provide training
to their respective sales and marketing teams, we assist in the
technical development of our combined platforms, and we participate
in direct sales calls with prospective clients. Of significance,
QMENTA recently obtained FDA 510(k) clearance for their platform,
and we anticipate another partner to receive FDA 510(k) clearance
for their platform in early '22. FDA market clearance allows
commercialization to commence in the USA. This is the pinnacle
milestone for being able to sell medical devices without
restriction, and companies must demonstrate compliance with federal
quality regulations in the design and development of each device.
In addition, a major pharmaceutical company is working with yet
another partner to develop their own custom platform which includes
3(rd) party artificial intelligence (AI) solutions. This company
was very selective in choosing which 3(rd) party applications would
participate in early launch activity in the USA and in Europe. IB
software was one of the few selected partners given our unique and
proven capabilities. This is highly encouraging as we expect an
accelerated penetration of our solution in the global medical
imaging market with the backing and broad outreach of a
multibillion-dollar organization.
Our IB Clinic suite of products are renowned for dramatically
improving the ability of hospitals, clinics, and research
organizations to get the most out of their magnetic resonance (MR)
and computed tomography (CT) data. This improves the medical
professional's ability to diagnosis and treat patients. In
addition, our products enable our customers to standardize imaging
protocols across various sites and platforms using the nationally
recognized standard for MR perfusion imaging and other quantitative
analyses. This is particularly meaningful for health care systems
and imaging chains that have multiple satellite facilities. For
instance, a patient could get scanned at one facility using vendor
A's scanner, and a few months later be scanned at another facility
using vendor B's scanner. If the data is processed using IB Clinic,
the two exams can be directly compared to assess if the patient is
responding to treatment. That is a key differentiator of IB's
quantitative platforms. If any other software platform was used in
this scenario, the two exams could not be directly compared to
quantify changes and assess treatment response because they cannot
generate output that is truly quantitative. Moreover, conventional
imaging is not capable of answering critical questions,
specifically, is the enhancing region tumor or is it an effect due
to treatment? Thus, IB software offers several distinct advantages
to patients. First, patients undergoing treatment can be scanned at
any location convenient to them or the data from their MRI exam can
be securely transferred to another site that has IB software. The
built-in technology of IB Clinic will account for all the
variations inherent with MR scanners and make the output
"standardized" and consistent from one scan to the next. This is
unique to IB Clinic and a reason why customers have repeatedly
commented and published how our software is influencing their
treatment and surgical decisions.
Optimizing surgical guidance is an area we believe the accuracy
of our solutions can be of additional benefit. Currently, surgical
navigation systems provide sophisticated technologies that direct
surgeons how to best navigate to the tumor site. Once at the tumor
site, however, the surgeon needs to know where to biopsy or how
much to cut. IB Neuro and IB Delta T1 maps can help provide
accurate information that is currently not available.
In June of 2021, we were awarded a US Patent for "gad free"
imaging; a 0% gadolinium AI technology. The ability to
synthetically generate a post-contrast image, using only
non-contrast images as input, highlights the power of AI and the
disruptive potential it is having in healthcare. Translating this
technology into routine clinical care remains a very high priority
for us, and we are on target of submitting a 510(k) application to
the FDA by the end of Q1, 2022. Motivating us is the fact that
there is an immediate patient population that could benefit from
this technology. Patients with compromised renal function cannot
receive gadolinium-based contrast agents (GBCAs) since they are at
risk of an untreatable condition called nephrogenic systemic
fibrosis (NSF). In addition, younger children who require multiple
MR contrast-enhanced scans, or any patient with concerns about GBCA
administration, may find IB Zero G as an attractive alternative.
From a hospital administration perspective, IB Zero G offers
workflow benefits. First, it will remove the intravenous injection
of GBCAs. This invasive step is not always performed properly,
rendering the scan meaningless and requiring the patient to
reschedule (and receive another dose of GBCA). Avoiding this step
will foster higher scanner throughput and make MRI departments more
productive due to the streamlined workflow. And the cost of GBCAs
can be reduced. Outside of the hospital, environmental concerns
have been steadily coming to the forefront as higher levels of
gadolinium have been detected in areas near and around MRI
departments, such as rivers, streams, and even drinking water.
Thus, IB Zero G has far reaching implications and may prove to be
an iconic landmark AI application in healthcare.
As mentioned above, we feel the pediatric and neonatal patient
populations represent a large and immediate market for IB Zero G.
Our company is extremely proud that near the end of the year we
signed a Data Use Agreement with St. Jude Children's Hospital. St.
Jude's is the only National Cancer Institute designated
comprehensive Care Center devoted solely to children. It has
received the highest ranking for the treatment of children
worldwide. The team at St. Jude's expressed immediate interest in
IB Zero G and responded by presenting us the agreement that
provides access to MRI datasets acquired in children of all ages.
The data will be used to understand how the AI technology performs
in rapidly developing brains of younger subjects, as well as the
testing and validation required for full commercialization of our
IB Zero G(TM) product.
In addition, a derivative algorithm that resulted from the
development of IB Zero G has been implemented in our core IB Clinic
processing platform for automatically generating perfusion-derived
"fractional tumor burden" maps. These maps classify the output of
IB Neuro's quantitative perfusion data per the specification of
clinicians. Currently, the semi-automated process includes one
final manual step: the outlining of the enhancing region on the
Delta T1 maps using our IB Rad Tech module. IB Rad Tech is a plugin
to the OsiriX DICOM viewer. The manual drawing of the enhancing
outlines leverages some fundamental capabilities of OsiriX.
However, OsiriX is dedicated to the Mac computer. Most hospitals
and imaging centers are PC-centric and are not always open to
installing or supporting 3(rd) party workstations. The automated
segmentation algorithm eliminates this final manual step and breaks
the dependence on OsiriX and Mac computers. We are in the process
of deploying the automated workflow as part of the
platform-independent and fully automated IB Clinic - container
edition platform to key sites and medical collaborators.
During 2021, we were awarded a European patent for dual-echo MRI
perfusion. This technology combines MR acquisition and
post-processing and is already patented in the USA. The development
and translation of this technology has been accelerated by funding
from an NIH grant awarded in collaboration with the Barrow
Neurological Institute (BNI). Using a single MR acquisition
sequence, two sets of parameter maps can be generated; DSC and
dynamic contrast enhanced (DCE). Moreover, the accepted pre-load
dose of gadolinium (shown to optimize the signal-to-noise ratio in
perfusion imaging) can be eliminated under this approach and
generate images of comparable quality. Harmonizing this protocol
across all vendor platforms is part of the funded BNI grant and
encompasses tremendous communication and coordination with the
major MRI vendors.
During the latter half of 2021, we worked alongside the team at
the Medical College of Wisconsin Cancer Center (MCWCC) to qualify
of a new supplier of encapsulated oral gallium maltolate (GaM) for
our sponsored Phase I clinical trial. Thanks to their diligence and
effort, we have successfully accomplished that and have further
completed the required stability testing for the newly encapsulated
agent. The results have been sent to the FDA as an amendment to the
already approved Investigational New Drug (IND) application, and
the entire team is anxiously awaiting their response which would
allow the first subject to enroll. In parallel with those efforts,
we have aggressively contacted over 50 organizations focused on
glioblastoma multiforme (GBM) brain tumors. These include
foundations, patient advocacy groups, and clinical trial research
organizations. Our goal is to not only heighten awareness about the
trial, but to share information about our quantitative imaging
platform and how it will be used to assess response in patients
throughout the trial. Thus far, the interest received for both the
trial and IB software has been very strong.
Brain tumor patients have limited options. The standard of care
remains maximal surgical resection followed by concurrent chemo-
and radiotherapy. These harsh treatments impose tremendous
financial burden on patients and their families. Monthly costs for
chemotherapy alone can exceed $20,000. Our hope is to offer a
minimally invasive and non-toxic treatment alternative for these
patients and their families. The entire team is eager to see if the
tremendous results shown in the pre-clinical trial can be
replicated in human subjects during this study.
We continue our development efforts on other key initiatives
including IB Trax(TM) for the tracking of metastatic lesions. Brain
metastases are 10x more prevalent than primary brain tumors and
clinicians lack a robust and streamlined tracking and monitoring
platform. IB Delta T1 maps (patent pending) will be used to help
delineate lesions. And since IB Delta T1 maps are quantitative,
volumetric longitudinal assessment can be done for both individual
lesion and whole brain analyses.
We have completed our marketing plans for 2022 and are
adequately resourced to execute them. We intend to participate at
several tradeshows directly and many more through our channel
partners and the conferences they attend. Maintaining and building
upon the momentum gained during 2021 with sales of IB-ce will be
critical to this year's results, and we are especially optimistic
that 2022 will be a breakthrough year for our channel partners. Our
regulatory strategy, including the preparation and submission of IB
Zero G's 510(k) application to the FDA, warrants adequate and
appropriate resources during Q1.
Our priorities are clear. We are focused on sustaining our
exclusive core imaging platform, allocating development resources
on novel and sophisticated imaging technologies, and we remain
dedicated to ensuring the Phase I clinical trial is completed. We
anticipate 2022 to be another record year for the company and I
look forward to providing future updates as the year
progresses."
The Directors of the Company accept responsibility for the
contents of this announcement
-ENDS-
For further information, please contact:
IQ-AI Limited
Trevor Brown/Brett Skelly/Vinod Kaushal
Tel: 020 7469 0930
Peterhouse Capital Limited (Financial Adviser and Broker)
Lucy Williams/Heena Karani
Tel: 020 7220 9797
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END
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