REG - IQ-AI Limited - Imaging Biometrics LLC - Letter to Shareholders

IQ-AIAnnouncement

27/01/2022 07:00

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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™ 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™ 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

 

Market Abuse Regulation (MAR) Disclosure

This announcement contains inside information for the purposes of Article 7 of
the Market Abuse Regulation EU 596/2014 as it forms part of retained EU law
(as defined in the European Union (Withdrawal) Act 2018).

 

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