TIDMIQAI
RNS Number : 0709Q
IQ-AI Limited
13 October 2023
IQ-AI Limited
("IQ-AI" or the "Company")
Imaging Biometrics LLC Letter to shareholders
IQ-AI Limited ("IQAI") (LSE: IQAI) a developer and manufacturer
of medical image processing platforms, has today released a letter
to shareholders on behalf of Michael Schmainda, CEO of IQ-AI's
wholly owned subsidiary Imaging Biometrics (the "Company"),
covering several material recent developments in the Company,
including, inter-alia,
-- Regulatory milestones achieved for oral Gallium Maltolate
-- IB Clinic(TM) & IB Nimble(TM) deployments
-- New applications for IB Neuro
The full text of Mr Schmainda's letter follows:
Dear Shareholders,
I am pleased to share this update with you. It summarises our
progress made and outlines some major milestones to be
achieved.
Earlier this year, we made the strategic decision to apply for a
Current Procedure Terminology (CPT) code specific to the DSC
perfusion technology available in IB Neuro. CPT codes are assigned
and maintained by the American Medical Association (AMA). They are
used to track and bill medical services for payer reimbursement.
Like regulatory clearance, CPT codes are a critical aspect in
achieving widespread commercial adoption in healthcare. Currently,
a few of our clients are using a general, non-specific CPT code to
get reimbursed for the MRI procedures that rely on IB Neuro, but
only a limited few. This lack of a reimbursement pathway makes it
more difficult for hospital administrators to justify investing in
IB products. Fortunately, enough scientific and clinical validation
have been performed by our co-founder, Kathleen Schmainda, PhD and
her colleagues over the years, and a growing number of sites are
routinely using IB Neuro as the standard of care, to warrant a
dedicated CPT code. The application is due in early November and a
final decision will be made in May 2024. A CPT code will help make
for easier buying decisions for healthcare administrators.
IB Clinic Deployment
Steady progress is being made in the deployment of IB Clinic;
both in terms of direct sales and through our established
partnerships. We are encouraging our long-standing clients to
migrate from our legacy, manual, and Mac-based platform, and
upgrade to our platform-independent and automated IB Clinic
application. This upgrade is being well received as it addresses
the many challenges facing busy radiology departments around the
world. For example, it consolidates needed information on a single
dedicated workstation and creates a one-stop-shop for busy
radiologists, it reduces the number of workstations requiring
support from IT personnel, and it offloads MR Technologists who no
longer have to manually process the information.
These gains in clinical efficiency dovetail perfectly with our
strategy of making IB products accessible on larger, more
comprehensive platforms, such as those offered by GE Healthare,
Bayer, TeraRecon, and our other partners. Currently, we are working
very closely with each of them in preparation for a busy tradeshow
season. And, as you can imagine, all our partners share in our
excitement of potentially receiving a CPT code for IB Neuro.
IB Nimble
Our development team has made tremendous enhancements to our
handheld / mobile application, IB Nimble. Specifically, the code
base is being re-engineered to enable widespread distribution and
efficient support. More work remains, but interest is steadily
growing from other brain (mets) cancer centers. As promised, we
also deployed IB Nimble for use in a new disease group, metastatic
bone cancer, at the Medical College of Wisconsin (MCW). We
anticipate at least one more installation in Q4 2023.
Also, we just accepted an invitation to participate in a new
initiative launched by the American Brain Tumor Association (ABTS)
called the Metastatic Brain Tumor Collaborative. Among other
benefits, this is an ideal opportunity to present IB Nimble and IB
Clinic to broad audiences throughout 2024.
IB Neuro
Our flagship product, IB Neuro, continues to be used to advance
the field of neuro imaging with ground-breaking research. Recently,
a major multi-center study was published in Nature Communications,
a prestigious scientific journal with a high impact-factor, in
which IB Neuro was used to identify infiltrating cancer in the
margins of tumors. Using IB Neuro, the team of researchers found
that the invasive tumor margins contain biologically distinct
genetic and molecular alterations. This information gives insights
regarding tumor aggressiveness and disease recurrence, and it also
provides information that can optimise treatments that could
improve future outcomes. Essentially, the information could
potentially direct which treatments will be most effective on a
personalised basis.
At the recent American Society for Functional Neuro Radiology
(ASFNR), Dr. Jerry Boxerman, MD presented preliminary results from
a study that used a specific output of IB Neuro called percent
signal recovery (PSR). The study showed promise in distinguishing
tumor types which is significant because it demonstrates a
noninvasive way to obtain critical information that is currently
obtained via invasive surgical procedures.
Finally, funding from current NIH grants continues and new
funding opportunities are being explored. It is through these grant
collaborations with top academic centers that result in the
translation of ground-breaking treatments into routine clinical
care. We have identified a large new grant opportunity that is
specific to our core imaging technologies, and we are evaluating
potential aims for a February submission.
Clinical Trial Update
Our sponsored phase 1 clinical trial of oral gallium maltolate
(GaM) has increased momentum since it opened in March of 2022.
Patients enrolled and were prescribed escalating doses of the agent
per the trial's design with the primary goal of identifying the
maximum tolerated dose (MTD) for a phase 2 trial. Because patients
have tolerated the agent so well, an amendment to the trial's IND
had to be written and has since been approved to allow subjects to
be administered higher dose levels. This is because the patients
have tolerated the initial doses of the agent extremely well and a
phase 2 trial requires that a MTD be determined. This dose
escalation corresponds to an increase of subjects from 24 to 36. As
soon as the MTD is determined, enrollment for the phase 1 trial
will halt, data will be summarised, and focus will shift for the
commencement of the phase 2 trial.
In addition, the FDA recently granted orphan drug designation
(ODD) status for GaM in the treatment of another rare cancer,
atypical teratoid rhabdoid tumor (ATRT), which was based on yet
another pre-clinical study conducted in the Schmainda lab at MCW.
This is the second ODD for GaM this year. We are currently working
on an application for FDA Fast Track Designation. This is a program
the FDA uses to fosters accelerated development and review of drugs
that treat conditions with an unmet clinical need. We are targeting
a submission by the end of October.
Once that submission is under review, and to leverage our ODD
designation for pediatric brain tumors (GBM and ATRT), we will
apply for a Rare Pediatric Disease Priority Review Voucher
(RPD-PRV). Like the Fast Track program, RPD-PRV is another
accelerated pathway authorised by the FDA which offers incentives
for development and approval for promising drugs. If IB is
successful in applying for an RPD-PRV, the vouchers can be
transferred (sold) to other companies and the trading price of a
PRV, per KIDS V CANCER (givekidsachanceact.org) , is averaging $100
million.
Finally, since the trial's launch, Dr. Jennifer Connelly, MD,
the principal investigator of the trial, has escalated the trial's
exposure to a global level through her many lectures and speaking
invitations. Recently, she was invited to speak at the Society of
Neuro Oncology (SNO) Africa meeting in early November.
Our optimism remains high for the multiple initiatives we are
pursuing, and we look forward to sharing additional information as
more progress and milestones are achieved.
Sincerely yours,
Michael Schmainda,
CEO
Imaging Biometrics, LLC
Director IQ-AI Ltd
--ENDS -
The Directors of the Company accept responsibility for the
contents of this announcement.
For further information, please contact:
IQ-AI Ltd
Trevor Brown/Vinod Kaushal/Brett Skelly/Michael Schmainda
Tel: 020 7469 0930
Peterhouse Capital (Financial Advisor and Broker)
Lucy Williams / Heena Karani
Tel: 020 7220 9797
About Imaging Biometrics(R) LLC: IB is a wholly-owned subsidiary
of IQ-AI Limited, (LON: IQAI), and focuses on delivering
quantitative imaging platforms and therapeutics that transform how
clinicians diagnose and treat patients more efficiently and
effectively. For more information about Imaging Biometrics, visit
the company ' s website at www.imagingbiometrics.com. Follow IB on
Twitter, @IQAI_IB.
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