IQ-AI LIMITED ISSUES LETTER TO SHAREHOLDERS
Imaging Biometrics, a subsidiary of IQ-AI Limited (OTCQB: IQAIF: LSE: IQAI), summarises the Company’s achievements in 2022 to date, which includes:
· Company focuses on deployment of IB Clinic™
· IB NIMBLE™ connects experts to help treat metastatic tumors
· Phase I Clinical trial continues to gain momentum
The entire letter from Director Michael Schmainda follows:
As Q3 2022 draws to a close, we want to provide an update on progress made to date, layout the work to be done on our key initiatives, and to thank you for your on-going support. Together, we are weathering the instabilities of the economy and markets by focusing on our core competencies and initiatives that can bring short term, revenue-generating impact.
The backbone of our business is our imaging solutions. We continue to deliver the most advanced magnetic resonance (“MR”) perfusion platform which enables our clients to make objective clinical decisions faster. We remain the only quantitative perfusion solution used in multi-center clinical trials, and we continue to gain interest from clients who are seeking more information from their routine MRI exams.
Maintaining the momentum generated from our record 2021 performance remains steadfast. Central to that effort is client retention and satisfaction. We are very proud of our outstanding client retention track record and our ability to quickly respond to the needs of our growing client base. As we onboard new clients, whether through direct sales or through our channel partners, we will remain committed to our client-centric focus. But we want to be more than that. Our commitment to quality is evidenced by zero (0) findings from this past summer’s FDA inspection and ISO13485 quality audits. Due to our collaborations with thought leaders around the world, we are uniquely positioned to innovate clinical solutions that have high probability of translating to routine clinical practice. All this is made possible by an exceptional and passionate team that wants to make a difference for patients.
Revenue from annual subscription renewals from our existing clients continue to fuel our business as well as our financial sponsorship of the Phase I clinical trial. Product demonstrations and software trials at major sites are at an all-time high due in large part to efforts made in 2022 by our channel partners. Despite underwhelming results from past partnerships, we are optimistic by the renewed focus of our newest partners. The post-pandemic market conditions are proving more favorable for artificial intelligence (“AI”) marketplace applications and, more specifically, we are being included early in the sales process and speaking directly with end users. Our upfront involvement has led to trial evaluations of our solutions and will ultimately compress the overall sales cycle.
IB Trax™ is our top development priority. Our developers are completing an overhaul of our software architecture which is foundational to the development of IB Trax. Specifically, their work simplifies the documentation required for regulatory compliance, fosters rapid integration of new or 3rd party applications, and reduces our cybersecurity footprint. As previously reported, IB Trax will be a phased development effort. The first phase, due for release during mid Q2 2023, will be a concise report that satisfies an unmet clinical need; the graphical quantification of volumetric changes over time. Once that initial phase is completed, a fully automated version will be released that systematically organises and tracks metastatic lesions.
IB NIMBLE™ is an exciting handheld application that we recently obtained world-wide exclusive rights to commercialise. Currently used at the Medical College of Wisconsin (MCW), IB NIMBLE has proven to significantly reduce in-patient hospital stays for patients with metastatic cancers. The novelty of IB NIMBLE lies in the built-in decision-tree algorithm specific for metastatic treatment decisions. The application enables instantaneous collaboration between multiple medical specialists which translates to optimal care and treatment decisions for patients. While we prepare to deploy the current version at other institutions, plans are already being made to replicate this technology for other diseases as well as to incorporate IB’s proprietary technology and quantitative reporting capabilities, such as IB Trax.
The Phase I clinical trial is gaining momentum. Patient recruitment, screening, and enrollment continue as existing enrolled subjects are monitored and receive follow-up imaging. Thus far, and as expected from prior studies that used gallium, the subjects are tolerating the agent extremely well. Dr. Jennifer Connelly, MD, the co-principal investigator of the trial, has presented her talk “Disappearing Spoon – Disappearing Cancer” at North Shore (Chicago) Health and at the recent Chasing Chad (www.chasingchad.com) annual fundraising event. Her talk is always received with much enthusiasm and interest. In addition, since IB’s quantitative imaging solutions are used to assess treatment response for the trial, there is a heightened awareness amongst patients and clinicians about our unique capabilities which have resulted in prospective sales. Bottom line, brain tumor patients need to know as soon as possible whether their treatment is working, and we can help determine that.
Work is also underway for the submission of a de novo FDA application for IB Zero G™ market clearance. As determined by the FDA reviewers, no currently marketed device compares to IB Zero G, which could be used as a predicate to establish substantial equivalence. The next step is to schedule a pre-submission meeting with the FDA for guidance and clarification.
More recently, we began offering a service option for the generation of our advanced mapping technology. While automation has enabled imaging chains and community hospitals access to our core output maps, those smaller sites do not have the volume of patients or experienced physicists to process some of our advanced maps. The service model is like the core lab processing services we offer to clinical research organizations (CROs). The pay-per-process service provides a low-risk option for those sites while avoiding lengthy budgetary justifications and IT security approvals.
We look forward to exhibiting at upcoming trade shows and scientific meetings. In November 2022, we will be attending two shows; the first will be an ISMRM (International Society of Magnetic Resonance in Medicine) workshop focused on cancer imaging. Then, in mid-November, we will be attending the annual SNO (Society of Neuro Oncology). At SNO, multiple scientific abstracts have been accepted for presentation that feature our software, the Phase I Clinical trial, and we will even have IB NIMBLE™ on display. Joining us at SNO will be Dr. Joseph Bovi, MD, an inventor of the NIMBLE app, as well as Dr. Jennifer Connelly who will discuss matters related to the clinical trial.
I look forward to providing you with future updates as we continue to achieve new milestones and grow. We have the laid the foundation of a great company and we are conducting business in an exciting and developing area. Thank you all for your continued support.
Michael Schmainda, CEO
Imaging Biometrics, LLC”
The Directors of the Company accept responsibility for the contents of this announcement
For further information, please contact:
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
About Imaging Biometrics, LLC
IQ-AI Limited, (LON: IQAI) (OTCQB: IQAIF), the parent company of Wisconsin-based Imaging Biometrics, LLC (IB), is focused 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.
Safe Harbor Statement
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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).