Iq-ai Ltd Regulatory News (IQAI)

IQ-AI Ltd

("IQ-AI" or the "Company")

IQ-AI Applies for FDA Pediatric Rare Disease Designation

November 8, 2023, Imaging Biometrics, LLC (IB), a wholly owned subsidiary of IQ-AI Ltd (LSE: IQAI, OTCBB: IQAIF), is pleased to announce it has submitted a Pediatric Rare Disease ("PRD") request to the US Food and Drug Administration ("FDA") for oral gallium maltolate ("GaM") for the treatment of pediatric brain tumors. 

The RPD program is intended to encourage the development of new drugs for the treatment of rare pediatric diseases and is granted by the FDA for serious or life-threatening diseases which affect fewer than 200,000 people under the age of 18 years in the U.S.

If IB's application is successful, the PRD designation provides incentives including eligibility for a priority review voucher that can be redeemed for a subsequent marketing application. This voucher can be used to reduce the time of an FDA new drug approval review or could be transferred (sold) to another company.

--ENDS-

The Directors of the Company accept responsibility for the contents of this announcement.

For further information, please contact:

About Imaging Biometrics® 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.