REG - IQ-AI Limited - FDA Application Update

IQ-AIAnnouncement

09/02/2024 13:00

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RNS Number : 6911C  IQ-AI Limited  09 February 2024

IQ-AI Ltd

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

 

FDA Application Update

 

Imaging Biometrics, LLC (IB), a wholly owned subsidiary of IQ-AI Ltd (LSE:
IQAI), reports that it will modify and resubmit its application for Pediatric
Rare Disease (PRD) Designation, in response to a letter from the FDA
encouraging a resubmission for a narrower target population.

 

IB is actively working on the request with plans to resubmit by the end of
next week.

 

Per the FDA's response, "pediatric brain tumors" is too broad of a term and,
with recent nomenclature changes made by the World Health Organization (WHO),
now includes many distinct brain tumor types and subtypes; all of which vary
in severity. Essentially, since low grade tumors are not necessarily terminal,
they should not be included in the request. The detailed guidance provided by
the FDA identified the exact subtypes to include in the resubmission.

 

--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 (tel:020%207469%200930)
 Peterhouse Capital Limited (Financial Adviser and Broker)

 Lucy Williams/Heena Karani

 Tel: 020 7220 9797 (tel:020%207220%209797)

 

 

 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 atwww.imagingbiometrics.com
(https://eur01.safelinks.protection.outlook.com/?url=https://protect-eu.mimecast.com/s/M_SLCE9EkfljEqsNN5Gd?domain=imagingbiometrics.com&data=05%257C02%257Chk@peterhousecap.com%257Cfeccf97d46e64dc9345e08dc150933d2%257C84c2ab3d172a440aaca526a12faeab25%257C0%257C0%257C638408376478871141%257CUnknown%257CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0=%257C3000%257C%257C%257C&sdata=AWlx9geNOFrkZzGTLgpNtuXp1951MeR4+dkwkjzAgjc=&reserved=0)
. Follow IB on Twitter, @IQAI_IB.

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