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Submission of FDA 510(k) Application for IB Zero G

31 May 2022 08:00

RNS Number : 3069N
IQ-AI Limited
31 May 2022
 

31 May 2022

 

IQ-AI Limited

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

 

Imaging Biometrics Submits FDA 510(k) Application for IB Zero G

Patented Artificial Intelligence Technology Eliminates the Need for Gadolinium-Based Contrast Agents in MRI Exams

Milwaukee - 31 May 2022: Imaging Biometrics, LLC (IB), a subsidiary of IQ-AI Limited, (OTCQB: IQAIF) (LSE: IQAI), today announced it has submitted an FDA 510(k) application for IB Zero G™; the patented artificial intelligence (AI) software that eliminates the need for gadolinium-based contrast agents ("GBCAs") in routine magnetic resonance imaging ("MRI") exams. The zero-dose GBCA exam offers potential benefits which include reduced concerns associated from the long-term side effects of repeated GBCA use, a more comfortable patient experience, and more productive radiology departments.

The FDA 510(k) submission is the first step in potentially transforming the global GBCA market and introducing a paradigm shift in radiology departments. Eliminating the need to intravenously inject GBCAs, without compromising the diagnostic quality of MRI exams, has the potential to benefit millions of patients annually. Patients with reduced kidney function who cannot tolerate GBCAs, children, and others where there are concerns about the potential effects of gadolinium retention in the body are particularly relevant to the availability of a zero-dose alternative.

"In addition to the potential benefits of eliminating or reducing the routine use of GBCAs, the recent world-wide shortages of iodinate contrast agents have illustrated how vulnerable routine radiology operations have become to the continuation of smooth-running global supply chains which we have previously taken for granted," said Trevor Brown, CEO of IQ-AI Limited.

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

 

About IQ-AI Limited

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

This press release includes statements that may constitute forward-looking statements made pursuant to the safe harbor provision of the Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as "will," "expects," "anticipates," "future," "intends," "plans," "believes," "estimates," or the negative of these words and/or similar statements. Statements that are not historical facts, including statements about the Company's beliefs and expectations, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties that could cause actual results to differ materially from the forward-looking statements. For example, statements about future revenues and the Company's ability to fund its operations and contractual obligations are forward looking and subject to risks. Several important factors could cause actual results to differ materially from those contained in any forward-looking statement. Potential risks and uncertainties include, but are not limited to, the inability to raise capital to support the Company through its growth stage, the Company's inability to generate projected sales and trade relations between the United States and China. The Company does not undertake any obligation to update any forward-looking statement, except as required under applicable law.

 

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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END
 
 
UPDSDDFMSEESEII
Date   Source Headline
5th Mar 20247:00 amRNSGrant of Options
1st Mar 20248:22 amRNSHolding(s) in Company
1st Mar 20248:20 amRNSHolding(s) in Company
26th Feb 20247:00 amRNSResult of Broker Option and Total Voting Rights
22nd Feb 20247:00 amRNSPlacing and Broker Option
9th Feb 202412:49 pmRNSFDA Application Update
2nd Feb 20248:39 amRNSIB awarded a $100,000 grant
22nd Jan 202410:05 amRNSHolding(s) in Company
15th Jan 20247:01 amRNSDirector Dealings and Conversion of CLNs
15th Jan 20247:00 amRNSHolding(s) in Company
10th Jan 20247:00 amRNSIB Launching an Expanded Access Program for GaM
19th Dec 20232:29 pmRNSImaging Biometrics granted FDA “Fast-Track”
5th Dec 202310:58 amRNSIQ-AI Announces Positive Interim Phase 1 Results
20th Nov 20231:42 pmRNSHolding(s) in Company
9th Nov 202311:38 amRNSDirector Dealing and Conversion of CLNs
8th Nov 202310:59 amRNSApplication for Pediatric Rare Disease Designation
6th Nov 20231:02 pmRNSHolding(s) in Company
18th Oct 20232:29 pmRNSUpdate Regarding Imaging Biometrics LLC
13th Oct 20238:55 amRNSIB Letter to Shareholders
9th Oct 20237:00 amRNSOrphan Drug Status to GaM and Total Voting Rights
3rd Oct 202311:30 amRNSHolding(s) in Company
19th Sep 20232:32 pmRNSIQ-AI shares cease trading on the OTCQB
8th Sep 20237:00 amRNSReduced Gadolinium Approach Validated'
18th Aug 202312:06 pmRNSUpdate on Collaboration Agreement with Mayo Clinic
18th Aug 202311:20 amRNSIB & GE HealthCare Enter into Commercial Agreement
17th Aug 20237:00 amRNSHalf-year Report
19th Jul 20237:00 amRNSImaging Biometrics Installs IB Nimble™ For MCW
13th Jul 20237:00 amRNSOrphan Drug Designation for GaM in Pediatric GBM
27th Jun 20237:00 amRNSStudies Show GaM Inhibits Pediatric Tumor Growth
23rd May 202311:02 amRNSResult of AGM
23rd May 20237:00 amRNSAGM Statement
3rd May 20234:14 pmRNSNotice of AGM
26th Apr 20237:00 amRNSFinal Results
28th Feb 20233:52 pmRNSOrphan Drug Designation Status
13th Jan 20232:05 pmRNSSecond Price Monitoring Extn
13th Jan 20232:00 pmRNSPrice Monitoring Extension
13th Jan 202311:05 amRNSSecond Price Monitoring Extn
13th Jan 202311:00 amRNSPrice Monitoring Extension
10th Jan 20237:00 amRNSLetter to Shareholders
2nd Dec 202211:11 amRNSHolding in Company
25th Oct 202211:00 amRNSPrice Monitoring Extension
30th Sep 20227:00 amRNSLetter to Shareholders
26th Sep 20227:00 amRNSIssue of Warrants to Employees
16th Aug 20224:40 pmRNSSecond Price Monitoring Extn
16th Aug 20224:35 pmRNSPrice Monitoring Extension
16th Aug 20229:28 amRNSHalf-year Report
3rd Aug 20221:01 pmRNSTR1 - Notification of Major Holdings
11th Jul 20227:00 amRNSImaging Biometrics Announces Channel Partnership
31st May 202211:05 amRNSSecond Price Monitoring Extn
31st May 202211:00 amRNSPrice Monitoring Extension

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