Imaging Biometrics - IB Provides Update on BTD Application

Imaging Biometrics

12/06/2025 10:30

RNS Number : 5919M

Imaging Biometrics Limited

12 June 2025

 

Imaging Biometrics, Ltd

("IB" or the "Company")

 

Imaging Biometrics Provides Update on Breakthrough Therapy Designation Application

 

Imaging Biometrics, Ltd, a leader in quantitative imaging solutions and novel therapies for CNS malignancies, today announces that following recent dialogue with the U.S. Food and Drug Administration (FDA), the Company was encouraged to voluntarily withdraw and resubmit its Breakthrough Therapy Designation (BTD) application for oral gallium maltolate (GaM), an investigational treatment targeting refractory brain tumors.

 

The FDA's recommendation stems from a shared recognition of the potential impact of the agent and a mutual desire to ensure the application reflects the most compelling and mature data. The agency expressed enthusiasm for preliminary findings and suggested that resubmission after completion of an expanded data analysis would strengthen the submission and facilitate review.

 

"We view this feedback as an encouraging step forward," said Trevor Brown, CEO of Imaging Biometrics Ltd. "We believe the FDA's interest reinforces the scientific rationale behind GaM and supports our mission to accelerate new treatment options for patients facing devastating brain tumors. We are diligently working to incorporate additional biomarker and imaging efficacy data that will provide a more comprehensive picture of its therapeutic potential."

 

Imaging Biometrics anticipates resubmitting the BTD application as part of its broader regulatory and clinical strategy. The Company remains committed to the advancement of innovative technologies that intersect imaging intelligence with novel therapeutics to improve outcomes in neuro-oncology.

 

--ENDS-

 

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

 

For further information, please contact:

 

IB Ltd
Trevor Brown/Dr Al Musella/Brett Skelly/Michael Schmainda
Tel: 020 7469 0930
Peterhouse Capital Limited(Financial Adviser and Broker)
Tel: 020 7220 9797

 

About Imaging Biometrics® LLC:  IB is a wholly-owned subsidiary of Imaging Biometrics Limited, (LON: IBAI), 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 X, @ImgBiometrics.  

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