TAE Life Sciences' Neutron Beam System Receives Acceptance, Allowing BNCT Clinical Trials to Begin in China

2024-04-03

放射疗法临床研究

A Key Component of Neuboron's NeuPex AB-BNCT System, TAE Life Sciences' Neutron Beam System Receives Performance Acceptance and Passes Class III Registration Inspection

IRVINE, Calif., April 3, 2024 /PRNewswire/ --

TAE Life Sciences, a pioneer in advancing Boron Neutron Capture Therapy (BNCT) for cancer treatment, proudly announces the successful completion of acceptance testing and regulatory registration inspection of its accelerator-based neutron beam system (NBS), marking a significant milestone in BNCT global market adoption. Developed and manufactured in the United States, TAE Life Sciences' NBS has met all specifications outlined by Neuboron Medical and the local regulatory body, enabling human BNCT clinical trials to begin this month in China.

The completion of acceptance testing underscores TAE Life Sciences' commitment to international safety and efficacy standards, making it the first US company to have its system achieve such recognition. This major technological progress demonstrates how TAE Life Sciences has solidified its leading position in the growing field of BNCT. As the company progresses in establishing Alphabeam™ BNCT sites worldwide, collaborating with Neuboron to provide them with a Neutron Beam System has paved a distinctive pathway into the Chinese market.

"We worked closely with Neuboron to ensure our accelerator-based NBS precisely delivered the results required for BNCT and are thrilled to have successfully completed acceptance testing and regulatory inspection," stated Rob Hill, CEO at TAE Life Sciences. "This milestone not only demonstrates our dedication to delivering cutting-edge cancer treatment solutions, but also signifies our ability to meet rigorous international standards."

Additionally, the Beijing Institute of Medical Device Testing has completed registration testing of Neuboron Medical's complete NeuPex AB-BNCT system, which includes TAE Life Science's NBS. This milestone marks a significant regulatory approval step, enabling Neuboron to move forward with clinical trials in China. Neuboron will commence clinical trials at Xiamen Humanity Hospital.

The latest market analysis report by Intel Market Research forecasts robust growth in the BNCT market, with global revenues projected to reach $2.2 billion by 2030. TAE Life Sciences, alongside industry leaders such as Neuboron, Sumitomo, and others, is poised to play a pivotal role in driving this exponential growth.

As the BNCT market continues to expand, TAE Life Sciences remains at the forefront of innovation, delivering transformative solutions to cancer patients worldwide.

For more information about TAE Life Sciences, Alphabeam, and the company's proprietary boronated BNCT drugs, please visit www.taelifesciences.com.

For more information about Neuboron and its technologies, please visit https://www.neuboron.com/.

About TAE Life Sciences

TAE Life Sciences is a privately held biotechnology company committed to developing a new biologically targeted radiation therapy based on Boron Neutron Capture Therapy (BNCT). TAE Life Sciences is the only company developing the next-generation targeted boron drugs and low-energy accelerator-based neutron system optimized for an in-hospital BNCT program that delivers cancer-killing radiation with cellular-level precision to treat patients with aggressive and refractory cancers. TAE Life Sciences' Alphabeam™ BNCT system and proprietary boronated drugs are still in the investigational stage, and not available commercially. More information about TAE Life Sciences is available at www.taelifesciences.com.

About Neuboron Medical Group

Neuboron Medical Group was founded in 2014 focusing on the development of BNCT total solution for hospital users, including a complete set of accelerator-based BNCT system, TPS, theranostic boron or gadolinium carriers (e.g., BPA and F-BPA), as well as facility design and construction. Currently, it has developed its own BPA and F-BPA in China. The F-BPA is currently undergoing clinical study in the famous Peking Union Medical College Hospital using nucleophilic radiosynthesis.

Press Contact:

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New Era Communications

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SOURCE TAE Life Sciences