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TAE Life Sciences Receives Acceptance in China, BNCT Clinical Trials to Begin

By News Release

 

TAE Life Sciences announces the successful completion of acceptance testing and regulatory registration inspection of its accelerator-based neutron beam system (NBS) in China, marking a significant milestone in BNCT global market adoption. Developed and manufactured in the US, 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.

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