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Advanced Oncotherapy obtains international quality standard for LIGHT system

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Advanced Oncotherapy PLC (LON:AVO) has received a quality standard certification for its LIGHT proton therapy system following an audit by compliance firm Lloyd’s Register.

ISO 13485:2016 is an internationally recognised quality standard that ensures the consistent design, development, production, installation and sale of medical devices that are safe for their intended purposes.

READ: Advanced Oncotherapy raises £10mln at a premium

The company said the certification was an important milestone that would allow it to continue developing its LIGHT system in compliance with the highest safety and product performance standards.

It would also allow it to make the product available for patient treatment once the medical device file had been approved.

The LIGHT system is focused on the use of protons, small sub-atomic particles, to treat tumour growths in patients using an accelerator beam similar to that of linear x-rays currently used in cancer treatment.

AVO is currently focused on increasing the power of the LIGHT proton beam to 230 mega-electron volts, the level required to treat deep-seated tumours in patients.

Dr Michel Baelen, the company’s director of regulatory affairs, said the compliance with the quality standard illustrated the importance the firm placed on the quality of its product, as well as “dedication to ensuring that the infrastructure to develop and manufacture our product is safe, effective and reliable”.

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