ISO 13485:2016 certification for medical devices

RNS Number : 5670N

Advanced Oncotherapy PLC

21 January 2019

 

ADVANCED ONCOTHERAPY PLC

("Advanced Oncotherapy" or the "Company")

ISO 13485:2016 certification for medical devices

Advanced Oncotherapy (AIM: AVO), the developer of a next-generation proton therapy system for cancer treatment, together with its subsidiary ADAM S.A., announces that it has obtained ISO 13485:2016 certification. The certification was awarded following an audit by independent compliance specialists Lloyd's Register.

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

This certification represents an important milestone for the Company. It reflects its commitment to safety and to providing a high-quality product and shows the focus that the Company has on risk-based decision making throughout the organisation.

This certification enables Advanced Oncotherapy and ADAM S.A. to continue to develop the LIGHT proton therapy system in compliance with the highest standards for safety and product performance, and to make its product available for the first patient treatment, once the LIGHT proton therapy system medical device file has been approved.

Dr Michel Baelen, Advanced Oncotherapy's Director of Regulatory Affairs and former Vice President for IBA's Regulatory and Quality Assurance Affairs, said: "This successful audit demonstrates our dedication to ensuring that the infrastructure to develop and manufacture our product is safe, effective and reliable. Advanced Oncotherapy's and ADAM S.A.'s compliance with this standard illustrates the importance that it places on the quality of its product and the need to have robust processes across our entire organisation in accordance with the stringent requirements associated with medical devices."

For further information, please contact:

Advanced Oncotherapy Plc	www.avoplc.com
Dr. Michael Sinclair, Executive Chairman	Tel: [phone]
Nicolas Serandour, CEO
Stockdale Securities (Nomad & Joint Broker)
Antonio Bossi	Tel: [phone]
Stifel Nicolaus Europe (Joint Broker)
Jonathan Senior	Tel: [phone]
Walbrook PR (Financial PR & IR)	Tel: [phone] or [e-mail]
Paul McManus / Anna Dunphy	Mob: [phone] / Mob: [phone]

About Advanced Oncotherapy Plc www.avoplc.com

Advanced Oncotherapy is a provider of particle therapy in the treatment of cancer, which harnesses the very best in modern technology. Advanced Oncotherapy's R&D team, ADAM, in Geneva, focuses on the development of a proprietary proton accelerator - LIGHT (Linac Image Guided Hadron Technology). LIGHT accelerates protons to the energy levels achieved in legacy machines but in a compact and truly modular unit, offering significant cost advantages. LIGHT also delivers proton beams in a way that facilitates greater precision and electronic control, which are not achievable with currently available alternative technologies.

Advanced Oncotherapy will offer healthcare providers affordable systems that will enable them to treat cancer with an innovative technology, offering better health outcomes and lower treatment related side effects.

Advanced Oncotherapy continually monitors the market for any emerging improvements in delivering proton or particle therapy and actively seeks working relationships with providers of these innovative technologies. Through these relationships, the Company will remain the prime provider of cutting edge, cost-effective systems for particle therapy.

 

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