Alpha Tau Medical, developer of the breakthrough alpha radiation cancer therapy, Alpha DaRT, announced today that it has obtained ISO 13485:2016 certification. The certification was awarded following an audit by the UK's independent national compliance body, British Standards Institution (BSI).
ISO 13485:2016 is the internationally-recognized 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 enables Alpha Tau to continue to develop the Alpha DaRT therapy in compliance with the highest standards for safety, efficacy and product performance, and to make its commercial product available for the first patient treatment, once the Alpha DaRT medical device regulatory file will be approved.
Yaniv Sagie, Quality Assurance and Regulatory Affairs Director of Alpha Tau Medical, said: "This official recognition demonstrates our dedication to ensuring that the infrastructure to develop, manufacture and distribute our therapy is safe, effective and reliable."
"This is a significant achievement for the company that moves us one step closer to the commercialization of the Alpha DaRT treatment in Europe," said Uzi Sofer, CEO of Alpha Tau Medical. "In the closely regulated and highly competitive industry of medical device manufacturing, by adhering to the latest ISO certification standard, we are proud to join other leading medical companies, to provide high quality products to our users and patients."
About Alpha Tau Medical
Founded in 2016, Alpha Tau Medical Ltd. is an Israeli biotech company that focuses on R&D and commercialization of the first alpha-radiation based cancer treatment for solid tumors, Alpha DaRT. Initially developed in 2003 by Prof. Itzhak Kelson and Prof. Yona Keisari from Tel Aviv University, Alpha DaRT delivers high-precision alpha radiation, that is released when radioactive substances decay inside the tumor. The short-range alpha particles effectively kill the cancer cells while sparing the surrounding healthy tissue. Interim results from three clinical trials show that 100% of the tumors shrank following treatment and more than 70% of the tumors disappeared completely, without causing any severe side effects. For more information, please visit www.alphatau.com.