BetaGlue Therapeutics, a LIFTT portfolio company, has reached an important milestone in its growth and consolidation: obtaining ISO 13485 certification for the design, development, manufacture, and distribution of sterile implantable devices for locoregional radiotherapy.
ISO 13485 certification is the leading international standard for quality management systems for medical devices. The certification attests to BetaGlue’s commitment to ensuring the highest levels of safety, efficacy, and quality at every stage of its products’ life cycle. This milestone naturally consolidates the trust of clinical partners, investors, and regulatory authorities, and helps strengthen the company’s position in the international biomedical deep tech landscape.
BetaGlue operates by combining innovation and scientific rigor, technological excellence, and clinical impact, with the aim of improving patients’ quality of life and supporting the medical community in the fight against cancer. The result further strengthens its mission to develop advanced therapeutic solutions for the locoregional treatment of tumors, with a particular focus on pancreatic cancer, the main clinical indication for its flagship device.
Founded in Milan, BetaGlue Therapeutics has developed the YntraDose® platform, an easy-to-use interventional radiotherapy technology designed to overcome the limitations of traditional radiotherapy techniques, such as SBRT or PBRT, which often encounter difficulties related to the movement of internal organs, the selection of treatable patients, and high infrastructure requirements. YntraDose® aims to make radiotherapy more accessible and customizable, offering an innovative solution for a wide range of solid tumors.
Achieving ISO 13485 certification represents a fundamental step towards full industrialization and entry into regulated markets, confirming the robustness of BetaGlue’s quality system and the credibility of its technological offering.
