AkiMed-c12: The Next-Gen Bioresorbable Breast Implant

Important results from the project

The project achieved its goals through the development and validation of AkiMed-c12, a biocompatible implant for breast reconstruction. International regulatory alignment opened up new market opportunities, while recruitment of regulatory expertise, a clear regulatory roadmap, and increased internal competence strengthened Akira Science for faster commercialization and sustainable growth.

Expected long term effects

Long-term effects include accelerated market access through streamlined regulatory pathways, expanded commercialization opportunities, reduced risks, enhanced internal competencies, and strengthened innovation capacity, positioning Akira Science for sustained growth, global market presence, and improved patient outcomes.

Approach and implementation

The project was structured around development, validation, and regulatory compliance of AkiMed-c12. Activities included workshops, technical documentation, quality management, and risk analyses. Collaboration with regulatory experts and partners proceeded effectively, though certain timelines were adapted due to detailed regulatory requirements and external validation processes.