Date of designation | Name of product | Proposed indication | Sponsor | |
1# | 02/10//2016 | Titanium Bridge (hinge-type titanium plates) | Adduction-type spasmodic dysphonia | Nobelpharma |
2 | 02/28/2017 | Tracheal prosthesis (made of polypropylene mesh and collagen sponge) | Aiding reconstruction of trachea while maintaining intratracheal structure after partial removal | Daiichi Medical |
3 | 02/28/2017 | Boron neutron capture therapy (BNCT) system (neutron irradiation system for BNCT) | Glioblastoma, head and neck cancer (selective destruction of tumor cells marked by boron agents) | Sumitomo Heavy Industries |
4 | 02/28/2018 | UT-Heart (software to aid cardiac resynchronization therapy) | Higher accuracy prediction of effectiveness of cardiac resynchronization therapy for patients with serious heart failure | UT-Heart Corporation |
5 | 02/28/2018 | Cardiac repair patch (combination of bioabsorbable and stretchable non-bioabsorbable synthetic polymeric threads and a bridging gelatin membrane) | A cardiac repair patch used during cardiovascular interventions
| Teijin |
6 | 02/28/2018 | CliniMACS CD34 System (CD34 +cell selection and isolation system) | Product capable of facilitating synostosis
| Miltenyi Biotec K.K. |
7 | 02/28/2019 | Microwave mammography | Identifies the tissues suspected of being breast cancer by microwave and provides information to the doctor | Integral Geometry Science Co. |
8 | 02/28/2019 | Molds of vascular grafts for lower extremity arterial bypass (in vivo tissue-engineered vascular grafts) | Improves the blood circulation failure condition below the knee by surgical reconstruction, and long-term patency of self-revascularization for patients with severe lower-limb ischemia | Biotube Co. |
9 | 02/28/2019 | Phosphorylated pullulan bioadhesive | Improves usability and retainability for bone defects by better formativeness and adhesiveness by mixing with autologous bones, allogeneic bones, heterogeneous bones, artificial bones, or a mixture; moreover, since it has an increasing effect, it can reduce the amount of autologous bone collected | BioARC Co. |
1#:Titanium Bridge was approved on December 15, 2017.
Three requirements to apply for Sakigake designation were as follows: (1) innovative medical products for serious diseases; (2) development in Japan being world’s first or simultaneous with other countries; (3) prominent effectiveness expected on non-clinical and early phase clinical studies.