CynosBio is a specialty pharma that develops autologous regenerative medicine products, using a patient’s own cells cultured on human amniotic membrane or collagen matrices. Its marketed eye treatment, Sakurashi®, restores corneal surface health from oral mucosal epithelial sheets, while its IK‑01 therapy aims to regenerate knee cartilage by implanting cultured autologous chondrocytes. Both products are fully developed, manufactured, and distributed in‑house, enabling streamlined production and regulatory control.
Funding
Funding not disclosed
Founders
Product
Problem
Patients with corneal epithelial stem cell deficiency (LSCD) and those suffering from knee cartilage damage have limited treatment options; existing therapies often fail to restore tissue function and may require invasive surgery or lead to poor long-term outcomes.
Solution
CynosBio develops autologous regenerative medicine products that use the patient’s own cells cultured on a human amniotic membrane scaffold. For ocular surface disease, the Sakurashi® epithelial cell sheet is harvested from the patient’s oral mucosa, expanded, and transplanted to restore a healthy corneal surface, reducing adhesion and improving visual outcomes. For knee cartilage lesions, the IK‑01 product embeds the patient’s cultured cartilage cells within a collagen matrix, which can be fixed to the defect site with fibrin glue, promoting cartilage regeneration without extensive surgery. Both products are manufactured, marketed, and sold entirely within the company, enabling streamlined production and regulatory control. Clinical trials are ongoing to validate efficacy and safety, supporting eventual adoption in ophthalmology and orthopedics.
Target Audience
Primary customers are ophthalmologists treating LSCD and orthopedic surgeons managing cartilage injuries or osteoarthritis, as well as hospitals and specialty clinics that perform regenerative procedures.
Features
- Autologous cell sourcing (oral mucosal epithelium for eye, patient’s own cartilage cells for knee) to minimize immune rejection
- Human amniotic membrane scaffold for the epithelial sheet, providing a biologically active matrix that supports cell attachment and survival
- Collagen gel matrix embedding cultured cartilage cells, allowing minimally invasive fixation with fibrin glue
- Full in‑house development pipeline from seed‑cell acquisition through GMP‑compliant manufacturing to commercial distribution
- Regulatory‑approved product (Sakurashi®) with insurance reimbursement in Japan; IK‑01 progressing through Phase III trials for osteoarthritis
- Proprietary cell expansion and sheet‑formation processes that ensure consistent product quality and sterility