Clinical & Regulatory

Development Stage and Regulatory Path

Clear communication about product status is essential in medical technology.

Ojonic is currently under development and has not yet received regulatory approval. Statements about safety or performance are based on preclinical and bench testing only. No clinical efficacy or safety claims can be made until appropriate clinical studies have been completed. The technology is being prepared for subsequent clinical and regulatory steps in accordance with applicable requirements. First-in-human implants are planned for 2028, subject to regulatory and ethical approvals.