Path to Commercialization
Amplex™ is a Class III medical device and is following a PMA route to approval and commercialization. That pathway involves Investigational Device Exemption (IDE) approval for a pilot clinical study (Phase I/II) to establish the safety and preliminary effectiveness in a limited number of patients, followed by a pivotal clinical study (Phase III) to establish the safety and effectiveness in a larger number of patients. In addition, the company is investigating product applications in foot and ankle fusion, cervical fusion and sports medicine indications, which will have a similar route to commercialization.