IlluminOss Medical has completed enrollment in its first U.S. clinical trial for its IlluminOss System.
Here are five key takeaways:
1. The trial includes 13 sites and 80 patients.
2. The IlluminOss System uses proprietary bone stabilization technology, allowing for fracture fixation through patient-specific intramedullary implants.
3. The system was developed as an alternative to standard-of-care nails and plates.
4. Approved in international markets, the system has been used to treat more than 1,500 patients worldwide.
5. The outcomes data from the trial allow the company to submit a DeNovo marketing application to the FDA.