Thank you for the great question! We responded to the FDA with their request for additional testing in August, 2023. We expect we will receive FDA approval by November this year. Once we receive FDA clearance, we will then do an alpha launch with a limited build to get feedback on the implant and instruments, followed by a full commercial launch. We look forward to any questions.
This is really impressive. Thanks for sharing this. Any idea when this might be approved and available for us?
Thank you for the great question! We responded to the FDA with their request for additional testing in August, 2023. We expect we will receive FDA approval by November this year.
Once we receive FDA clearance, we will then do an alpha launch with a limited build to get feedback on the implant and instruments, followed by a full commercial launch.
We look forward to any questions.