Amedica responded to the FDA inquiries about the company's cervical composite silicon nitride interbody device and received feedback on wear testing for femoral head protocols.
Here are five things to know:
1. Amedica submitted the Valeo C Interbody with CsC Osteo-Conductive Scaffolding in the first quarter of 2015. The device related to Amedica's CASCADE clinical trial of the composite silicon nitride spinal interbody devices.
2. The FDA sent questions to Amedica requesting additional information about the clinical performance data and indications for use as well as the device description. The company sent in responses on June 30 and is waiting clearance for the Class II medical device for commercial distribution, or additional communication from the FDA.
3. CEO Sonny Bal, MD, expects to receive a response from the FDA during the third quarter of 2015.
4. The device is available in Europe and sales momentum has grown in recent months.
5. In addition to the correspondence about the Valeo C Interbody with CsC Osteo-Conductive Scaffolding, Amedica received constructive feedback from the FDA on the proposed wear testing protocol for silicon nitride femoral heads. The company now has a clearer understanding of the pathway to market for the device.
"The comments by the FDA will ensure that the testing of our material, as compared to other ceramic predicate devices on the market, will meet or exceed existing testing standards," said Dr. Bal. Studies comparing the device to all other femoral head materials is expected to begin later this year.