Amedica (NSDQ:AMDA) said today that it is refiling an application with the FDA seeking approval for its cancellous-structure ceramic cervical implant.
The decision comes on the heels of “encouraging results” from a study which showed rapid bone growth into porous silicon nitride, according to the Salt Lake City, Utah-based company.
“We anticipate these preliminary findings will be confirmed with additional retrieval data in the near future. The porous silicon nitride sample used in this study is the cancellous-structured ceramic used in the center of our composite cervical implants that were the subject of recent FDA communications. With this submission, the goal is to introduce our proprietary CsC technology platform into the U.S. market without further delay,” prez & CEO Dr. B. Sonny Bal said in a prepared statement.
In October, Amedica said it laid off approximately 38% of its workforce to lower operating expenses. The company said the layoffs were part of a plan implemented on October 3 and completed the next day, which resulted in savings of approximately $2 million in annual cash operating expenses.
Amedica said the action also incurred approximately $465,000 in one-time severance and related costs, which will be recorded in its 4th quarter of the 2016 fiscal year.
In August, Amedica said it won expanded FDA clearance for additional sizes of its Valeo II lateral lumbar interbody fusion device. The Valeo II lateral lumbar fusion device is made out of proprietary medical grade silicon nitride ceramic and includes 2nd-generation instrumentation for improved patient safety, the company said.
The device is indicated for intervertebral body fusion of the spine in skeletally mature patients with the use of an autograft to facilitate fusion, the company said.