Amedica wins expanded FDA indication for Valeo II spinal fusion devices

Amedica (NSDQ:AMDA) said yesterday 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 Salt Lake City, Utah-based 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.

“I’m delighted to announce the recent FDA clearance of our expanded silicon nitride lateral lumbar implant offerings. It’s estimated that lateral lumbar procedures will remain one of the fastest growing interbody fusion segments over the next 5 years. The minimally invasive nature of the procedure provides patients with benefits such as less blood loss, smaller incisions and shorter hospital and intraoperative times. We believe these clinical benefits, coupled with our unique silicon nitride biomaterial will lead to an improved continuum of care for individuals,” CEO Dr. Sonny Bal said in a press release.

The newly cleared additional sizes allow for a wider range of patient anatomies with shapes designed to distribute weight over a larger surface area. The company expects the devices will be available August 29.

In July, Amedica said it closed its most recent underwritten public offering, bringing in $12.7 million to support its silicone nitride implants.

The company sold a total of 3.6 million Class A units comprised of 1 share of common stock and 1 warrant to purchase 1 share of common stock and 7,392 Class B units comprised of 1 share of preferred stock convertible into 1,000 shares of common stock and warrants to purchase 11 million shares of common stock.

The round included an fully exercised underwriters option to purchase an additional 1.7 million shares of common stock and warrants for the purchase of an additional 1.7 million at the public offering price.

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