Amedica wins Down Under nod for Valeo interbody fusion line

Amedica (NSDQ:AMDA) said today it won regulatory clearance in Australia for its Valeo product line of interbody fusion devices.

The Salt Lake City, Utah.-based company’s Valeo products are made from its proprietary medical grade silicon nitride ceramic, which Amedica touts as “an ideal material for fusion” due to its nanostructured surgace, osteoconductivity, osteoinductivity, anti-microbial properties and ease of radiographic imaging.

“The Australian clearance is a tremendous opportunity for Amedica. Interestingly, during 1986-1988, Australian surgeons and engineers were the first to synthesize reaction-bonded silicon nitride, and implant the material in lumbar spine fusion patients. Favorable outcomes in terms of pain relief and successful fusion were reported at the 15-year follow-up time interval. Thus, the pioneering clinical use of silicon nitride in spine fusion originated in Australia, and we are excited to see the material return to its place of birth. The successful outcomes from Australia are now validated by 45 scientific papers published by Amedica in top-tier peer journals, and clinical data that will be published throughout this year. We look forward to working with Australian surgeons, and providing them with improved options for spinal fusion surgery,” CEO Dr. Sonny Bal said in a press release.

Earlier this month, Amedica said that it would delay the filing of its Annual Report on Form 10-K for its 2016 fiscal year for a 2nd time.

The company said it filed a notification of late filing form on March 31, expecting to be able to file the 10-K within the 15 days granted by the late filing form.

However, the company said it was unable to file the form on time, and needs additional time to “fully consider whether there is any potential impairment in relation to certain of its long-lived assets.” Amedica said that it will file the form with the SEC “as soon as possible,” according to a press release.

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