Amedica Corporation02.10.16
Amedica Corporation has regained compliance with Nasdaq's minimum bid price requirement. On Feb. 8, the company received a letter from the Nasdaq Listing Qualifications department confirming it is now in compliance with the minimum bid price requirement under Listing Rule 5450(a)(1), as the firm's common shares have been priced at $1.00 per share or greater for 10 consecutive trading days.
Additionally, Amedica provided select preliminary 2015 year-end financial results. The Company has made significant advancements in its ongoing initiative toward improving its capitalization table, capitalization, and operational structure. The company expects its full year 2015 financials will represent a positive trajectory change in its fourth quarter sales, resulting in annual sales finishing the year at the high end of its previously stated guidance of $19 million to $19.5 million. The company also expects to report operational cash burn reductions in excess of 30 percent as compared to the prior year period. As of Feb. 9, the Company had approximately 11.3 million shares of common stock outstanding and approximately 12.2 million shares on a fully diluted basis.
"2015 was transformative for Amedica," said Dr. Sonny Bal, chairman/CEO. "We were able to resolve the variability in our capitalization table and consolidate our share structure along with positioning ourselves to continue the trajectory from our fourth-quarter sales into 2016. We've built strong momentum during the second half of 2015 to become a leading biomaterials company focused on commercialization and development of our silicon nitride ceramic biomaterial for spine, hip, knee, dental and other applications. Our performance reflects the strength of our hybrid sales model, a commitment to continued innovation, and the competitive advantage of our research and development team. We are seeing solid results from our investment in innovation, a newly energized sales force, and a re-engagement with the medical and surgical community."
Company executives forecast a continued decrease in annual operational cash burn in 2016, improving an additional 40 percent to 50 percent from prior-year levels. Also, officials expect to finalize agreements with four additional private-label or OEM partners, as well as providing three new spine solution offerings -- a composite cervical interbody fusion device, an enhanced lateral lumber interbody solution, and a next-generation cannulated pedicle screw system.
"Management is also pleased to announce that we've passed the administrative review process on our 510(k) submission to the FDA [U.S. Food and Drug Administration] for our silicon nitride composite interbody fusion device. We're currently in the clinical review process with the FDA and have recently received questions regarding our 24-month clinical data," Bal said. "We hope to provide another update in the near future regarding our responses to the FDA questions. Going forward, Amedica will continue our focus on innovation, improving operational efficiencies and scaling our hybrid sales model to deliver enhanced value for our shareholders, while continuing to transform healthcare with our revolutionary silicon nitride technology platform."
Amedica develops interbody implants manufactured with medical-grade silicon nitride ceramic. Amedica markets spinal fusion products and is developing a new generation of wear- and corrosion-resistant implant components for hip and knee arthroplasty as well as dental applications. Its spine products are FDA-cleared, CE-marked, and currently marketed in the United States and select markets in Europe and South America through its distributor network and its OEM and private label partnerships.
Additionally, Amedica provided select preliminary 2015 year-end financial results. The Company has made significant advancements in its ongoing initiative toward improving its capitalization table, capitalization, and operational structure. The company expects its full year 2015 financials will represent a positive trajectory change in its fourth quarter sales, resulting in annual sales finishing the year at the high end of its previously stated guidance of $19 million to $19.5 million. The company also expects to report operational cash burn reductions in excess of 30 percent as compared to the prior year period. As of Feb. 9, the Company had approximately 11.3 million shares of common stock outstanding and approximately 12.2 million shares on a fully diluted basis.
"2015 was transformative for Amedica," said Dr. Sonny Bal, chairman/CEO. "We were able to resolve the variability in our capitalization table and consolidate our share structure along with positioning ourselves to continue the trajectory from our fourth-quarter sales into 2016. We've built strong momentum during the second half of 2015 to become a leading biomaterials company focused on commercialization and development of our silicon nitride ceramic biomaterial for spine, hip, knee, dental and other applications. Our performance reflects the strength of our hybrid sales model, a commitment to continued innovation, and the competitive advantage of our research and development team. We are seeing solid results from our investment in innovation, a newly energized sales force, and a re-engagement with the medical and surgical community."
Company executives forecast a continued decrease in annual operational cash burn in 2016, improving an additional 40 percent to 50 percent from prior-year levels. Also, officials expect to finalize agreements with four additional private-label or OEM partners, as well as providing three new spine solution offerings -- a composite cervical interbody fusion device, an enhanced lateral lumber interbody solution, and a next-generation cannulated pedicle screw system.
"Management is also pleased to announce that we've passed the administrative review process on our 510(k) submission to the FDA [U.S. Food and Drug Administration] for our silicon nitride composite interbody fusion device. We're currently in the clinical review process with the FDA and have recently received questions regarding our 24-month clinical data," Bal said. "We hope to provide another update in the near future regarding our responses to the FDA questions. Going forward, Amedica will continue our focus on innovation, improving operational efficiencies and scaling our hybrid sales model to deliver enhanced value for our shareholders, while continuing to transform healthcare with our revolutionary silicon nitride technology platform."
Amedica develops interbody implants manufactured with medical-grade silicon nitride ceramic. Amedica markets spinal fusion products and is developing a new generation of wear- and corrosion-resistant implant components for hip and knee arthroplasty as well as dental applications. Its spine products are FDA-cleared, CE-marked, and currently marketed in the United States and select markets in Europe and South America through its distributor network and its OEM and private label partnerships.