0001493152-16-012828.txt : 20160824 0001493152-16-012828.hdr.sgml : 20160824 20160824090556 ACCESSION NUMBER: 0001493152-16-012828 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20160824 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20160824 DATE AS OF CHANGE: 20160824 FILER: COMPANY DATA: COMPANY CONFORMED NAME: AMEDICA Corp CENTRAL INDEX KEY: 0001269026 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] IRS NUMBER: 000000000 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-33624 FILM NUMBER: 161848315 BUSINESS ADDRESS: STREET 1: 1885 WEST 2100 STREET CITY: SALT LAKE CITY STATE: UT ZIP: 84119 BUSINESS PHONE: 801-839-3516 MAIL ADDRESS: STREET 1: 1885 WEST 2100 STREET CITY: SALT LAKE CITY STATE: UT ZIP: 84119 FORMER COMPANY: FORMER CONFORMED NAME: AMEDICA CORP DATE OF NAME CHANGE: 20031104 8-K 1 form8-k.htm FORM 8-K

 

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

 

 

FORM 8-K

 

CURRENT REPORT

 

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

 

Date of report (Date of earliest event reported): August 24, 2016

 

Amedica Corporation

(Exact name of registrant as specified in its charter)

 

Delaware   001-33624   84-1375299

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

 

1885 West 2100 South

Salt Lake City, UT

  84119
(Address of principal executive offices)   (Zip Code)

 

Registrant’s telephone number, including area code: (801) 839-3500

 

(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

[  ] Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

[  ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

[  ] Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

[  ] Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 

   
   

 

Item 8.01 Other Events.

 

On August 24, 2016, Amedica Corporation issued a press release announcing the U.S. Food and Drug Administration clearance of expanded Valeo® II Lateral Lumbar interbody fusion device sizes.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits.
   
99.1 Amedica Corporation Press Release dated August 24, 2016.

 

   
   

 

SIGNATURE

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

  AMEDICA CORPORATION
   
Date: August 24, 2016 /s/ Ty Lombardi
  Ty Lombardi
  Chief Financial Officer

 

   
   

 

 

EX-99.1 2 ex99-1.htm EXHIBIT 99.1

 

Exhibit 99.1

 

Amedica Receives FDA Clearance for Additional Valeo® II Lateral Lumbar Interbody Fusion Device Offerings

Additional sizes provide greater accommodation for a wider range of patient anatomies

 

SALT LAKE CITY, August 24, 2016 – Amedica Corporation (Nasdaq:AMDA), an innovative biomaterial company that develops and commercializes silicon nitride as a platform for biomedical applications, is pleased to announce the U.S. Food and Drug Administration (FDA) clearance of expanded Valeo® II Lateral Lumbar sizes. The additional sizes of the Valeo II LL interbody fusion device will be commercially available August 29, 2016.

 

The Valeo II LL interbody fusion device is made entirely of Amedica’s proprietary medical grade silicon nitride ceramic – an ideal material for fusion, due to its inherent osteoconductivity, anti-infective properties, bone-like imaging (artifact-free & radiotranslucent), and exceptional strength. The system includes second generation instrumentation to improve patient safety and surgeon ease of use.

 

"I’m delighted to announce the recent FDA clearance of our expanded silicon nitride lateral lumbar implant offerings," said Dr. Sonny Bal, Chairman and Chief Executive Officer. "It’s estimated that lateral lumbar procedures will remain one of the fastest growing interbody fusion segments over the next five 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.”

 

The recently cleared sizes allow for greater accommodation for a wide range of patient anatomies as well as greater stability as the shape of the implant distributes weight over a larger surface area. The design of the interbody fusion device consists of aggressive teeth for expulsion resistance, knurls for added stability, a threaded insertion feature for precision implant control, and two central cavities maximized for optimal bone graft packing.

 

The Valeo II LL is indicated for intervertebral body fusion of the spine in skeletally mature patients and is designed for use with autograft to facilitate fusion. Additional information about Amedica's complete line of products can be found at www.amedica.com.

 

About Amedica Corporation

 

Amedica is focused on the development and application of 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. The Company’s products are manufactured in its ISO 13485 certified manufacturing facility and through its partnership with Kyocera, one of the world's largest ceramic manufacturers. Amedica's FDA-cleared and CE-marked spine products are currently marketed in the U.S. and select markets in Europe and South America through its distributor network and its growing OEM and private label partnerships.

 

For more information on Amedica or its silicon nitride material platform, please visit www.amedica.com.

 

Forward-Looking Statements

This press release contains statements that constitute forward-looking statements within the meaning of the Securities Act of 1933 and the Securities Exchange Act of 1934, as amended by the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties that could cause actual results to differ materially from those contemplated within this press release. A discussion of those risks and uncertainties can be found in Amedica's Risk Factors disclosure in its Annual Report on Form 10-K, filed with the Securities and Exchange Commission (SEC) on March 23, 2016, and in Amedica's other filings with the SEC. Amedica disclaims any obligation to update any forward-looking statements.

 

Contacts:

Mike Houston

VP, Commercialization

801-839-3534

IR@amedica.com

 

 
  

 

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