0001193125-14-226904.txt : 20140624 0001193125-14-226904.hdr.sgml : 20140624 20140605144753 ACCESSION NUMBER: 0001193125-14-226904 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20140605 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20140605 DATE AS OF CHANGE: 20140605 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: 14893394 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 d739187d8k.htm 8-K 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): June 5, 2014

 

 

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 June 5, 2014, the Registrant issued a press release announcing that it will cease distribution of amniotic derived allograft products under a distribution agreement with a third party supplier. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits.

 

99.1    Press Release dated June 5, 2014.


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: June 5, 2014      

/s/ Kevin Ontiveros

      Kevin Ontiveros
      Chief Legal Officer
EX-99.1 2 d739187dex991.htm EX-99.1 EX-99.1

Exhibit 99.1

 

LOGO

For Immediate Release: 06-05-14

AMEDICA ANNOUNCES TERMINATION OF BIOLOGIC DISTRIBUTION AGREEMENT

New strategy allows company to sharpen focus on porous Silicon Nitride bioceramic technology

Salt Lake City, June 5, 2014 – Amedica Corporation (NASDAQ: AMDA), a commercial biomaterial company focused on using its Silicon Nitride technology platform to develop, manufacture and sell a broad range of medical devices, announced today that it will cease distribution of amniotic derived allograft products under a distribution agreement with a third party supplier.

The decision to cease distribution of these allograft products and terminate the agreement allows the company to direct resources to obtaining FDA 510(k) clearance on the company’s Silicon Nitride Cancellous Structured Ceramic (CSC) biomaterial, a potential alternative to allograft bone with superior characteristics. This hydrophilic and osteoconductive bioceramic is designed to facilitate bone growth in the center lumen of an interbody spinal device, which should allow surgeons to reduce or eliminate the use of allograft bone and other osteoconductive biomaterials.

Amedica’s interbody devices utilizing CSC have received a CE mark and are currently being distributed in the Netherlands, Spain and Germany. Additionally, the company is conducting a prospective randomized clinical trial in Europe named CASCADE comparing its Valeo composite Silicon Nitride interbody devices, which combine an existing Amedica Valeo interbody product design with CSC, to PEEK interbody devices to obtain additional safety and efficacy data to support a 510(k) clearance in the United States. The trial is 100% enrolled with 100 patients, and results are expected to be published in the second half of 2014.

Eric Olson, CEO and President of Amedica, commented, “Amedica’s Silicon Nitride interbody devices, with and without Cancellous Structured Ceramic, offer significant advantages over other spinal implants. With this in mind, the company is focused on driving the technology forward for rapid acceptance in the marketplace to the ultimate benefit of patients worldwide.”

Jay Moyes, CFO of Amedica, added, “Revenue from the amniotic derived allograft products accounted for less than 4% of overall sales in Q1 of 2014, but was as high as 12% in 2013. However, gross margin from these products was negligible. While our decision to cease distribution of these allograft products under the distribution agreement may initially result in a decline in top-line revenue in the short-term, we believe it is in the best interest of our customers and shareholders that our company focuses on our proprietary biomaterials which yield much higher gross margins.”

About Amedica Corporation

Amedica is a commercial biomaterial company focused on using its Silicon Nitride technology platform to develop, manufacture and sell a broad range of medical devices. Amedica markets spinal fusion products and is developing product candidates for use in total hip and knee joint replacements. Amedica operates an ISO 13485 certified manufacturing facility and its spine products are FDA cleared, CE marked, and currently marketed in the U.S. and select markets in Europe and South America.


The company’s website for news releases and other information is 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. Forward-looking statements contained in this press release include the intent, belief or current expectations of Amedica and members of its management team with respect to Amedica’s future business operations, as well as the assumptions upon which such statements are based. Forward-looking statements include specifically, but are not limited to, Amedica’s market opportunities, growth, future products, market acceptance of its products, sales and financial results and such statements are subject to risks and uncertainties such as the timing and success of new product introductions, physician acceptance, endorsement, and use of Amedica’s products, regulatory matters, competitor activities, changes in and adoption of reimbursement rates, potential product recalls, and effects of global economic conditions. Additional factors that could cause actual results to differ materially from those contemplated within this press release can also 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 31, 2014, and in Amedica’s other filings with the SEC. Amedica disclaims any obligation to update any forward-looking statements.

Contact

Amedica Investor Relations:

Gordon Esplin

VP, Finance

(801) 839-3516

gesplin@amedica.com

# # #

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