Item 7.01 Regulation FD Disclosure.

On January 3, 2013, the Registrant disclosed through a press release that it submitted an Investigational Device Exemption to the U.S. Food and Drug Administration.

The press release is attached hereto as Exhibit 99.1.

Limitation on Incorporation by Reference

In accordance with General Instruction B.2 of Form 8-K, the information in this Item 7.01 shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, nor shall such information be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such a filing.