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): January 31, 2007
ORTHOVITA, INC.
(Exact Name of Registrant Specified in Charter)
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Pennsylvania | | 0-24517 | | 23-2694857 |
(State or Other Jurisdiction of Incorporation) | | (Commission File Number) | | (IRS Employer Identification No.) |
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77 Great Valley Parkway Malvern, Pennsylvania | | 19355 |
(Address of Principal Executive Offices) | | (Zip Code) |
Registrant’s telephone, including area code: (610) 640-1775
Not applicable.
(Former Name and 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)) |
On January 31, 2007, Orthovita, Inc. received confirmation from the U.S. Food and Drug Administration that a 510(k) premarket submission, accompanied by supporting clinical and preclinical data, is the appropriate regulatory pathway for CORTOSS® Bone Augmentation Material for vertebroplasty. The press release issued by Orthovita on February 5, 2007 announcing the FDA’s confirmation is attached to this Current Report on Form 8-K as Exhibit 99.1.
Item 9.01 | Financial Statements and Exhibits |
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99.1 | | Press Release, dated February 5, 2007, issued by Orthovita, Inc. |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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ORTHOVITA, INC. |
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By: | | /s/ Joseph M. Paiva |
| | Joseph M. Paiva |
| | Chief Financial Officer |
Dated: February 5, 2007