Item 8.01

Other Events.

 

On August 24, 2005, Refocus Group, Inc., or the Company, issued a press release announcing that the U.S. Food & Drug Administration granted the Company approval to begin enrollment for its Phase III clinical trial for treatment of presbyopia utilizing its Scleral Spacing Procedure. A copy of the press release announcing this approval is filed as Exhibit 99.1 to this Current Report on Form 8-K.

 

Section 9 – Financial Statements and Exhibits

 

Item 9.01 Financial Statements and Exhibits.

 

(a)

Financial statements of businesses acquired.

 

Not applicable.

 

(b)

Pro forma financial information.

 

Not applicable.

 

(c)

Exhibits.

 

The following exhibits are furnished in accordance with the provisions of Item 601 of Regulation S-B:

 

Exhibit

Number

 

Description of Exhibit

 

 

99.1

 

 

Press release issued by the Company on August 24, 2005, announcing approval from the U.S. Food & Drug Administration to initiate Phase III clinical trials for the treatment of presbyopia utilizing its Scleral Spacing Procedure.

 

 

 

 

 

 

SIGNATURES

 

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.

 

REFOCUS GROUP, INC.

 

 

Date: August 24, 2005

By:

/s/ MARK A. COX

 

 

Name:

Mark A. Cox

 

 

Title:

Vice President and Chief Financial Officer

 

 

 

 

 

INDEX TO EXHIBITS

 

Exhibit

Number

 

Description of Exhibit

 

99.1

 

 

Press release issued by the Company on August 24, 2005, announcing approval from the U.S. Food & Drug Administration to initiate Phase III clinical trials for the treatment of presbyopia utilizing its Scleral Spacing Procedure

 

 

 

 

 

 

 

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