Anulex Technologies Receives FDA 510(k) Clearance for the Inclose(TM) Surgical Mesh System.

MINNEAPOLIS -- Anulex Technologies, Inc. announced today that it has received FDA FDA
abbr.
Food and Drug Administration

FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration. 510(k) clearance of its Inclose in·close
v.
Variant of enclose.

Verb 1. inclose - surround completely; "Darkness enclosed him"; "They closed in the porch with a fence"
shut in, close in, enclose (TM) Surgical Mesh System.

The Inclose(TM) Surgical Mesh System is a novel, patented implant that is designed to provide a barrier and scaffold to facilitate the repair of soft tissue. The surgical mesh implant is comprised of polyethylene terephthalate Ter`eph´tha`late

n. 1. (Chem.) A salt of terephthalic acid. (PET) monofilament monofilament,
n a single strand of untwisted synthetic material such as nylon; used to create surgical sutures.

monofilament braid material that is preloaded on a disposable delivery tool. The mesh implant loaded on its delivery tool has a low profile allowing it to be inserted in a minimally invasive manner prior to being expanded below the aperture of a tissue defect. The mesh implant can be secured in place with anchors comprised of nonabsorbable surgical suture.

Commenting on the approval, Mike McCormick, CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of Anulex Technologies, Inc. said, "Receiving FDA 510(k) clearance is a significant corporate milestone for Anulex. We are pleased to receive U.S. regulatory clearance of our surgical mesh that is designed to provide a fast, simple, and safe way for surgeons to repair soft tissue."

McCormick indicated that the company plans to conduct additional studies of the Inclose(TM) Surgical Mesh System as commercial initiatives and support programs continue to evolve.

About Anulex

Anulex Technologies, Inc. is a privately held company privately held company

A firm whose shares are held within a relatively small circle of owners and are not traded publicly. located in Minneapolis, Minnesota which is focused on developing medical technology to repair soft tissue with primary interests in the soft tissues of the spine.

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Publication:	Business Wire
Date:	Aug 22, 2005
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