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OrthoNetx, Inc. Receives FDA-Clearance to Commercialize New Small Bone Distraction Osteogenesis Device; Enables Bone Growth in Children and Small Bones in Adults With Less Pain and Scarring

Posted on: Monday, 1 August 2005, 09:01 CDT

OrthoNetx, Inc., a privately-held, Colorado-based leading provider of medical devices for osteoplastic surgery, today announced that it has received clearance from the Food and Drug Administration (FDA) to market its GenerOs(TM) SB small bone generator.

"This device, which incorporates the same patented technology as in our FDA-cleared GenerOs CF craniofacial bone generator and our GenerOs EX limb lengthener, is designed to help correct bone deficiencies and deformities in the small bones of the hands, wrists, feet, ankles, and pediatric forearms. Now with a full spectrum of devices, we can supply doctors and their patients with the means to correct bone deficiencies throughout the body via distraction osteogenesis," said Randolph Robinson, MD, DDS, the Company's founder and Medical Director.

Distraction osteogenesis is the process of generating new, healthy bone by attaching a device across a surgical bone cut, then using the device to separate the bone ends in a precise, continuous manner to generate 1 mm of new bone per day. In this manner deficient bone can be lengthened virtually anywhere in the body, using the patient's own natural healing mechanisms.

"With our family of GenerOs(TM) products, we are now able to address bone deficiencies in the skull, face, jaws, long bones of the legs and small bones throughout the body-in children as well as adults," said Terry Knapp, MD, President and CEO of OrthoNetx and a former reconstructive hand and facial surgeon. "Not only can our devices enable new bone formation, they are less painful and produce less scarring than most of the competition yet remain extremely doctor and patient friendly. Moreover, with our SmartDevice-Connect(SM) Web-based product support system coming on line soon, we expect to be able to serve bone deficient patients and their doctors all over the globe."

In March 2005 Eye Dynamics, Inc. (OTCBB:EYDY), a leading provider of health and safety products, announced it had signed a letter of intent to acquire OrthoNetx, Inc., with Dr. Knapp to lead the merged companies as CEO. The acquisition will be completed as a stock transaction. The parties have successfully completed bilateral due diligence. The acquisition is subject to certain customary conditions including certain regulatory approvals.

About OrthoNetx, Inc.

OrthoNetx, Inc. designs, develops, manufactures and markets patented, FDA-approved medical devices and systems for osteoplastic surgery and distraction osteogenesis--the practice of generating, forming and molding bone. Physician customers include plastic surgeons, oral and maxillofacial surgeons, otolaryngologists, and orthopedic surgeons who correct deformities and deficiencies of the skeleton caused by errors of birth, trauma, infections and tumors. OrthoNetx, Inc. is also developing a "smart device" process management system to support a broad range of medical devices that leverage the body's physiological and biological attributes to create medical benefits. The privately-held company is headquartered in Superior, CO. From more information visit: www.orthonetx.com.

Safe Harbor for Forward-Looking Statements

This news release includes forward-looking statements that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. While these statements are made to convey to the public the company's progress, business opportunities and growth prospects, readers are cautioned that such forward-looking statements represent management's opinion. Whereas management believes such representations to be true and accurate based on information and data available to the company at this time, actual results may differ materially from those described. The company's operations and business prospects are always subject to risk and uncertainties. Important factors that may cause actual results to differ are set forth in the company's periodic filings with the U.S. Securities and Exchange Commission.


Source: Business Wire

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