Healthcare Industry News:  cataract 

Devices Ophthalmology Regulatory

 News Release - January 9, 2006

Tekia, Inc. Receives Approval to Market in Europe Its Accommodating Intraocular Lens for Treatment of Presbyopia

IRVINE, Calif., Jan. 9 (HSMN NewsFeed) -- Tekia, Inc., a privately owned medical device company, announced today that it has received a CE Mark approval from the European Union for its Accommodating Intraocular Lens. The CE Mark approval allows Tekia to market its lens throughout the European Union. The Accommodating Intraocular Lens is for the treatment of presbyopia, a condition that affects near vision in many middle aged and older patients.

Presbyopia results from the gradual loss of flexibility in the natural lens of the eye as a person ages, making the lens harder and less elastic. With less elasticity, the eye has a harder time focusing on objects up close. The Accommodating Intraocular Lens is implanted after removing the presbyopic lens.

"The artificial lens is designed to utilize the eye's ocular structures to shift the lens forward, enabling a person to see close up, and then shift back to the resting position so the person will see distant objects," stated Gene Currie, Tekia's President and COO. "The lens could be used during cataract surgery to restore near vision and at the same time correct for other visual disorders, such as farsightedness. It also could be used in pre-cataract patients with presbyopia to restore near and intermediate vision, replacing corrective glasses or contact lens," Currie added.

William C. Huddleston, Tekia's CEO and CFO, said, "Later in 2006 the Company expects to submit to the U.S. Food and Drug Administration an investigational device exemption (IDE) for the Accommodating Intraocular Lens to initiate clinical studies in the United States as the first step in obtaining FDA approval. The FDA approval process is costly. For this reason the Company expects to pursue financing options and/or a strategic partner to provide additional resources for this important step in our development.

Tekia is a medical device company that designs, develops, manufactures and distributes Intraocular Lenses (IOLs) to treat visual disorders such as cataracts, myopia, hyperopia and astigmatism. The company currently distributes its Kelman Duet Refractive IOL in the EU and some South American countries. The Kelman Duet IOL was co-developed by Tekia and Dr. Charles D. Kelman and is designed for the treatment of myopia and hyperopia in non- cataract patients. The company has various lens and materials designs under development to provide eye care patients with higher satisfaction. The company has also filed several patents to protect its intellectual properties and designs.

Source: Tekia

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