Devices Ophthalmology

 News Release - November 13, 2012

Transcend Medical Announces 12-Month European Study Results of the CyPass Micro-Stent(R) at AAO 2012

Micro-Invasive Stent Implanted During Phaco-Cataract Surgery Achieves Sustained IOP Lowering Effect in Glaucomatous Eyes at 12 Months

CHICAGO, IL--(Healthcare Sales & Marketing Network) - Transcend Medical, Inc., an ophthalmic device company dedicated to developing minimally invasive glaucoma therapies, announced the 12-month results of the European multicenter CyPass Clinical Experience (CyCLE) study, a clinical trial designed to evaluate the long-term safety, effectiveness and clinical experience of the CyPass Micro-Stent®. The outcomes were presented today by Steven D. Vold, MD of Vold Vision (Fayettevile, Arkansas) during the 2012 American Academy of Ophthalmology Annual Meeting in Chicago.

In the study, 238 patients received the CyPass Micro-Stent in conjunction with cataract surgery. Study data were divided into two cohorts. In the first cohort, 90 eyes had uncontrolled intraocular pressure (IOP) ? 21mmHg at baseline. Of the 40 eyes that had reached the 12-month postoperative follow-up visit, a mean IOP of 16.3 mmHg (35 percent IOP pairwise reduction) and a reduction in mean medication usage of 48 percent was achieved. In the second cohort, 148 eyes had controlled IOP < 21mmHg at baseline. In this cohort, the 73 eyes reaching the 12-month postoperative follow-up visit maintained a stable IOP and achieved a 75 percent reduction in mean medication usage. No serious adverse events were reported among either cohort.

"These preliminary results demonstrate that, when used in combination with cataract surgery, the CyPass Micro-Stent can reduce and stabilize IOP while minimizing the need for glaucoma medications," said Dr. Vold.

About the CyPass Micro-Stent®

The CyPass Micro-Stent is the first micro-invasive glaucoma stent designed to reduce IOP by enhancing aqueous outflow to the supraciliary and suprachoroidal spaces. This device bypasses the ciliary body by creating a stented micro-cyclodialysis into the supraciliary space, thereby avoiding the trabecular meshwork and Schlemm's canal -- drainage paths that may be diseased in glaucomatous eyes. The CyPass Micro-Stent is currently being studied in combination with cataract surgery in the COMPASS multicenter clinical trial, one of the largest randomized, controlled studies in surgical glaucoma to-date.

About the COMPASS Clinical Study

For more information about the COMPASS clinical study, which is underway at more than 20 study sites in the U.S., please visit www.compassclinicalstudy.com.

About Transcend Medical, Inc.

Transcend Medical (www.transcendmedical.com) is focused on the development of minimally invasive medical devices for the treatment of glaucoma, the leading cause of adult irreversible blindness. Over 4 million people in the U.S. and roughly 60 million worldwide are afflicted with the disease today and the numbers are expected to grow to nearly 6 million in the U.S. and over 70 million worldwide by the year 2015.

Source: Transcend Medical

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