Paradigm Medical Industries To Market Proprietary Electrophysiology Device For Early Detection Of Glaucoma

Main Category: Eye Health / Blindness
Also Included In: Medical Devices;  MRI / PET / Ultrasound
Article Date: 30 Jan 2008 - 3:00 PDT

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Paradigm Medical Industries, Inc. (OTCBB: PMED.OB), a leader in glaucoma diagnostic and management devices, disclosed today it has signed an exclusive agreement with LACE Elettronica srl (Rome, Italy) to distribute the latter's proprietary GLAID electrophysiology instrument for the early detection of glaucoma. Terms were not disclosed.

LACE's GLAID is a revolutionary diagnostic device that utilizes Pattern Electroretinogram (PERG) to provide a visual stimulus that generates electrical responses of the retina to measure the physical condition of the retina's ganglion cells. Retinal ganglion cells collectively transmit visual information from the retina to several regions in the midbrain. There are about 1.2-1.5 million retinal ganglion cells in the human retina. The GLAID device was approved by the U.S. Food and Drug Administration (FDA) in 2007.

The GLAID device has undergone extensive testing and clinical studies in the U.S., Canada and Italy, including Bascom Palmer Eye Institute (Miami and Palm Beach, FL), University of California at San Diego's Hamilton Glaucoma Center, New York State College of Optometry, University of Laval (Quebec, Canada), and the University of Alabama. The current state of the GLAID technology was developed by Dr. Vittorio Porciatti, who is also involved in further GLAID-related research at Bascom Palmer Eye Institute.

"We believe the GLAID device is the most significant development in glaucoma detection in the last 20 years," said Paradigm Medical's Chief Executive Officer, Raymond Cannefax. "It represents a multimillion-dollar market opportunity for our Company."

"We are pleased to be working with Paradigm Medical in introducing and promoting GLAID," said Alessio Romani, chief executive of LACE. "The Company is well known and respected for its glaucoma diagnostic devices. The agreement is expected to accelerate acceptance of the GLAID technology in North America and Canada in 2008."

"The GLAID device is believed to be the fastest method of testing for retinal ganglion cell loss," Mr. Cannefax noted. "The GLAID not only measures dead and living ganglion cells, but also detects ailing ganglion cells. Due to the device's ability to detect dying ganglion cells, in most cases the viability of these cells can be fully restored with treatment."

Mr. Cannefax added that "GLAID provides a test that is fast and easy to understand and administer, easy to interpret by the clinician, and is non-invasive. It is reliable, operator independent, and is able to detect dysfunction of the ganglion cells in patients who are glaucoma suspects. GLAID can detect the onset of retinal defects significantly earlier than can be measured by the current standard of detection method of Visual Fields Analysis (Perimeters). We expect to begin filling orders during the first quarter of 2008."

Glaucoma, caused by deterioration of the optic nerve and related ganglion cells, is the second leading cause of permanent vision loss. It affects one in five people over age 50. Some 75% of glaucoma goes undiagnosed because of the lack of sophisticated instrumentation. There are more than 64 million cases of glaucoma worldwide, including more than three million in the U.S. About 120,000 people in this country are blind as a result of glaucoma. Nearly 16,000 surgeries are performed in the U.S. each year on patients with glaucoma, with the cost averaging about $3,200, depending on the severity of the glaucoma. In terms of Social Security benefits, loss of income tax revenues and health-care expenditures, the cost to the U.S. government related to glaucoma is estimated to be more than $1.5 billion annually.

Paradigm Medical Industries, Inc., is a leader in Ultrasound devices, and glaucoma detection and management products.

This press release contains statements that, if not verifiable historic fact, may be viewed as forward-looking statements that could predict future events and outcomes with respect to Paradigm and its business. The predictions embodied in these statements will involve risks and uncertainties and, accordingly, actual results may differ significantly from the results discussed or implied in such forward-looking statements.

Paradigm Medical Industries, Inc.