Healthcare Technology Featured Article

April 12, 2013

New FDA-Approved myVisionTrack Medical Device Provides Hope for Patients with Deteriorating Eye, Retinal Conditions

Vital Art and Science (VAS) was founded in 2006 by a multi-disciplinary team with extensive expertise in ophthalmology, electronics, software and business development. This team formed the company in order to identify, advance and commercialize innovative home diagnostics for treatable chronic diseases, though currently the company focuses on ophthalmic medical devices.

Several weeks ago the company took a critical step in fulfilling this promise for degenerative eye diseases when the U.S. Food and Drug Administration (FDA) gave the company full clearance to market myVisionTrack, a prescription-only medical device designed to give patients with retinal diseases the ability to monitor their vision function between regular visits to their eye-care professionals.

The goal of myVisionTrack is to help ensure that patients obtain care and treatments on a timely basis.

The target audience for myVisionTrack is the more than 40 million people in countries with advanced healthcare systems that suffer from age-related macular degeneration (AMD), diabetic retinopathy (DR) and other retinal diseases.  In the United States alone, it is estimated that there are about 13 million people who suffer from these diseases. According to VAS, these diseases are characterized by stable periods of disease inactivity, with the periodic renewal of disease activity during which vision loss occurs.

Treatments to minimize vision loss are most effective during these bursts of renewed activity, before vision loss becomes permanent.

For this reason, frequent and accurate ongoing monitoring is needed for those patients diagnosed with early disease stages. Just as well, over the last 10 years various new therapies have been developed and emerged to treat these degenerative eye diseases - but all of them require a timely diagnosis and timely treatment to ensure they are used to full effectiveness. Unfortunately, more often than not, patients - or in many cases “future patients”- either do not know to seek treatment or don’t get around to such treatments until it’s too late to help them.

Currently the only effective means eye care professionals have available are in-office tests that are expensive to administer and that require constant visits from patients - or those future patients. More often than not patients simply cannot manage the costs or the time associated with in-office testing.

With myVisionTrack available, eye care providers can now assess patients for potential future problems and prescribe myVisionTrack as a tool to guard against a failure to get timely diagnoses, and if needed, treatments. For patients, it becomes a potential life-saving device, in the sense that losing one’s eyesight is a devastating issue that most people find impossible to recover from – by which we mean that it becomes impossible for people who encounter any level of blindness to recover enough to eventually lead normal if never the less eye-impaired lives.

How myVisionTrack Works

Using a proprietary patented shape discrimination hyperacuity (SDH) test, myVisionTrack enables patients to regularly assess their vision function. myVisionTrack stores test results, tracks disease progression and can automatically alert a healthcare provider if it suspects significant deterioration of visual function in the patient. Clinical studies demonstrate that myVisionTrack’s shape discrimination hyperacuity test has comparable or higher sensitivity and specificity compared to clinically available standard visual function tests for detecting advanced maculopathy from high-risk moderate maculopathy.

myVisionTrack can be used either in vision care provider offices, but the real goal is for myVisionTrack to be used regularly at home by patients with maculopathy to help track disease progression, detect disease condition changes for earlier intervention and document treatment effects. VAS claims that research confirms high satisfaction and compliance rates among patients able and willing to self-test at home with myVisionTrack.

Currently, VAS president Mike Bartlett notes that VAS is seeking strategic partnering opportunities for the marketing and distribution of myVisionTrack.  As we write, pricing has not yet been determined. We’re still in the early stages of getting the new technology out the door, but certainly hope it happens in short order.

Edited by Braden Becker

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