Current statistics from the American Association of Retired People (AARP), the American Diabetes Association (ADA), the American Academy of Ophthalmology (AAO), the US Department of Health and Human Services, and the Centers for Disease Control (CDC) in Atlanta, GA state that at the end of 2007, there was a combined total of roughly 61.5 million people in the US that fall into the loss of sight and retinal disease prone categories of Age Related Macular Degeneration (AMD) and Diabetic Maculopathy. The figure includes those in the populations who are already diagnosed and are being treated for these two blinding diseases.

The U.S. population age 65 and over is currently 12.6% (male 15,858,477; female 21,991,195) of the total population, and is expected to double in the next 25 years. By 2030 almost one out of five Americans (some 72 million people) will be 65 years or older. The age group 85 and older is now the fastest growing segment of the U.S. population.

23.6 million Children and adults -- 8.0% of the population -- have diabetes and thus are at risk for Diabetic Maculopathy and Diabetic related blindness. 1.6 million New cases of diabetes were diagnosed in people aged 20 years or older in 2007.

According to the ADA, blindness is the 3rd most common serious complication of Diabetes. When allowed to advance, the blindness becomes incurable.

Implications Early detection, regular monitoring, and treatment is the only way to manage the onset and progression of AMD and Diabetic Maculopathy.

According to the American Academy of Ophthalmology, persons aged 55 and over should begin to be screened for AMD at least twice annually throughout their lifetime, and Diabetics should begin to be screened by testing in the physician office and even “home” testing themselves, as soon as they are diagnosed with diabetes throughout the rest of their lives.

Problem The current screening process and test that best detects the possibility and probability of macular disease is known as a “Dark adaptation examination with interpretation and report” which is CPT Code 92284 and is performed with a wide variety of devices and equipment and interpreted in wide variables of results and baselines for what is “normal” verses “abnormal” results. The current devices used by Physicians to perform this test are everything from bright flashlights, to Brightness Acuity Testers (BAT‟s), and Ophthalmoscopes, none of which were designed to perform this type of test for retinal health monitoring with proved sensitivity, specificity, reproducibility and accuracy.

Resolution/Product The very inexpensive, MDD-1TM Macular Defective Detection Device‟ developed and produced by Health Research Sciences, Inc. (HRS) enables Optometrist, Ophthalmologist, Endocrinologist, Primary Care Doctors, and even patients themselves in the home environment to easily and efficiently test for the early detection of Age Related Macular Degeneration and Diabetic Maculopathy as well as other types of central retinal diseases in the human eye. The MDD-1 also permits monitoring of central retinal health over time, and can warn of deterioration in function at an early stage.

The MDD-1 is a Patented, unique design that solves the problem of inconsistent testing and screening as currently performed by providing reproducible measurements of macular function (light flash recovery, dark adaptation) that are recorded and made available in a concise reporting format for health professional interpretation. The instrument also warns end users that a doctor‟s visit is warranted.

It is envisioned that the MDD-1 would be sold directly to these Physicians in enough quantity per office to facilitate the screening of patients that fit the target patient demographic in their normal busy weekly schedules.

HRS will develop the educational and marketing material required to supply the physicians with what is needed to inform and educate their patient populations about the presence of the MDD-1 in their office and the need and ability to have screening and monitoring performed on patients that are in the risk demographic. The educational material developed for this purpose by HRS will contain the statistical information about the screened and monitored diseases and the need to be screened.

It is estimated that the total reduction in cost of care is significant as many large Eye Health Organizations in the US have already evaluated the MDD-1 and concluded and reported to HRS that “early detection and standardization of the test parameters and baselines is what is needed to catch these diseases at an early stage which would allow the initiation or augmentation of inexpensive initial therapies (including the use of Nutriceuticles), or more involved treatments (laser, anti-VEGF injections) as may be indicated for more advanced disease.

Conclusion The MDD-1 Macular Defective Detection Device is the only testing and screening device of its type in the world and the same “large Eye Health Organizations in the US” that have initially reviewed the MDD-1 have stated that they believe that “every Doctor they know needs to have one to raise the standard of care for screening for these diseases and monitoring the success of applied therapies and corrective surgery”.