JOHN JARDIN, O.D., FAAO: I want to take this opportunity to inform you of a Feasibility Study now underway by Acuity Medical, Inc. This study is being conducted under the auspices of the Food and Drug Administration (FDA). Acuity Medical holds the license for new, patented technology using biocurrent to treat Age-Related Macular Degeneration. The new instrument, the TheraMac, uses low microcurrent with a very specific range of frequencies. Because any medical device used above the neck is considered a class 3 device by the FDA, it must pass the rigors of FDA double-masked, randomized, placebo-controlled studies. The instrument must have been granted an Investigational Device Exemption (IDE), which has been granted. By being granted an IDE, the FDA is satisfied with safety and the instrument may now be used in FDA trials. The feasibility study is overseen by an Institutional Review Board (IRB) and is now being conducted at two sites, one in South Carolina and one in North Carolina. The clinical research organization monitoring the study is Discovery Alliance, Inc.

I am fully aware of all of the controversy on treating macular degeneration patients with microcurrent. I have been involved with this research since 1985. I have felt that it was only appropriate to follow FDA protocol when treating patients. Until we prove the benefits of BioCurrent Therapy to the FDA, it is not appropriate to sell instruments or advertise the benefits of BioCurrent for the treatment of macular degeneration. These are FDA rules. These are things we plan to prove or disprove to the FDA through the trials.

Because there are significant differences in microcurrent instruments, none of which are FDA approved for the treatment of macular degeneration, appropriate research in current amounts, current frequencies, and frequency of use must be studied. Through my work with electrical engineers and a cell biologist, The TheraMac instrument has passed these items to the FDA's satisfaction, allowing it to be used in clinical trials. I have had a continued fear that uncontrolled use of microcurrent and unapproved instruments would shed unfair and negative light on my work. My open clinical studies have shown very positive results using the appropriate current, frequency levels and frequency of use with TheraMac and BioCurrent. Sixty two percent of the eyes treated have gained 2 or more lines of best-corrected visual acuity.

We hope to conclude our feasibility study within the next 2 to 3 months. We plan to publish the results in a juried journal of our peers. I look forward to presenting you this information. Immediately following the feasibility study, the approval phase of research will begin.

DAN: It is good to hear that approved trials will soon be underway. A number of years have passed since you helped to pioneer this therapy under Dr. Michaels, and I hope that some scientifically-based positive results will finally be forthcoming. Thank you for contributing this important information to our discussion.