Questions & Answers

Why have I not heard about the Acuity Medical Systems age related macular degeneration (AMD) treatment before?

This is a new treatment, just out of clinical trials and available to the public for the first time in the summer of 2010.  Acuity Medical Systems, Inc. of Minneapolis, Minnesota has been careful during its FDA trials, European and Canadian approval period and patent development period to protect its rights and to avoid giving the public false hopes about the success of the therapy until it was satisfied its medical devices could make a substantial difference in the vision of dry AMD patients.

In addition the cost to inform the public and medical community about a successful new AMD treatment it can take a long time to achieve recognition.  Many doctors will also be very conservative and wait until the treatment has been in use for years before recommending it. LASIK eye surgery, which began in the 1970’s, is just such an example of the time delay and costs involved in telling the public about a very helpful treatment for vision problems.  It is just now, 40 years later, gaining broad recognition and acceptance.

Information about the Acuity Medical Systems device and therapy is available in public databases and has been the subject of peer reviews, professional presentations and has been included in medical textbooks (Bioelectromangnetic Medicine by Rosch & Markov) during the last seven years.  Acuity Medical Systems, Inc. is a legitimate medical research company, which bases its 10 years of AMD research and development on quality, safety and compliance and does not promote itself based on inaccurate or false reporting.

With the success of the FDA trials and the opening of professional medical eye care centers around the world you will be seeing more information related to Acuity AMD patient’s successes.

Is it an expensive Treatment?

No, as a matter of fact it is less expensive than drugs or laser treatments and may be covered in some places by insurance. Your doctor will provide you specific information about the cost of treatments.

Is it painful or uncomfortable like some of the wet AMD injection treatments or laser treatments?

No it is not.  The Acuity treatment uses a very low level of microcurrent stimulation that helps supports specific retinal metabolic processes. This process helps to promote drusen re-absorption, removes toxins and metabolic byproducts from the eye, and helps improve vision.  It has no significant documented side effects; a few individuals may feel a tingling sensation. Most people feel nothing.  Substantial amounts of published research in molecular and cell biology has shown that this type and level of stimulation can help diseased retinal cells and tissues recover, which enables patients to improve sight.

Can I do treatments myself?

Good question.  For the first sessions you will go to your professional medical eye care specialist and he/she will do a series of treatments to improve the initial quality of your vision.  They will, with some individuals train them to do home therapy if they are physically and mentally able to follow the procedures. If you do quality for a home therapy system a special unit has been designed for you.  It will look different from the system your doctor uses.

Every few months you will return to your eye care specialist for a checkup. You should never purchase a micro stimulation device that is not professionally prescribed or your course of therapy is not followed by an eye care specialist; doing so could lead to permanent blindness.

I have seen electrotherapeutic microcurrent AMD devices for sale on the Internet, are they worth buying?

NO, buying an off-label device on the Internet is dangerous and can cause blindness.  Although electrotherapy has been successful for everything from cancer treatments to wound healing and pain management, these devices are not designed for use in visual disease applications. Buying these off-label devices in the US for use in AMD treatment violates FDA regulations. Going to a clinic that offers these devices for procedures is also extremely dangerous. We have the only device that has had 2 successful AMD FDA trials and is approved for sale and use in Europe and Canada. Our devices are not sold in the US at this time so you should avoid any clinic offering them for use without FDA approval for visual disease applications. Our certified doctors are highly trained to use these systems, do not let yourself be taken advantage of by fake or fraudulent systems.  If you are in doubt immediately contact our Customer Service group, the FDA or your Attorney General.

There are other companies in the market that claim to be the only suppliers of this kind of therapy, are they legitimate?

We have not tested other MD therapy company products, only reviewed public data. This data indicates these products lack sufficient testing. We do know that one of the larger profile companies, making some significant claims, has not had any FDA trials or are shown on the records of the FDA as having any pending trials, even though their web site and press releases make these claims. We also have noted with some interest that they quote our founders technical papers, clinicals and presentations on why this technology is effective. Again we caution you to make safe and logical choices when it comes to your eye health. Review our FDA trail data in the section called Clinical Research.

When are the vascular endothelial growth factor (VEGF) and gene therapy programs going to be available?

There has been some success with these treatments. Some of these are currently in clinical trials for Wet MD.  They are very expensive.  Lucentis and Macugen are already FDA approved.   Others will likely not be available soon. While waiting for them your vision could deteriorate. Starting treatments with a device like the Acuity Medical systems device is a good way to keep your visual health intact until other therapy programs someday emerge. Listen to your doctor and visit our website database to see what is new with MD research.

How does the Acuity medical device work?

Your doctor will use a small handheld electrode that is placed on the eyelid of a closed eye.  He/she will touch the eyelid for about 40 seconds in eight key locations as you rotate your eye. During this time you will close your eyes and relax. It is all painless, very simple and easy for you.  The doctor’s computers will tell them how well the system is performing.  By the end of the first session, many patients have reported an improvement in visual quality.

Can anyone benefit?

No, this is not going to work for everyone.  However, the trials indicate many patients have had significantly improved vision. We suggest if you are diabetic or have very advanced AMD you consider all the options.  While the system has worked successfully on a variety of AMD patients the best results are from patients that fall between certain visual acuity ranges.  Some patients have stabilized; others have shown a reversal disease symptoms.  It will take a number of sessions with your doctor before you can determine if this treatment is for you. Before you can start, your doctor will evaluate your eyes to see if you qualify for the treatment. If at any time you notice deterioration in your vision and ability to see clearly or have a new health problem, discontinue treatments and immediately see your eye care specialist.

Is it a dangerous medical treatment, can I damage my retinas?

No, not with the microcurrent levels used by TheraMac™.  With the constraints designed into the device, there have been no documented serious side effects.   To prevent infection the probe and the outer eye should be cleaned with each treatment.  If this is a home treatment, individuals that do not have steady hands should let another person do the treatments to be sure correct contact is made with the skin. Failure to do the prescribed number of treatments may result in your vision backsliding.  Failure to perform the prescribed number of treatments may result in the continued deterioration of initial visual acuity progress and improvements.

What were the side effects?

A few patients noticed tingling sensations, a mild burning or pinching sensation of a small point on the eyelid (no burning occurred) upon the first treatment; some patients noticed small light flashes during the treatments.  No patients had lasting effects or sensations.

Where can I go for treatments?

TheraMac™ treatments will begin in Europe and Canada in 2010 in professional, medical eye clinics or hospitals. The treatments are prescribed and monitored by doctors and eye care specialists.  After initial clinical treatments some patients will begin doing treatments at their homes or nursing facilities and return to their doctor for regular checkups.

TheraMac™ treatments will not be offered in the US until a final FDA pre-market approval (PMA) clinical trial is completed. It is difficult for people to understand that the US has different and longer clinical trial protocols than Europe and other parts of the world.  Each nation is different and the expense of complying with each country makes the process both slow and expensive. Acuity has elected to begin in Europe and Canada where it has already met approved protocol requirements, then moved to the US. To locate a medical treatment facility go to our website under Our Medical Products and the go to Referral Centers.  Acuity Medical Systems does not solicit sales in the US and complies with all FDA regulatory procedures.

Is this treatment done more than one time?

Once you begin the treatment your doctor will help you define the number of times you must use it.  Because your eyes are no longer capable of removing the drusen or toxins you will likely use this treatment for an extended period of time. The thing to remember is the treatment is painless, easy, takes only a few minutes about every other day and can restore your visual health. We believe that development in the science of micro stimulation of the eyes will become even easier in the future. Our R&D medical team is working on some very unique concepts, but that is still a ways off.

I have dry AMD; will it progress to wet AMD if I take this treatment?

At the present time we cannot answer that completely without long-term studies (15 to 20 years).  At this point, some patients have delayed the progress to wet macular degeneration for more than 10 years.  If dry AMD is corrected it is possible to stop the progression pattern in some people. You always want to have your eye health monitored by a professional during this or any other treatment.

Do I plug my medical device into a wall socket?

NO, the medical device is powered by batteries and uses only a small amount of current, similar to what is used in hearing aids.

How do I know if the treatments are working?

Unlike off-label devices, your doctor or eye care professional will monitor your progress and may adjust the Acuity Medical Systems device from time to time.  It is important for your doctor to know if your device is working properly, if you are doing the correct procedure, and if you are using this system at your home.

My doctor tells me this is not going to work, what is your response to that?

Doctors are busy people, they see patients every 15 minutes of every day, and they don’t have time to read all the medical journals or go to every medical seminar on eye diseases.  Most doctors deal with many different eye problems not just AMD.  So, don’t expect them to know about every treatment out there.  It takes as many as 10 years for a new treatment to be accepted in the medical community. As an AMD sufferer it is up to you to research new treatments and bring them to your doctor’s or eye care specialist attention.  If they have not heard of it before, they will continue to do what they know best.  Help educate them and perhaps your vision will be the beneficiary of new treatments.

Remember this is an internationally patented medical device that has been through two successful FDA trials (FDA pre-IDE Nos. 1980275, 100038, and FDA IDE No. G020106) in the US and is approved for sale in Europe and shortly Canada for the treatment of Dry Macular Degeneration and Age Related Macular Degeneration.

Who developed the Acuity Medical Systems AMD treatment?

The treatment and devices were developed by medical eye specialists in the US and Europe, physicians, electrical engineers, biomedical engineers, along with an International scientific medical manufacturing firm over a period of many years.

The TheraMac™ device concept-design-development effort was the responsibility of Dr. G.D. O’Clock. Dr. J.B.Jarding provided improvements in treatment protocol, compatibility with the FDA clinical trial environment, and the manufacturing interface.

Testing of the TheraMac™ device goes back to the late 1990’s.  FDA clinical results and other tests are available on this website or can be accessed from the FDA, European or Canadian regulatory agencies.

On your website I see two medical devices, what are they?

The large unit is a prototype of a treatment and computer system used by your doctor to treat dry AMD. It will shortly be in your doctor’s office.  It is designed to help them determine how well the treatment is going and has features that can increase the treatments success.  The smaller white unit is designed for home and healthcare facilities.

Can I use my device to treat my family or friends?

Tempting as it might be, the answer is NO. This is a prescribed device and each unit is programmed specifically for each patient’s specific needs.

Will the VA or Medicare or other US insurance programs pay for this treatment?

Not at this time. If you live outside the US ask your provider for specific insurance related support.

How do I get more information about the Acuity Medical Systems treatment program with the TheraMac Vision II®?

Ask your eye care specialist or use this website for more information. Referral / Treatment Centers will be listed in Europe and Canada as they open.