Clinical Research

Acuity Medical Systems has completed two FDA trials and is preparing for a 3rd clinical trial on the TheraMac Vision II® medical device. The company will be conducting additional studies in Europe and Canada, where TheraMac™ has already been approved for treatment and sale.

The TheraMac™ BioCurrent Ocular Therapy device has been in development and testing for ten years and is the first medical device for visual disease applications using this technology to go through two successful FDA studies.

• 2 FDA Sanctioned age related macular degeneration (AMD) studies
• Trial 1 FDA pre-IDE Nos. 1980275 and 100038  (open label) 404 patients, 808 eyes
• Trial 2 FDA IDE No. G020106  (Clinical Feasibility) 40 patients
• 85% of all patients showed improvement in Trial 1
• After 12 days 59% of treated eyes showed improvement in Trial 2

The system is currently approved for sale in Europe and Canada and has a CE approval.  This medical device is designed for dry AMD; the device has been designed to address a variety of visual disease conditions. However at the present time, the FDA Phase I and Phase II clinical trial philosophy restricts the testing and application of the device to dry macular degeneration Your referral center and eye care specialist will tell you if this device is right for you. This device must be prescribed, it is not an over the counter device.

Interested Individuals may view the FDA Study Data here and find a list of scientific articles here

THIS DEVICE IS NOT FOR SALE IN THE USA AT THIS TIME AND HAS NOT YET RECEIVED FINAL FDA APPROVAL FOR SALE IN THE USA. INFORMATION REGARDING THE FDA TESTS IS NOT INTENDED AS A SOLICITATION TO SELL YOU THESE DEVICES OR PROMOTE THEM, IT IS INTENDED FOR INFORMATIONAL DATA ONLY. THE CE MARK ALLOWS FOR SALE OF THESE PRODUCTS IN CANADA AND EUROPE.  THE THERAMAC DEVICES ARE PRODUCED IN AN ISO 13485  (MEDICAL DEVICE) CERTIFIED PRODUCTION FACILITY IN DENVER COLORADO, USA