Mr. Christopher Moreau reports

MIRACULINS UPDATES MARKET ON ITS U.S. FDA STRATEGY FOR THE SCOUT DS(R) DEVICE

Miraculins Inc. plans to file presubmission documentation with the U.S. Food and Drug Administration regarding the de novo classification of its Scout DS device, as a next step in securing marketing clearance in the United States.

The de novo classification process provides a potential pathway to Class I or Class II classification for medical devices for which general controls, or general and special controls, provide a reasonable assurance of safety and effectiveness, but for which there is no legally marketed predicate device.

The Scout DS device is the world's first non-invasive and highly sensitive test designed to measure diabetes related biomarkers in the skin. It does not require a blood draw or fasting and generates a result in as little as 80 seconds. The Scout DS device uses visible light to measure the optical signature of fluorescent biomarkers in the skin, the accumulation of which are accelerated by abnormal blood sugar levels and oxidative stress.

The company had previously filed documentation with the USFDA for the Scout DS device in December, 2013. The purpose of that documentation was to solicit general feedback from regulatory officials for assistance in establishing a specific clinical and regulatory plan for the marketing clearance of the Scout DS device in the United States. The process highlighted the need for the company to compile a more detailed information package including a study protocol intended to support regulatory clearance.

The presubmission for a de novo process is intended to allow the USFDA to review and provide feedback on the suitability of the de novo classification process for the Scout DS device, as well as for the planned data to be gathered and submitted by the company to obtain marketing clearance. The de novo process is generally considered to be appropriate for "novel" medical devices whose risk profiles do not warrant Class III designation which is a more expensive and time-consuming approval process.

Almost 26 million people in the United States are presently estimated to have diabetes, with seven million of these being undiagnosed. A further estimated 80 million people in the United States are prediabetic, with approximately 90 per cent of these being completely unaware of their condition. It is expected that more than 500 million people globally could be affected by diabetes by the year 2030.

We seek Safe Harbor.