FDA Okays ALRT Diabetes Device, Shares Mushroom 8,200%

Looking for one of the biggest movers on Wall Street on Tuesday? Look at ALR Technologies Inc. (OTCPK:ALRT), a company that for years has been nose down working to develop a leading diabetes management system.

Today, the company seems to have struck paydirt with the U.S. Food and Drug Administration granting marketing clearance for ALR's innovative insulin dose adjustment (IDA) feature for its already cleared system.

What the Richmond, Virginia-based tech company has developed is a simple, highly efficient system to improve diabetes care for the 30.3 million Americans (9.4% of the population) with diabetes.

Diabetes is one of the biggest financial burdens the country faces, with 1.5 million new cases diagnosed annually and over 330,000 deaths listing diabetes as the primary or underlying cause. Odds are that figure is low given the fact that millions of people go through life with undiagnosed diabetes.

With ALR's system, diabetes patients upload data from their blood glucose meters for monitoring, improving compliance problems that plague the healthcare system, as non-compliance leads to higher hemoglobin A1c levels, which leads to diabetes complications and co-morbidities.

The company has now added a tremendous complement to the system with the FDA green-lighting the analysis of the current insulin regimen and blood glucose data for comparison to the guidelines of the American Association of Clinical Endocrinologists (AACE) and American Diabetes Association (ADA) for necessary adjustments to optimize treatment.

Classified as a device by FDA standards, the IDA feature is only indicated for use with insulin-requiring adults with Type 2 diabetes and not for patients on insulin pumps. ALRT is not only addressing an area of unmet healthcare need to better monitor glucose levels and reduce financial burden, but also providing a solution to help overcome medication errors.

Novo Nordisk, a leading global insulin manufacturer, estimates that about $1,900 is added to every patient each year due to increased morbidity and mortality rates at the hands of medication errors, with about half of that cost resulting from insulin mistakes.

To that point, the technology has broad appeal, assuming ALR's goal is to license or sell it rather than try and build out all the infrastructure. Health-care providers and insulin makers should be particularly interested as there are serious financial implications for driving revenue and increasing margins. Wall Street apparently sees strong upside potential as well.

Shares of ALRT were just muddling around a 10th of a penny before today's news hit, which has sent shares skyrocketing up to around nine cents, up over 8,000% from Monday's closing price.