ArKal's needle-free, easy to use
and highly accurate
GlucoPod™ CGM System

MARKET OPPORTUNITY

Diabetes is a chronic, life-threatening disease for which there is no known cure. It affects more than 26 million people in the U.S. and over 300 million adults worldwide. Monitoring of glucose levels is essential to managing the disease and reducing its complications. Despite newer pharmacologic and monitoring tools, attaining good glycemic control remains elusive for many patients. Studies have shown that CGM is effective in improving glucose control while minimizing severe hypoglycemia. Since the first CGM introduction in 1999, adoption of CGMs has steadily increased among providers and patients. Key opinion leaders now believe CGM will be the future of glucose testing and the American Association of Clinical Endocrinologists recently published a positive consensus statement on CGM use. Reimbursement is established and growing and many of the nation's largest insurance companies now provide coverage.

CURRENT CGM CHALLENGES

Currently, three CGM systems have been approved for use by the FDA and are indicated for adjunctive use only. These early generation invasive needle sensors are difficult and inconvenient to use and painful to insert. They are implanted subcutaneously for 3-7 days and require frequent and multiple calibrations using finger-stick blood glucose values. In addition, implanted sensors are reported to cause tissue trauma leading to pain, severe irritation, sensor bio-fouling and site infection under the skin; 26-33% of all injuries from CGM reported to the FDA in 2010 are sensor-related injuries. As a result these current products attract only a very small fraction of the more than 4.0 million insulin dependent Type 1 and especially Type 2 diabetics in the US.

THE ARKAL SOLUTION & ADVANTAGE

ArKal Medical has developed the next generation continuous glucose monitoring system, using its minimally invasive, proprietary and patented MicroTip™ technology.  The Microtips™ provide painless access to ISF glucose. The ArKal CGM sensor is worn externally on the skin like a patch and measures glucose using classical electrochemical glucose oxidase enzyme-based chemistry.  The GlucoPod™ CGM system consists of three main components:  a disposable sensor patch, a reusable transmitter, and a reusable wireless smart receiver.

ArKal Medical’s GlucoPod™ CGM system is designed to address all of the shortcomings of current CGM systems. Unique to ArKal, the sensor is worn externally, unlike current invasive needle-based subcutaneous CGM sensors, to minimize tissue trauma and enable painless and accurate glucose monitoring. In addition, the ArKal GlucoPod™ CGM system can be worn on various body sites as opposed to subcutaneous needle sensors which are restricted mainly to regions of adipose tissue such as the abdomen.

We believe ArKal Medical’s less painful, highly accurate, and easy to use GlucoPod™ CGM system has the potential to grow the CGM category significantly from greater adoption by all Type 1 and insulin-dependent Type 2 diabetic patients leading to improved disease management and reduced long term complications.