Diabetes can strike anyone, from every walk of life and the numbers are dramatically increasing every year. Over the last decade, the number of people living with diabetes has increased by almost 50 percent, and more than 30 million Americans are living with the disease today.

Worldwide, it afflicts more than 422 million people. And the World Health Organization estimates that by 2030 the number of people living with diabetes will be doubled.

Today, diabetes takes more lives than AIDS and breast cancer combined -claiming the life of 1 American every 3 minutes. It is the main cause of blindness, kidney failure, amputations, heart failure and stroke.

Living with diabetes places an enormous emotional, physical and financial burden on the entire family. Annually, diabetes costs the American public more than 245 billion dollars.

Industry Overview and Market Opportunity

According to the "Global Report on Diabetes 2016" of the World Health Organization, it has been estimated that 422 million adults were living with diabetes in 2014, compared to 108 million in 1980. The global prevalence (age-standardized) of diabetes has nearly doubled since 1980, rising from 4.7% to 8.5% in the adult population.

Based on cost estimates from a recent systematic review, the annual cost of diabetes is more than 827 billion US dollars.

The International Diabetes Federation (IDF) estimates that the total global health-care spending on diabetes has been tripled over the period of 2003 to 2013.

Currently, available drugs can only treat type 2 diabetes symptoms but do not address the underlying medical problem.
Changes in lifestyle are one of the possible treatments for type 2 diabetes, although it's rarely achieved. Another possible treatment is bariatric bypass surgeries, such as Roux-en-Y gastric bypass, or RYGB. An RYGB procedure rearranges the small intestine to create a bypass of the duodenum and a portion of the proximal jejunum, which in turn allows digested food to pass directly from the stomach into the distal jejunum while the gastric juices, bile, and pancreatic exocrine products enter the duodenum and flow onward to the distal jejunum.

According to the American Society for Metabolic and Bariatric Surgery, 196,000 bypass surgeries were conducted during 2015 in the United States alone. While diabetes is a symptoms treatable disease, only 1% of the 18 million eligible United States adults pursue bariatric surgery for reasons such as its perceived invasiveness, associated risks and complications, cost and restricted insurance coverage. Less invasive approaches, performed through the gastrointestinal tract with flexible endoscopes, such as adjustable bands and gastric sleeves, are often recommended to a broader patient base, offer a higher level of safety and increased cost-effectiveness, but have proven to be less effective in managing the disease.

NobiX System Description

Allevetix is designed as a barrier between the digested food and the duodenal section of the small intestine, which significantly reduces sugar and fat absorption using a proprietary gastro-duodenal sleeve. The Allevetix device is comprised of a synthetic (polymer) sleeve and intra-gastric anchors. The sleeve, positioned in the proximal small intestine, functions as a barrier that restricts caloric absorption by the intestinal walls and prevents chime, or partly digested food from mixing with bile and pancreatic fluids. The gastro-duodenal sleeve is used to create an internal bypass in the small intestine, thus mimicking the effects of RYGB without surgery. The device is intended to remain in place for a period of one year.

The NobiX System was designed to be minimally invasive, reversible, and quickly inserted endoscopically, which we believe will ensure a less traumatic procedure with a relatively short and easy recovery. Our system is intended for a 12-month indwelling time, following which, it is endoscopically removed and a new system can be implanted if needed. Many diabetic and obese patients are not ideal candidates for invasive bariatric surgery due to low recovery statistics related to their poor physical condition. We believe that our product has a strong potential to provide an alternative solution for these patients.

The NobiX System has shown strong pre-clinical results in trials on large animals and is now in the final stages of design development. A small-scale first in man clinical trial in humans is planned for 2018, to be followed by a pivotal clinical trial for receiving CE approval and initiating a commercial launch of the product in Europe.