Obesity

Implantica’s Solution, AppetiteControl™

Implantica’s AppetiteControl™ is subject to further development and approval process. AppetiteControl™ is a device designed to control appetite a completely new treatment approach that, according to the surgical input which far exceeds expectations, supports a possible paradigm shift in obesity surgery.

While maintaining complete weight control, AppetiteControl™ patients are expected to be able to enjoy food intake with full appetite and no restrictions on what to eat.

AppetiteControl™ is an implant designed for inducing satiety, imitating the body’s own natural functions by stretching the upper part of the stomach in the same way as when the stomach becomes full of food. Patients should be able to eat normally to feel full after an average portion of food. Hindering overeating will result in permanent weight loss. Patients will be able to enjoy food intake with full appetite and no restrictions on what to eat but are still expected to maintain weight control.

AppetiteControl™ will use Implantica’s wireless energized technology platform to not only provide wireless recharging and remote-control capabilities, but also the device is designed to be programmable, with the potential that patients set their own target weight level. Also, the level of satiety should be easily adjustable, for example, lowered to enjoy a sensible lunch and then increased between and after meals to maintain low calorie intake.

Benefits of AppetiteControl™

Naturally feel full while losing or controlling weight

With AppetiteControl™ obese patients are no longer expected to struggle with hunger. Healthy weight management is anticipated to be achieved where patients will feel hunger at meal time and eat the amount that is desired to maintain a certain weight without over eating. AppetiteControl™ is designed provide the solution by imitating nature and stretching the upper part of the stomach wall to cause satiety.

Programmable, remote-controlled, wirelessly recharged

Patients should be able to take control of their appetite since the level of satiety is designed to be easily adjustable. By pressing a remote control or a small button placed underneath the skin, the amount that is desired to be consumed during a meal may be controlled and a sense of fullness is targeted with no desire to eat more between meals. Patients should be able to set their own target weight level and have the flexibility to increase consumption for a special occasion and then reduce consumption to return to the target weight.

Maintain full quality of life while controlling appetite

Existing surgical methods are plagued with complications including excessive vomiting and inability to eat certain foods. AppetiteControl™ is designed to allow patients to enjoy food intake, eat what they want and still be able to maintain weight control. Affecting the appetite rather than physically stopping the food from passing is expected to provide higher quality of life while still losing weight.

Field Description

The prevalence of obesity is large and growing dramatically, having nearly tripled since 1975, with over 1.9 billion overweight adults worldwide in 2016 and of those, more than 650 million obese (WHO 2017). The World Health Organization (WHO) defines obese as having a Body Mass Index (BMI) of greater than or equal to 30, calculated by dividing the weight in kilograms by the square of the height in meters. The fundamental cause of obesity is an energy imbalance between calories consumed and calories expended.

From once having been considered a problem only in developed countries, overweight and obesity are now on the rise in low- and middle-income countries, particularly in urban settings. The rising epidemic reflects for the most part profound changes in society and in behavioral patterns: foods rich in fat, especially saturated fat, and sugar are readily available and generously consumed in a time when lifestyles are more and more sedentary.

Overweight and obesity can lead to many serious health consequences and sufferers have a shorter life expectancy. Depression and isolation are both common among obese and quality of life is affected by physical restrictions and by the negative image held by society. Many serious diseases can result from obesity including heart disease, diabetes, cancer, high blood pressure, infertility and acid reflux.

The Swedish Obese Subjects (SOS) study – a prospective controlled intervention study of bariatric surgery – is a significant research study involving 2010 subjects that underwent bariatric surgery and 2037 contemporaneously matched obese control subjects with a follow up period up to 20 years. The SOS study results showed that bariatric surgery is associated with long-term weight loss and decreased overall mortality as well as a decreased incidence in many serious illnesses including diabetes, myocardial infarction, stroke and cancer¹. The overall conclusion is that society saves a lot of money by operating the obese people.

1. 1L SJöström, University of Gothenburg 2013, J Intern Med. 2013 Mar;273(3):219-34. doi: 10.1111/joim.12012. Epub 2013 Feb

Existing Treatments

Bariatric surgery refers to any surgical procedure on the stomach or intestines to induce weight loss. Today’s obesity surgical treatment methods include restrictive procedures, where the size of the stomach is reduced with a restricted outlet and, therefore, the amount of food that can be consumed, is restricted and, malabsorptive procedures, where the stomach and the small intestines are removed, thereby changing the absorption of food and nutrition. A few examples are disclosed below.

The Laparoscopic Adjustable Gastric Band is an example of a restrictive procedure, which involves wrapping a belt-like adjustable band around the upper portion of the stomach in order to decrease its size. The smaller upper part fills rapidly during food intake leading to a reduced capacity to eat and a feeling of satiety. While the gastric band is shown to be effective in weight loss, it can lead to reduced quality of life due to side effects including excessive vomiting and restricted intake of specific food types, such as meat or vegetables.

The most common forms of surgical treatments today include gastric bypass and sleeve gastrectomy. Gastric bypass involves removing a part of the stomach and the small intestine to restrict not only consumption but also absorption of food and nutrition. This surgical method is a restrictive procedure with a malabsorptive component. Gastric bypass procedures are highly invasive and involve changes in the anatomy, which has a large impact on the patient.

Sleeve gastrectomy is a surgical procedure for severely obese patients where approximately 80% of the stomach is removed. The stomach takes on the shape of a tube or sleeve and can hold much less food, thereby inducing weight loss by restricting food intake.

Intragastric balloons are used to treat less obese patients. The balloon is delivered down the esophagus and inflated in the stomach to reduce the amount of space inside the stomach. It can remain for up to six months before it erodes from gastric acid, and is therefore, not a long-term solution and not an alternative to bariatric surgery.

Detailed Treatment Field Information

The prevalence of obesity is rapidly growing worldwide. Implantica is developing new innovative products for the obese population. New and more convenient as well as dynamically adjustable products are being developed to improve the quality of life for patients worldwide.

Overview

The prevalence of obesity is large and growing dramatically, having nearly tripled since 1975, with over 1.9 billion overweight adults worldwide in 2016 and of those, more than 650 million obese (WHO 2017).

Being obese not only leads to serious health issues while alive, it also drastically shortens life expectancy. As an example men age 20 to 30 with a BMI above 45 have an YLL (Years of life lost) of 13. That is equivalent to a 16% reduction of total life time. (Fontaine et al, 2003)

There is no easy solution for the morbidly obese who need to lose weight, but a number of drugs and surgical methods are available on the market today.

Description and definition

Obesity is the term used to describe severe overweight. WHO defines obese as having a BMI, Body Mass Index, over 30, see Table 2, but more importantly they emphasize the fact that it is also defined as abnormal excessive fat accumulation that may impair health (WHO, 2006). Obesity class III, BMI 40 and over, is commonly known as morbid obesity. BMI can be calculated by dividing the weight in kilograms by the square of the height in meters. It is a measurement tool used worldwide to classify under- and overweight, but BMI does not distinguish between weight associated with muscle and weight associated with fat. It is important to consider not only the weight of a person but also the amount of fat mass and the distribution of the fat in the body. Excess abdominal fat is a great risk factor for diseases associated with obesity as is excess body fat.

Obesity in itself is rarely the only problem, since there also are severe associated diseases and mobility problems that come with it.

Another measurement that can function as a complement to BMI, used to determine the amount of abdominal fat, is WHR, Waist to Hip Ratio. A WHR over 1.0 in men and 0.85 in women indicate abdominal fat accumulation. (WHO global database on body mass index, 2007)

Causes and effects

The fundamental cause of obesity and overweight is an energy imbalance between calories consumed and calories expended. The rising epidemic reflects the profound changes in society and in behavioural patterns of communities over recent decades and it has recently become a much more considerable health issue. The alarming increase in obesity has led to intense research and although genetics are partly to blame it is changes in our lifestyle that can be regarded as the biggest cause. Foods rich in fats, saturated fats and sugars are readily available and generously consumed in a time when people’s lifestyles are becoming more and more sedentary. There are a number of medical conditions than can lead to obesity, but properly treated these can often be prevented. Many people turn to food for comfort and reward, and in that way they consume much more than their body really needs.

Once considered a problem only in high-income countries, overweight and obesity are now dramatically on the rise in low- and middle-income countries, particularly in urban settings. Women generally have higher rates of obesity than men, although men have higher rates of overweight.

Overweight and obesity can lead to many serious health consequences. Depression and isolation are both common among the obese. It often affects quality of life, due to both lacking social acceptance and physical restrictions.

There are a number of serious conditions related to obesity. Risk increases progressively with BMI for diseases such as (Riley, 2004):

• Cardiovascular disease, mainly heart disease and stroke

• Type II diabetes
• Cancer
• High blood pressure
• Osteoarthritis
• Obstructive sleep apnoea/other respiratory problems
• Gastro oesophageal reflux and heartburn
• Infertility
• Swollen legs and skin ulcers
• Urinary stress incontinence
• Lipid metabolism abnormalities
• Pulmonary embolus

Some of these related conditions are caused by the increased pressure in the abdomen due to the excess fat. Others are simply effects of a person carrying around too much body mass and having excess tissue. Another example of related problems can be the lack of insulin causing type II diabetes.

Existing treatments

There are many different treatments for overweight and obesity. Governments around the world are trying preventive measures such as health education in schools. These might give results in the long term, but the current obese population is in need of more immediate measures.

Patients always start with diet, behaviour modification and exercise programs. There are also a number of drugs on the market usually more suited for patients with a BMI of more than 30 with no obesity-related conditions, or a BMI greater than 27 with two or more obesity-related conditions. There are two approved drugs currently in use for long term treatment of overweight and obesity, Sibutramine and Orlistat.

Treatment with drugs does not include the morbidly obese and others in greater need of help and that is where bariatric surgery comes in (Bonney, 2002). Severe obesity is a chronic condition that has proven difficult to treat through diet and exercise alone. So far drug therapy has also proven disappointing leaving gastrointestinal surgery as currently the best option.

Recent studies have shown that bariatric surgery on severe obese patients is associated with long-term weight loss and decreases overall mortality. One of these studies involved 4 047 test subjects in two groups with an average of 10.9 year follow-up. The two most common causes of death were cancer and cardiovascular diseases, both were more frequent in the group that did not have bariatric surgery (Bengtsson, 2007). Weight loss also improves many of the obesity associated conditions, such as diabetes.

For surgically treating obesity today there are surgical procedures divided into two main categories; restrictive procedures and malabsorptive procedures.

The restrictive procedures do not change the absorption of food and nutrition but they do restrict the amount of food that can be consumed. The two most common procedures are different gastric bypass procedures and gastric sleeve, however, these procedures fundamentally and irrevocably change the anatomy of the patients with a large portion of the stomach being thrown away. Vomiting is also a common complication of these procedures.

Socio-economic burden

Overweight and obesity puts a massive cost burden on society today and it is constantly on the rise as the prevalence of these conditions increases worldwide.

The Swedish Obese Subjects (SOS) study – a prospective controlled intervention study of bariatric surgery – is a significant research study involving 2010 subjects that underwent bariatric surgery and 2037 contemporaneously matched obese control subjects with a follow up period of up to 20 years. The SOS study results showed that bariatric surgery is associated with long-term weight loss and decreased overall mortality as well as a decreased incidence in many serious illnesses including diabetes, myocardial infarction, stroke and cancer1. The overall conclusion is that society saves a lot of money by operating the obese people.

Obese people missing out on work because of their obesity cost US employers an estimated USD 4 billion in 2006 (M. Herper, 2006).

Field conclusion

Well over 600 million people are obese worldwide today and the numbers are constantly rising. Currently the best option for the morbidly obese is bariatric surgery. Implantica is developing treatment solutions to improve the quality of life for the obese population.