Working with GI Dynamics of Lexington, Massachusetts (U.S.A.), prof.dr. Jan Willem Greve and his team (dr. N. Bouvy, dr. G. Hameeteman and dr. G. Koek) are studying the efficacy of the EndoBarrier™ Gastrointestinal Liner, designed to impact metabolic processes without surgical intervention.
Watch on the GI Dynamics website an impression of the nonsurgical procedure inserting sleeve into duodenum via oesophagus and stomach helps promote weight loss.

Obesity
Obesity is, quite literally, a growing problem, not only for the patients who suffer from it but also for surgeons who operate on obese patients. University Hospital Maastricht (azM) is the first hospital in Europe to use a new device in the fight against obesity: the EndoBarrier. Inserting a sleeve into the duodenum (guided there via the oesophagus and the stomach) allows obese patients to quickly lose weight before they undergo surgery. That reduces the risk of surgical complications and helps surgeons do a better job and achieve better results for their patient.

Dr Jan Willem Greve and Dr Nicole Bouvy of azM were the first surgeons to perform the procedure in Europe. They cooperated with gastro-enterologists Dr Wim Hameeteman and Dr Ger Koek. The procedures were carried out as part of the first randomised study worldwide of the use and effects of the EndoBbarrier.

Non-invasive
The EndoBarrier - an endoluminal sleeve - is an elongated and narrow medical implant that the surgeon inserts right behind the pylorus, in the duodenal bulb, the channel between the stomach and the duodenum, by guiding it through the oesophagus and the stomach with the help of a capsule.
The surgeon performs an endoscopy (i.e. a non-invasive procedure in which a tube is inserted into the patient's oesophagus and stomach) to guide the capsule to the duodenum. The capsule contains the folded sleeve with a collapsible anchor on one end. The surgeon uses the anchor to fasten the EndoBarrier in place. After the Endobarrier is inserted, the food the patient eats is diverted away from the duodenum and the gastric juices remain on the outside of the sleeve.

Idea
The idea for the Endobarrier came from researchers working for the US company GI Dynamics, where specialists developed and tested the device. Feasibility studies were then carried out in Chile and Brazil, and the invention was of course tested extensively experimentally. The Maastricht surgeons have thus far inserted a similar sleeve in 15 patients as part of a pre-operative treatment programme, generally prior to a gastric bypass.
 
Expectations are high for the Endobarrier. Not only will patients quickly lose weight once the Endobarrier is inserted (about 15 kilos in three months), but the implant will reduce the risk of surgery and improve organ function because the fat surrounding the organs is the first to disappear.

Advantages
Greve and Bouvy have identified other important long-term advantages: "The desire to eat will also fade because there is a change in the rate at which the stomach empties. The Endobarrier also alleviates the symptoms of diabetes; in fact, diabetic patients were able to cease taking medication within a week. That is probably because the sleeve changes the way intestinal hormones are released, which in turn alters insulin sensitivity. This needs to be studied in greater depth."

Until now, EndoBarriers were removed after a total of three months. The surgeons are now exploring the effects of leaving the Endobarrier in place for longer. At this moment the procedure appears to be ideal for patients for whom surgery presents too great a risk or to bridge the period patients are on the waiting list for a gastric bypass.

 Maastricht UMC+
Health care and health care research are both highly dynamic fields. Doctors, paramedics and scientists are constantly having to deal with changes, be it in the organisation, in the financing of care, or in the growing demand for high-quality care products. In addition to developments in curative health care, there is a growing focus on prediction and prevention

The University Hospital Maastricht (azM) and the Faculty of Health, Medicine and Life Sciences of Maastricht University (UM) are in the midst of these developments and are continually looking for effective and ambitious solutions to the challenges they face.
 
The main tasks of the university hospital Maastricht are patient care, education and research, all of which are closely interrelated. In addition to standard patient care, top referral care and advanced clinical care play an important role at azM.
Advanced clinical care and top referral care require fine-tuning and close cooperation with the fundamental research at the Faculty of Health, Medicine and Life Sciences of Maastricht University  and (experimental) clinical research at azM.
Key research areas are cardiovascular diseases, oncology, chronic diseases and mental health care and neurosciences.

azM is located in the centre of the Euregion Meuse-Rhine. University hospitals in Liege and Aachen lie within a range of just thirty kilometres. Intensifying collaboration in the Euregion is one of the hospital's main goals.

The university hospital Maastricht ( www.azm.nl and www.summum.mumc.nl ) has 715 hospital beds and over 4.700 employees. It is part of the 'Dutch Federation of University Medical Centers', the NFU ( www.nfu.nl ). The NFU is a cooperative venture involving the eight university medical centers (UMCs) in the Netherlands, with the primary aim of promoting the UMCs' common interests.

GI Dynamics Information

Obesity and diabetes are rapidly growing worldwide healthcare epidemics.  Each affects over 1 billion people. Together, diabetes and obesity are leading to huge increases in healthcare costs and mortality rates, as well as a substantial reduction in quality of life for those affected.

The EndoBarrier™ is initially being tested as a short-term, removable weight loss device that is implanted endoscopically (through the mouth) for up to 6 months in patients who are candidates for bariatric surgery, to help them lose weight prior to their surgery.  Eventually, the device will be tested for longer periods of time.

"We are quite excited to start these trials," said prof. Greve. "We believe that this product may be able to provide patients with a noninvasive way to lose weight that is significantly more effective than drug therapy, and safer and less invasive than surgery.  It is an entirely new concept that provides us with a novel therapy for obesity and type 2 diabetes."

Stuart Randle, CEO of GI Dynamics, said, "We are honored to be working with Dr. Greve and his team.  Their expertise in bariatric and diabetes care is an enormous asset to our development and commercialization efforts. This study is an important step in creating solutions to the growing problems of obesity and diabetes. It holds the potential to have a profound impact on public health."

About GI Dynamics
GI Dynamics is in clinical trials in South America, Europe and the US with its EndoBarrier™ technology. GI Dynamics, founded in 2003, is leading the development of novel, noninvasive approaches to treat obesity, type 2 diabetes and related co-morbidities. The patented EndoBarrier™ technology is designed to impact metabolic processes by lining the proximal intestine, resulting in weight loss and improved glycemic control. The company has raised $46 million in three rounds from top-tier investors such as Advanced Technology Ventures, Cutlass Capital, Domain Associates, Johnson & Johnson Development Corporation and Polaris Venture Partners.  GI Dynamics is led by an experienced management team and has assembled a scientific advisory board that includes internationally recognized leaders in bariatric surgery, gastroenterology, obesity medicine and endocrinology.

Background
With an estimated 70 million adults now obese in America, the Surgeon General and the health care community are awakening to the epidemic proportions of this disease and its socioeconomic implications.  In the face of this growing crisis, attempts at medical weight loss with or without pharmacologic intervention have been found ineffective in the five million people annually seeking help.  Bariatric surgery works well but due to its invasiveness and cost, surgeries are limited to 200,000 procedures performed annually.  While the US has the lead in this epidemic, the world wide impact is now also being felt in numerous developing countries. The obesity problem cries out for a new, innovative approach to help patients deal with this disease.  GI Dynamics is developing and commercializing revolutionary, noninvasive, removable devices that modify metabolic pathways to treat obesity and diabetes.  In its animal and human clinical research, GI Dynamics has discovered that use of its devices has an immediate and profound effect on weight reduction as well as on reversing the clinical impact of type 2 diabetes.

Product Technology Concept
GI Dynamics has developed novel technologies for endoscopically-delivered and retrieved implants that directly effect metabolic pathways.  Its EndoBarrier™ intestinal liner is an impermeable barrier that blocks food contact in the duodenum and proximal jejunum.  This intestinal bypass mimics the effect of the Roux-en-Y gastric bypass surgery, producing similar weight loss and rapid resolution of type 2 diabetes.

GI Dynamics is conducting several clinical trials which are showing that the EndoBarrier technology can produce excess weight-loss of 30% at 6 months in morbidly obese patients.  It has also shown the potential for the rapid elimination of the need for medications to control glucose in diabetics.

Studies in animal models of both obesity and diabetes have begun to elucidate mechanisms of action that include a direct effect on glucose homeostasis as a result of duodenal exclusion and the delivery of undigested food to the proximal jejunum as well as delayed gastric emptying.

Current Status
EndoBarrier™ intestinal implants are in clinical trials globally and will begin a pivotal trial in the US next year.  The target market is substantial – twenty million Americans are candidates for invasive bariatric surgery, and 60 million have BMI’s between 30 and 40.  These represent strong candidates for a safe, noninvasive alternative to surgery or drug therapy.

History GID
GI Dynamics was founded in 2003 based on the recognition of the emerging obesity problem and the invention of the Endobarrier™ patented technology. It has subsequently raised $46 million in three rounds from top tier venture capital companies including Advanced Technology Ventures, Cutlass Capital, Domain Associates, Johnson & Johnson Development Corporation and Polaris Venture Partners.  The company has also assembled a world class group of advisors with specialties in bariatric surgery, gastroenterology, endocrinology and medical weight loss.

Management GID
Stuart Randle, CEO; Andy Levine, CTO; Sherrie Coval-Goldsmith, VP Clinical and Regulatory; Jonathan Hartmann, VP Marketing, and Robert Crane, CFO.