Full Sense™ Device animal and clinical data presented at the Emerging Technology Session at 2009 SAGES Meeting in Phoenix

A NOVEL ENDOSCOPIC REVERSIBLE BARIATRIC DEVICE: ANIMAL RESULTS AND INITIAL CLINICAL EXPERIENCE

J Foote MD, R Baker MD, J Treviño MD,P Kemmeter MD, F Walburn PhD, P Freswick BS, Grand Health Partners, Grand Rapids MI, Sentinel Group, Grand Rapids MI, Hospital Galenia, Cancun Mexico, Michigan State Medical School, East Lansing, MI

Background: In the US alone there are nearly 100 million overweight, obese and morbidly obese individuals. Existing bariatric surgical therapies address a very small percentage of these individuals. Of the 23 million morbidly obese patients in the United States, approximately 1% undergoes conventional weight loss surgery. Diet, exercise, and medications produce minimal weight loss at best and most regain or exceed baseline weight within 5 years. The typical result is decreased metabolism, constant hunger, depression which results in a high failure rate. Additionally many bariatric patients experience weight regain over time due to difficulty in achieving continued satiety. As a result there is a critical need for a non-invasive, reversible, safe device that can deliver effective satiety and result in weight loss.

Description: The Full Sense™ is a reversible bariatric device, deployed and removed endoscopically. It incorporates an esophageal component and a gastric disk connected by a strut. It is designed to induce satiety and fullness in the absence of food by placing pressure on the distal esophagus and cardia of the stomach.

Clinical Animal Results: In four separate studies, animals lost approximately 23% of their body weight whereas controls gained 3% in 28 days.

Clinical Human Results: The device was endoscopically placed in 3 female patients (mean BMI of 44.0, mean age of 38 years), and secured via laparoscopic assistance. Patients lost an average of 28% of their excess body weight in 46 days. The devices were removed endoscopically. There was no device migration, no ulcers and no compromise of the GE junction. Inflammation, which was present at the time of explantation was confirmed resolved at three week post operative follow up endoscopy. The patients were required to record their satiety levels daily using a standardized satiety scale. All patients recorded increased satiety with The Full Sense™ Device in place than after removal.

Conclusions: The Full Sense™ Device has been shown to be an effective endoscopically placed and removable bariatric treatment in pre-clinical and clinical studies.

Full Sense™ Device completes successful clinical evaluation

The first study of the Full Sense™ Device was conducted at Galenia Hospital in Cancun, Mexico by American doctors Randal Baker MD, James Foote MD and Mexican doctor Jorge Trevino MD.  The study protocol was designed to have the devices implanted for 6 weeks to evaluate weight loss, satiety (lack of hunger), safety, and removability.

The Full Sense™ Device is a stent like device placed through the mouth into the top of the stomach to cause satiety thus decreased hunger and increased fullness.  It causes satiety by placing pressure on the bottom of the esophagus and the top of the stomach.

Patients not only lost significant weight in the study but also noted significant satiety with the device in place.  Without the device they noted extreme hunger before meals whereas with the pressure from the Full Sense™ Device they experienced at most slight to no hunger before meals.  The devices were removed safely and patients have stopped losing weight and are beginning to regain the weight that they had lost.

“The patients were extremely happy with the lack of hunger and resulting weight loss.  They did not want the devices removed but reluctantly underwent removal per the protocol to demonstrate that the device could be easily removed,” said Fred Walburn.  “This technology represents potentially a new era of safe non-surgical weight loss treatment and offers hope for the millions of Americans who need treatment for obesity but can’t afford the cost or possible complications of traditional weight loss surgery.”

“Obesity is increasingly causing devastating effects on individuals and our society as a whole.  This technology, I believe, offers the best opportunity yet to deliver consistent satiety and weight loss.  Even many people with traditional weight loss surgery are experiencing significant hunger and subsequent weight regain.  The potential to deliver satiety without classic incisions and surgery will give hope to many more people struggling with weight and weight related medical conditions,” stated Randal Baker MD.

“The patients were very pleased with the results of the Full Sense™ Device,”said Dr. Trevino, Head of Bariatric Surgery.  “They are asking for the device to be implanted again!”

ABOUT GALENIA

The Galenia Hospital located in Cancun, Quintana Roo, Mexico is a modern facility with state of the art equipment which goes beyond the everyday services, with highly trained doctors and a wide range of medical specialties along with experienced people working for health care of national and international patients.

Recent results of the Full Sense™ Bariatric Device at the In3 East conference held in Boston, Mass

In3 East Conference Summary

The Full Sense™ Device is composed of an esophageal member, a cardiac disk and a connecting strut (Figure 1). It is placed via endoscopy in the esophageal / cardiac region of the stomach. It induces satiety by influencing the neurohormonal feedback mechanism. It augments fullness caused by food and simulates fullness in the absence of food by placing pressure in the distal esophagus and cardiac region of the stomach. The device is easily removable via endoscopy.

Figure 1. Full Sense™ Device

A series of studies demonstrate conclusively the ability of the Full Sense™ Device to cause significant weight loss in experimental animals.In four separate studies, animals lost approximately 1% of their body weight per day (Figure 2). Studies were halted after approximately 28 days due to weight loss exceeding 25% of their body weight, i.e., the animals were euthanized per Animal Care and Use Protocols.In spite of severe weight loss the animals were not lethargic and, in fact, were playful.

Figure 2. Composite data from four studies